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Statins reduce recurrent thromboembolism risk
DALLAS – Current use of a statin was associated with significantly reduced risk of recurrent venous thromboembolism in a large national Danish observational study.
The fully adjusted 17% reduction in risk noted in statin users compared with nonusers was driven by a sharp reduction in the risk of recurrent deep venous thrombosis. In contrast, statin use provided no protection against recurrent pulmonary embolism, Dr. Morten Schmidt said at the American Heart Association scientific sessions.
He reported on all 40,780 Danish patients who experienced a first-ever venous thromboembolism (VTE) as recorded in the national hospital registry during 2004-2011.
Statin nonusers had close to an 8% cumulative incidence of recurrent VTE through 12 months of follow-up. The unadjusted risk of a recurrent VTE during months 3-12 after the initial event was 29% lower in current statin users as compared to nonusers. However, statin users were on average older and had a greater burden of comorbidities than nonusers. In a multivariate logistic regression analysis adjusted for these and other potential confounders, including aspirin or anticoagulant use, current statin use remained associated with a 17% lower relative risk of recurrent VTE, according to Dr. Schmidt of Aarhus (Denmark) University.
Current statin users had an unadjusted 48% reduction in the risk of deep venous thrombosis, which in a multivariate regression analysis was modified to a still-highly-significant 26% relative risk reduction.
Session cochair Dr. Brendan M. Everett commented that the results of the earlier landmark JUPITER trial support the Danish national observational study findings. In the nearly 19,000-subject, randomized, double-blind JUPITER study, subjects assigned to rosuvastatin had a highly significant 43% reduction in the risk of incident VTE during follow-up compared with placebo-treated controls. This was driven by a 55% reduction in the risk of incident deep venous thrombosis, with statin therapy having no significant effect on the risk of incident pulmonary embolism (N. Engl. J. Med. 2009;360:1851-61).
The JUPITER results strengthen the Danish study conclusions because JUPITER’s randomized design balances out inherent potential confounders in the observational study design, such as the possibility that statin-treated Danes with a first VTE might have received more comprehensive medical care, noted Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.
Dr. Schmidt reported having no financial conflicts of interest with regard to his study, which was funded by Danish scientific research grants.
DALLAS – Current use of a statin was associated with significantly reduced risk of recurrent venous thromboembolism in a large national Danish observational study.
The fully adjusted 17% reduction in risk noted in statin users compared with nonusers was driven by a sharp reduction in the risk of recurrent deep venous thrombosis. In contrast, statin use provided no protection against recurrent pulmonary embolism, Dr. Morten Schmidt said at the American Heart Association scientific sessions.
He reported on all 40,780 Danish patients who experienced a first-ever venous thromboembolism (VTE) as recorded in the national hospital registry during 2004-2011.
Statin nonusers had close to an 8% cumulative incidence of recurrent VTE through 12 months of follow-up. The unadjusted risk of a recurrent VTE during months 3-12 after the initial event was 29% lower in current statin users as compared to nonusers. However, statin users were on average older and had a greater burden of comorbidities than nonusers. In a multivariate logistic regression analysis adjusted for these and other potential confounders, including aspirin or anticoagulant use, current statin use remained associated with a 17% lower relative risk of recurrent VTE, according to Dr. Schmidt of Aarhus (Denmark) University.
Current statin users had an unadjusted 48% reduction in the risk of deep venous thrombosis, which in a multivariate regression analysis was modified to a still-highly-significant 26% relative risk reduction.
Session cochair Dr. Brendan M. Everett commented that the results of the earlier landmark JUPITER trial support the Danish national observational study findings. In the nearly 19,000-subject, randomized, double-blind JUPITER study, subjects assigned to rosuvastatin had a highly significant 43% reduction in the risk of incident VTE during follow-up compared with placebo-treated controls. This was driven by a 55% reduction in the risk of incident deep venous thrombosis, with statin therapy having no significant effect on the risk of incident pulmonary embolism (N. Engl. J. Med. 2009;360:1851-61).
The JUPITER results strengthen the Danish study conclusions because JUPITER’s randomized design balances out inherent potential confounders in the observational study design, such as the possibility that statin-treated Danes with a first VTE might have received more comprehensive medical care, noted Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.
Dr. Schmidt reported having no financial conflicts of interest with regard to his study, which was funded by Danish scientific research grants.
DALLAS – Current use of a statin was associated with significantly reduced risk of recurrent venous thromboembolism in a large national Danish observational study.
The fully adjusted 17% reduction in risk noted in statin users compared with nonusers was driven by a sharp reduction in the risk of recurrent deep venous thrombosis. In contrast, statin use provided no protection against recurrent pulmonary embolism, Dr. Morten Schmidt said at the American Heart Association scientific sessions.
He reported on all 40,780 Danish patients who experienced a first-ever venous thromboembolism (VTE) as recorded in the national hospital registry during 2004-2011.
Statin nonusers had close to an 8% cumulative incidence of recurrent VTE through 12 months of follow-up. The unadjusted risk of a recurrent VTE during months 3-12 after the initial event was 29% lower in current statin users as compared to nonusers. However, statin users were on average older and had a greater burden of comorbidities than nonusers. In a multivariate logistic regression analysis adjusted for these and other potential confounders, including aspirin or anticoagulant use, current statin use remained associated with a 17% lower relative risk of recurrent VTE, according to Dr. Schmidt of Aarhus (Denmark) University.
Current statin users had an unadjusted 48% reduction in the risk of deep venous thrombosis, which in a multivariate regression analysis was modified to a still-highly-significant 26% relative risk reduction.
Session cochair Dr. Brendan M. Everett commented that the results of the earlier landmark JUPITER trial support the Danish national observational study findings. In the nearly 19,000-subject, randomized, double-blind JUPITER study, subjects assigned to rosuvastatin had a highly significant 43% reduction in the risk of incident VTE during follow-up compared with placebo-treated controls. This was driven by a 55% reduction in the risk of incident deep venous thrombosis, with statin therapy having no significant effect on the risk of incident pulmonary embolism (N. Engl. J. Med. 2009;360:1851-61).
The JUPITER results strengthen the Danish study conclusions because JUPITER’s randomized design balances out inherent potential confounders in the observational study design, such as the possibility that statin-treated Danes with a first VTE might have received more comprehensive medical care, noted Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.
Dr. Schmidt reported having no financial conflicts of interest with regard to his study, which was funded by Danish scientific research grants.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: Patients on statin therapy had an adjusted 17% lower risk of recurrent venous thromboembolism in the year following their first such event, compared with those not on a statin.
Data source: This was a retrospective observational study involving nearly 41,000 Danes who had a first venous thromboembolism during 2004-2011.
Disclosures: Dr. Schmidt reported having no financial conflicts of interest with regard to his study, which was funded by Danish scientific research grants.
In the real world, persistence on warfarin is low
DALLAS – Less than half of patients with a first venous thromboembolism in real-world clinical practice started on warfarin within 10 days after the event, according to a large U.S. study.
Among those who did start, three-quarters discontinued use of the anticoagulant within 1 year.
"Effective and convenient anticoagulants with significant reduction in bleeding risk are needed for long-term treatment of venous thromboembolism and prevention of VTE recurrence," Dr. Xianchen Liu said at the American Heart Association scientific sessions.
Dr. Liu, director of global health economics and outcomes research at Pfizer, presented an analysis of 153,809 adults with a first deep venous thrombosis and/or pulmonary embolus was recorded in the Truven Health MarketScan Commercial and Medicare Supplemental databases. Within 10 days of diagnosis, 46% were treated with warfarin.
Dr. Liu focused on the 39,719 patients with at least 1 year of follow-up, of whom 73% had DVT as their index VTE, 24% had a pulmonary embolism, and 3% had both.
Nearly one in four patients who started on warfarin within 10 days after their index VTE discontinued the anticoagulant after 3 months, 47% after 6 months, and 75% within 1 year. The average treatment duration was 5 months, according to Dr. Liu.
Factors linked to reduced likelihood of warfarin discontinuation included comorbid atrial fibrillation, which was associated with a 25% reduction in risk of discontinuation; thrombophilia, with a 34% relative risk reduction; and pulmonary embolism, with a 24% reduction in discontinuation compared to patients with DVT only.
On the other hand, history of fracture, pregnancy, hormone therapy, or major bleeding within 6 months prior to the index VTE was associated with 24%, 35%, 13%, and 9% increased risks for warfarin discontinuation, respectively.
The clinical importance of these observations lies in the fact that roughly 900,000 incident cases of VTE occur annually in the United States. It is the most common preventable cause of death in hospitalized patients. Indeed, 2%-10% of all hospital deaths are attributed to pulmonary embolism. The VTE recurrence rate is 7%-14% within 1 year, Dr. Liu said.
Pfizer is codeveloper of the novel oral anticoagulant apixaban. Dr. Liu’s MarketScan study is based on data from 2006-2011, before novel anticoagulants became available.
Stroke prevention’s ‘major problem’
In a separate presentation, Dr. Geoffrey D. Barnes called poor warfarin persistence for stroke prevention in patients with atrial fibrillation "a major problem," citing the 38% probability of discontinuation within 1 year in his study of patients started on the drug for this indication at seven anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative.
A silver lining: One-year persistence with warfarin therapy was significantly associated with increasing CHADS2 scores. The 1-year persistence rate among the 1,901 subjects was 29% in those with a CHADS2 score of 0, 56% with a CHADS2 of 1, and 71% in those with a high CHADS2 of 2-6.
In contrast, bleeding risk as determined by baseline HAS-BLED score was unrelated to warfarin persistence, said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.
He reported that 85% of the Michigan patients with atrial fibrillation who discontinued warfarin did so for a known reason. That reason was a bleeding event in 8.3% of cases, change in bleeding risk in 4.7%, death in 9.5%, and ‘indication resolved’ in two-thirds of discontinuations. The likelihood of warfarin discontinuation was particularly high in patients who underwent cardioversion or catheter ablation, even though the implications of those procedures in terms of stroke risk are unresolved.
The ongoing Michigan Anticoagulation Quality Improvement Initiative is funded by Blue Cross Blue Shield of Michigan. Dr. Barnes reported having no financial conflicts of interest.
DALLAS – Less than half of patients with a first venous thromboembolism in real-world clinical practice started on warfarin within 10 days after the event, according to a large U.S. study.
Among those who did start, three-quarters discontinued use of the anticoagulant within 1 year.
"Effective and convenient anticoagulants with significant reduction in bleeding risk are needed for long-term treatment of venous thromboembolism and prevention of VTE recurrence," Dr. Xianchen Liu said at the American Heart Association scientific sessions.
Dr. Liu, director of global health economics and outcomes research at Pfizer, presented an analysis of 153,809 adults with a first deep venous thrombosis and/or pulmonary embolus was recorded in the Truven Health MarketScan Commercial and Medicare Supplemental databases. Within 10 days of diagnosis, 46% were treated with warfarin.
Dr. Liu focused on the 39,719 patients with at least 1 year of follow-up, of whom 73% had DVT as their index VTE, 24% had a pulmonary embolism, and 3% had both.
Nearly one in four patients who started on warfarin within 10 days after their index VTE discontinued the anticoagulant after 3 months, 47% after 6 months, and 75% within 1 year. The average treatment duration was 5 months, according to Dr. Liu.
Factors linked to reduced likelihood of warfarin discontinuation included comorbid atrial fibrillation, which was associated with a 25% reduction in risk of discontinuation; thrombophilia, with a 34% relative risk reduction; and pulmonary embolism, with a 24% reduction in discontinuation compared to patients with DVT only.
On the other hand, history of fracture, pregnancy, hormone therapy, or major bleeding within 6 months prior to the index VTE was associated with 24%, 35%, 13%, and 9% increased risks for warfarin discontinuation, respectively.
The clinical importance of these observations lies in the fact that roughly 900,000 incident cases of VTE occur annually in the United States. It is the most common preventable cause of death in hospitalized patients. Indeed, 2%-10% of all hospital deaths are attributed to pulmonary embolism. The VTE recurrence rate is 7%-14% within 1 year, Dr. Liu said.
Pfizer is codeveloper of the novel oral anticoagulant apixaban. Dr. Liu’s MarketScan study is based on data from 2006-2011, before novel anticoagulants became available.
Stroke prevention’s ‘major problem’
In a separate presentation, Dr. Geoffrey D. Barnes called poor warfarin persistence for stroke prevention in patients with atrial fibrillation "a major problem," citing the 38% probability of discontinuation within 1 year in his study of patients started on the drug for this indication at seven anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative.
A silver lining: One-year persistence with warfarin therapy was significantly associated with increasing CHADS2 scores. The 1-year persistence rate among the 1,901 subjects was 29% in those with a CHADS2 score of 0, 56% with a CHADS2 of 1, and 71% in those with a high CHADS2 of 2-6.
In contrast, bleeding risk as determined by baseline HAS-BLED score was unrelated to warfarin persistence, said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.
He reported that 85% of the Michigan patients with atrial fibrillation who discontinued warfarin did so for a known reason. That reason was a bleeding event in 8.3% of cases, change in bleeding risk in 4.7%, death in 9.5%, and ‘indication resolved’ in two-thirds of discontinuations. The likelihood of warfarin discontinuation was particularly high in patients who underwent cardioversion or catheter ablation, even though the implications of those procedures in terms of stroke risk are unresolved.
The ongoing Michigan Anticoagulation Quality Improvement Initiative is funded by Blue Cross Blue Shield of Michigan. Dr. Barnes reported having no financial conflicts of interest.
DALLAS – Less than half of patients with a first venous thromboembolism in real-world clinical practice started on warfarin within 10 days after the event, according to a large U.S. study.
Among those who did start, three-quarters discontinued use of the anticoagulant within 1 year.
"Effective and convenient anticoagulants with significant reduction in bleeding risk are needed for long-term treatment of venous thromboembolism and prevention of VTE recurrence," Dr. Xianchen Liu said at the American Heart Association scientific sessions.
Dr. Liu, director of global health economics and outcomes research at Pfizer, presented an analysis of 153,809 adults with a first deep venous thrombosis and/or pulmonary embolus was recorded in the Truven Health MarketScan Commercial and Medicare Supplemental databases. Within 10 days of diagnosis, 46% were treated with warfarin.
Dr. Liu focused on the 39,719 patients with at least 1 year of follow-up, of whom 73% had DVT as their index VTE, 24% had a pulmonary embolism, and 3% had both.
Nearly one in four patients who started on warfarin within 10 days after their index VTE discontinued the anticoagulant after 3 months, 47% after 6 months, and 75% within 1 year. The average treatment duration was 5 months, according to Dr. Liu.
Factors linked to reduced likelihood of warfarin discontinuation included comorbid atrial fibrillation, which was associated with a 25% reduction in risk of discontinuation; thrombophilia, with a 34% relative risk reduction; and pulmonary embolism, with a 24% reduction in discontinuation compared to patients with DVT only.
On the other hand, history of fracture, pregnancy, hormone therapy, or major bleeding within 6 months prior to the index VTE was associated with 24%, 35%, 13%, and 9% increased risks for warfarin discontinuation, respectively.
The clinical importance of these observations lies in the fact that roughly 900,000 incident cases of VTE occur annually in the United States. It is the most common preventable cause of death in hospitalized patients. Indeed, 2%-10% of all hospital deaths are attributed to pulmonary embolism. The VTE recurrence rate is 7%-14% within 1 year, Dr. Liu said.
Pfizer is codeveloper of the novel oral anticoagulant apixaban. Dr. Liu’s MarketScan study is based on data from 2006-2011, before novel anticoagulants became available.
Stroke prevention’s ‘major problem’
In a separate presentation, Dr. Geoffrey D. Barnes called poor warfarin persistence for stroke prevention in patients with atrial fibrillation "a major problem," citing the 38% probability of discontinuation within 1 year in his study of patients started on the drug for this indication at seven anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative.
A silver lining: One-year persistence with warfarin therapy was significantly associated with increasing CHADS2 scores. The 1-year persistence rate among the 1,901 subjects was 29% in those with a CHADS2 score of 0, 56% with a CHADS2 of 1, and 71% in those with a high CHADS2 of 2-6.
In contrast, bleeding risk as determined by baseline HAS-BLED score was unrelated to warfarin persistence, said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.
He reported that 85% of the Michigan patients with atrial fibrillation who discontinued warfarin did so for a known reason. That reason was a bleeding event in 8.3% of cases, change in bleeding risk in 4.7%, death in 9.5%, and ‘indication resolved’ in two-thirds of discontinuations. The likelihood of warfarin discontinuation was particularly high in patients who underwent cardioversion or catheter ablation, even though the implications of those procedures in terms of stroke risk are unresolved.
The ongoing Michigan Anticoagulation Quality Improvement Initiative is funded by Blue Cross Blue Shield of Michigan. Dr. Barnes reported having no financial conflicts of interest.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: Less than one-half of patients with a first VTE started on warfarin within 10 days; of those who did, nearly 75% discontinued therapy within 1 year. In a separate study, 38% of Michigan patients with AF placed on warfarin for stroke prevention discontinued treatment within 1 year.
Data source: The VTE study included nearly data from 40,000 patients placed on warfarin within 10 days after the index event and followed for at least 1 year. The atrial fibrillation study included 1,901 patients placed on warfarin for stroke prevention.
Disclosures: The VTE study was funded by Pfizer and presented by a company executive. The AF study was conducted by the Michigan Anticoagulation Quality Improvement Initiative and presented by a cardiologist without financial conflicts of interest.
Extracorporeal shock wave therapy promising for lymphedema
SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.
In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.
Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).
A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm2 once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.
None of the patients had to interrupt ECSW therapy due to complications.
The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.
The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.
No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.
Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.
SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.
In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.
Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).
A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm2 once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.
None of the patients had to interrupt ECSW therapy due to complications.
The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.
The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.
No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.
Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.
SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.
In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.
Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).
A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm2 once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.
None of the patients had to interrupt ECSW therapy due to complications.
The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.
The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.
No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.
Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.
AT SABCS 2013
Major finding: Women with lymphedema following axillary lymphadenectomy had a median 192.5-mL reduction in whole-arm water volume displacement following 10 weekly sessions of extracorporeal shock wave therapy. Controls who underwent sham therapy had a modest 12.5-mL decrease.
Data source: This is an interim report on the first 10 patients in a planned 30-patient, randomized, sham-controlled trial.
Disclosures: Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.
Ten-year outcomes for ablation in atrial fibrillation impressive
DALLAS – At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
DALLAS – At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
DALLAS – At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: A decade after 513 patients underwent extensive pulmonary vein antrum isolation for drug-resistant paroxysmal atrial fibrillation, 87% were free of atrial fibrillation/atrial tachycardia, including 59% with single-procedure arrhythmia-free survival.
Data source: A retrospective case series involving 513 patients who underwent pulmonary vein antrum isolation during 2000-2002 at a single high-volume center.
Disclosures: The presenter reported having no financial conflicts.
Ten-year outcomes for ablation in atrial fibrillation impressive
DALLAS - At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David?s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
DALLAS - At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David?s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
DALLAS - At 10 years after their procedures, the rate of freedom from atrial fibrillation and atrial tachycardia was 87% in 513 patients who underwent pulmonary vein antrum isolation for drug-refractory paroxysmal atrial fibrillation at a single high-volume center in Texas.
After a single radiofrequency ablation procedure, 59% of patients remained arrhythmia free for the full decade and another 28% of the cohort was rendered arrhythmia free after an average of two repeat ablation procedures, Dr. Pasquale Santangeli reported at the American Heart Association scientific sessions.
A particularly striking finding in this series was the low 4% rate of recurrent atrial arrhythmias during years 3-6 of follow-up, and the 5% rate between years 6 and 10. Those late recurrence rates are much lower than those in previous reports from other centers. The likely explanation lies in the fact that electrophysiologists at the Austin center routinely extended their pulmonary vein antrum isolation to the posterior wall and performed empiric isolation of the superior vena cava in all patients. Other centers reporting long-term outcomes generally performed segmental or less extensive antral isolation, observed Dr. Santangeli of the Texas Cardiac Arrhythmia Institute at St. David?s Medical Center in Austin, Tex., and the University of Foggia (Italy).
Follow-up, including Holter monitoring, was performed every 3 months during year 1 and every 6-9 months thereafter. The rate of recurrent atrial arrhythmia was 21% at 1 year and 11% during years 1-3.
All patients with a recurrence were offered a repeat procedure, and 74% of them underwent repeat ablation. Reconnection in the pulmonary vein antrum was found in 31% of patients at the time of their first repeat procedure and in no patients who underwent a second repeat ablation.
Patients with recurrent atrial arrhythmia after two failed procedures underwent a high-dose isoproterenol challenge to identify nonpulmonary vein triggers, which were then targeted for ablation. The predictors of very late recurrence due to nonpulmonary vein triggers were increased left atrial size, obesity, and female gender.
Dr. Santangeli reported having no financial conflicts in connection with this study, which was honored as the top presentation by an early career investigator in the core area of heart rhythm disorders and resuscitation science at the annual meeting.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: A decade after 513 patients underwent extensive pulmonary vein antrum isolation for drug-resistant paroxysmal atrial fibrillation, 87% were free of atrial fibrillation/atrial tachycardia, including 59% with single-procedure arrhythmia-free survival.
Data source: A retrospective case series involving 513 patients who underwent pulmonary vein antrum isolation during 2000-2002 at a single high-volume center.
Disclosures: The presenter reported having no financial conflicts.
In utero exposure to dyslipidemia magnifies LDL risk in offspring
DALLAS – Elevated LDL cholesterol in women before childbirth was associated with a fivefold increased risk of elevated LDL 2 decades later in their young adult offspring in a new analysis from the Framingham Heart Study.
In contrast, paternal elevation of LDL pre pregnancy was not associated with increased likelihood of hyperlipidemia in children at age 20 years.
In utero exposure to maternal dyslipidemia appears to have lasting adverse consequences in terms of cardiovascular disease risk. If confirmed, the implications of the findings are huge, given that an estimated 25% of American women of childbearing age have elevated LDL, according to National Health and Nutrition Examination Survey data, Dr. Michael M. Mendelson noted at the American Heart Association scientific sessions.
"We postulate that identifying young women of childbearing age with dyslipidemia and reducing abnormal LDL with lipid-specific healthy lifestyle interventions may further reduce the transgenerational cycle of dyslipidemia and cardiovascular disease risk," declared Dr. Mendelson of Boston Children’s Hospital.
He presented prospectively acquired data on 343 maternal-child pairs enrolled in the Framingham Heart Study. Parental serum lipids were measured roughly 3 years prior to childbirth and again 20 years later, when the now young-adult offspring also had their serum lipids measured as part of their first comprehensive assessment as Framingham participants.
Women with an LDL level greater than 130 mg/dL at their prebirth assessment were fivefold more likely to have young-adult offspring with an elevated LDL in a multivariate analysis adjusted for maternal age and offspring gender. With further adjustment for prepregnancy maternal body mass index, smoking status, and genetic variants known to be associated with LDL level – most notably familial hypercholesterolemia – maternal dyslipidemia pre pregnancy remained associated with a highly significant 3.7-fold increased risk of dyslipidemia in young-adult offspring (P = .004).
In contrast, high paternal LDL pre pregnancy was not associated with increased odds of adult dyslipidemia in the offspring. And neither high maternal nor paternal LDL measured 20 years after childbirth was linked to increased likelihood of dyslipidemia in 20-year-old children in the fully adjusted multivariate logistic regression analysis.
The Framingham Heart Study is funded by the National Institutes of Health. Dr. Mendelson reported having no financial conflicts of interest.
DALLAS – Elevated LDL cholesterol in women before childbirth was associated with a fivefold increased risk of elevated LDL 2 decades later in their young adult offspring in a new analysis from the Framingham Heart Study.
In contrast, paternal elevation of LDL pre pregnancy was not associated with increased likelihood of hyperlipidemia in children at age 20 years.
In utero exposure to maternal dyslipidemia appears to have lasting adverse consequences in terms of cardiovascular disease risk. If confirmed, the implications of the findings are huge, given that an estimated 25% of American women of childbearing age have elevated LDL, according to National Health and Nutrition Examination Survey data, Dr. Michael M. Mendelson noted at the American Heart Association scientific sessions.
"We postulate that identifying young women of childbearing age with dyslipidemia and reducing abnormal LDL with lipid-specific healthy lifestyle interventions may further reduce the transgenerational cycle of dyslipidemia and cardiovascular disease risk," declared Dr. Mendelson of Boston Children’s Hospital.
He presented prospectively acquired data on 343 maternal-child pairs enrolled in the Framingham Heart Study. Parental serum lipids were measured roughly 3 years prior to childbirth and again 20 years later, when the now young-adult offspring also had their serum lipids measured as part of their first comprehensive assessment as Framingham participants.
Women with an LDL level greater than 130 mg/dL at their prebirth assessment were fivefold more likely to have young-adult offspring with an elevated LDL in a multivariate analysis adjusted for maternal age and offspring gender. With further adjustment for prepregnancy maternal body mass index, smoking status, and genetic variants known to be associated with LDL level – most notably familial hypercholesterolemia – maternal dyslipidemia pre pregnancy remained associated with a highly significant 3.7-fold increased risk of dyslipidemia in young-adult offspring (P = .004).
In contrast, high paternal LDL pre pregnancy was not associated with increased odds of adult dyslipidemia in the offspring. And neither high maternal nor paternal LDL measured 20 years after childbirth was linked to increased likelihood of dyslipidemia in 20-year-old children in the fully adjusted multivariate logistic regression analysis.
The Framingham Heart Study is funded by the National Institutes of Health. Dr. Mendelson reported having no financial conflicts of interest.
DALLAS – Elevated LDL cholesterol in women before childbirth was associated with a fivefold increased risk of elevated LDL 2 decades later in their young adult offspring in a new analysis from the Framingham Heart Study.
In contrast, paternal elevation of LDL pre pregnancy was not associated with increased likelihood of hyperlipidemia in children at age 20 years.
In utero exposure to maternal dyslipidemia appears to have lasting adverse consequences in terms of cardiovascular disease risk. If confirmed, the implications of the findings are huge, given that an estimated 25% of American women of childbearing age have elevated LDL, according to National Health and Nutrition Examination Survey data, Dr. Michael M. Mendelson noted at the American Heart Association scientific sessions.
"We postulate that identifying young women of childbearing age with dyslipidemia and reducing abnormal LDL with lipid-specific healthy lifestyle interventions may further reduce the transgenerational cycle of dyslipidemia and cardiovascular disease risk," declared Dr. Mendelson of Boston Children’s Hospital.
He presented prospectively acquired data on 343 maternal-child pairs enrolled in the Framingham Heart Study. Parental serum lipids were measured roughly 3 years prior to childbirth and again 20 years later, when the now young-adult offspring also had their serum lipids measured as part of their first comprehensive assessment as Framingham participants.
Women with an LDL level greater than 130 mg/dL at their prebirth assessment were fivefold more likely to have young-adult offspring with an elevated LDL in a multivariate analysis adjusted for maternal age and offspring gender. With further adjustment for prepregnancy maternal body mass index, smoking status, and genetic variants known to be associated with LDL level – most notably familial hypercholesterolemia – maternal dyslipidemia pre pregnancy remained associated with a highly significant 3.7-fold increased risk of dyslipidemia in young-adult offspring (P = .004).
In contrast, high paternal LDL pre pregnancy was not associated with increased odds of adult dyslipidemia in the offspring. And neither high maternal nor paternal LDL measured 20 years after childbirth was linked to increased likelihood of dyslipidemia in 20-year-old children in the fully adjusted multivariate logistic regression analysis.
The Framingham Heart Study is funded by the National Institutes of Health. Dr. Mendelson reported having no financial conflicts of interest.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: With further adjustment for prepregnancy maternal body mass index, smoking status, and genetic variants known to be associated with LDL level – most notably familial hypercholesterolemia – maternal dyslipidemia before pregnancy remained associated with a highly significant 3.7-fold increased risk of dyslipidemia in young-adult offspring (P = .004).
Data source: Prospectively acquired data on 343 maternal-child pairs enrolled in the Framingham Heart Study.
Disclosures: The study is funded by the National Institutes of Health. The presenter reported having no financial disclosures.
Routinely screen relatives when thoracic aortic aneurysm disease presents before age 60
DALLAS – Routine screening is warranted for the first-degree relatives of patients who present with thoracic aortic disease before age 60 years in the absence of predisposing conditions such as hypertension, Marfan syndrome, or bicuspid aortic valve, Dr. Elizabeth N. Robertson said at the American Heart Association scientific sessions.
"We’ve shown that screening of first-degree relatives for familial thoracic aortic aneurysm disease is essential, as we detected an average of two additional affected individuals per initial patient," noted Dr. Robertson of Royal Prince Alfred Hospital in Camperdown, Australia.
Thoracic aortic aneurysm and dissection (TAAD) is more common than previously recognized. It accounted for one in seven cases of thoracic aortic disease in a series of 1,276 patients who presented with thoracic aortic disease to the tertiary center during a recent 12-year period.
TAAD is an asymptomatic progressive dilatation of the thoracic aorta characterized by cystic medial necrosis. It has no evident predisposing cause. It can occur sporadically or in a familial form, which has been linked to multiple gene mutations transmitted in autosomal dominant fashion in large family studies. Unlike Marfan syndrome, Ehler-Danlos syndrome, and other genetic causes of thoracic aortic disease, TAAD has no characteristic external physical features. The clinical signs of TAAD are minimal and nonpathognomonic: an aortic flow murmur or a prominent A2 second heart sound.
"The most common first indication of a problem is occurrence of aortic dissection, by which time it’s often too late," she said.
Dr. Robertson and her coinvestigators did a retrospective review of 1,276 patients who presented with thoracic aortic disease at the Royal Prince Alfred Hospital cardiovascular myopathy service during 2000-2012. TAAD was seen in 178. TAAD was defined as aortic dilatation or dissection before age 60 years with no predisposing condition and with confirmation of cystic medial necrosis whenever possible. TAAD was sporadic in 93 patients. The other 85 had familial TAAD based upon their history of having one or more affected family members. Screening was offered to all first-degree relatives of the patients with familial TAAD.
Two-dimensional echocardiographic screening of 383 first-degree family members identified an additional 181 affected individuals, bringing the total study population with familial TAAD to 266. When the screened patients were added to the 93 patients with sporadic TAAD, thoracic aortic aneurysm and dissection became the second most common cause of thoracic aortic dilatation or dissection seen at the hospital during the study period.
The median age at diagnosis was 46 years both in the sporadic and familial TAAD groups. However, the detection rate was steady from the teen years through old age, underscoring the importance of surveillance of younger at-risk individuals. Most of the at-risk population was male, 73% of the familial and 86% of the sporadic cases. The aortic diameter at diagnosis varied, but it was 50 mm or greater in 25% of the subjects in the familial and sporadic groups. Under current guidelines, this measure warrants semi-urgent surgical intervention.
Of the first-degree relatives identified through screening, 26% experienced aortic dissection, as did more than 60% of the initial 85 probands with familial TAAD. The familial phenotype appears to be more aggressive: 40% of patients with familial TAAD who had an aortic dissection died as a result, compared with less than 15% of patients with sporadic TAAD who had aortic dissection.
Dissection in patients with familial TAAD frequently occurred at smaller aortic diameters, including less than 40 mm. Dr. Robertson noted this width would not typically be flagged as a problematic in routine screening.
The rate of progression of dilatation in patients with familial TAAD was 0.5 mm per year, which is roughly half the rate typically seen in patients with Marfan syndrome, according to Dr. Robertson.
Session cochair Dr. Brendan M. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston, called Dr. Robertson’s study "fascinating" and thanked her for bringing to his attention a serious and relatively common condition he was hitherto unaware of. Given that aortic size is age-, gender-, and body surface area–dependent, what’s the best threshold aortic diameter in defining a positive screening test in first-degree relatives?, he asked.
Because of those associations, Dr. Robertson replied, the best definition of a positive screening test is a Z score greater than 2, rather than simply relying upon a given aortic diameter measurement.
Dr. Robertson’s study was conducted free of commercial support. She reported having no financial conflicts of interest.
DALLAS – Routine screening is warranted for the first-degree relatives of patients who present with thoracic aortic disease before age 60 years in the absence of predisposing conditions such as hypertension, Marfan syndrome, or bicuspid aortic valve, Dr. Elizabeth N. Robertson said at the American Heart Association scientific sessions.
"We’ve shown that screening of first-degree relatives for familial thoracic aortic aneurysm disease is essential, as we detected an average of two additional affected individuals per initial patient," noted Dr. Robertson of Royal Prince Alfred Hospital in Camperdown, Australia.
Thoracic aortic aneurysm and dissection (TAAD) is more common than previously recognized. It accounted for one in seven cases of thoracic aortic disease in a series of 1,276 patients who presented with thoracic aortic disease to the tertiary center during a recent 12-year period.
TAAD is an asymptomatic progressive dilatation of the thoracic aorta characterized by cystic medial necrosis. It has no evident predisposing cause. It can occur sporadically or in a familial form, which has been linked to multiple gene mutations transmitted in autosomal dominant fashion in large family studies. Unlike Marfan syndrome, Ehler-Danlos syndrome, and other genetic causes of thoracic aortic disease, TAAD has no characteristic external physical features. The clinical signs of TAAD are minimal and nonpathognomonic: an aortic flow murmur or a prominent A2 second heart sound.
"The most common first indication of a problem is occurrence of aortic dissection, by which time it’s often too late," she said.
Dr. Robertson and her coinvestigators did a retrospective review of 1,276 patients who presented with thoracic aortic disease at the Royal Prince Alfred Hospital cardiovascular myopathy service during 2000-2012. TAAD was seen in 178. TAAD was defined as aortic dilatation or dissection before age 60 years with no predisposing condition and with confirmation of cystic medial necrosis whenever possible. TAAD was sporadic in 93 patients. The other 85 had familial TAAD based upon their history of having one or more affected family members. Screening was offered to all first-degree relatives of the patients with familial TAAD.
Two-dimensional echocardiographic screening of 383 first-degree family members identified an additional 181 affected individuals, bringing the total study population with familial TAAD to 266. When the screened patients were added to the 93 patients with sporadic TAAD, thoracic aortic aneurysm and dissection became the second most common cause of thoracic aortic dilatation or dissection seen at the hospital during the study period.
The median age at diagnosis was 46 years both in the sporadic and familial TAAD groups. However, the detection rate was steady from the teen years through old age, underscoring the importance of surveillance of younger at-risk individuals. Most of the at-risk population was male, 73% of the familial and 86% of the sporadic cases. The aortic diameter at diagnosis varied, but it was 50 mm or greater in 25% of the subjects in the familial and sporadic groups. Under current guidelines, this measure warrants semi-urgent surgical intervention.
Of the first-degree relatives identified through screening, 26% experienced aortic dissection, as did more than 60% of the initial 85 probands with familial TAAD. The familial phenotype appears to be more aggressive: 40% of patients with familial TAAD who had an aortic dissection died as a result, compared with less than 15% of patients with sporadic TAAD who had aortic dissection.
Dissection in patients with familial TAAD frequently occurred at smaller aortic diameters, including less than 40 mm. Dr. Robertson noted this width would not typically be flagged as a problematic in routine screening.
The rate of progression of dilatation in patients with familial TAAD was 0.5 mm per year, which is roughly half the rate typically seen in patients with Marfan syndrome, according to Dr. Robertson.
Session cochair Dr. Brendan M. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston, called Dr. Robertson’s study "fascinating" and thanked her for bringing to his attention a serious and relatively common condition he was hitherto unaware of. Given that aortic size is age-, gender-, and body surface area–dependent, what’s the best threshold aortic diameter in defining a positive screening test in first-degree relatives?, he asked.
Because of those associations, Dr. Robertson replied, the best definition of a positive screening test is a Z score greater than 2, rather than simply relying upon a given aortic diameter measurement.
Dr. Robertson’s study was conducted free of commercial support. She reported having no financial conflicts of interest.
DALLAS – Routine screening is warranted for the first-degree relatives of patients who present with thoracic aortic disease before age 60 years in the absence of predisposing conditions such as hypertension, Marfan syndrome, or bicuspid aortic valve, Dr. Elizabeth N. Robertson said at the American Heart Association scientific sessions.
"We’ve shown that screening of first-degree relatives for familial thoracic aortic aneurysm disease is essential, as we detected an average of two additional affected individuals per initial patient," noted Dr. Robertson of Royal Prince Alfred Hospital in Camperdown, Australia.
Thoracic aortic aneurysm and dissection (TAAD) is more common than previously recognized. It accounted for one in seven cases of thoracic aortic disease in a series of 1,276 patients who presented with thoracic aortic disease to the tertiary center during a recent 12-year period.
TAAD is an asymptomatic progressive dilatation of the thoracic aorta characterized by cystic medial necrosis. It has no evident predisposing cause. It can occur sporadically or in a familial form, which has been linked to multiple gene mutations transmitted in autosomal dominant fashion in large family studies. Unlike Marfan syndrome, Ehler-Danlos syndrome, and other genetic causes of thoracic aortic disease, TAAD has no characteristic external physical features. The clinical signs of TAAD are minimal and nonpathognomonic: an aortic flow murmur or a prominent A2 second heart sound.
"The most common first indication of a problem is occurrence of aortic dissection, by which time it’s often too late," she said.
Dr. Robertson and her coinvestigators did a retrospective review of 1,276 patients who presented with thoracic aortic disease at the Royal Prince Alfred Hospital cardiovascular myopathy service during 2000-2012. TAAD was seen in 178. TAAD was defined as aortic dilatation or dissection before age 60 years with no predisposing condition and with confirmation of cystic medial necrosis whenever possible. TAAD was sporadic in 93 patients. The other 85 had familial TAAD based upon their history of having one or more affected family members. Screening was offered to all first-degree relatives of the patients with familial TAAD.
Two-dimensional echocardiographic screening of 383 first-degree family members identified an additional 181 affected individuals, bringing the total study population with familial TAAD to 266. When the screened patients were added to the 93 patients with sporadic TAAD, thoracic aortic aneurysm and dissection became the second most common cause of thoracic aortic dilatation or dissection seen at the hospital during the study period.
The median age at diagnosis was 46 years both in the sporadic and familial TAAD groups. However, the detection rate was steady from the teen years through old age, underscoring the importance of surveillance of younger at-risk individuals. Most of the at-risk population was male, 73% of the familial and 86% of the sporadic cases. The aortic diameter at diagnosis varied, but it was 50 mm or greater in 25% of the subjects in the familial and sporadic groups. Under current guidelines, this measure warrants semi-urgent surgical intervention.
Of the first-degree relatives identified through screening, 26% experienced aortic dissection, as did more than 60% of the initial 85 probands with familial TAAD. The familial phenotype appears to be more aggressive: 40% of patients with familial TAAD who had an aortic dissection died as a result, compared with less than 15% of patients with sporadic TAAD who had aortic dissection.
Dissection in patients with familial TAAD frequently occurred at smaller aortic diameters, including less than 40 mm. Dr. Robertson noted this width would not typically be flagged as a problematic in routine screening.
The rate of progression of dilatation in patients with familial TAAD was 0.5 mm per year, which is roughly half the rate typically seen in patients with Marfan syndrome, according to Dr. Robertson.
Session cochair Dr. Brendan M. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston, called Dr. Robertson’s study "fascinating" and thanked her for bringing to his attention a serious and relatively common condition he was hitherto unaware of. Given that aortic size is age-, gender-, and body surface area–dependent, what’s the best threshold aortic diameter in defining a positive screening test in first-degree relatives?, he asked.
Because of those associations, Dr. Robertson replied, the best definition of a positive screening test is a Z score greater than 2, rather than simply relying upon a given aortic diameter measurement.
Dr. Robertson’s study was conducted free of commercial support. She reported having no financial conflicts of interest.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: One in seven patients presenting with thoracic aortic disease in a large series had thoracic aortic aneurysm and dissection, or TAAD, an under-recognized, asymptomatic condition characterized by cystic medial necrosis and a strong genetic component.
Data source: This was a review of 1,276 patients who presented to a tertiary center with thoracic aortic disease. Systemic screening of first-degree relatives of patients with familial TAAD turned up two additional cases per proband.
Disclosures: The study was conducted free of commercial support. The presenter reported having no financial conflicts.
Opportunities to Boost Cardiovascular Disease Awareness
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care clinicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care clinicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care clinicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
AT THE AHA SCIENTIFIC SESSIONS
Opportunities to boost cardiovascular disease awareness
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.
"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.
The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.
"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.
The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.
Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: Two-thirds of the women whose primary care provider was an ob.gyn. said their physician does not discuss heart health with them.
Data source: This was a survey of 1,013 women attending five ob.gyn. clinics affiliated with Montefiore Medical Center in New York.
Disclosures: The presenter of this unfunded study reported having no financial conflicts.
No link found between high-potency statins andacute kidney injury
DALLAS – High-potency statin therapy given post acute coronary syndrome did not raise serum creatinine or cause more risk of acute kidney injury than low-potency statin regimens did in a new analysis of two published landmark randomized clinical trials.
"Considering the recently updated AHA/American College of Cardiology lipid guidelines, which call for the use of high-potency statins in millions more patients, these findings provide important reassurance that a high-potency statin regimen will not increase the incidence of adverse renal events," Dr. Amy Sarma said in presenting the study results at the American Heart Association scientific sessions.
She noted that a recent Canadian observational study utilizing Canadian and U.S. administrative databases totaling more than 2 million patients over age 40 who were newly placed on statin therapy showed an adjusted 1.34-fold increased rate of hospitalization for acute kidney injury within the first 120 days in those on a high- as compared to a low-potency regimen, and a 1.11-fold increased risk beyond 120 days through the end of the first year (BMJ 2013;346:f880). Both risk elevations were statistically significant.
However, observational studies such as this are prone to bias in the form of potentially crucial differences between the patients given a prescription for statins and those who aren’t. For this reason, Dr. Sarma and her coinvestigators turned for guidance to two randomized trials of high- versus low-dose statins, since this study design obviates the risks of confounding. The trials were PROVE IT-TIMI 22 (N. Engl. J. Med. 2004;350:1495-504) and the A-to-Z trial (JAMA 2004;292:1307-16).
PROVE IT included 4,122 patients randomized within 10 days post ACS to standard background therapy plus either pravastatin at 40 mg/day or atorvastatin at 80 mg/day. A-to-Z involved 4,497 patients who were placed on simvastatin at either 20 or 80 mg/day within 5 days post ACS. Both trials had a median follow-up of 2 years, and both featured serial measurements of serum creatinine. Two-thirds of subjects in PROVE IT had a baseline estimated glomerular filtration rate below 90 mL/min per 1.73 m2, while two-thirds of those in A-to-Z had a baseline eGFR less than 60, noted Dr. Sarma of Brigham and Women’s Hospital, Boston.
In both studies, mean serum creatinine rose equally during the first 30 days of statin therapy, regardless of treatment potency, and then levels declined. In PROVE IT, for example, serum creatinine in the pravastatin and atorvastatin arms rose by 0.96% and 0.97% above baseline, respectively, at 30 days. Values then dropped by 2.88% and 3.85% from baseline at 4 months, and by 3.88% and 5.83% at 16 months.
In both studies, there was no difference between the high- and low-potency statin groups in the incidence of any increase in serum creatinine of at least 1.5-fold, 2.0-fold, or 3.0-fold greater than baseline. In other words, there was no hint of a safety signal, she added.
Dr. Sarma reported having no financial conflicts of interest.
I’m not convinced by the PROVE IT and A-to-Z data. In the combined analysis, the high-potency statin group had a 15% greater risk of acute kidney injury compared with the low-potency statin group during the first 4 months of treatment. Although that wasn’t a statistically significant difference due to limited patient numbers and broad confidence intervals, it was quite similar to the long-term 11% increased risk seen in the Canadian observational database study with 2 million patients.
Moreover, an even bigger recent observational study led by investigators at the University of North Carolina, Chapel Hill, involving 3.9 million U.S. statin initiators found a 42% greater rate of acute kidney injury during the first year on high- as compared to lower-dose simvastatin in commercially insured patients and a 24% increased risk in the Medicare population. Both risk increases were statistically significant due to the huge patient numbers (Pharmacoepidemiol. Drug Saf. 2013;22:1061-70).
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Also, PROVE IT and A-to-Z featured patient populations who were of a younger average age and less likely to be male and to have diabetes than the general American population of acute MI patients as depicted in the National Cardiovascular Data Registry (J. Am. Coll. Cardiol. 2013;62:1931-47). Advancing age, diabetes, and male gender are predisposing factors for acute kidney disease.
The Canadian observational study defined high-potency statin therapy as at least 20 mg/day of atorvastatin or 40 mg or simvastatin. The University of North Carolina study also defined high-potency simvastatin as at least 40 mg/day as opposed to the 80 mg/day employed in the A-to-Z trial. One wonders whether they would have seen an even larger magnitude of association had they used a higher threshold to define high potency.
I don’t necessarily disagree with Dr. Sarma’s conclusion that for most people after ACS a high-potency statin will be warranted. I just think we need to be cautious and think about the individual patient when we consider the risks and benefits.
It may well be the case that high-potency statin therapy means fewer cardiovascular events at the cost of a greater risk of acute kidney injury and other adverse events. With lower-potency statins, the trade-off may be more cardiovascular events but a lower acute kidney injury risk.
Dr. Tara Chang is a nephrologist at Stanford (Calif.) University. She was the discussant of the paper at the meeting. Dr. Chang disclosed having no financial conflicts.
I’m not convinced by the PROVE IT and A-to-Z data. In the combined analysis, the high-potency statin group had a 15% greater risk of acute kidney injury compared with the low-potency statin group during the first 4 months of treatment. Although that wasn’t a statistically significant difference due to limited patient numbers and broad confidence intervals, it was quite similar to the long-term 11% increased risk seen in the Canadian observational database study with 2 million patients.
Moreover, an even bigger recent observational study led by investigators at the University of North Carolina, Chapel Hill, involving 3.9 million U.S. statin initiators found a 42% greater rate of acute kidney injury during the first year on high- as compared to lower-dose simvastatin in commercially insured patients and a 24% increased risk in the Medicare population. Both risk increases were statistically significant due to the huge patient numbers (Pharmacoepidemiol. Drug Saf. 2013;22:1061-70).
|
|
Also, PROVE IT and A-to-Z featured patient populations who were of a younger average age and less likely to be male and to have diabetes than the general American population of acute MI patients as depicted in the National Cardiovascular Data Registry (J. Am. Coll. Cardiol. 2013;62:1931-47). Advancing age, diabetes, and male gender are predisposing factors for acute kidney disease.
The Canadian observational study defined high-potency statin therapy as at least 20 mg/day of atorvastatin or 40 mg or simvastatin. The University of North Carolina study also defined high-potency simvastatin as at least 40 mg/day as opposed to the 80 mg/day employed in the A-to-Z trial. One wonders whether they would have seen an even larger magnitude of association had they used a higher threshold to define high potency.
I don’t necessarily disagree with Dr. Sarma’s conclusion that for most people after ACS a high-potency statin will be warranted. I just think we need to be cautious and think about the individual patient when we consider the risks and benefits.
It may well be the case that high-potency statin therapy means fewer cardiovascular events at the cost of a greater risk of acute kidney injury and other adverse events. With lower-potency statins, the trade-off may be more cardiovascular events but a lower acute kidney injury risk.
Dr. Tara Chang is a nephrologist at Stanford (Calif.) University. She was the discussant of the paper at the meeting. Dr. Chang disclosed having no financial conflicts.
I’m not convinced by the PROVE IT and A-to-Z data. In the combined analysis, the high-potency statin group had a 15% greater risk of acute kidney injury compared with the low-potency statin group during the first 4 months of treatment. Although that wasn’t a statistically significant difference due to limited patient numbers and broad confidence intervals, it was quite similar to the long-term 11% increased risk seen in the Canadian observational database study with 2 million patients.
Moreover, an even bigger recent observational study led by investigators at the University of North Carolina, Chapel Hill, involving 3.9 million U.S. statin initiators found a 42% greater rate of acute kidney injury during the first year on high- as compared to lower-dose simvastatin in commercially insured patients and a 24% increased risk in the Medicare population. Both risk increases were statistically significant due to the huge patient numbers (Pharmacoepidemiol. Drug Saf. 2013;22:1061-70).
|
|
Also, PROVE IT and A-to-Z featured patient populations who were of a younger average age and less likely to be male and to have diabetes than the general American population of acute MI patients as depicted in the National Cardiovascular Data Registry (J. Am. Coll. Cardiol. 2013;62:1931-47). Advancing age, diabetes, and male gender are predisposing factors for acute kidney disease.
The Canadian observational study defined high-potency statin therapy as at least 20 mg/day of atorvastatin or 40 mg or simvastatin. The University of North Carolina study also defined high-potency simvastatin as at least 40 mg/day as opposed to the 80 mg/day employed in the A-to-Z trial. One wonders whether they would have seen an even larger magnitude of association had they used a higher threshold to define high potency.
I don’t necessarily disagree with Dr. Sarma’s conclusion that for most people after ACS a high-potency statin will be warranted. I just think we need to be cautious and think about the individual patient when we consider the risks and benefits.
It may well be the case that high-potency statin therapy means fewer cardiovascular events at the cost of a greater risk of acute kidney injury and other adverse events. With lower-potency statins, the trade-off may be more cardiovascular events but a lower acute kidney injury risk.
Dr. Tara Chang is a nephrologist at Stanford (Calif.) University. She was the discussant of the paper at the meeting. Dr. Chang disclosed having no financial conflicts.
DALLAS – High-potency statin therapy given post acute coronary syndrome did not raise serum creatinine or cause more risk of acute kidney injury than low-potency statin regimens did in a new analysis of two published landmark randomized clinical trials.
"Considering the recently updated AHA/American College of Cardiology lipid guidelines, which call for the use of high-potency statins in millions more patients, these findings provide important reassurance that a high-potency statin regimen will not increase the incidence of adverse renal events," Dr. Amy Sarma said in presenting the study results at the American Heart Association scientific sessions.
She noted that a recent Canadian observational study utilizing Canadian and U.S. administrative databases totaling more than 2 million patients over age 40 who were newly placed on statin therapy showed an adjusted 1.34-fold increased rate of hospitalization for acute kidney injury within the first 120 days in those on a high- as compared to a low-potency regimen, and a 1.11-fold increased risk beyond 120 days through the end of the first year (BMJ 2013;346:f880). Both risk elevations were statistically significant.
However, observational studies such as this are prone to bias in the form of potentially crucial differences between the patients given a prescription for statins and those who aren’t. For this reason, Dr. Sarma and her coinvestigators turned for guidance to two randomized trials of high- versus low-dose statins, since this study design obviates the risks of confounding. The trials were PROVE IT-TIMI 22 (N. Engl. J. Med. 2004;350:1495-504) and the A-to-Z trial (JAMA 2004;292:1307-16).
PROVE IT included 4,122 patients randomized within 10 days post ACS to standard background therapy plus either pravastatin at 40 mg/day or atorvastatin at 80 mg/day. A-to-Z involved 4,497 patients who were placed on simvastatin at either 20 or 80 mg/day within 5 days post ACS. Both trials had a median follow-up of 2 years, and both featured serial measurements of serum creatinine. Two-thirds of subjects in PROVE IT had a baseline estimated glomerular filtration rate below 90 mL/min per 1.73 m2, while two-thirds of those in A-to-Z had a baseline eGFR less than 60, noted Dr. Sarma of Brigham and Women’s Hospital, Boston.
In both studies, mean serum creatinine rose equally during the first 30 days of statin therapy, regardless of treatment potency, and then levels declined. In PROVE IT, for example, serum creatinine in the pravastatin and atorvastatin arms rose by 0.96% and 0.97% above baseline, respectively, at 30 days. Values then dropped by 2.88% and 3.85% from baseline at 4 months, and by 3.88% and 5.83% at 16 months.
In both studies, there was no difference between the high- and low-potency statin groups in the incidence of any increase in serum creatinine of at least 1.5-fold, 2.0-fold, or 3.0-fold greater than baseline. In other words, there was no hint of a safety signal, she added.
Dr. Sarma reported having no financial conflicts of interest.
DALLAS – High-potency statin therapy given post acute coronary syndrome did not raise serum creatinine or cause more risk of acute kidney injury than low-potency statin regimens did in a new analysis of two published landmark randomized clinical trials.
"Considering the recently updated AHA/American College of Cardiology lipid guidelines, which call for the use of high-potency statins in millions more patients, these findings provide important reassurance that a high-potency statin regimen will not increase the incidence of adverse renal events," Dr. Amy Sarma said in presenting the study results at the American Heart Association scientific sessions.
She noted that a recent Canadian observational study utilizing Canadian and U.S. administrative databases totaling more than 2 million patients over age 40 who were newly placed on statin therapy showed an adjusted 1.34-fold increased rate of hospitalization for acute kidney injury within the first 120 days in those on a high- as compared to a low-potency regimen, and a 1.11-fold increased risk beyond 120 days through the end of the first year (BMJ 2013;346:f880). Both risk elevations were statistically significant.
However, observational studies such as this are prone to bias in the form of potentially crucial differences between the patients given a prescription for statins and those who aren’t. For this reason, Dr. Sarma and her coinvestigators turned for guidance to two randomized trials of high- versus low-dose statins, since this study design obviates the risks of confounding. The trials were PROVE IT-TIMI 22 (N. Engl. J. Med. 2004;350:1495-504) and the A-to-Z trial (JAMA 2004;292:1307-16).
PROVE IT included 4,122 patients randomized within 10 days post ACS to standard background therapy plus either pravastatin at 40 mg/day or atorvastatin at 80 mg/day. A-to-Z involved 4,497 patients who were placed on simvastatin at either 20 or 80 mg/day within 5 days post ACS. Both trials had a median follow-up of 2 years, and both featured serial measurements of serum creatinine. Two-thirds of subjects in PROVE IT had a baseline estimated glomerular filtration rate below 90 mL/min per 1.73 m2, while two-thirds of those in A-to-Z had a baseline eGFR less than 60, noted Dr. Sarma of Brigham and Women’s Hospital, Boston.
In both studies, mean serum creatinine rose equally during the first 30 days of statin therapy, regardless of treatment potency, and then levels declined. In PROVE IT, for example, serum creatinine in the pravastatin and atorvastatin arms rose by 0.96% and 0.97% above baseline, respectively, at 30 days. Values then dropped by 2.88% and 3.85% from baseline at 4 months, and by 3.88% and 5.83% at 16 months.
In both studies, there was no difference between the high- and low-potency statin groups in the incidence of any increase in serum creatinine of at least 1.5-fold, 2.0-fold, or 3.0-fold greater than baseline. In other words, there was no hint of a safety signal, she added.
Dr. Sarma reported having no financial conflicts of interest.
AT THE AHA SCIENTIFIC SESSIONS
Major finding: Patients randomized to a high-potency statin regimen shortly after an acute coronary syndrome did not have higher serum creatinine levels or a greater risk of acute kidney injury than those randomized to a low-potency statin.
Data source: PROVE IT-TIMI 22 and the A-to-Z trial were randomized, double-blind clinical trials in which a total of 8,619 patients with a recent acute coronary syndrome were assigned to high- or lower-potency statin therapy and prospectively followed for a median of 2 years.
Disclosures: Dr. Sarma reported having no financial conflicts of interest.
