A preliminary analysis of long-term follow-up data (up to 5 years) involving patients with peripheral arterial disease (PAD) treated with paclitaxel-coated products revealed a ‘potentially concerning’ signal of increased long-term mortality when compared with those treated with uncoated devices, according to the Food and Drug Administration (FDA).
Among the 3 trials that included 5-year follow-up data (N=975), treatment with paclitaxel-coated devices was associated with an approximately 50% increased risk of death when compared with control devices (20.1% vs 13.4% crude risk of death at 5 years). The agency stressed that the data should be interpreted with caution, however they stated that “alternative treatment options should generally be used for most patients while we continue to further evaluate the increased long-term mortality signal and its impact on the overall benefit-risk profile of these devices.”
The FDA decided to conduct this analysis after a meta-analysis published in the Journal of the American Heart Association (JAHA) showed that all-cause mortality at 2 years was significantly increased in PAD patients who received paclitaxel-coated balloons and paclitaxel-eluting stents vs patients who received non-coated balloons or bare metal stents.
Based on the preliminary review, the FDA recommends that healthcare providers:
- Continue diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- 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 risks/benefits of all available PAD treatment options with patients. For most patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents should generally be used until additional analysis of the safety signal has been performed.
- For some individual patients at particularly high risk for restenosis, clinicians may determine that the benefits of using a paclitaxel-coated product may outweigh the risks.
- 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.
Paclitaxel-coated balloons and paclitaxel-eluting stents are indicated to treat de novo or restenotic lesions in the femoropopliteal artery. As the balloon and stent devices work to open the obstructed vessel, the drug is released to prevent restenosis. Paclitaxel-coated balloons are also indicated to treat stenotic lesions in dysfunctional naive arteriovenous dialysis fistulae.
For more information visit FDA.gov.