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.

MedStar author(s):
Citation: Catheterization & Cardiovascular Interventions. 92(7):E502-E511, 2018 Dec 01.PMID: 30079472Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *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 OutcomeYear: 2018Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006ISSN:
  • 1522-1946
Name of journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsAbstract: 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.All authors: 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 RFiscal year: FY2019Digital Object Identifier: ORCID: Date added to catalog: 2018-08-16
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30079472 Available 30079472

Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006

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.

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