Article (Scientific journals)
Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.
Latib, Azeem; Agostoni, Pierfrancesco; Dens, Jo et al.
2021In Journal of Invasive Cardiology, 33 (11), p. 863-E869
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Keywords :
Cardiovascular Agents; Coated Materials, Biocompatible; Pharmaceutical Preparations; P88XT4IS4D (Paclitaxel); Coronary Artery Disease/diagnosis/surgery; Coronary Restenosis/diagnosis/epidemiology; Coronary Vessels/diagnostic imaging/surgery; Humans; Paclitaxel; Prospective Studies; Treatment Outcome; DCB; drug-coated balloon; in-stent restenosis; ischemia; revascularization
Abstract :
[en] OBJECTIVES: The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease. METHODS: PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful. RESULTS: Mean in-stent (in-balloon) LLL was 0.05 ± 0.44 mm at 6 months post procedure. There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months. The incidence of clinically driven target-lesion revascularization was 6.0% at 12 months and clinically driven target-vessel revascularization was 10.0%. CONCLUSIONS: Paclitaxel DCB treatment of coronary de novo and first ISR lesions led to low LLL at 6 months and low rates of revascularization and safety events through 12 months.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Latib, Azeem;  Montefiore-Einstein Center for Heart and Vascular Care, 111 East 210th Street,
Agostoni, Pierfrancesco
Dens, Jo
Patterson, Mark
LANCELLOTTI, Patrizio  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Tam, Frankie C C
Schotborgh, Carl
Kedhi, Elvin
Stella, Pieter
Shen, Cheryl
Wetzels, Gwenn
Testa, Luca
PREVAIL Study, Investigators
More authors (3 more) Less
Language :
English
Title :
Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.
Publication date :
November 2021
Journal title :
Journal of Invasive Cardiology
ISSN :
1042-3931
eISSN :
1557-2501
Publisher :
HMP Communications, Us pa
Volume :
33
Issue :
11
Pages :
E863-E869
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 18 May 2022

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