FDA to investigate safety of stents, balloons coated with paclitaxel

The U.S. Food and Drug Administration is investigating the safety of certain stents and medical balloons coated with the drug paclitaxel following publication of a wide-ranging study that documented a surprising increase in the risk of death two years after the devices were used above the knee. Paclitaxel acts as an anti-inflammatory agent when applied to medical devices for reopening clogged blood vessels. These "drug-eluting" devices are intended to prevent vessels from reclosing, which is a risk when using the same devices without drug coatings.

But a systematic review of past randomized controlled trials of paclitaxel devices to open blocked vessels in the legs found that after two years, the death rates were markedly higher in the paclitaxel patient cohorts as compared to control groups that got the same treatments for peripheral artery disease without paclitaxel.

The review, published in the Journal of the American Heart Association in December, found that in 12 clinical trials with two full years of data, the paclitaxel group had a 7.2 percent risk of death from any cause, while the non-paclitaxel patients had a 3.8 percent risk of death from any cause. In three studies with five-year outcomes, there was a 14.7 percent risk of death following paclitaxel-device use vs. 8.1 percent in the control patients.

No definitive explanation has been offered about potential biological causes of the phenomenon. Paclitaxel has long been used as a chemotherapy agent, and no similar finding has been reported in oncology literature.

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http://www.startribune.com/fda-to-investigate-safety-of-stents-balloons-coated-with-paclitaxel/504495712/