December 20, 2018
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DCBs confer similar patency in 1-year interim analysis

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Dierk Scheinert
Dierk Scheinert

A drug-coated balloon with a low dose of paclitaxel showed similar patency to a standard-dose paclitaxel-eluting balloon, according to an interim analysis presented at VEITHSymposium.

Dierk Scheinert, MD, chairman of the division of interventional angiology at the University Hospital Leipzig in Germany, and Andrej Schmidt, MD, senior interventionalist at University Hospital Leipzig, presented 1-year results of the first 150 patients with peripheral artery disease (mean age, 69 years; 65% men) enrolled in the COMPARE Pilot trial, a head-to-head study of the low-dose paclitaxel-coated balloon (Ranger, Boston Scientific) with the standard-dose DCB (IN.PACT Admiral or IN.PACT Pacific, Medtronic).

According to the researchers, the full cohort will include 414 patients; enrollment completed in November.

The primary efficacy endpoint was 1-year patency. The primary safety endpoint was freedom from device- and procedure-related death at 1 year plus freedom from target limb amputation and clinically driven target lesion revascularization.

Mean lesion length was 117.4 mm in the Ranger group and 122.3 mm in the IN.PACT group. Rates of total occlusion were 39.2% in the Ranger group and 44.7% in the IN.PACT group, and most patients in both groups had moderately severe or severe calcification.

Bailout stenting was necessary in 25.7% of the Ranger group and 22.4% of the IN.PACT group (P = .6), according to the researchers.

Scheinert and Schmidt reported that embolic events occurred in 2.7% of the Ranger group vs. 1.3% of the IN.PACT group, arteriovenous fistulas developed in 6.8% of the Ranger group and 6.6% of the IN.PACT group, and target vessel perforation was observed in 1.4% of the Ranger group and 1.3% of the IN.PACT group.

Kaplan-Meier estimates of 1-year primary patency were 84% for the Ranger group and 89% for the IN.PACT group.

“There was excellent efficacy at 1 year of both tested DCBs in the interim analysis of the first 150 randomized patients,” the researchers wrote in a slide presentation. “There was similar primary patency of the low-dose Ranger DCB (2 µg/mm2) compared to the IN.PACT DCB (3.5 µg/mm2) during the 1-year surveillance period.” – by Erik Swain

Reference:

Scheinert D, et al. Session 26: New Developments in Drug-Coated Balloons, Other Devices for Treatment of Lower Extremity Occlusive Lesions, Randomized Trials and BTK Treatments. Presented at: VEITHSymposium; Nov. 13-17, 2018; New York.

Disclosures: The study was investigator-initiated and funded through a research grant from Boston Scientific. Scheinert reports he consults or serves on an advisory board for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical/Allium, Medtronic, TriReme Medical, Trivascular and Upstream Peripheral Technologies. Schmidt reports he consults for Abbott, Cook Medical, Cordis, CR Bard, Medtronic, Reflow Medical and Upstream Peripheral Technologies.