How Safe Are Paclitaxel-Coated Devices for Treatment of Peripheral Artery Disease?

A patient-level meta-analysis shows excess mortality with these devices but also highlights issues with the available data.

Paclitaxel-eluting balloons and stents have substantial benefits in reducing repeat procedures in patients undergoing catheter-based interventions for peripheral artery disease (PAD). However, a meta-analysis using aggregate data from randomized, clinical trials (RCTs) has raised concerns about possible excess mortality with these devices, leading to a series of FDA warnings. Because of questions about the validity and robustness of the meta-analytic findings, the current investigators conducted a new meta-analysis pooling individual patient-level data from eight manufacturer-sponsored RCTs of FDA-approved paclitaxel-coated devices versus uncoated devices in 2185 patients.

The primary analysis demonstrated higher all-cause mortality with the…

Reviewing Author

David J. Cohen, MD, MSc

Disclosures

Consultant/Advisory BoardMedtronic; Edwards Lifesciences; Abbott Vascular; Boston Scientific; St. Francis Hospital

Speaker’s BureauBoston Scientific; ZOLL Medical

Grant/Research SupportEdwards Lifesciences; Abbott Vascular; Boston Scientific; Corvia Medical; National Heart, Lung, and Blood Institute; Phillips, Inc.; St. Paul’s Hospital; V-Wave, Inc; ZOLL Medical; CathWorks, ANCORA

Editorial BoardsJACC; American Heart Journal; EuroIntervention; JSCAI; Structural Heart Journal

Leadership Positions in Professional SocietiesSociety of Thoracic Surgeons/American College of Cardiology TVT Registry (Co-Chair, Risk Model Development Committee); Cardiovascular Research Foundation (Co-Director, TCT Annual Meeting; Co-Director, New York Valves Annual Meeting)