Initial findings from the SAFE-PAD study of Medicare beneficiaries suggest that DCDs are no less effective than non-drug-coated devices (NDCDs) with respect to mortality. The finding remained robust in sensitivity analyses and across subgroups.
The study was published in JAMA Internal Medicine and presented at ACC.21, the virtual annual meeting of the American College of Cardiology, by Dr. Eric Secemsky of Beth Israel Deaconess Medical Center in Boston.
A recent meta-analysis of randomized clinical trials reported increased mortality with paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg.
As a result, ongoing clinical trials were halted, restrictions were placed on use of peripheral DCD use by medical centers, and the U.S. Food and Drug Administration (FDA) issued a letter of caution to clinicians.
Nonetheless, potential sources of bias were noted in the studies and the FDA called for additional long-term data.
The SAFE-PAD study, designed with feedback from the FDA, is a long-term observational study evaluating the safety of DCDs for femoropopliteal-artery revascularization.
Among more than 168,000 Medicare beneficiaries who underwent femoropopliteal artery revascularization from 2015 through 2018, the weighted cumulative incidence of mortality after a median of 2.7 years was 53.8% among those treated with DCDs and 55.1% among those treated with NDCDs (hazard ratio, 0.95; 95% confidence interval, 0.94 to 0.97), "meeting noninferiority for drug-coated devices," Dr. Secemsky said in his presentation.
"The findings were robust to evaluations of confounding by many different analyses and the results were consistent in prespecified subgroups," Dr. Secemsky said, including those treated with stents or balloons, with or without critical limb ischemia and those within the lowest quartile of total comorbidities.
"Thus, this analysis did not confirm the signal of harm," say the authors of an editorial in JAMA Internal Medicine.
However, the study "raises a new and important question" about the high rates of mortality in Medicare beneficiaries with PAD undergoing endovascular revascularization, write Dr. Rita Redberg of the University of California, San Francisco, and Dr. Mary McDermott of Northwestern University Feinberg School of Medicine, in Chicago.
"More than half of the patients with PAD died during just 2.7 years of follow-up regardless of the type of device they received," they point out.
"It is well documented that people with PAD have increased rates of death from cardiovascular events compared with those without PAD, and recent evidence shows a high rate of death from cancer and infection in people with PAD. Peripheral revascularization does not address any of these causes of death," they write.
"Thus, while this well-done observational study provides new information on the association of paclitaxel stents with mortality, a major conclusion should be that mortality is high among Medicare beneficiaries undergoing revascularization with any devices," they add.
"Physicians should continue to focus on conservative treatment, including smoking cessation and exercise therapy for improving quality of life, in patients with PAD," the editorial writers conclude.
Funding for the study was provided by a multi-industry consortium of device makers. Several authors disclosed financial relationships with industry. Dr. Redberg is deputy editor of JAMA.
SOURCE: https://bit.ly/3byBQIy and https://bit.ly/3wj2EVj JAMA Internal Medicine, online May 16, 2021.
By Megan Brooks
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