A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week.
The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated ballon (DCB) to the higher-dose (3.5 μg/mm2) Medtronic In.Pact DCB. The study results were presented at the Leipzig Interventional Course Congress and published in the European Heart Journal.
Paclitaxel-coated devices came under scrutiny following the December 2018 publication of a meta-analysis in the Journal of the American Heart Association suggesting that PAD patients treated with paclitaxel-coated balloons and stents could be at a higher risk for late death. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials to find a 68% relative risk increase in all-cause death with paclitaxel-coated devices after two years and a 93% relative risk increase after five years, compared to therapy with an uncoated device.
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