Novel DCB noninferior to established DCB in treating femoropopliteal lesions

According to initial results of the first head-to-head trial of two drug-coated balloons for treatment of peripheral artery disease, a novel device was noninferior to an established device.

Dierk Scheinert, MD, chairman of the division of interventional angiology at the University Hospital Leipzig in Germany, presented the results of the COMPARE-Pilot study of 150 patients (mean age, 69 years; 65% men) with PAD and at least 70% stenosis or occlusion of the superficial femoral or proximal popliteal arteries who were randomly assigned to the novel DCB (Ranger, Boston Scientific) or the established DCB (IN.PACT Admiral or IN.PACT Pacific, Medtronic) at the Leipzig Interventional Course.

The study, which is investigator-initiated, will ultimately enroll up to 414 patients to test a formal noninferiority hypothesis, Scheinert said.

The novel DCB elutes a lower dose of paclitaxel than the established DCB (2 µg/mm²vs. 3.5 µg/mm²), and the DCBs have different coatings, he said.

The primary efficacy endpoint was patency at 12 months, defined as absence of clinically driven target lesion revascularization or restenosis with peak velocity ratio greater than 2.4 as assessed by duplex ultrasound.

There were no significant differences between the groups in bailout stent placement, postprocedure mean vessel diameter, postprocedure percent diameter stenosis, residual stenosis or dissection, according to the researchers.

Patency at 12 months occurred in 89% of the established DCB group and 84% of the novel DCB group (log-rank P = .7013), Scheinert said, noting at 410 days, patency in the novel DCB group remained at 84% but dropped to 62% in the established DCB group.

“There was excellent efficacy at 1 year for both tested DCB in the interim analysis of the first 150 randomized patients,” Scheinert said. “Recruitment of the full study cohort will be finished in the second quarter of 2018.” – by Erik Swain

Reference:

Scheinert D, et al. Latest results with new technologies for femoropopliteal obstructions: Drug-eluting devices, atherectomy and new implants. Presented at: Leipzig Interventional Course; Jan. 30-Feb. 2, 2018; Leipzig, Germany.

Disclosures: The study was sponsored by the University of Leipzig and funded through a research grant from Boston Scientific. Scheinert reports he serves as a consultant and/or advisory board member for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical/Allium, Medtronic, TriReme Medical, Trivascular and Upstream Peripheral Technologies.