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Steiner, S. ; Schmidt, A.* ; Zeller, T.* ; Tepe, G.* ; Thieme, M.* ; Maiwald, L.* ; Schröder, H.* ; Euringer, W.* ; Popescu, C.* ; Brechtel, K.* ; Brucks, S.* ; Blessing, E.* ; Schuster, J.* ; Langhoff, R.* ; Schellong, S.M.* ; Weiss, N.* ; Beschorner, U.* ; Wittig, T.* ; Scheinert, D.*

Low-dose vs high-dose paclitaxel-coated balloons for femoropopliteal lesions: 2-Year results from the COMPARE Trial.

JACC-Cardiovasc. Interv. 15, 2093-2102 (2022)
Verlagsversion DOI PMC
Free by publisher
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/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. 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)
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Paclitaxel-coated Balloons ; Patency ; Peripheral Vascular Disease ; Superficial Femoral Artery; Drug-eluting Stent; Real-world; Angioplasty; Outcomes
ISSN (print) / ISBN 1936-8798
e-ISSN 1876-7605
Zeitschrift JACC: Cardiovascular Interventions
Quellenangaben Band: 15, Heft: 20, Seiten: 2093-2102 Artikelnummer: , Supplement: ,
Verlag Elsevier
Verlagsort Ste 800, 230 Park Ave, New York, Ny 10169 Usa
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Helmholtz Institute for Metabolism, Obesity and Vascular Research (HI-MAG)
Förderungen Boston Scientific
C.R. Bard
480 Biomedical
Bard Peripheral Vascular
Veryan
Biotronik
Cook Medical
Gore Associates
Medtronic
Philips
Terumo
TriReme
Shockwave
University of Leipzig
Intact Vascular
B. Braun
Bard
Bayer
Cardiovascular Systems
Gore
Verian
Optimed
Amgen
Esperion
Pfizer
Pluristem
Ticeba
Med Alliance