No increase in long-term mortality seen with peripheral drug-coated devices

Drug-coated devices (DCDs) are not associated with increased long-term mortality among older patients who undergo femoropopliteal artery revascularization, according to a research letter published online May 20 in Circulation: Cardiovascular Interventions to coincide with the Society for Cardiovascular Angiography and Interventions 2022 Scientific Sessions, held from May 19 to 21 in Atlanta.

Eric A. Secemsky, M.D., from the Beth Israel Deaconess Medical Center in Boston, and colleagues presented the most contemporary follow-up data for more than 70,000 patients aged 66 years or older treated with DCDs. The study included all Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with either a DCD (drug-eluting stent or drug-coated balloon) or a non-DCD (NDCD; bare metal stent or percutaneous transluminal angioplasty). Of 168,553 patients, 41.9 percent were treated with a DCD; the median follow-up was 3.52 years.

The researchers found that the weighted cumulative incidence of mortality was 63.6 and 62.5 percent with NDCDs and DCDs, respectively, at 6.31 years (hazard ratio, 0.98), meeting noninferiority for survival between the groups. No association between DCD and increased mortality was seen for low-risk patients, low comorbid patients, inpatient treatment, outpatient treatment, patients with and without critical limb ischemia, patients treated with stents, or patients treated with balloon angioplasty alone.

"In this updated report from the Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices study with follow-up extending to 6.3 years, DCDs remained noninferior to NDCDs in respect to long-term survival," the authors write.

Several authors disclosed financial ties to pharmaceutical and medical device companies, including BD, Boston Scientific, Cook Medical, Medtronic, and Philips, which provided funding for the study as part of a multi-industry consortium.