TY  - BOOK
AU  - Garcia-Garcia, Hector M
AU  - Waksman, Ron
TI  - Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III
SN  - 1522-1946
PY  - 2018///
KW  - *Absorbable Implants
KW  - *Coronary Artery Disease/th [Therapy]
KW  - *Coronary Vessels
KW  - *Drug-Eluting Stents
KW  - *Metals
KW  - *Percutaneous Coronary Intervention/is [Instrumentation]
KW  - Aged
KW  - Coronary Angiography
KW  - Coronary Artery Disease/dg [Diagnostic Imaging]
KW  - Coronary Restenosis/dg [Diagnostic Imaging]
KW  - Coronary Restenosis/et [Etiology]
KW  - Coronary Thrombosis/dg [Diagnostic Imaging]
KW  - Coronary Thrombosis/et [Etiology]
KW  - Coronary Vessels/dg [Diagnostic Imaging]
KW  - Female
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Percutaneous Coronary Intervention/ae [Adverse Effects]
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Risk Factors
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
N2  - BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures; CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis; Copyright (c) 2018 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc; METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III); OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data; RESULTS: Mean patient age was 65.5 +/- 10.8 years and mean lesion reference diameter was 2.70 +/- 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 +/- 0.31 mm in-segment and 0.39 +/- 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed
UR  - https://dx.doi.org/10.1002/ccd.27680
ER  -