COMPARE Pilot RCT 2-Year Results Show Similar Patency for Low-Dose and High-Dose Drug-Coated Balloons

Hollywood, FL (January 24, 2020) – Michael R. Jaff, DO, Vice President of Clinical Affairs, Innovation, Technology and Peripheral Interventions at Boston Scientific, presented results from the COMPARE Pilot randomized clinical trial on Friday morning at the International Symposium on Endovascular Therapy (ISET).

The head-to-head study of the Ranger drug-coated balloon (DCB) (Boston Scientific) vs the IN.PACT DCB (Medtronic) in high-grade stenotic or occluded superficial femoral artery (SFA) lesions (n=150) showed that the low-dose Ranger DCB demonstrated patency similar to the  higher-dose IN.PACT DCB out to two years (66% vs 60% at 770 days, respectively). Both DCBs demonstrated excellent efficacy out to two years in this complex, real-world lesion subset (Rutherford class 2-4) with lesion length at approximately 12 cm and the proportion of chronic total occlusions at approximately 40%.

Dr. Jaff noted that clinical results for the Ranger DCB have shown to be consistent across trials. In the RANGER II randomized clinical trial, 1-year patency for the Ranger DCB (89.2%) was superior to percutaneous transluminal angioplasty (PTA) (72.9%) and it demonstrated non-inferior safety.

The Ranger DCB has a paclitaxel dose of 2 μg/mm², and is compatible with .14- and .18-inch guidewires, and the IN.PACT Admiral DCB has a paclitaxel dose of 3.5 μg/mm² and offers .035 over-the-wire delivery. The Ranger DCB has a CE mark, but is not yet FDA approved.

COMPARE I full cohort (n=414) results will be presented January 28th, 2020, by Sabine Steiner, MD, at the Leipzig Interventional Course (LINC).