TY - JOUR
T1 - Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions
T2 - 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study
AU - Latib, Azeem
AU - Agostoni, Pierfrancesco
AU - Dens, Jo
AU - Patterson, Mark
AU - Lancellotti, Patrizio
AU - Tam, Frankie C C
AU - Schotborgh, Carl
AU - Kedhi, Elvin
AU - Stella, Pieter
AU - Shen, Cheryl
AU - Wetzels, Gwenn
AU - Testa, Luca
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
KW - Cardiovascular Agents
KW - Coated Materials, Biocompatible
KW - Coronary Artery Disease/diagnosis
KW - Coronary Restenosis/diagnosis
KW - Coronary Vessels/diagnostic imaging
KW - Humans
KW - Paclitaxel
KW - Pharmaceutical Preparations
KW - Prospective Studies
KW - Treatment Outcome
UR - https://pubmed.ncbi.nlm.nih.gov/34433695/
M3 - Article
C2 - 34433695
SN - 1042-3931
VL - 33
SP - E863-E869
JO - The journal of invasive cardiology
JF - The journal of invasive cardiology
IS - 11
ER -