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.
Katsanos’ team recently published a second meta-analysis comparing critical limb ischemia (CLI) treatment with paclitaxel-coated balloons with conventional balloon treatment. Published in the Journal of Vascular and Interventional Radiology, the analysis of eight trials with a total of 1,420 patients found that amputation-free survival was 13.7% in patients treated with paclitaxel-coated balloons compared with 9.4% for patients treated with uncoated balloons.
The new study of 414 patients showed non-inferiority for the Boston Scientific Ranger device at 12 months. Primary patency for the Ranger came in at 83% versus was 81.5% for InPact. Patients treated with InPact had 92.6% freedom from major adverse events, compared with 91.0% in the Ranger group.
The study included complex patients with lesion length ~120 mm, ~40% with chronic total occlusion and ~30% with diabetes. All-cause mortality was 2.5% for the Ranger and 1.6% for the In.Pact, and no major amputation occurred.