Mitchel L. Zoler, PhD

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

Human infection with H5N1 influenza may not be nearly as deadly as supposed up to now, based on a meta-analysis published online on Feb. 23 that reviewed 20 reports since 1999 that included a total of more than 12,000 people from areas of H5N1 outbreaks.

Until now, estimates of the risk posed by avian H5N1 flu infection came from reports on 573 documented infections in people, which had a 59% fatality rate. But these cases may have only represented the most severe infections that required hospitalizations, while other, milder or subclinical infections may have been overlooked, suggested Dr. Peter Palese and his co-workers at Mount Sinai School of Medicine in New York.

Courtesy CDC/Cynthia Goldsmith, Jackie Katz

If their hypothesis is correct, if could mean that the intense concerns raised about the safety of recent H5N1 research may be overwrought.

To get a better sense of how many people may have been infected by H5N1, they searched the medical literature since 1999 and found 20 published studies that included assessment of 12,677 people. These studies primarily occurred in East Asia — China, Thailand, Cambodia, Vietnam, and Indonesia — as well as in Turkey and Nigeria, and mostly included people who worked with poultry, were health-care workers, or had other sources of exposure. When tallied together, the reports collectively showed a seropositivity rate that averaged 1%-2%.

“If one assumes a 1%-2% infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide,” the researchers concluded in their study. Although their data do not allow calculation of a revised fatality rate, the numbers they found suggested that “the true fatality rate for H5N1 influenza viruses is likely to be less than the frequently reported rate of more than 50%.”

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

• Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.
• Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.
• Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

©WHO/P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the meeting.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said. Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II).

The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

"These are revolutionary outcomes," said Dr. Gary M. Ansel, an interventional cardiologist and clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. "The results show it’s not just the engineering, but also the use of the technology" that produces better outcomes. The new findings show the Viabahn heparin-coated stent graft comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Ansel, who was a coinvestigator on the pivotal trials for both devices.

"Right now, these two, without a doubt, take it to a different level. They are better than everything else [for treating SFA stenoses], and are the standards against which everyone needs to compare their technology," Dr. Ansel said in an interview.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision.

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease. Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound. The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was "markedly oversized," Dr. Saxon said. A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status. Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the meeting.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said. Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II).

The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

"These are revolutionary outcomes," said Dr. Gary M. Ansel, an interventional cardiologist and clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. "The results show it’s not just the engineering, but also the use of the technology" that produces better outcomes. The new findings show the Viabahn heparin-coated stent graft comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Ansel, who was a coinvestigator on the pivotal trials for both devices.

"Right now, these two, without a doubt, take it to a different level. They are better than everything else [for treating SFA stenoses], and are the standards against which everyone needs to compare their technology," Dr. Ansel said in an interview.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision.

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease. Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound. The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was "markedly oversized," Dr. Saxon said. A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status. Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the meeting.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said. Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II).

The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

"These are revolutionary outcomes," said Dr. Gary M. Ansel, an interventional cardiologist and clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. "The results show it’s not just the engineering, but also the use of the technology" that produces better outcomes. The new findings show the Viabahn heparin-coated stent graft comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Ansel, who was a coinvestigator on the pivotal trials for both devices.

"Right now, these two, without a doubt, take it to a different level. They are better than everything else [for treating SFA stenoses], and are the standards against which everyone needs to compare their technology," Dr. Ansel said in an interview.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision.

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease. Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound. The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was "markedly oversized," Dr. Saxon said. A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status. Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

NEW ORLEANS – The combination of aspirin and clopidogrel proved no more effective than aspirin alone for secondary stroke prevention, and dual therapy significantly boosted the major hemorrhage rate and patient mortality in a randomized, multicenter trial with more than 3,000 patients.

The poor performance of this dual antiplatelet combination in this large study, called the Secondary Prevention of Small Subcortical Strokes (SPS3) trial, leaves the secondary stroke prevention guideline published last year by the American Heart Association and American Stroke Association unchanged in its recommendation of three antiplatelet drug options for patients with a history of stroke or transient ischemic attack: aspirin, aspirin plus dipyridamole, or clopidogrel (Stroke 2011;42:227-76), Dr. Oscar R. Benavente said at the International Stroke Conference.

The new trial results "do not support the use of combination therapy for secondary stroke prevention in patients with lacunar strokes," said Dr. Benavente, the study’s co-principal investigator and research director of the Stroke and Cerebrovascular Disease Program at the Vancouver Coastal Health Research Institute.

The SPS3 study enrolled 3,020 patients within 180 days of a small, subcortical, lacunar stroke at 81 sites in eight countries during 2003-2011. The trial excluded patients with cortical stroke, cardioembolic disease, or carotid stenosis. More than half of the enrolled patients received care at U.S. centers. Their average age was 63 years, about two-thirds were men, and they entered the study an average of 76 days following their index stroke.

The study randomized 1,503 patients to treatment with 325 mg of aspirin daily, and 1,517 patients to the same aspirin dosage plus 75 mg of clopidogrel (Plavix) daily.

The study’s data and safety monitoring board stopped this portion of the trial early last July, after an average follow-up of 3.5 years, because of safety and futility. (The study continues with a concurrent randomization that is comparing the efficacy of usual and "intensive" blood pressure control.) The antiplatelet randomization stopped because the results showed a "surprising," statistically significant increased rate of all-cause mortality and major hemorrhages in patients treated with dual antiplatelet therapy, Dr. Benavente said.

All-cause mortality occurred at a rate of 1.4%/patient-year in the aspirin-only group, and a rate of 2.1%/patient-year in the dual-therapy arm, a 50% relative risk difference. A breakdown of the causes of death showed a statistically significant difference for only one subgroup, "probable vascular" death, which was threefold higher in the aspirin plus clopidogrel patients than in those on aspirin only. The causes of death will require more analysis to better understand the danger posed by the dual-drug regimen, Dr. Benavente said at the meeting, which was sponsored by the American Heart Association.

Major hemorrhages occurred in 1.1% of the aspirin-only patients and in 2.1% of those on the dual regimen. When separated by type of hemorrhage, the only significant difference between the two treatment groups was in the incidence of non–central nervous system hemorrhages, a category that mostly consisted of gastrointestinal bleeds, he said.

The two regimens showed no significant difference for the study’s primary efficacy outcome, the incidence of ischemic and hemorrhagic strokes, which occurred at 2.7%/patient-year among those on aspirin only and 2.5%/patient-year in those on both drugs. The rates of ischemic strokes only, hemorrhagic strokes only, major vascular events, and myocardial infarctions also showed no significant differences between the two treatment arms.

SPS3 did not include a patient group treated only with clopidogrel because previous, large studies had already compared clopidogrel alone with aspirin alone, and with aspirin plus dipyridamole. The results of those studies "have not clearly established that [clopidogrel] is superior to or even equivalent to" aspirin, aspirin plus dipyridamole, and ticlopidine (Ticlid), said last year’s treatment recommendations from the American Heart Association and American Stroke Association.

The SPS3 study was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Benavente said that he has received research support from Sanofi-Aventis and Bristol-Myers Squibb.

NEW ORLEANS – The combination of aspirin and clopidogrel proved no more effective than aspirin alone for secondary stroke prevention, and dual therapy significantly boosted the major hemorrhage rate and patient mortality in a randomized, multicenter trial with more than 3,000 patients.

The poor performance of this dual antiplatelet combination in this large study, called the Secondary Prevention of Small Subcortical Strokes (SPS3) trial, leaves the secondary stroke prevention guideline published last year by the American Heart Association and American Stroke Association unchanged in its recommendation of three antiplatelet drug options for patients with a history of stroke or transient ischemic attack: aspirin, aspirin plus dipyridamole, or clopidogrel (Stroke 2011;42:227-76), Dr. Oscar R. Benavente said at the International Stroke Conference.

The new trial results "do not support the use of combination therapy for secondary stroke prevention in patients with lacunar strokes," said Dr. Benavente, the study’s co-principal investigator and research director of the Stroke and Cerebrovascular Disease Program at the Vancouver Coastal Health Research Institute.

The SPS3 study enrolled 3,020 patients within 180 days of a small, subcortical, lacunar stroke at 81 sites in eight countries during 2003-2011. The trial excluded patients with cortical stroke, cardioembolic disease, or carotid stenosis. More than half of the enrolled patients received care at U.S. centers. Their average age was 63 years, about two-thirds were men, and they entered the study an average of 76 days following their index stroke.

The study randomized 1,503 patients to treatment with 325 mg of aspirin daily, and 1,517 patients to the same aspirin dosage plus 75 mg of clopidogrel (Plavix) daily.

The study’s data and safety monitoring board stopped this portion of the trial early last July, after an average follow-up of 3.5 years, because of safety and futility. (The study continues with a concurrent randomization that is comparing the efficacy of usual and "intensive" blood pressure control.) The antiplatelet randomization stopped because the results showed a "surprising," statistically significant increased rate of all-cause mortality and major hemorrhages in patients treated with dual antiplatelet therapy, Dr. Benavente said.

All-cause mortality occurred at a rate of 1.4%/patient-year in the aspirin-only group, and a rate of 2.1%/patient-year in the dual-therapy arm, a 50% relative risk difference. A breakdown of the causes of death showed a statistically significant difference for only one subgroup, "probable vascular" death, which was threefold higher in the aspirin plus clopidogrel patients than in those on aspirin only. The causes of death will require more analysis to better understand the danger posed by the dual-drug regimen, Dr. Benavente said at the meeting, which was sponsored by the American Heart Association.

Major hemorrhages occurred in 1.1% of the aspirin-only patients and in 2.1% of those on the dual regimen. When separated by type of hemorrhage, the only significant difference between the two treatment groups was in the incidence of non–central nervous system hemorrhages, a category that mostly consisted of gastrointestinal bleeds, he said.

The two regimens showed no significant difference for the study’s primary efficacy outcome, the incidence of ischemic and hemorrhagic strokes, which occurred at 2.7%/patient-year among those on aspirin only and 2.5%/patient-year in those on both drugs. The rates of ischemic strokes only, hemorrhagic strokes only, major vascular events, and myocardial infarctions also showed no significant differences between the two treatment arms.

SPS3 did not include a patient group treated only with clopidogrel because previous, large studies had already compared clopidogrel alone with aspirin alone, and with aspirin plus dipyridamole. The results of those studies "have not clearly established that [clopidogrel] is superior to or even equivalent to" aspirin, aspirin plus dipyridamole, and ticlopidine (Ticlid), said last year’s treatment recommendations from the American Heart Association and American Stroke Association.

The SPS3 study was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Benavente said that he has received research support from Sanofi-Aventis and Bristol-Myers Squibb.

NEW ORLEANS – The combination of aspirin and clopidogrel proved no more effective than aspirin alone for secondary stroke prevention, and dual therapy significantly boosted the major hemorrhage rate and patient mortality in a randomized, multicenter trial with more than 3,000 patients.

The poor performance of this dual antiplatelet combination in this large study, called the Secondary Prevention of Small Subcortical Strokes (SPS3) trial, leaves the secondary stroke prevention guideline published last year by the American Heart Association and American Stroke Association unchanged in its recommendation of three antiplatelet drug options for patients with a history of stroke or transient ischemic attack: aspirin, aspirin plus dipyridamole, or clopidogrel (Stroke 2011;42:227-76), Dr. Oscar R. Benavente said at the International Stroke Conference.

The new trial results "do not support the use of combination therapy for secondary stroke prevention in patients with lacunar strokes," said Dr. Benavente, the study’s co-principal investigator and research director of the Stroke and Cerebrovascular Disease Program at the Vancouver Coastal Health Research Institute.

The SPS3 study enrolled 3,020 patients within 180 days of a small, subcortical, lacunar stroke at 81 sites in eight countries during 2003-2011. The trial excluded patients with cortical stroke, cardioembolic disease, or carotid stenosis. More than half of the enrolled patients received care at U.S. centers. Their average age was 63 years, about two-thirds were men, and they entered the study an average of 76 days following their index stroke.

The study randomized 1,503 patients to treatment with 325 mg of aspirin daily, and 1,517 patients to the same aspirin dosage plus 75 mg of clopidogrel (Plavix) daily.

The study’s data and safety monitoring board stopped this portion of the trial early last July, after an average follow-up of 3.5 years, because of safety and futility. (The study continues with a concurrent randomization that is comparing the efficacy of usual and "intensive" blood pressure control.) The antiplatelet randomization stopped because the results showed a "surprising," statistically significant increased rate of all-cause mortality and major hemorrhages in patients treated with dual antiplatelet therapy, Dr. Benavente said.

All-cause mortality occurred at a rate of 1.4%/patient-year in the aspirin-only group, and a rate of 2.1%/patient-year in the dual-therapy arm, a 50% relative risk difference. A breakdown of the causes of death showed a statistically significant difference for only one subgroup, "probable vascular" death, which was threefold higher in the aspirin plus clopidogrel patients than in those on aspirin only. The causes of death will require more analysis to better understand the danger posed by the dual-drug regimen, Dr. Benavente said at the meeting, which was sponsored by the American Heart Association.

Major hemorrhages occurred in 1.1% of the aspirin-only patients and in 2.1% of those on the dual regimen. When separated by type of hemorrhage, the only significant difference between the two treatment groups was in the incidence of non–central nervous system hemorrhages, a category that mostly consisted of gastrointestinal bleeds, he said.

The two regimens showed no significant difference for the study’s primary efficacy outcome, the incidence of ischemic and hemorrhagic strokes, which occurred at 2.7%/patient-year among those on aspirin only and 2.5%/patient-year in those on both drugs. The rates of ischemic strokes only, hemorrhagic strokes only, major vascular events, and myocardial infarctions also showed no significant differences between the two treatment arms.

SPS3 did not include a patient group treated only with clopidogrel because previous, large studies had already compared clopidogrel alone with aspirin alone, and with aspirin plus dipyridamole. The results of those studies "have not clearly established that [clopidogrel] is superior to or even equivalent to" aspirin, aspirin plus dipyridamole, and ticlopidine (Ticlid), said last year’s treatment recommendations from the American Heart Association and American Stroke Association.

The SPS3 study was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Benavente said that he has received research support from Sanofi-Aventis and Bristol-Myers Squibb.

NEW ORLEANS – Nearly half of adult Americans who self-reported a history of stroke also had poorly-controlled hypertension, based on a review of data collected from a U.S. nationwide sample during 1999-2004.

In addition, another 8% of stroke survivors had undiagnosed hypertension, Dr. Amytis Towfighi and her associates reported in a poster at the International Stroke Conference.

"Several medical and lifestyle modification factors could be potential targets of intervention to bridge this evidence practice gap," said Dr. Towfighi, a neurologist at the University of Southern California, Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

Dr. Towfighi and her associates used data collected in the National Health and Nutrition Examination Survey (NHANES) during 1999-2004. Among the 9,145 Americans aged 40 years or older included in the NHANES surveys during those years, 490 (5%) self-reported a history of stroke.

Within this subgroup of stroke survivors, 72% said that they had been diagnosed with hypertension, and 47% had hypertension that was poorly controlled, with a blood pressure at the time of NHANES data collected that exceeded 140/90 mm Hg. An additional 8% of the stroke survivors had hypertension based on their NHANES data but did not self-report a previous diagnosis of hypertension.

Mortality follow-up of the 490 stroke patients through the end of 2006 showed that the mortality rates of these people did not differ significantly regardless of their initially measured blood pressure in the NHANES survey, nor by the number of antihypertensive medications these people reported receiving at baseline.

A multivariate analysis that adjusted for several demographic and clinical features identified Hispanic ethnicity, female sex, and diabetes as correlates of poor hypertension control, while hyperlipidemia and male gender were correlates of stroke patients not receiving any antihypertensive medications.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – Nearly half of adult Americans who self-reported a history of stroke also had poorly-controlled hypertension, based on a review of data collected from a U.S. nationwide sample during 1999-2004.

In addition, another 8% of stroke survivors had undiagnosed hypertension, Dr. Amytis Towfighi and her associates reported in a poster at the International Stroke Conference.

"Several medical and lifestyle modification factors could be potential targets of intervention to bridge this evidence practice gap," said Dr. Towfighi, a neurologist at the University of Southern California, Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

Dr. Towfighi and her associates used data collected in the National Health and Nutrition Examination Survey (NHANES) during 1999-2004. Among the 9,145 Americans aged 40 years or older included in the NHANES surveys during those years, 490 (5%) self-reported a history of stroke.

Within this subgroup of stroke survivors, 72% said that they had been diagnosed with hypertension, and 47% had hypertension that was poorly controlled, with a blood pressure at the time of NHANES data collected that exceeded 140/90 mm Hg. An additional 8% of the stroke survivors had hypertension based on their NHANES data but did not self-report a previous diagnosis of hypertension.

Mortality follow-up of the 490 stroke patients through the end of 2006 showed that the mortality rates of these people did not differ significantly regardless of their initially measured blood pressure in the NHANES survey, nor by the number of antihypertensive medications these people reported receiving at baseline.

A multivariate analysis that adjusted for several demographic and clinical features identified Hispanic ethnicity, female sex, and diabetes as correlates of poor hypertension control, while hyperlipidemia and male gender were correlates of stroke patients not receiving any antihypertensive medications.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – Nearly half of adult Americans who self-reported a history of stroke also had poorly-controlled hypertension, based on a review of data collected from a U.S. nationwide sample during 1999-2004.

In addition, another 8% of stroke survivors had undiagnosed hypertension, Dr. Amytis Towfighi and her associates reported in a poster at the International Stroke Conference.

"Several medical and lifestyle modification factors could be potential targets of intervention to bridge this evidence practice gap," said Dr. Towfighi, a neurologist at the University of Southern California, Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

Dr. Towfighi and her associates used data collected in the National Health and Nutrition Examination Survey (NHANES) during 1999-2004. Among the 9,145 Americans aged 40 years or older included in the NHANES surveys during those years, 490 (5%) self-reported a history of stroke.

Within this subgroup of stroke survivors, 72% said that they had been diagnosed with hypertension, and 47% had hypertension that was poorly controlled, with a blood pressure at the time of NHANES data collected that exceeded 140/90 mm Hg. An additional 8% of the stroke survivors had hypertension based on their NHANES data but did not self-report a previous diagnosis of hypertension.

Mortality follow-up of the 490 stroke patients through the end of 2006 showed that the mortality rates of these people did not differ significantly regardless of their initially measured blood pressure in the NHANES survey, nor by the number of antihypertensive medications these people reported receiving at baseline.

A multivariate analysis that adjusted for several demographic and clinical features identified Hispanic ethnicity, female sex, and diabetes as correlates of poor hypertension control, while hyperlipidemia and male gender were correlates of stroke patients not receiving any antihypertensive medications.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – An elevated Framingham Risk Score identified recent ischemic stroke patients at high risk for a myocardial infarction or vascular death over the next 2 years, in a retrospective analysis of data from more than 2,500 stroke survivors without documented coronary heart disease.

If prospective study results confirm this finding, it could establish the Framingham Risk Score (FRS) as an important prognostic assessment for patients with a recent ischemic stroke, Dr. Amytis Towfighi said at the International Stroke Conference. If used this way, the FRS could identify stroke survivors who would benefit from more intensive risk-factor modification, she said.

"Considering every stroke to be a coronary risk equivalent could expose patients with a low risk for subsequent coronary events to unnecessary treatment," said Dr. Towfighi, a neurologist at the University of Southern California in Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

"Unlike coronary atherosclerosis, there are lots of different causes of stroke, including nonatherosclerotic mechanisms.

"Many stroke survivors harbor asymptomatic coronary heart disease, and beyond the acute period they are often at higher risk for cardiac death than for recurrent cerebrovascular events," she said. Identifying patients with high FRSs of 20% or greater could flag those who would benefit from treatment with a beta- blocker; coronary diagnostic imaging; coronary revascularization; or more intensive vascular risk reduction by reducing body mass index, lowering triglycerides, exercising tighter diabetes management, and smoking cessation.

"Today, the FRS is usually not calculated for stroke patients," Dr. Towfighi said in an interview. "Part of the issue is that the FRS was initially developed for people who had not yet had a [cardiovascular] event, so it has not been studied in patients who had a stroke. We didn’t know going into our study whether or not a high FRS would predict a myocardial infarction or vascular death in patients who had a stroke."

To test whether the FRS could help stratify coronary risk in stroke patients, Dr. Towfighi and her associates analyzed data collected from 3,509 patients who had a recent ischemic stroke and who participated in the Vitamin Intervention for Stroke Prevention trial during 1996-2003 (JAMA 2004;291:565-75). The analysis primarily focused on the 2,547 patients from this group who did not have documented coronary heart disease at the time of their enrollment.

Calculation of the FRS for these patients identified 933 (37%) with a score of 20% or greater, and 1,614 (63%) with a score of less than 20%.

The researchers then tallied the rates of myocardial infarction, vascular death, or stroke in these two subgroups during 2 years of follow-up, and compared the rates between the two FRS groups in a multivariate analysis that controlled for baseline differences in age, race, prior stroke, body mass index, heart failure, carotid endarterectomy, stroke severity, alcohol use, low-density lipoprotein cholesterol, triglyceride levels, mean systolic blood pressure while in the study, antidyslipidemia drug treatment, antithrombotic drug treatment.

In this analysis, patients with an FRS of 20% or greater at baseline had a 2.8-fold increased risk for a myocardial infarction during 2 years of follow-up compared with patients with a lower FRS. The risk of vascular death during follow-up was 80% higher in the high-FRS subgroup than in patients with a lower score. However, a higher FRS had no link with an increased risk for a subsequent stroke.

In addition, the FRS components most strongly linked to subsequent myocardial infarction risk were smoking, which raised the risk by 70%, and diabetes, which doubled the risk.

These findings are not conclusive because they came from a retrospective analysis and may have been influenced by unmeasured confounding. Ideally, the findings need confirmation in a prospective study, Dr. Towfighi said.

Despite this limitation, Dr. Towfighi noted that she and her associates at Rancho Los Amigos now calculate an FRS for their stroke patients "because we feel it’s useful," she said at the meeting, which was sponsored by the American Heart Association.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – An elevated Framingham Risk Score identified recent ischemic stroke patients at high risk for a myocardial infarction or vascular death over the next 2 years, in a retrospective analysis of data from more than 2,500 stroke survivors without documented coronary heart disease.

If prospective study results confirm this finding, it could establish the Framingham Risk Score (FRS) as an important prognostic assessment for patients with a recent ischemic stroke, Dr. Amytis Towfighi said at the International Stroke Conference. If used this way, the FRS could identify stroke survivors who would benefit from more intensive risk-factor modification, she said.

"Considering every stroke to be a coronary risk equivalent could expose patients with a low risk for subsequent coronary events to unnecessary treatment," said Dr. Towfighi, a neurologist at the University of Southern California in Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

"Unlike coronary atherosclerosis, there are lots of different causes of stroke, including nonatherosclerotic mechanisms.

"Many stroke survivors harbor asymptomatic coronary heart disease, and beyond the acute period they are often at higher risk for cardiac death than for recurrent cerebrovascular events," she said. Identifying patients with high FRSs of 20% or greater could flag those who would benefit from treatment with a beta- blocker; coronary diagnostic imaging; coronary revascularization; or more intensive vascular risk reduction by reducing body mass index, lowering triglycerides, exercising tighter diabetes management, and smoking cessation.

"Today, the FRS is usually not calculated for stroke patients," Dr. Towfighi said in an interview. "Part of the issue is that the FRS was initially developed for people who had not yet had a [cardiovascular] event, so it has not been studied in patients who had a stroke. We didn’t know going into our study whether or not a high FRS would predict a myocardial infarction or vascular death in patients who had a stroke."

To test whether the FRS could help stratify coronary risk in stroke patients, Dr. Towfighi and her associates analyzed data collected from 3,509 patients who had a recent ischemic stroke and who participated in the Vitamin Intervention for Stroke Prevention trial during 1996-2003 (JAMA 2004;291:565-75). The analysis primarily focused on the 2,547 patients from this group who did not have documented coronary heart disease at the time of their enrollment.

Calculation of the FRS for these patients identified 933 (37%) with a score of 20% or greater, and 1,614 (63%) with a score of less than 20%.

The researchers then tallied the rates of myocardial infarction, vascular death, or stroke in these two subgroups during 2 years of follow-up, and compared the rates between the two FRS groups in a multivariate analysis that controlled for baseline differences in age, race, prior stroke, body mass index, heart failure, carotid endarterectomy, stroke severity, alcohol use, low-density lipoprotein cholesterol, triglyceride levels, mean systolic blood pressure while in the study, antidyslipidemia drug treatment, antithrombotic drug treatment.

In this analysis, patients with an FRS of 20% or greater at baseline had a 2.8-fold increased risk for a myocardial infarction during 2 years of follow-up compared with patients with a lower FRS. The risk of vascular death during follow-up was 80% higher in the high-FRS subgroup than in patients with a lower score. However, a higher FRS had no link with an increased risk for a subsequent stroke.

In addition, the FRS components most strongly linked to subsequent myocardial infarction risk were smoking, which raised the risk by 70%, and diabetes, which doubled the risk.

These findings are not conclusive because they came from a retrospective analysis and may have been influenced by unmeasured confounding. Ideally, the findings need confirmation in a prospective study, Dr. Towfighi said.

Despite this limitation, Dr. Towfighi noted that she and her associates at Rancho Los Amigos now calculate an FRS for their stroke patients "because we feel it’s useful," she said at the meeting, which was sponsored by the American Heart Association.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – An elevated Framingham Risk Score identified recent ischemic stroke patients at high risk for a myocardial infarction or vascular death over the next 2 years, in a retrospective analysis of data from more than 2,500 stroke survivors without documented coronary heart disease.

If prospective study results confirm this finding, it could establish the Framingham Risk Score (FRS) as an important prognostic assessment for patients with a recent ischemic stroke, Dr. Amytis Towfighi said at the International Stroke Conference. If used this way, the FRS could identify stroke survivors who would benefit from more intensive risk-factor modification, she said.

"Considering every stroke to be a coronary risk equivalent could expose patients with a low risk for subsequent coronary events to unnecessary treatment," said Dr. Towfighi, a neurologist at the University of Southern California in Los Angeles and director of the acute neurology/acute stroke unit at Rancho Los Amigos National Rehabilitation Center in Downey, Calif.

"Unlike coronary atherosclerosis, there are lots of different causes of stroke, including nonatherosclerotic mechanisms.

"Many stroke survivors harbor asymptomatic coronary heart disease, and beyond the acute period they are often at higher risk for cardiac death than for recurrent cerebrovascular events," she said. Identifying patients with high FRSs of 20% or greater could flag those who would benefit from treatment with a beta- blocker; coronary diagnostic imaging; coronary revascularization; or more intensive vascular risk reduction by reducing body mass index, lowering triglycerides, exercising tighter diabetes management, and smoking cessation.

"Today, the FRS is usually not calculated for stroke patients," Dr. Towfighi said in an interview. "Part of the issue is that the FRS was initially developed for people who had not yet had a [cardiovascular] event, so it has not been studied in patients who had a stroke. We didn’t know going into our study whether or not a high FRS would predict a myocardial infarction or vascular death in patients who had a stroke."

To test whether the FRS could help stratify coronary risk in stroke patients, Dr. Towfighi and her associates analyzed data collected from 3,509 patients who had a recent ischemic stroke and who participated in the Vitamin Intervention for Stroke Prevention trial during 1996-2003 (JAMA 2004;291:565-75). The analysis primarily focused on the 2,547 patients from this group who did not have documented coronary heart disease at the time of their enrollment.

Calculation of the FRS for these patients identified 933 (37%) with a score of 20% or greater, and 1,614 (63%) with a score of less than 20%.

The researchers then tallied the rates of myocardial infarction, vascular death, or stroke in these two subgroups during 2 years of follow-up, and compared the rates between the two FRS groups in a multivariate analysis that controlled for baseline differences in age, race, prior stroke, body mass index, heart failure, carotid endarterectomy, stroke severity, alcohol use, low-density lipoprotein cholesterol, triglyceride levels, mean systolic blood pressure while in the study, antidyslipidemia drug treatment, antithrombotic drug treatment.

In this analysis, patients with an FRS of 20% or greater at baseline had a 2.8-fold increased risk for a myocardial infarction during 2 years of follow-up compared with patients with a lower FRS. The risk of vascular death during follow-up was 80% higher in the high-FRS subgroup than in patients with a lower score. However, a higher FRS had no link with an increased risk for a subsequent stroke.

In addition, the FRS components most strongly linked to subsequent myocardial infarction risk were smoking, which raised the risk by 70%, and diabetes, which doubled the risk.

These findings are not conclusive because they came from a retrospective analysis and may have been influenced by unmeasured confounding. Ideally, the findings need confirmation in a prospective study, Dr. Towfighi said.

Despite this limitation, Dr. Towfighi noted that she and her associates at Rancho Los Amigos now calculate an FRS for their stroke patients "because we feel it’s useful," she said at the meeting, which was sponsored by the American Heart Association.

Dr. Towfighi said that she had no disclosures.

NEW ORLEANS – The largest, best controlled comparison of aspirin and warfarin ever done in patients with heart failure showed no overall difference between the two drugs for preventing thromboembolic events that cause death or stroke.

As a consequence, for the time being physicians should feel comfortable prescribing either drug to patients with a left ventricular ejection fraction of 35% or less and in sinus rhythm, Dr. Shunichi Homma reported at the International Stroke Conference.

"Most heart failure patients are put on aspirin or warfarin" to deal with their elevated risk for thromboembolic events," said Dr. Homma, a cardiologist and professor of medicine at Columbia University in New York, and until now it’s remained an open question whether one drug surpassed the other. The study compared a daily 325-mg aspirin dosage with a warfarin regimen targeted to maintain patients at a target international normalized ratio (INR) of 2.75.

"Overall, there was no benefit of one over the other" for the study’s primary end point of the combined rate of death, ischemic stroke, or intracerebral hemorrhage, he said in an interview. Aspirin is more convenient and cheaper than a warfarin regimen that requires regular INR monitoring, and the results also showed that aspirin led to significantly fewer hemorrhagic events. In addition, total major hemorrhagic events, including intracranial, intracerebral, and gastrointestinal bleeding, ran 0.9% in the aspirin patients and 1.8% in the warfarin patients, a statistically significant difference.

But findings from the Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial also showed advantages for warfarin. While the primary, combined end point showed a virtual dead heat of a 6.6% event rate with warfarin and a 6.5% rate with aspirin, warfarin treatment showed a statistically significant edge over aspirin for preventing ischemic strokes. This end point occurred in 0.7% of the warfarin patients and in 1.4% of those on aspirin, a significant difference.

In addition, warfarin treatment produced a hard-to-explain advantage for the study’s primary end point that appeared once patients were followed for more than 3 years. Although average follow-up for all 2,305 patients in the study was 3.5 years, follow-up for more than 1,000 of the enrollees extended to 4 years, and nearly 700 patients had a follow-up of 5 years. After 4 years, warfarin produced a statistically significant, roughly 25% reduction in the study’s primary end point compared with aspirin, an advantage maintained through 5 years and then out to 6 years.

Because this separate analysis of the study results after prolonged follow-up was a prespecified end point, it represented a major finding of the trial, although its full interpretation will need additional analysis and its clinical implications are not yet clear, Dr. Homma said.

"While there was no overall difference in the outcomes, there is a group of patients, those followed for 4 or more years, who benefited from warfarin. We don’t know who they are or why this happens. It’s important to find out, before we decide to [routinely use] warfarin," he said. "Also, in years 1-3 there was no significant difference between the two drugs, and given the bleeding risk with warfarin we need to clarify the characteristics of the patients who might benefit from one medication or the other."

For the time, being, until a better understanding of the long-term warfarin effect is available, "I think the results of our study will tip physicians toward using aspirin over warfarin," he said.

"We suspected, based on prior results, that there might be a change in the effect [of warfarin] over time," said J.L.P. Thompson, Ph.D., professor of clinical biostatistics and clinical neurology at Columbia and co-principal investigator on the study. "The benefit from warfarin is modest, but it is there. It does not lead to a clinical recommendation at the moment, but it is an unexpected finding and the clinical investigators want to look at it further," he said in an interview.

An additional, important observation was that daily aspirin treatment led to a strong trend toward a reduced rate of heart failure hospitalizations compared with the warfarin arm. Results from a prior study that compared aspirin and warfarin in heart failure patients, the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial, had indicated that aspirin boosted the rate of heart failure hospitalizations for acute exacerbations, and at the least the new findings "show that aspirin certainly did not make hospitalization any worse," and may possibly have even reduced the heart-failure hospitalization rate, Dr. Homma said.

"It is a very important finding. Aspirin use in heart failure was a concern, but we didn’t see that," he said at the meeting, which was sponsored by the American Heart Association.

WARCEF enrolled patients at 176 centers in 11 countries between 2002 and January 2010, with more than a third of the patients enrolled in the United States. The study was funded by the National Institute of Neurological Disorders and Stroke.

The study also featured an unusual design, in that it was completely double-blinded even though half the patients received warfarin and half did not. To maintain the blind, all patients regularly went to warfarin clinics where their blood was drawn and INR reports generated that their physicians then used to adjust their warfarin dosages, even for the patients who received dummy warfarin pills.

"Neither patients nor their physicians knew who was on warfarin and who was on aspirin, so this gives us great confidence about the study results. It removes the possibility that one group received more intensive care," Dr. Thompson said.

WARCEF was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Homma and Dr. Thompson said that they had no disclosures.

NEW ORLEANS – The largest, best controlled comparison of aspirin and warfarin ever done in patients with heart failure showed no overall difference between the two drugs for preventing thromboembolic events that cause death or stroke.

As a consequence, for the time being physicians should feel comfortable prescribing either drug to patients with a left ventricular ejection fraction of 35% or less and in sinus rhythm, Dr. Shunichi Homma reported at the International Stroke Conference.

"Most heart failure patients are put on aspirin or warfarin" to deal with their elevated risk for thromboembolic events," said Dr. Homma, a cardiologist and professor of medicine at Columbia University in New York, and until now it’s remained an open question whether one drug surpassed the other. The study compared a daily 325-mg aspirin dosage with a warfarin regimen targeted to maintain patients at a target international normalized ratio (INR) of 2.75.

"Overall, there was no benefit of one over the other" for the study’s primary end point of the combined rate of death, ischemic stroke, or intracerebral hemorrhage, he said in an interview. Aspirin is more convenient and cheaper than a warfarin regimen that requires regular INR monitoring, and the results also showed that aspirin led to significantly fewer hemorrhagic events. In addition, total major hemorrhagic events, including intracranial, intracerebral, and gastrointestinal bleeding, ran 0.9% in the aspirin patients and 1.8% in the warfarin patients, a statistically significant difference.

But findings from the Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial also showed advantages for warfarin. While the primary, combined end point showed a virtual dead heat of a 6.6% event rate with warfarin and a 6.5% rate with aspirin, warfarin treatment showed a statistically significant edge over aspirin for preventing ischemic strokes. This end point occurred in 0.7% of the warfarin patients and in 1.4% of those on aspirin, a significant difference.

In addition, warfarin treatment produced a hard-to-explain advantage for the study’s primary end point that appeared once patients were followed for more than 3 years. Although average follow-up for all 2,305 patients in the study was 3.5 years, follow-up for more than 1,000 of the enrollees extended to 4 years, and nearly 700 patients had a follow-up of 5 years. After 4 years, warfarin produced a statistically significant, roughly 25% reduction in the study’s primary end point compared with aspirin, an advantage maintained through 5 years and then out to 6 years.

Because this separate analysis of the study results after prolonged follow-up was a prespecified end point, it represented a major finding of the trial, although its full interpretation will need additional analysis and its clinical implications are not yet clear, Dr. Homma said.

"While there was no overall difference in the outcomes, there is a group of patients, those followed for 4 or more years, who benefited from warfarin. We don’t know who they are or why this happens. It’s important to find out, before we decide to [routinely use] warfarin," he said. "Also, in years 1-3 there was no significant difference between the two drugs, and given the bleeding risk with warfarin we need to clarify the characteristics of the patients who might benefit from one medication or the other."

For the time, being, until a better understanding of the long-term warfarin effect is available, "I think the results of our study will tip physicians toward using aspirin over warfarin," he said.

"We suspected, based on prior results, that there might be a change in the effect [of warfarin] over time," said J.L.P. Thompson, Ph.D., professor of clinical biostatistics and clinical neurology at Columbia and co-principal investigator on the study. "The benefit from warfarin is modest, but it is there. It does not lead to a clinical recommendation at the moment, but it is an unexpected finding and the clinical investigators want to look at it further," he said in an interview.

An additional, important observation was that daily aspirin treatment led to a strong trend toward a reduced rate of heart failure hospitalizations compared with the warfarin arm. Results from a prior study that compared aspirin and warfarin in heart failure patients, the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial, had indicated that aspirin boosted the rate of heart failure hospitalizations for acute exacerbations, and at the least the new findings "show that aspirin certainly did not make hospitalization any worse," and may possibly have even reduced the heart-failure hospitalization rate, Dr. Homma said.

"It is a very important finding. Aspirin use in heart failure was a concern, but we didn’t see that," he said at the meeting, which was sponsored by the American Heart Association.

WARCEF enrolled patients at 176 centers in 11 countries between 2002 and January 2010, with more than a third of the patients enrolled in the United States. The study was funded by the National Institute of Neurological Disorders and Stroke.

The study also featured an unusual design, in that it was completely double-blinded even though half the patients received warfarin and half did not. To maintain the blind, all patients regularly went to warfarin clinics where their blood was drawn and INR reports generated that their physicians then used to adjust their warfarin dosages, even for the patients who received dummy warfarin pills.

"Neither patients nor their physicians knew who was on warfarin and who was on aspirin, so this gives us great confidence about the study results. It removes the possibility that one group received more intensive care," Dr. Thompson said.

WARCEF was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Homma and Dr. Thompson said that they had no disclosures.

NEW ORLEANS – The largest, best controlled comparison of aspirin and warfarin ever done in patients with heart failure showed no overall difference between the two drugs for preventing thromboembolic events that cause death or stroke.

As a consequence, for the time being physicians should feel comfortable prescribing either drug to patients with a left ventricular ejection fraction of 35% or less and in sinus rhythm, Dr. Shunichi Homma reported at the International Stroke Conference.

"Most heart failure patients are put on aspirin or warfarin" to deal with their elevated risk for thromboembolic events," said Dr. Homma, a cardiologist and professor of medicine at Columbia University in New York, and until now it’s remained an open question whether one drug surpassed the other. The study compared a daily 325-mg aspirin dosage with a warfarin regimen targeted to maintain patients at a target international normalized ratio (INR) of 2.75.

"Overall, there was no benefit of one over the other" for the study’s primary end point of the combined rate of death, ischemic stroke, or intracerebral hemorrhage, he said in an interview. Aspirin is more convenient and cheaper than a warfarin regimen that requires regular INR monitoring, and the results also showed that aspirin led to significantly fewer hemorrhagic events. In addition, total major hemorrhagic events, including intracranial, intracerebral, and gastrointestinal bleeding, ran 0.9% in the aspirin patients and 1.8% in the warfarin patients, a statistically significant difference.

But findings from the Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial also showed advantages for warfarin. While the primary, combined end point showed a virtual dead heat of a 6.6% event rate with warfarin and a 6.5% rate with aspirin, warfarin treatment showed a statistically significant edge over aspirin for preventing ischemic strokes. This end point occurred in 0.7% of the warfarin patients and in 1.4% of those on aspirin, a significant difference.

In addition, warfarin treatment produced a hard-to-explain advantage for the study’s primary end point that appeared once patients were followed for more than 3 years. Although average follow-up for all 2,305 patients in the study was 3.5 years, follow-up for more than 1,000 of the enrollees extended to 4 years, and nearly 700 patients had a follow-up of 5 years. After 4 years, warfarin produced a statistically significant, roughly 25% reduction in the study’s primary end point compared with aspirin, an advantage maintained through 5 years and then out to 6 years.

Because this separate analysis of the study results after prolonged follow-up was a prespecified end point, it represented a major finding of the trial, although its full interpretation will need additional analysis and its clinical implications are not yet clear, Dr. Homma said.

"While there was no overall difference in the outcomes, there is a group of patients, those followed for 4 or more years, who benefited from warfarin. We don’t know who they are or why this happens. It’s important to find out, before we decide to [routinely use] warfarin," he said. "Also, in years 1-3 there was no significant difference between the two drugs, and given the bleeding risk with warfarin we need to clarify the characteristics of the patients who might benefit from one medication or the other."

For the time, being, until a better understanding of the long-term warfarin effect is available, "I think the results of our study will tip physicians toward using aspirin over warfarin," he said.

"We suspected, based on prior results, that there might be a change in the effect [of warfarin] over time," said J.L.P. Thompson, Ph.D., professor of clinical biostatistics and clinical neurology at Columbia and co-principal investigator on the study. "The benefit from warfarin is modest, but it is there. It does not lead to a clinical recommendation at the moment, but it is an unexpected finding and the clinical investigators want to look at it further," he said in an interview.

An additional, important observation was that daily aspirin treatment led to a strong trend toward a reduced rate of heart failure hospitalizations compared with the warfarin arm. Results from a prior study that compared aspirin and warfarin in heart failure patients, the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial, had indicated that aspirin boosted the rate of heart failure hospitalizations for acute exacerbations, and at the least the new findings "show that aspirin certainly did not make hospitalization any worse," and may possibly have even reduced the heart-failure hospitalization rate, Dr. Homma said.

"It is a very important finding. Aspirin use in heart failure was a concern, but we didn’t see that," he said at the meeting, which was sponsored by the American Heart Association.

WARCEF enrolled patients at 176 centers in 11 countries between 2002 and January 2010, with more than a third of the patients enrolled in the United States. The study was funded by the National Institute of Neurological Disorders and Stroke.

The study also featured an unusual design, in that it was completely double-blinded even though half the patients received warfarin and half did not. To maintain the blind, all patients regularly went to warfarin clinics where their blood was drawn and INR reports generated that their physicians then used to adjust their warfarin dosages, even for the patients who received dummy warfarin pills.

"Neither patients nor their physicians knew who was on warfarin and who was on aspirin, so this gives us great confidence about the study results. It removes the possibility that one group received more intensive care," Dr. Thompson said.

WARCEF was sponsored by the National Institute of Neurological Disorders and Stroke. Dr. Homma and Dr. Thompson said that they had no disclosures.

MIAMI BEACH – Devices for endovascular repair of abdominal aortic aneurysms are evolving, with new sizing or other innovations either recently on the market or in studies.

The new products expand the scope of patients who are candidates for endovascular aneurysm repair (EVAR), and in one case bring a new approach to EVAR into the clinic.

During a session at ISET 2012, an international symposium on endovascular therapy, seven experts gave the following quick updates on what’s new in EVAR for 2012:

• Making devices smaller. Downsizing constitutes a major trend for several new EVAR devices. The Endurant device helped blaze the lower-profile path, introducing a device delivered in an 18-Fr catheter for 23- to 25-mm diameter aortic stent grafts. Endurant received Food and Drug Administration marketing approval in 2010, and results from the U.S. pivotal trial for this device appeared last year (J. Vasc. Surg. 2011;54:601-8). In the pivotal trial, the major adverse event rate after 30 days was 4%; after 1 year, the patency rate was 97%, no patients had type I endoleaks, and the rate of secondary procedures was 5%, said Dr. Dittmar Böckler, professor and medical director of vascular surgery at the University of Heidelberg (Germany). An even smaller version of the same device, Endurant II, places a 28-mm bifurcated segment of an aortic stent graft into an 18-Fr delivery catheter – reduced from 20 Fr in the existing Endurant device – and has longer limbs to maximize coverage, changes that will further "expand options" for this device, he said.

Other EVAR devices take the downsizing trend even further. The Ovation Abdominal Stent Graft System, which received FDA marketing approval last November, has a 14-Fr outer diameter. For the time being, Ovation "is the lowest-profile commercially available device, expanding the population that is suitable for EVAR," said Dr. Horst Sievert, director of the cardiovascular center at Sankt Katharinen Hospital in Frankfurt, Germany. The FDA also made Ovation the first EVAR to be approved as a humanitarian use device (defined as an instrument aimed at a U.S. patient population that grows by fewer than 4,000 new cases annually). Ovation is approved for use in patients with iliac or femoral artery access that is less than 7 mm in diameter, and for treating an aorta with an inner neck diameter of 15.5-17.4 mm. The clinical trial results for Ovation showed "excellent short-term results," Dr. Sievert said. In the U.S. pivotal trial with 161 patients, the major adverse event rate after 1 month was 2.5%, he noted.

The Zenith Low Profile, a third low-profile EVAR device delivered in a 16-Fr sheath, is nearing marketing approval. The FDA already has data from a U.S. pivotal trial with 120 patients, and a decision on marketing approval should come sometime this year, said Dr. Roy K. Greenberg, a vascular surgeon at the Cleveland Clinic. Although he voiced enthusiasm for lower-profile devices that allow EVAR in patients who would not be able to accommodate larger devices, he also cautioned that "as we get lower-profile devices, we need to pay more attention to iliac disease. Postimplantation residual stenosis is critical for patients with [calcified] iliac disease."

Another issue with new devices is establishing their long-term performance. "New devices aren’t necessarily better; they’re just different. I think there are some advantages to new devices, but we don’t have a track record with respect to their long-term behavior," Dr. Greenberg said.

Finally, the INCRAFT low-profile EVAR device starts testing in a pivotal U.S. trial in February. INCRAFT matches Ovation with a 14-F outer-diameter delivery sheath, said Dr. Robert M. Bersin, medical director of endovascular services at Swedish Medical Center in Seattle. Its track record so far comes from the first 60 patients who received the device, at six centers in Germany and Italy, he added.

• High aortic neck angles. Aside from size, the aortic-neck angle provides another opportunity to broaden the EVAR device market. The Aorfix EVAR device is highly flexible and designed to deal with aortic neck angles of 60 degrees or greater. The stent has a "unique design, because a 60-degree angle is typically an exclusion for most [EVAR] devices," said Dr. William A. Gray, director of endovascular services at Columbia University in New York.

He reviewed the roll-in phase data from the PYTHAGORAS trial, which enrolled 62 patients with aortic neck angles smaller than 60 degrees; two-thirds of these first-phase patients had necks angled at more than 45 degrees. In the roll-in phase, "the Aorflex device has given excellent results in patients with typical anatomy," and the results serve "as a good prelude to the high-angle cases," he said.

The main phase of the trial, which planned to enroll up to 150 patients with high-angle aortic necks, has also finished, but those data are not yet publicly available. Lombard Medical, the company developing this device, submitted the main-phase data to the FDA, and should make the results public in the next 6 months, he said.

• Prefenestrations. Perhaps one of the more exciting new devices is the Ventana fenestrated system, an "off-the-shelf" device that comes with prefenestrations for the renal arteries that precludes the need for a custom-made device.

A current "unmet clinical need" for EVAR is a device to address patients with a short or nonexistent infrarenal neck, something that occurs in about a quarter of abdominal aortic aneurysm patients, said Dr. Daniel Clair, professor and chairman of vascular surgery at the Cleveland Clinic.

The system can potentially treat even aneurysms that include the renal arteries. The material used in the device is a multilayer polytetrafluoroethylene that forms small branches at the fenestrations that reach out into the renal arteries, and the device is delivered in a 22-Fr sheath.

Pilot studies used this system successfully on 15 patients outside the United States last year, and in February the next phase starts with another 30-50 patients scheduled for treatment both in and outside the United States, he said.

The pivotal U.S. trial (with 122 patients scheduled for treatment) also starts this year, with Dr. Clair as the principal investigator.

• Aneurysm sealing. Also in development is an EVAR-like device that’s not a stent. The Nellix system seals an aneurysm endovascularly, by deploying bags that fill with a liquid polymer that quickly solidifies to seal an aneurysm sac around a pair of stents. The system delivers the polymer at greater than blood pressure to extrude all blood from the aneurysm sac, said Dr. Lindsay Machan, a vascular surgeon at the University of British Columbia in Vancouver. This facilitates treatment of aortas with short or severely angulated necks. "The polymer anchors the devise at the bifurcation," Dr. Machan said, producing "remarkable" stability, better than devices that rely on barbs for anchoring.

So far, operators have used the Nellix system in 47 patients in New Zealand and Latvia, the first 31 with a first-generation device and, more recently, the remaining 16 patients with a second-generation version. More than 1 year of follow-up exists for 34 patients. These cases had 100% technical success with no ruptures, no conversions to open repair, and no endoleaks (either persistent or type II), he said. Two patients needed a secondary procedure, one for renal insufficiency, the other for a type I endoleak after 15 months.

The pivotal U.S. trial is planned to start later this year. "This ‘out-of-the-box’ technology addresses many shortcomings of EVAR, and uses a simple insertion procedure that takes 20-30 minutes," Dr. Machan said.

Dr. Böckler said that he has financial relationships with W.L. Gore, Medtronic, VASCOPS, and Siemens. Dr. Sievert said that he has financial relationships with TriVascular, W.L. Gore, and 55 other device companies. Dr. Greenberg said that he has an ownership interest in Cook Medical. Dr. Bersin said that he has financial relationships with Cordis Endovascular, W.L. Gore, Cook, and Bard. Dr. Gray said that he is a consultant to Cordis. Dr. Clair said that he has financial relationships with Endologix, ev3, Medtronic, Boston Scientific, and Covidien. Dr. Machan said that he has financial relationships with Boston Scientific, Cook, Calgary Scientific, Endologix, and Ikomed.

MIAMI BEACH – Devices for endovascular repair of abdominal aortic aneurysms are evolving, with new sizing or other innovations either recently on the market or in studies.

The new products expand the scope of patients who are candidates for endovascular aneurysm repair (EVAR), and in one case bring a new approach to EVAR into the clinic.

During a session at ISET 2012, an international symposium on endovascular therapy, seven experts gave the following quick updates on what’s new in EVAR for 2012:

• Making devices smaller. Downsizing constitutes a major trend for several new EVAR devices. The Endurant device helped blaze the lower-profile path, introducing a device delivered in an 18-Fr catheter for 23- to 25-mm diameter aortic stent grafts. Endurant received Food and Drug Administration marketing approval in 2010, and results from the U.S. pivotal trial for this device appeared last year (J. Vasc. Surg. 2011;54:601-8). In the pivotal trial, the major adverse event rate after 30 days was 4%; after 1 year, the patency rate was 97%, no patients had type I endoleaks, and the rate of secondary procedures was 5%, said Dr. Dittmar Böckler, professor and medical director of vascular surgery at the University of Heidelberg (Germany). An even smaller version of the same device, Endurant II, places a 28-mm bifurcated segment of an aortic stent graft into an 18-Fr delivery catheter – reduced from 20 Fr in the existing Endurant device – and has longer limbs to maximize coverage, changes that will further "expand options" for this device, he said.

Other EVAR devices take the downsizing trend even further. The Ovation Abdominal Stent Graft System, which received FDA marketing approval last November, has a 14-Fr outer diameter. For the time being, Ovation "is the lowest-profile commercially available device, expanding the population that is suitable for EVAR," said Dr. Horst Sievert, director of the cardiovascular center at Sankt Katharinen Hospital in Frankfurt, Germany. The FDA also made Ovation the first EVAR to be approved as a humanitarian use device (defined as an instrument aimed at a U.S. patient population that grows by fewer than 4,000 new cases annually). Ovation is approved for use in patients with iliac or femoral artery access that is less than 7 mm in diameter, and for treating an aorta with an inner neck diameter of 15.5-17.4 mm. The clinical trial results for Ovation showed "excellent short-term results," Dr. Sievert said. In the U.S. pivotal trial with 161 patients, the major adverse event rate after 1 month was 2.5%, he noted.

The Zenith Low Profile, a third low-profile EVAR device delivered in a 16-Fr sheath, is nearing marketing approval. The FDA already has data from a U.S. pivotal trial with 120 patients, and a decision on marketing approval should come sometime this year, said Dr. Roy K. Greenberg, a vascular surgeon at the Cleveland Clinic. Although he voiced enthusiasm for lower-profile devices that allow EVAR in patients who would not be able to accommodate larger devices, he also cautioned that "as we get lower-profile devices, we need to pay more attention to iliac disease. Postimplantation residual stenosis is critical for patients with [calcified] iliac disease."

Another issue with new devices is establishing their long-term performance. "New devices aren’t necessarily better; they’re just different. I think there are some advantages to new devices, but we don’t have a track record with respect to their long-term behavior," Dr. Greenberg said.

Finally, the INCRAFT low-profile EVAR device starts testing in a pivotal U.S. trial in February. INCRAFT matches Ovation with a 14-F outer-diameter delivery sheath, said Dr. Robert M. Bersin, medical director of endovascular services at Swedish Medical Center in Seattle. Its track record so far comes from the first 60 patients who received the device, at six centers in Germany and Italy, he added.

• High aortic neck angles. Aside from size, the aortic-neck angle provides another opportunity to broaden the EVAR device market. The Aorfix EVAR device is highly flexible and designed to deal with aortic neck angles of 60 degrees or greater. The stent has a "unique design, because a 60-degree angle is typically an exclusion for most [EVAR] devices," said Dr. William A. Gray, director of endovascular services at Columbia University in New York.

He reviewed the roll-in phase data from the PYTHAGORAS trial, which enrolled 62 patients with aortic neck angles smaller than 60 degrees; two-thirds of these first-phase patients had necks angled at more than 45 degrees. In the roll-in phase, "the Aorflex device has given excellent results in patients with typical anatomy," and the results serve "as a good prelude to the high-angle cases," he said.

The main phase of the trial, which planned to enroll up to 150 patients with high-angle aortic necks, has also finished, but those data are not yet publicly available. Lombard Medical, the company developing this device, submitted the main-phase data to the FDA, and should make the results public in the next 6 months, he said.

• Prefenestrations. Perhaps one of the more exciting new devices is the Ventana fenestrated system, an "off-the-shelf" device that comes with prefenestrations for the renal arteries that precludes the need for a custom-made device.

A current "unmet clinical need" for EVAR is a device to address patients with a short or nonexistent infrarenal neck, something that occurs in about a quarter of abdominal aortic aneurysm patients, said Dr. Daniel Clair, professor and chairman of vascular surgery at the Cleveland Clinic.

The system can potentially treat even aneurysms that include the renal arteries. The material used in the device is a multilayer polytetrafluoroethylene that forms small branches at the fenestrations that reach out into the renal arteries, and the device is delivered in a 22-Fr sheath.

Pilot studies used this system successfully on 15 patients outside the United States last year, and in February the next phase starts with another 30-50 patients scheduled for treatment both in and outside the United States, he said.

The pivotal U.S. trial (with 122 patients scheduled for treatment) also starts this year, with Dr. Clair as the principal investigator.

• Aneurysm sealing. Also in development is an EVAR-like device that’s not a stent. The Nellix system seals an aneurysm endovascularly, by deploying bags that fill with a liquid polymer that quickly solidifies to seal an aneurysm sac around a pair of stents. The system delivers the polymer at greater than blood pressure to extrude all blood from the aneurysm sac, said Dr. Lindsay Machan, a vascular surgeon at the University of British Columbia in Vancouver. This facilitates treatment of aortas with short or severely angulated necks. "The polymer anchors the devise at the bifurcation," Dr. Machan said, producing "remarkable" stability, better than devices that rely on barbs for anchoring.

So far, operators have used the Nellix system in 47 patients in New Zealand and Latvia, the first 31 with a first-generation device and, more recently, the remaining 16 patients with a second-generation version. More than 1 year of follow-up exists for 34 patients. These cases had 100% technical success with no ruptures, no conversions to open repair, and no endoleaks (either persistent or type II), he said. Two patients needed a secondary procedure, one for renal insufficiency, the other for a type I endoleak after 15 months.

The pivotal U.S. trial is planned to start later this year. "This ‘out-of-the-box’ technology addresses many shortcomings of EVAR, and uses a simple insertion procedure that takes 20-30 minutes," Dr. Machan said.

Dr. Böckler said that he has financial relationships with W.L. Gore, Medtronic, VASCOPS, and Siemens. Dr. Sievert said that he has financial relationships with TriVascular, W.L. Gore, and 55 other device companies. Dr. Greenberg said that he has an ownership interest in Cook Medical. Dr. Bersin said that he has financial relationships with Cordis Endovascular, W.L. Gore, Cook, and Bard. Dr. Gray said that he is a consultant to Cordis. Dr. Clair said that he has financial relationships with Endologix, ev3, Medtronic, Boston Scientific, and Covidien. Dr. Machan said that he has financial relationships with Boston Scientific, Cook, Calgary Scientific, Endologix, and Ikomed.

MIAMI BEACH – Devices for endovascular repair of abdominal aortic aneurysms are evolving, with new sizing or other innovations either recently on the market or in studies.

The new products expand the scope of patients who are candidates for endovascular aneurysm repair (EVAR), and in one case bring a new approach to EVAR into the clinic.

During a session at ISET 2012, an international symposium on endovascular therapy, seven experts gave the following quick updates on what’s new in EVAR for 2012:

• Making devices smaller. Downsizing constitutes a major trend for several new EVAR devices. The Endurant device helped blaze the lower-profile path, introducing a device delivered in an 18-Fr catheter for 23- to 25-mm diameter aortic stent grafts. Endurant received Food and Drug Administration marketing approval in 2010, and results from the U.S. pivotal trial for this device appeared last year (J. Vasc. Surg. 2011;54:601-8). In the pivotal trial, the major adverse event rate after 30 days was 4%; after 1 year, the patency rate was 97%, no patients had type I endoleaks, and the rate of secondary procedures was 5%, said Dr. Dittmar Böckler, professor and medical director of vascular surgery at the University of Heidelberg (Germany). An even smaller version of the same device, Endurant II, places a 28-mm bifurcated segment of an aortic stent graft into an 18-Fr delivery catheter – reduced from 20 Fr in the existing Endurant device – and has longer limbs to maximize coverage, changes that will further "expand options" for this device, he said.

Other EVAR devices take the downsizing trend even further. The Ovation Abdominal Stent Graft System, which received FDA marketing approval last November, has a 14-Fr outer diameter. For the time being, Ovation "is the lowest-profile commercially available device, expanding the population that is suitable for EVAR," said Dr. Horst Sievert, director of the cardiovascular center at Sankt Katharinen Hospital in Frankfurt, Germany. The FDA also made Ovation the first EVAR to be approved as a humanitarian use device (defined as an instrument aimed at a U.S. patient population that grows by fewer than 4,000 new cases annually). Ovation is approved for use in patients with iliac or femoral artery access that is less than 7 mm in diameter, and for treating an aorta with an inner neck diameter of 15.5-17.4 mm. The clinical trial results for Ovation showed "excellent short-term results," Dr. Sievert said. In the U.S. pivotal trial with 161 patients, the major adverse event rate after 1 month was 2.5%, he noted.

The Zenith Low Profile, a third low-profile EVAR device delivered in a 16-Fr sheath, is nearing marketing approval. The FDA already has data from a U.S. pivotal trial with 120 patients, and a decision on marketing approval should come sometime this year, said Dr. Roy K. Greenberg, a vascular surgeon at the Cleveland Clinic. Although he voiced enthusiasm for lower-profile devices that allow EVAR in patients who would not be able to accommodate larger devices, he also cautioned that "as we get lower-profile devices, we need to pay more attention to iliac disease. Postimplantation residual stenosis is critical for patients with [calcified] iliac disease."

Another issue with new devices is establishing their long-term performance. "New devices aren’t necessarily better; they’re just different. I think there are some advantages to new devices, but we don’t have a track record with respect to their long-term behavior," Dr. Greenberg said.

Finally, the INCRAFT low-profile EVAR device starts testing in a pivotal U.S. trial in February. INCRAFT matches Ovation with a 14-F outer-diameter delivery sheath, said Dr. Robert M. Bersin, medical director of endovascular services at Swedish Medical Center in Seattle. Its track record so far comes from the first 60 patients who received the device, at six centers in Germany and Italy, he added.

• High aortic neck angles. Aside from size, the aortic-neck angle provides another opportunity to broaden the EVAR device market. The Aorfix EVAR device is highly flexible and designed to deal with aortic neck angles of 60 degrees or greater. The stent has a "unique design, because a 60-degree angle is typically an exclusion for most [EVAR] devices," said Dr. William A. Gray, director of endovascular services at Columbia University in New York.

He reviewed the roll-in phase data from the PYTHAGORAS trial, which enrolled 62 patients with aortic neck angles smaller than 60 degrees; two-thirds of these first-phase patients had necks angled at more than 45 degrees. In the roll-in phase, "the Aorflex device has given excellent results in patients with typical anatomy," and the results serve "as a good prelude to the high-angle cases," he said.

The main phase of the trial, which planned to enroll up to 150 patients with high-angle aortic necks, has also finished, but those data are not yet publicly available. Lombard Medical, the company developing this device, submitted the main-phase data to the FDA, and should make the results public in the next 6 months, he said.

• Prefenestrations. Perhaps one of the more exciting new devices is the Ventana fenestrated system, an "off-the-shelf" device that comes with prefenestrations for the renal arteries that precludes the need for a custom-made device.

A current "unmet clinical need" for EVAR is a device to address patients with a short or nonexistent infrarenal neck, something that occurs in about a quarter of abdominal aortic aneurysm patients, said Dr. Daniel Clair, professor and chairman of vascular surgery at the Cleveland Clinic.

The system can potentially treat even aneurysms that include the renal arteries. The material used in the device is a multilayer polytetrafluoroethylene that forms small branches at the fenestrations that reach out into the renal arteries, and the device is delivered in a 22-Fr sheath.

Pilot studies used this system successfully on 15 patients outside the United States last year, and in February the next phase starts with another 30-50 patients scheduled for treatment both in and outside the United States, he said.

The pivotal U.S. trial (with 122 patients scheduled for treatment) also starts this year, with Dr. Clair as the principal investigator.

• Aneurysm sealing. Also in development is an EVAR-like device that’s not a stent. The Nellix system seals an aneurysm endovascularly, by deploying bags that fill with a liquid polymer that quickly solidifies to seal an aneurysm sac around a pair of stents. The system delivers the polymer at greater than blood pressure to extrude all blood from the aneurysm sac, said Dr. Lindsay Machan, a vascular surgeon at the University of British Columbia in Vancouver. This facilitates treatment of aortas with short or severely angulated necks. "The polymer anchors the devise at the bifurcation," Dr. Machan said, producing "remarkable" stability, better than devices that rely on barbs for anchoring.

So far, operators have used the Nellix system in 47 patients in New Zealand and Latvia, the first 31 with a first-generation device and, more recently, the remaining 16 patients with a second-generation version. More than 1 year of follow-up exists for 34 patients. These cases had 100% technical success with no ruptures, no conversions to open repair, and no endoleaks (either persistent or type II), he said. Two patients needed a secondary procedure, one for renal insufficiency, the other for a type I endoleak after 15 months.

The pivotal U.S. trial is planned to start later this year. "This ‘out-of-the-box’ technology addresses many shortcomings of EVAR, and uses a simple insertion procedure that takes 20-30 minutes," Dr. Machan said.

Dr. Böckler said that he has financial relationships with W.L. Gore, Medtronic, VASCOPS, and Siemens. Dr. Sievert said that he has financial relationships with TriVascular, W.L. Gore, and 55 other device companies. Dr. Greenberg said that he has an ownership interest in Cook Medical. Dr. Bersin said that he has financial relationships with Cordis Endovascular, W.L. Gore, Cook, and Bard. Dr. Gray said that he is a consultant to Cordis. Dr. Clair said that he has financial relationships with Endologix, ev3, Medtronic, Boston Scientific, and Covidien. Dr. Machan said that he has financial relationships with Boston Scientific, Cook, Calgary Scientific, Endologix, and Ikomed.