Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices

Abstract

Importance: In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up.

Objective: To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization.

Design, setting, and participants: This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017.

Exposures: Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon).

Main outcomes and measures: The primary outcome was all-cause mortality analyzed through the end of follow-up.

Results: Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48).

Conclusions and relevance: In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Jaff reports serving as a noncompensated advisor to Abbott Vascular and Boston Scientific; as a compensated advisor to Medtronic, American Orthotic and Prosthetics Association, Biotronik, BTG, Philips, Sanofi, and Vactronix; and as an equity investor to Embolitech, Gemini, PQ Bypass, and Vascular Therapies. Dr Parikh reports serving as an advisory board member for Abbott Vascular, Boston Scientific, Medtronic Vascular, Philips, and Cardiovascular Systems, Inc. He performs sponsored research for Shockwave Medical and TriReme Medical and serves as consultant to Terumo and Asahi. Dr Beckman reports consulting with Antidote Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, and Sanofi. He serves on a data safety monitoring committee for Bayer and Novartis. Dr Mustapha reports serving on the advisory medical board for BSC, CSI, MDT, and Bard. He is a shareholder in Cardioflow and Reflow Medical. Dr Rosenfield reports serving as a scientific advisory board member for Abbott Vascular, Access Closure, BTG, Cordis-Cardinal Health, EXIMO, Volcano-Philips, Surmodics, Shockwave, Cruzar, Endospan, Janssen, Magneto, Micell, Silk Road, Valcare, Thrombolex, and the University of Maryland. He receives grants from the National Institutes of Health and Inari and reports equity interest in Access Closure, Contego, Endospan, Embolitech, EXIMO, JanaCare, PQ Bypass, Primacea, MD Insider, Silk Road, Cruzar Systems, Capture Vascular, Micell, and Valcare. He serves as a board member for VIVA Physicians and the National PERT Consortium. Dr Yeh reports serving as an advisory board member for Abbott Vascular, Boston Scientific, and Medtronic and has investigator-initiated research grants from Abbott Vascular and Boston Scientific. No other disclosures are reported.

Figures

Figure 1.. Long-term Survival Following Femoropopliteal Artery Revascularization With Drug-Coated Devices Compared With Non–Drug-Coated Devices

Displayed are the cumulative incidence curves for all-cause mortality after femoropopliteal artery revascularization, stratified by treatment with drug-coated devices (drug) vs non–drug-coated devices (nondrug) (A), drug-coated balloons (DCB) vs uncoated balloons (PTA) (B), and drug-eluting stents (DES) vs bare metal stents (BMS) (C).

Figure 2.. Long-term Survival Following Femoropopliteal Artery Revascularization With Drug-Coated Devices Compared With Non–Drug-Coated Devices Among Patients With Critical Limb Ischemia

Displayed are the cumulative incidence curves for all-cause mortality after femoropopliteal artery revascularization among patients with critical limb ischemia, stratified by treatment with drug-coated devices (drug) vs non–drug-coated devices (nondrug) (A), drug-coated balloons (DCB) vs uncoated balloons (PTA) (B), and drug-eluting stents (DES) vs bare metal stents (BMS) (C).

Figure 3.. Long-term Survival Following Femoropopliteal Artery Revascularization With Drug-Coated Devices Compared With Non–Drug-Coated Devices Among Patients Without Critical Limb Ischemia

Displayed are the cumulative incidence curves for all-cause mortality after femoropopliteal artery revascularization among patients without critical limb ischemia, stratified by treatment with drug-coated devices (drug) vs non–drug-coated devices (nondrug) (A), drug-coated balloons (DCB) vs uncoated balloons (PTA) (B), and drug-eluting stents (DES) vs bare metal stents (BMS) (C).