Will Drug-Eluting Devices Suffer from JAHA Publication?

A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA).
Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD of Patras University Hospital in Rion, Greece is the lead author of the analysis. VIVA Physicians, a not-for-profit organization dedicated to peripheral artery disease (PAD) education and research, said it will host a forum in February to discuss the Katsanos analysis.
The Birmingham Clinical Trials Unit at the University of Birmingham's College of Medical and Dental Sciences in Birmingham, United Kingdom is directing the BASIL-3 trial. BASIL-3 is a multicenter, randomized controlled trial evaluating the clinical efficacy and cost-effectiveness of drug-coated balloons, drug-eluting stents, and plain balloon angioplasty with bailout bare-metal stent revascularization strategies for severe limb ischemia caused by atherosclerotic femoropopliteal PAD.
The trial investigators said that although the population of the reviewed trials differs from those ...

Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news