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No Mortality Difference Found With Paclitaxel-Coated Devices in Interim Analysis of SWEDEPAD Trial

December 9, 2020—In The New England Journal of Medicine (NEJM), Joakim Nordanstig, MD, et al published findings from an unplanned interim analysis of all-cause mortality in the SWEDEPAD clinical trial, in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices.

SWEDEPAD Trials Explore Resumption of Enrollment

May 31, 2019—Investigators from the SWEDEPAD 1 and 2 trials are aiming to resume recruitment of patients, having reviewed mortality data from the trials following concerns raised by the Katsanos meta-analysis published in December 2018.

FDA Publishes Perspective on Paclitaxel-Coated Devices in PAD

January 14, 2021—Andrew Farb, MD; Misti Malone, PhD; and William H. Maisel, MD, from the Office of Product Evaluation and Quality (OPEQ) at the FDA’s Center for Devices and Radiological Health, published a Perspective article on the latest findings of paclitaxel-coated devices (PCDs) for peripheral artery disease (PAD) in The New England Journal of Medicine (NEJM; 2021;384:99-101).

ESVS Focused Update of PAD Guidelines Addresses Safety Concerns of Paclitaxel

June 23, 2026—The European Society of Vascular Surgery (ESVS) announced the publication of a focused update on the ESVS peripheral artery disease (PAD) guidelines addressing the new findings on the safety of paclitaxel-coated devices.

Paclitaxel-Coated Devices for PAD Evaluated in SWEDEPAD 1 and 2 Trials

September 3, 2025—The European Society of Cardiology (ESC) announced the presentation of new findings from the SWEDEPAD 1 and 2 trials of chronic limb-threatening ischemia (CLTI) and intermittent claudication, respectively, demonstrating that paclitaxel-coated devices were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices.