Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.

Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.

“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.

In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.

Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.

Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.

“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.

“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.

“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.

The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.

Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.

SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.

Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.

Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.

“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.

In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.

Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.

Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.

“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.

“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.

“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.

The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.

Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.

SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.

Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.

Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.

“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.

In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.

Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.

Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.

“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.

“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.

“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.

The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.

Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.

SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.

Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.

Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.

In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.

Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.

In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.

The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”

The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.

“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.

“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.

The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.

SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.

Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.

Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.

In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.

Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.

In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.

The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”

The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.

“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.

“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.

The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.

SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.

Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.

Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.

In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.

Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.

In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.

The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”

The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.

“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.

“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.

The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.

SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.

CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.

The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.

Survival at 2 years was 92% for SFK patients and 84% for controls.

“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).

In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.

“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.

The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.

Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.

When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.

Ms. Pather had no financial relationships to disclose.

CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.

The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.

Survival at 2 years was 92% for SFK patients and 84% for controls.

“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).

In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.

“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.

The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.

Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.

When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.

Ms. Pather had no financial relationships to disclose.

CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.

The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.

Survival at 2 years was 92% for SFK patients and 84% for controls.

“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).

In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.

“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.

The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.

Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.

When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.

Ms. Pather had no financial relationships to disclose.

New results for secukinumab (Cosentyx) in the PREVENT trial continue its promising trend for treatment of the full spectrum of axial spondyloarthritis (axSpA), according to a release from Novartis. The PREVENT trial is assessing this therapy in nonradiographic axSpA (nr-axSpA); it’s already approved in ankylosing spondylitis.

Results of 16-week data were presented in mid-September, and the new results represent 52-week data. Full details and data will be revealed at an upcoming scientific congress.

The PREVENT trial is an ongoing, 2-year trial with a 2-year extension phase; it enrolled 550 men and women with nr-axSpA and assessed their response to secukinumab with an induction phase, to it without induction, or to placebo. The trial met its primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS40) criteria at 16 and 52 weeks, which indicates meaningful and sustained improvement. ASAS40 is defined as an improvement of at least 40% and both 10 out of 100 points in three of four domains (patient global assessment, pain, function, and inflammation) and no worsening in the remaining one. The safety profile in this trial was consistent with those seen in previous trials.

Overall, the most common adverse reactions seen with this interleukin-17A antagonist are nasopharyngitis, diarrhea, and upper respiratory tract infections. Patients should be evaluated for tuberculosis before initiating treatment. Serious infections have been observed, so be mindful of patients with chronic infections and discontinue secukinumab in patients who develop infections. Caution should be exercised when prescribing to patients with inflammatory bowel disease. Full prescribing information can be found on the Novartis website.

cpalmer@mdedge.com

New results for secukinumab (Cosentyx) in the PREVENT trial continue its promising trend for treatment of the full spectrum of axial spondyloarthritis (axSpA), according to a release from Novartis. The PREVENT trial is assessing this therapy in nonradiographic axSpA (nr-axSpA); it’s already approved in ankylosing spondylitis.

Results of 16-week data were presented in mid-September, and the new results represent 52-week data. Full details and data will be revealed at an upcoming scientific congress.

The PREVENT trial is an ongoing, 2-year trial with a 2-year extension phase; it enrolled 550 men and women with nr-axSpA and assessed their response to secukinumab with an induction phase, to it without induction, or to placebo. The trial met its primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS40) criteria at 16 and 52 weeks, which indicates meaningful and sustained improvement. ASAS40 is defined as an improvement of at least 40% and both 10 out of 100 points in three of four domains (patient global assessment, pain, function, and inflammation) and no worsening in the remaining one. The safety profile in this trial was consistent with those seen in previous trials.

Overall, the most common adverse reactions seen with this interleukin-17A antagonist are nasopharyngitis, diarrhea, and upper respiratory tract infections. Patients should be evaluated for tuberculosis before initiating treatment. Serious infections have been observed, so be mindful of patients with chronic infections and discontinue secukinumab in patients who develop infections. Caution should be exercised when prescribing to patients with inflammatory bowel disease. Full prescribing information can be found on the Novartis website.

cpalmer@mdedge.com

New results for secukinumab (Cosentyx) in the PREVENT trial continue its promising trend for treatment of the full spectrum of axial spondyloarthritis (axSpA), according to a release from Novartis. The PREVENT trial is assessing this therapy in nonradiographic axSpA (nr-axSpA); it’s already approved in ankylosing spondylitis.

Results of 16-week data were presented in mid-September, and the new results represent 52-week data. Full details and data will be revealed at an upcoming scientific congress.

The PREVENT trial is an ongoing, 2-year trial with a 2-year extension phase; it enrolled 550 men and women with nr-axSpA and assessed their response to secukinumab with an induction phase, to it without induction, or to placebo. The trial met its primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS40) criteria at 16 and 52 weeks, which indicates meaningful and sustained improvement. ASAS40 is defined as an improvement of at least 40% and both 10 out of 100 points in three of four domains (patient global assessment, pain, function, and inflammation) and no worsening in the remaining one. The safety profile in this trial was consistent with those seen in previous trials.

Overall, the most common adverse reactions seen with this interleukin-17A antagonist are nasopharyngitis, diarrhea, and upper respiratory tract infections. Patients should be evaluated for tuberculosis before initiating treatment. Serious infections have been observed, so be mindful of patients with chronic infections and discontinue secukinumab in patients who develop infections. Caution should be exercised when prescribing to patients with inflammatory bowel disease. Full prescribing information can be found on the Novartis website.

cpalmer@mdedge.com

New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.

The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.

Nationally, there have been 1,250 cases of measles reported in 31 states during 2019, the CDC reported on Oct. 7. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”

rfranki@mdedge.com

New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.

The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.

Nationally, there have been 1,250 cases of measles reported in 31 states during 2019, the CDC reported on Oct. 7. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”

rfranki@mdedge.com

New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.

The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.

Nationally, there have been 1,250 cases of measles reported in 31 states during 2019, the CDC reported on Oct. 7. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”

rfranki@mdedge.com

Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”

William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.


Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.

Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.

Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.

Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.

Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.

Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.

Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.

This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.

“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”

jensmith@mdedge.com

Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”

William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.


Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.

Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.

Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.

Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.

Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.

Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.

Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.

This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.

“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”

jensmith@mdedge.com

Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”

William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.


Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.

Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.

Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.

Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.

Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.

Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.

Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.

This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.

“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”

jensmith@mdedge.com

ROCKVILLE, MD – Those suffering from rare diseases could see treatments being developed at a faster pace thanks to a research tool developed by the National Organization for Rare Disorders (NORD) and the Critical Path Institute (C-Path). Developed with grant money from the Food and Drug Administration, the platform, currently named the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP), is designed to “promote the sharing of existing patient level data and encourage the standardization of new data collection,” according to information provided at a launch event held Sept. 18, 2019.

By integrating data in a regulatory-grade format suitable for analytics, the RDCA-DAP hopes to accelerate the understanding of disease progression – including source of variability to optimize the characterization of subpopulations – develop clinical outcome measures and biomarkers, facilitate the development of mathematical models of disease, and promote innovative clinical trial designs.

The RDCA-DAP works as a database that will house patient-level data from a variety of sources, including clinical trials, longitudinal observational studies, patient registries, and other sources, such as real-world data collected from electronic health records across a wide range of rare diseases from all over the world. Data will then be made available to researchers to help speed the development of new treatments.

“The database and analytics we are creating will enable us to obtain new insight into these rare diseases,” C-Path President and CEO Joseph Scheeren, PharmD, said at the launch event. “Not only within specific diseases, but also we hope across related diseases.”

Gregory Twachtman/MDedge News

The key to the platform’s success will be data. “We need access to clinical data from the industry, patient groups, and academia,” Dr. Scheeren said. “Even more so, the RDCA-DAP will need to incorporate data from many sources. In addition to data from clinical trials conducted by industry and academia, we will want to access data from patients, hospitals, and any organization that can provide data.”

Dr. Scheeren said the data will take many forms, including numeric data, images, genomic information, and other forms of clinical information.

“The database will be able to handle these diverse datasets,” he said, adding that C-Path is preparing to be able to analyze the data sets “with the most sophisticated tools available.”

Dr. Scheeren made a call for all interested stakeholders with rare disease data to contribute to the platform.

Gregory Twachtman/MDedge News

NORD President and CEO Peter Saltonstall echoed that call. “We need data. We are accepting it immediately.”

Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, applauded the new platform. “I think foundations and patient advocacy groups and others that have been trying to help in this space have realized that simply funding basic research, although it is necessary and really important, it is not enough to get those therapies in the hands of doctors and patients,” she said. “You have to enable translation of research for that disease.”

gtwachtman@mdedge.com

ROCKVILLE, MD – Those suffering from rare diseases could see treatments being developed at a faster pace thanks to a research tool developed by the National Organization for Rare Disorders (NORD) and the Critical Path Institute (C-Path). Developed with grant money from the Food and Drug Administration, the platform, currently named the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP), is designed to “promote the sharing of existing patient level data and encourage the standardization of new data collection,” according to information provided at a launch event held Sept. 18, 2019.

By integrating data in a regulatory-grade format suitable for analytics, the RDCA-DAP hopes to accelerate the understanding of disease progression – including source of variability to optimize the characterization of subpopulations – develop clinical outcome measures and biomarkers, facilitate the development of mathematical models of disease, and promote innovative clinical trial designs.

The RDCA-DAP works as a database that will house patient-level data from a variety of sources, including clinical trials, longitudinal observational studies, patient registries, and other sources, such as real-world data collected from electronic health records across a wide range of rare diseases from all over the world. Data will then be made available to researchers to help speed the development of new treatments.

“The database and analytics we are creating will enable us to obtain new insight into these rare diseases,” C-Path President and CEO Joseph Scheeren, PharmD, said at the launch event. “Not only within specific diseases, but also we hope across related diseases.”

Gregory Twachtman/MDedge News

The key to the platform’s success will be data. “We need access to clinical data from the industry, patient groups, and academia,” Dr. Scheeren said. “Even more so, the RDCA-DAP will need to incorporate data from many sources. In addition to data from clinical trials conducted by industry and academia, we will want to access data from patients, hospitals, and any organization that can provide data.”

Dr. Scheeren said the data will take many forms, including numeric data, images, genomic information, and other forms of clinical information.

“The database will be able to handle these diverse datasets,” he said, adding that C-Path is preparing to be able to analyze the data sets “with the most sophisticated tools available.”

Dr. Scheeren made a call for all interested stakeholders with rare disease data to contribute to the platform.

Gregory Twachtman/MDedge News

NORD President and CEO Peter Saltonstall echoed that call. “We need data. We are accepting it immediately.”

Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, applauded the new platform. “I think foundations and patient advocacy groups and others that have been trying to help in this space have realized that simply funding basic research, although it is necessary and really important, it is not enough to get those therapies in the hands of doctors and patients,” she said. “You have to enable translation of research for that disease.”

gtwachtman@mdedge.com

ROCKVILLE, MD – Those suffering from rare diseases could see treatments being developed at a faster pace thanks to a research tool developed by the National Organization for Rare Disorders (NORD) and the Critical Path Institute (C-Path). Developed with grant money from the Food and Drug Administration, the platform, currently named the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP), is designed to “promote the sharing of existing patient level data and encourage the standardization of new data collection,” according to information provided at a launch event held Sept. 18, 2019.

By integrating data in a regulatory-grade format suitable for analytics, the RDCA-DAP hopes to accelerate the understanding of disease progression – including source of variability to optimize the characterization of subpopulations – develop clinical outcome measures and biomarkers, facilitate the development of mathematical models of disease, and promote innovative clinical trial designs.

The RDCA-DAP works as a database that will house patient-level data from a variety of sources, including clinical trials, longitudinal observational studies, patient registries, and other sources, such as real-world data collected from electronic health records across a wide range of rare diseases from all over the world. Data will then be made available to researchers to help speed the development of new treatments.

“The database and analytics we are creating will enable us to obtain new insight into these rare diseases,” C-Path President and CEO Joseph Scheeren, PharmD, said at the launch event. “Not only within specific diseases, but also we hope across related diseases.”

Gregory Twachtman/MDedge News

The key to the platform’s success will be data. “We need access to clinical data from the industry, patient groups, and academia,” Dr. Scheeren said. “Even more so, the RDCA-DAP will need to incorporate data from many sources. In addition to data from clinical trials conducted by industry and academia, we will want to access data from patients, hospitals, and any organization that can provide data.”

Dr. Scheeren said the data will take many forms, including numeric data, images, genomic information, and other forms of clinical information.

“The database will be able to handle these diverse datasets,” he said, adding that C-Path is preparing to be able to analyze the data sets “with the most sophisticated tools available.”

Dr. Scheeren made a call for all interested stakeholders with rare disease data to contribute to the platform.

Gregory Twachtman/MDedge News

NORD President and CEO Peter Saltonstall echoed that call. “We need data. We are accepting it immediately.”

Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, applauded the new platform. “I think foundations and patient advocacy groups and others that have been trying to help in this space have realized that simply funding basic research, although it is necessary and really important, it is not enough to get those therapies in the hands of doctors and patients,” she said. “You have to enable translation of research for that disease.”

gtwachtman@mdedge.com

Click here to access Federal Health Care Cancer Data Trends 2019

Table of Contents

• Introduction
• Cancer in the VA: The Big Picture
• Hepatocellular Carcinoma
• Prostate Cancer
• Multiple Myeloma
• Lung Cancer in the VA at a National Level
• Lung Cancer – Regional Snapshot: Kansas City VA
• Colorectal Cancer
• Leukemias
• Lymphomas
• Renal Cell Carcinoma
• Bladder Cancer
• Afterword

Click here to access Federal Health Care Cancer Data Trends 2019

Table of Contents

• Introduction
• Cancer in the VA: The Big Picture
• Hepatocellular Carcinoma
• Prostate Cancer
• Multiple Myeloma
• Lung Cancer in the VA at a National Level
• Lung Cancer – Regional Snapshot: Kansas City VA
• Colorectal Cancer
• Leukemias
• Lymphomas
• Renal Cell Carcinoma
• Bladder Cancer
• Afterword

Click here to access Federal Health Care Cancer Data Trends 2019

Table of Contents

• Introduction
• Cancer in the VA: The Big Picture
• Hepatocellular Carcinoma
• Prostate Cancer
• Multiple Myeloma
• Lung Cancer in the VA at a National Level
• Lung Cancer – Regional Snapshot: Kansas City VA
• Colorectal Cancer
• Leukemias
• Lymphomas
• Renal Cell Carcinoma
• Bladder Cancer
• Afterword

CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.

“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.

The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).

In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.

Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.

“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.

“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.

“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.

“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”

Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.

Dr. Vogel had no relevant financial relationships to disclose.

CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.

“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.

The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).

In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.

Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.

“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.

“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.

“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.

“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”

Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.

Dr. Vogel had no relevant financial relationships to disclose.

CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.

“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.

The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).

In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.

Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.

“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.

“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.

“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.

“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”

Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.

Dr. Vogel had no relevant financial relationships to disclose.