FDA Investigating Late Risk With Paclitaxel Balloons, Stents in PAD

Patrice Wendling

January 17, 2019

In a letter issued to healthcare providers today, the US Food and Drug Administration (FDA) said it is evaluating recent data suggesting a higher risk for long-term death in patients with peripheral arterial disease (PAD) treated with paclitaxel-coated balloons or paclitaxel-eluting stents.

"There are a number of paclitaxel-coated balloons or paclitaxel-eluting stents approved or under study for peripheral vascular use in the US," the agency said. "Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use."

The action follows a meta-analysis last month that reported an excess risk for death after 2 years in patients with femoropopliteal lesions treated with paclitaxel-coated balloon and stents.

It showed that the relative risk for all-cause death in the paclitaxel-treated device group increased 68% at 2 years and 93% at 5 years, compared with that for patients treated with noncoated devices. The absolute risk differences were 3.5% and 7.2%, respectively.

Within days of publication of the meta-analysis, organizers halted enrollment in two ongoing PAD trials, BASIL-3 and SWEDEPAD 1 and SWEDEPAD 2. Both groups are reviewing their data and have not reopened enrollment as of press time; the SWEDEPAD team initially stated the temporary stop would apply until at least early February.

The FDA said it is evaluating long-term follow-up data from studies that supported approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the United States and other available datasets.

"This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes," according to the agency. "Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks."

The FDA is also working with manufacturers of paclitaxel-coated devices, who have stood by the safety of their devices in recent calls with investors.

Paclitaxel-coated balloons and stents are intended to treat de novo or restenotic lesions in the femoropopliteal artery and are also marketed for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae.

Paclitaxel-coated stents have been approved for use in the treatment of coronary artery disease, although no paclitaxel-coated balloons or paclitaxel-eluting stents are currently marketed for this use.

The letter recommends providers discuss the risks and benefits of all available PAD treatments with their patients and continue to monitor patients who have already been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.

Providers are asked to report any adverse events or suspected adverse events experienced with these devices through MedWatch, the FDA Safety Information and Adverse Event Reporting program .

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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