ArticleEClinicalMedicine2026
Safety of paclitaxel-coated devices in patients with peripheral artery disease: an updated systematic review and meta-analysis of randomized controlled trials.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Paclitaxel-coated devices have been widely used to reduce restenosis in patients with peripheral artery disease (PAD). However, their long-term safety, particularly regarding mortality and amputation risks, remains controversial. Methods: A systematic search of PubMed, Web of Science, the Cochrane Library, and Embase was conducted to identify studies published from the inception of each database through September 2025. Randomized controlled trials (RCTs) comparing paclitaxel-coated devices with noncoated devices in patients with PAD were included with a minimum clinical follow-up duration of 24 months. Primary outcomes were all-cause mortality and limb amputation. Secondary outcomes included target lesion revascularization (TLR) and primary patency. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using fixed- or random-effects models. Heterogeneity was assessed using the Findings: A total of 15 RCTs involving 5859 patients were included. No significant differences were observed in all-cause mortality between the paclitaxel and control groups at 1 year (RR: 1.04, 95% CI: 0.87-1.24), 2 years (RR: 1.28, 95% CI: 0.95-1.74), or 5 years (RR: 1.13, 95% CI: 0.93-1.38). Similarly, no significant differences in amputation rates were observed at 1 year (RR: 1.07, 95% CI: 0.88-1.31), 2 years (RR: 0.65, 95% CI: 0.34-1.24), or 5 years (RR: 1.03, 95% CI: 0.88-1.20). Paclitaxel-coated devices significantly reduced TLR at 1 year (RR: 0.64, 95% CI: 0.48-0.87) and 2 years (RR: 0.45, 95% CI: 0.38-0.54), but this benefit was not sustained at 5 years (RR: 0.81, 95% CI: 0.64-1.01). Primary patency at 2 years was significantly improved with paclitaxel devices (RR: 1.57, 95% CI: 1.24-1.99). Interpretation: This updated meta-analysis indicates that paclitaxel-coated devices are not associated with increased risks of all-cause mortality or major amputation for up to 5 years. Although these devices offer mid-term benefits in reducing TLR and improving patency, these advantages decrease over the long term. These findings support the continued use of paclitaxel-coated devices in selected patients with symptomatic femoropopliteal disease, while emphasizing the need for individualized decision-making and long-term clinical follow-up. Funding: None.
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