Sustained safety and performance of the second-generation sirolimus-eluting absorbable metal scaffold: Pooled outcomes of the BIOSOLVE-II and -III trials at 3 years.
Citation: Cardiovascular Revascularization Medicine. 2020 Apr 13PMID: 32917533Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2020Local holdings: Available in print through MWHC library: 2002 - presentISSN:- 1878-0938
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 32917533 | Available | 32917533 |
Available in print through MWHC library: 2002 - present
ANNOTATED TABLE OF CONTENTS: BIOSOLVE-II- and III are prospective international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically-driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis. Copyright (c) 2020. Published by Elsevier Inc.
BACKGROUND/PURPOSE: To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption.
CONCLUSION: In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis.
METHODS/MATERIALS: BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6-months.
RESULTS: Patients were 65.5 +/- 10.8 years old, and lesions were 12.1 +/- 4.5 mm long and located in vessels with a diameter of 2.7 +/- 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically-driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.
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