Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

BACKGROUND: Randomized trials have shown that paclitaxel-coated devices are more effective than uncoated devices for the treatment of peripheral artery disease, but a meta-analysis raised concern about increased mortality with paclitaxel-coated devices. METHODS: We studied all patients in Sweden who had undergone revascularization with a paclitaxel-coated device (drug-coated balloon or drug-eluting stent) for peripheral artery disease in the femoral or popliteal arteries between 2005 and 2018 (the paclitaxel group). For each patient, we identified two controls (the control group) who had undergone revascularization with an uncoated device and were matched for sex, age, type of procedure, calendar year, and indication for revascularization. The primary outcome was all-cause mortality. RESULTS: A total of 15,263 patients (mean age, 74.8 years; 37.6% women) underwent revascularization with a paclitaxel-coated device, and 30,520 controls underwent revascularization with an uncoated device. The median follow-up was 3.1 years (interquartile range, 1.6 to 5.4). The estimated 5-year rate of all-cause mortality was 37.1% (95% confidence interval [CI], 36.1 to 38.0) in the paclitaxel group and 35.8% (95% CI, 35.2 to 36.4) in the control group (adjusted hazard ratio, 1.07; 95% CI, 1.02 to 1.12). Among patients with intermittent claudication, the adjusted hazard ratio for all-cause mortality in the paclitaxel group as compared with the control group was 1.10 (95% CI, 1.03 to 1.18); among patients with critical limb ischemia, the adjusted hazard ratio was 1.04 (95% CI, 0.98 to 1.10). CONCLUSIONS: In this register-based cohort study, paclitaxel-coated devices were associated with an increased risk of all-cause mortality among patients with peripheral artery disease in the femoral or popliteal arteries.

BACKGROUND: Randomized trials have shown that paclitaxel-coated devices are more effective than uncoated devices for the treatment of peripheral artery disease, but a meta-analysis raised concern about increased mortality with paclitaxel-coated devices. METHODS: We studied all patients in Sweden who had undergone revascularization with a paclitaxel-coated device (drug-coated balloon or drug-eluting stent) for peripheral artery disease in the femoral or popliteal arteries between 2005 and 2018 (the paclitaxel group). For each patient, we identified two controls (the control group) who had undergone revascularization with an uncoated device and were matched for sex, age, type of procedure, calendar year, and indication for revascularization. The primary outcome was all-cause mortality. RESULTS: A total of 15,263 patients (mean age, 74.8 years; 37.6% women) underwent revascularization with a paclitaxel-coated device, and 30,520 controls underwent revascularization with an uncoated device. The median follow-up was 3.1 years (interquartile range, 1.6 to 5.4). The estimated 5-year rate of all-cause mortality was 37.1% (95% confidence interval [CI], 36.1 to 38.0) in the paclitaxel group and 35.8% (95% CI, 35.2 to 36.4) in the control group (adjusted hazard ratio, 1.07; 95% CI, 1.02 to 1.12). Among patients with intermittent claudication, the adjusted hazard ratio for all-cause mortality in the paclitaxel group as compared with the control group was 1.10 (95% CI, 1.03 to 1.18); among patients with critical limb ischemia, the adjusted hazard ratio was 1.04 (95% CI, 0.98 to 1.10). CONCLUSIONS: In this register-based cohort study, paclitaxel-coated devices were associated with an increased risk of all-cause mortality among patients with peripheral artery disease in the femoral or popliteal arteries.