• Krystal Dinh, Miguel Lemos Gomes, Shannon D Thomas, Sharath C V Paravastu, Andrew Holden, Peter A Schneider, and Ramon L Varcoe.
• Department of Vascular Surgery, Westmead Hospital, Sydney, NSW, Australia.
• J. Endovasc. Ther. 2020 Apr 1; 27 (2): 175-185.

PurposeTo report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI).Materials And MethodsA search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI).ResultsThe mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45).ConclusionThere was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.

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