TY - JOUR
T1 - Association of Survival with Femoropopliteal Artery Revascularization with Drug-Coated Devices
AU - Secemsky, Eric A.
AU - Kundi, Harun
AU - Weinberg, Ido
AU - Jaff, Michael R.
AU - Krawisz, Anna
AU - Parikh, Sahil A.
AU - Beckman, Joshua A.
AU - Mustapha, Jihad
AU - Rosenfield, Kenneth
AU - Yeh, Robert W.
N1 - Funding Information:
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.
Publisher Copyright:
© 2019 American Medical Association. All rights reserved.
PY - 2019/4
Y1 - 2019/4
N2 - 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 16560 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 16560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12232 (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.
AB - 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 16560 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 16560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12232 (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.
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U2 - 10.1001/jamacardio.2019.0325
DO - 10.1001/jamacardio.2019.0325
M3 - Article
C2 - 30747949
AN - SCOPUS:85061474306
SN - 2380-6583
VL - 4
SP - 332
EP - 340
JO - JAMA Cardiology
JF - JAMA Cardiology
IS - 4
ER -