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

• Published in: The Journal of invasive cardiology Vol. 33; no. 11; pp. E863 - E869
• Main Authors: Latib, Azeem, Agostoni, Pierfrancesco, Dens, Jo, Patterson, Mark, Lancellotti, Patrizio, Tam, Frankie C C, Schotborgh, Carl, Kedhi, Elvin, Stella, Pieter, Shen, Cheryl, Wetzels, Gwenn, Testa, Luca
• Format: Journal Article Web Resource
• Language: English
• Published: HMP Communications 01.11.2021
• Subjects: Cardiovascular & respiratory systems; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease/diagnosis/surgery; Coronary Restenosis/diagnosis/epidemiology; Coronary Vessels/diagnostic imaging/surgery; DCB; drug-coated balloon; Human health sciences; Humans; in-stent restenosis; ischemia; P88XT4IS4D (Paclitaxel); Paclitaxel; Pharmaceutical Preparations; Prospective Studies; revascularization; Sciences de la santé humaine; Systèmes cardiovasculaire & respiratoire; Treatment Outcome
• ISSN: 1557-2501; 1042-3931; 1557-2501

OBJECTIVESThe 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. METHODSPREVAIL 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. RESULTSMean 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%. CONCLUSIONSPaclitaxel 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.