Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

• Published in: Journal of the American Heart Association Vol. 7; no. 24; p. e011245
• Main Authors: Katsanos, Konstantinos, Spiliopoulos, Stavros, Kitrou, Panagiotis, Krokidis, Miltiadis, Karnabatidis, Dimitrios
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 18.12.2018; Wiley
• Subjects: Aged; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Angioplasty, Balloon - mortality; balloon angioplasty; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery - physiopathology; Humans; Male; paclitaxel; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; paclitaxel‐coated balloon; paclitaxel‐eluting stent; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - mortality; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - therapy; Popliteal Artery - physiopathology; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Systematic Review and Meta‐analysis; Time Factors; Treatment Outcome; Vascular Access Devices; paclitaxel; balloon angioplasty; paclitaxel‐coated balloon; paclitaxel‐eluting stent
• ISSN: 2047-9980; 2047-9980
• DOI: 10.1161/jaha.118.011245

Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta-analysis of RCT s investigating paclitaxel-coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCT s with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCT s with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCT s with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; -number-needed-to-harm, 29 patients [95% CI , 19-59]). All-cause death up to 5 years (3 RCT s with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI , 1.27-2.93; -number-needed-to-harm, 14 patients [95% CI , 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL : www.crd.york.ac.uk/PROSPERO . Unique identifier: CRD 42018099447.