FDA Still Monitoring Safety Signal With Paclitaxel Stents in PAD

Megan Brooks

December 03, 2021

The US Food and Drug Administration (FDA) continues to acknowledge a possible mortality risk with paclitaxel-coated balloons and stents intended to treat new or recurring atherosclerotic lesions in the femoropopliteal artery.

In an update posted on its website this week, the agency says it continues to advise "close monitoring" of patients who received a paclitaxel-coated balloon and stent to treat peripheral artery disease (PAD).

As previously reported by theheart.org | Medscape Cardiology, in early 2019, an FDA letter sent to clinicians warned of a potential late mortality safety signal with endovascular stents and balloons coated with paclitaxel.

An FDA meta-analysis of long-term follow-up data from premarket randomized trials for paclitaxel-coated devices used to treat PAD showed an increased risk of late mortality in patients treated with paclitaxel-coated devices compared to those treated with uncoated devices.

The relative risk for increased mortality at 5 years was 1.57 (95% CI, 1.16 - 2.13).

A subsequent meta-analysis of patient-level data found generally similar, albeit somewhat lower, late mortality risk with paclitaxel-coated devices (hazard ratio, 1.38; 95% CI, 1.06 - 1.80).

However, additional data from three major clinical trials — SAFE-PAD, VOYAGER PAD, SWEDEPAD — gave no hint of increased mortality risk associated with the use of paclitaxel-coated devices for treatment of PAD.   

In their latest update on the issue, the FDA says it is continuing to analyze new data as it becomes available and is collaborating with device manufacturers, clinical investigators, and clinical societies to develop more evidence to assess the long-term safety of paclitaxel-coated devices for PAD.

The FDA is currently participating in a "pan-industry updated analysis," which includes a re-evaluation of the mortality signal using updated clinical study data as well as additional long-term follow-up and study data that was not evaluated earlier.

The agency is also participating in the registry assessment of peripheral interventional devices (RAPID), a public/private collaborative effort to re-evaluate relevant data sources, including registries and other real-world data.

For now, in addition to close monitoring of patients with paclitaxel-coated devices, the FDA recommends the following: 

  • When making treatment recommendations, and as part of the informed consent process, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.

  • Discuss the benefits and risks, including the possibility of increased mortality, of all available PAD treatment options with your patients.

  • Consider that for some patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents could provide a more favorable benefit-risk profile.

  • For others, the benefits of using a paclitaxel-coated device may outweigh the risk of late mortality.

  • In discussing treatment options, explore patients' expectations, concerns, and treatment preferences.

  • Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.

  • Report adverse events or suspected adverse events experienced by patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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