Early Data From COMPARE-1 Trial of Boston Scientific's Ranger DCB Presented at LINC
January 31, 2018—Twelve-month results from the pilot phase of the COMPARE-1 clinical trial were presented by Professor Dierk Scheinert, MD, at LINC 2018: the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
The investigators found that Boston Scientific Corporation's new-generation Ranger drug-coated balloon (DCB) showed no statistically significant difference in patency compared with the In.Pact DCB (Medtronic). In addition, they noted that the Ranger device uses approximately half the dose of paclitaxel as the In.Pact device (2 μg/mm2 vs 3.5 μg/mm2). The Ranger DCB is built on Boston Scientific's 0.018-inch Sterling balloon. The Medtronic In.Pact DCB devices used in the study are built on either the Admiral or Pacific platforms.
As Prof. Scheinert reported, the head-to-head prospective, randomized (1:1) controlled trial compared the two different paclitaxel-coated balloons (with different coatings and different paclitaxel dose density) in the treatment of high-grade stenotic or occluded lesions (≥ 70% stenosis) in the native nonstented superficial femoral artery and/or proximal popliteal artery in patients with Rutherford class 2 to 4 peripheral artery disease. Other inclusion criteria were no previous treatment with DCBs or drug-eluting stents in the treated limb, lesion length ≤ 300 mm, and reference vessel diameter ≥ 4 and ≤ 6.5 mm.
The phase 1 pilot study enrolled and evaluated 150 patients. Stratification was done according to lesion length. The study is designed for follow-up clinical visits at 6, 12, and 24 months.
Efficacy was the core lab–adjudicated patency rate after 1 year, defined as the absence of clinically driven target lesion revascularization caused by symptoms and drop of the ankle-brachial index of ≥ 20% or > 0.15 when compared to postprocedure or restenosis with peak velocity ratio > 2.4 evaluated by duplex ultrasound.
A phase 2 extension of the trial will be composed of up to 414 patients for testing of a formal noninferiority hypothesis. Phase 2 enrollment is expected to be completed in the first half of 2018.
In the 150-patient, phase 1 cohort, 74 patients were treated with the Ranger DCB and 76 patients were treated with the In.Pact DCB. Baseline characteristics for Ranger versus In.Pact included total occlusions (39% vs 45%; P = .5), total occlusion length (111 mm vs 95 mm; P = .5), target lesion length (117 mm vs 122 mm; P = .8), moderate-to-severe claudication (58% vs 61%; P = .7), and patients with diabetes (34% vs 37%; P = .7).
In the pilot phase 1 cohort, 1-year patency was 84% for the Ranger DCB versus 89% for the In.Pact DCB reported Prof. Scheinert at the LINC meeting.