MedStar Authors catalog › Details for: 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.
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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.

by Garcia-Garcia, Hector M; Waksman, Ron.
Citation: Catheterization & Cardiovascular Interventions. 92(7):E502-E511, 2018 Dec 01..Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.Published: 2018; ISSN: 1522-1946.Full author list: Abizaid A; Alves Lemos P; Barbato E; BIOSOLVE-II and III investigators; Christiansen EH; Garcia-Garcia HM; Haude M; Ince H; Kische S; Tolg R; Van Mieghem NM; Verheye S; von Birgelen C; Waksman R.UI/PMID: 30079472.Subject(s): *Absorbable Implants | *Coronary Artery Disease/th [Therapy] | *Coronary Vessels | *Drug-Eluting Stents | *Metals | *Percutaneous Coronary Intervention/is [Instrumentation] | Aged | Coronary Angiography | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Restenosis/dg [Diagnostic Imaging] | Coronary Restenosis/et [Etiology] | Coronary Thrombosis/dg [Diagnostic Imaging] | Coronary Thrombosis/et [Etiology] | Coronary Vessels/dg [Diagnostic Imaging] | Female | Humans | Male | Middle Aged | Percutaneous Coronary Intervention/ae [Adverse Effects] | Prospective Studies | Prosthesis Design | Risk Factors | Time Factors | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1002/ccd.27680 (Click here) ORCID: Waksman, Ron https://orcid.org/0000-0002-4063-9226 (Click here) Abbreviated citation: Catheter Cardiovasc Interv. 92(7):E502-E511, 2018 Dec 01.Local Holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006.Abstract: BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures.Abstract: 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.Abstract: Copyright (c) 2018 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.Abstract: 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).Abstract: 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.Abstract: 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.

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