Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial.

BACKGROUND

So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.

OBJECTIVES

The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm

METHODS

Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes.

RESULTS

At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups.

CONCLUSIONS

The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

Informations de copyright

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The study sponsor is the University of Leipzig, with funding through a research grant from Boston Scientific. The funding source was not involved in collecting, monitoring, or analyzing study data. Investigators (Drs Steiner and Scheinert) prepared all data presentation and manuscript drafts, which were then critically reviewed and edited by the other authors. The funding source had no access to data or manuscript review. Dr Steiner has been a consultant for Bayer, Boston Scientific, and Cook Medical; and has received research funding from C.R. Bard. Dr Schmidt has received consulting and speaker honoraria from C.R. Bard, Cook, and Cordis. Dr Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, and Shockwave; has consulted for Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, B. Braun, Shockwave, Bayer, and Vesper Medical; has received research, clinical trial, or drug study funding from 480 Biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Veryan, Shockwave, Med Alliance, Intact Vascular, and B. Braun; and holds common stock in QT Medical. Dr Tepe is on the advisory board for Medtronic and Philips; and has received study support from Bard, Bayer, B. Braun, Biotronik, Boston Scientific, Cardiovascular Systems, Gore, Verian, and Shockwave. Dr Blessing has received honoraria from Abbott Vascular, B. Braun, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, and Shockwave; and is a consultant for Boston Scientific, Medtronic, and Bayer. Dr Langhoff has received consulting and speaker honoraria from Boston Scientific, Biotronik, Abbott, Contego Medical, Terumo, Cardinal Health, Alvimedica, B. Braun, and Kardionet; and has received speaker honoraria from C. R. Bard and Bayer. Dr Weiss has received speaker honoraria or research funding from C.R. Bard, Terumo, Optimed, Amgen, Bayer, Esperion, Pfizer, Pluristem, and Ticeba. Dr Scheinert is a consultant or an advisory board member for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.