(HealthDay)—A preliminary analysis has revealed a “potentially concerning signal” of increased long-term mortality risk with paclitaxel-coated products indicated for peripheral arterial disease (PAD), according to a March 15 update from the U.S. Food and Drug Administration.
In January, the FDA notified health care providers about a possible increased risk for long-term mortality in patients who receive paclitaxel-coated balloons and paclitaxel-eluting stents for PAD in the femoropopliteal artery. The notification was based on data from a meta-analysis published in the Journal of the American Heart Association.
The agency conducted a preliminary analysis of data from premarket randomized trials with up to five years of follow-up. In the ongoing analyses, researchers found that compared with patients treated with uncoated devices, those treated with paclitaxel-coated products showed higher mortality rates. In three trials with five-year follow-up and a total of 975 patients, those treated with paclitaxel-coated devices had an approximately 50 percent increased risk for mortality compared with those treated with uncoated devices (20.1 versus 13.4 percent crude risk for death).
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