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January 28, 2020

One-Year COMPARE Data Show Similar Efficacy and Safety for High- and Low-Dose Paclitaxel-Coated Balloons for PAD Treatment

January 28, 2020—One-year data from the COMPARE trial comparing the use of high- versus low-dose paclitaxel-coated balloons in femoropopliteal interventions were presented by Sabine Steiner, MD, at LINC 2020, the Leipzig Interventional Course held January 28–31 in Leipzig, Germany. The study was simultaneously published online ahead of print in European Heart Journal.

The COMPARE trial directly compared the efficacy and safety of the high-dose (3.5 μg/mm2) In.Pact drug-coated balloon (DCB; Medtronic) and low-dose (2 μg/mm2) Ranger DCB (Boston Scientific Corporation) in the treatment of high-grade stenotic or occluded lesions in the superficial femoral artery and/or proximal popliteal artery in patients with peripheral artery disease with Rutherford class 2 to 4.

The investigator-initiated, prospective, multicenter, noninferiority trial included 414 patients with a 1:1 randomization after stratification for lesion length. The primary efficacy endpoint was primary patency at 12 months defined as the absence of clinically driven target lesion revascularization (CD-TLR) or restenosis with peak systolic velocity ratio > 2.4 evaluated by duplex ultrasound. The primary safety endpoint was freedom from major adverse events (MAE) at 12 months, defined as device- and procedure-related deaths through 1 month, major amputations, and CD-TLR through 12 months.

Mean lesion length was similar for both arms (128.3 ± 97.3 mm for the high-dose and 123.9 ± 97.8 mm for the low-dose arm). Chronic total occlusions were present in 43% and 40.6% of cases in the high- arm and low-dose DCB arms, respectively.

A noninferiority margin of −10% at 12 months was met for both primary endpoints. Primary patency was 81.5% in the high-dose DCB arm and 83% in low-dose DCB arm (Pnoninferiority < .01). Freedom from MAE in the high-dose DCB arm was 92.6% and 91% in the low-dose DCB arm (Pnoninferiority < .01). The overall death rate was low (2%), and no major amputation occurred. Investigators reported follow-up will continue up to 5 years.

In comments to Endovascular Today, Dr. Steiner said "Longer follow-up will reveal if these positive results after 1 year can be maintained. Subsequent studies will need to focus on comparative effectiveness research for various endovascular devices including sirolimus-eluting balloons and stents as well as dedicated lesion-modifying devices." She also commented that the investigators plan to report 2-year follow-up data including primary patency and TLR rates next year at LINC 2021 with annual safety results reported thereafter. 

The investigators concluded in the European Heart Journal that both DCBs (each with different coating characteristics) exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions, including a wide range of lesion lengths.

The study was sponsored by the University of Leipzig with funding through a research grant from Boston Scientific; however, the company was not involved in collecting, monitoring, or analyzing study data and did not review the manuscript, noted the authors.

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January 28, 2020

Four-Year ILLUMENATE Data Presented for Philips Stellarex 0.035-Inch Low-Dose DCB

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One-Year TINTIN Data Presented for iVascular’s Luminor DCB and iVolution Stent