High and low dose drug coated balloons equally effective in PAD
A Boston Scientific device coated with less of the controversial drug paclitaxel than one made by Medtronic 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.