In December 2018, a study-level meta-analysis published in JAHA indicated a link between the use of paclitaxel-delivery devices for peripheral artery disease and increased mortality. Subsequently, regulators, clinical trial investigators, and manufacturers of drug-coated balloons and drug-eluting stents have initiated reviews of patient-level data in order to determine whether a causal link could be established or denied.
Links to key primary source documents and Endovascular Today's ongoing coverage can be found below. This page will be updated as new data and reports emerge.
December 5, 2018
Katsanos et al: 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 [Journal of the American Heart Association]
Meta-Analysis Observes Increased Mortality Trend in Trials of Paclitaxel Coated SFA Devices, But No Definitive Cause [Endovascular Today]
December 13, 2018
Recruitment in BASIL-3 and SWEDEPAD Trials Paused After Report of 5-Year Mortality Risk With DCB/DES in SFA [Endovascular Today]
December 14, 2018
VIVA Physicians to Hold Forum on Drug Elution in Peripheral Artery Disease [Endovascular Today]
December 19, 2018
VIVA Physicians' Vascular Leaders Forum on Drug-Eluting Devices in PAD Scheduled [Endovascular Today]
January 17, 2019
Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers [FDA.gov]
FDA Issues Letter on Potential Increased Mortality With Paclitaxel-Coated Devices in SFA [Endovascular Today]
January 24, 2019
LINC 2019: Patient-Level Data Presentations at LINC Aim to Disprove Causality Between Paclitaxel and Increased Mortality [Endovascular Today]
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