Veterans study: No evidence of increased risk of death with use of PCDs out to three years

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A study of more than 10,000 U.S. veterans with peripheral arterial disease (PAD) undergoing endovascular interventions in the femoropopliteal segment found that rates of two‐ and three‐year all‐cause mortality were similar among patients undergoing revascularization with a paclitaxel-coated device (PCD) and those treated with an uncoated device.

The findings, recently published in the Journal of the American Heart Association (JAHA), were derived from Veterans Health Administration (VHA) data contained in the VA Corporate Data Warehouse as well as the National Death Index.

“Given the unique aspects of the VHA model of healthcare delivery, patients generally stay within the VHA for both follow‐up medical care and pharmacy refills,” first-named author Jorge Antonio Gutierrez, MD, a cardiologist in the department of medicine at Duke University School of Medicine in Durham, North Carolina, and colleagues observed. “A large patient sample, a complete data set, and no loss to follow‐up are key strengths of the VA [Corporate Data Warehouse] that enhance the robustness of our findings.”

The retrospective cohort study analyzed patients with PAD treated within the Veterans Administration for femoropopliteal artery revascularization between October 2015 and June 2019.

Of 10,505 patients who underwent femoropopliteal peripheral endovascular intervention, 2,265 (21.6%) were treated with a PCD while 8,240 (78.4%) received percutaneous angioplasty balloon and/or a bare metal stent.

The investigators found survival rates at two years of 77.4% for PCD patients vs. 79.7% for those treated with an uncoated device. At three years, survival was 70.7% vs. 71.8%. The adjusted hazard for all‐cause mortality for patients treated with a PCD vs. an uncoated device was 1.06 (95% confidence interval [CI] 0.95–1.18; p=0.3013). Among patients who died between Oct. 1, 2015, and Dec. 31, 2017, the cause of death according to treatment group—PCD vs. uncoated device—was similar.

The research team acknowledged study limitations, including observational, nonrandomized treatment “that cannot account for operator selection bias” and the potential presence of unmeasured confounders. They also pointed out that the nature of the dataset means the sample is predominantly male, so “the findings may not be applicable to female patients.”

The researchers conclude: “In this large, contemporary cohort of patients undergoing femoropopliteal [peripheral vascular interventions] within the VHA, there was no evidence of an associated increased risk of long‐term, all‐cause mortality among patients treated with PCDs when compared with those treated with non‐PCDs. Cause‐specific mortality rates were similar between both cohorts.”

Additionally, the study highlights the “vast possibilities” of using the VHA Corporate Data Warehouse with the National Death Index for future postmarket safety surveillance of PAD devices, they remark.

SOURCE: doi/10.1161/JAHA.120.018149

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