Sustained safety and performance of a second-generation sirolimus-eluting absorbable metal scaffold: Long-term data of the BIOSOLVE-II first-in-man trial at 5 years.
Citation: Cardiovascular Revascularization Medicine. 2021 Jul 22PMID: 34364807Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2021ISSN:- 1878-0938
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 34364807 | Available | 34364807 |
ANNOTATED TABLE OF CONTENTS: BIOSOLVE-II is a prospective, multi-centre, first-in-man trial enrolling 123 patients with de novo coronary artery lesions. Target lesion failure rate at 5 years was low (8.0%), including 2 cardiac deaths, 2 target-vessel myocardial infarction and 6 clinically-driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. Copyright (c) 2021. Published by Elsevier Inc.
BACKGROUND: Permanent drug-eluting stents are associated with a steady increase of late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years.
CONCLUSION: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.
METHODS: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints target lesion failure and rate of definite or probable stent thrombosis.
RESULTS: 123 patients with 123 lesions were enrolled. Lesions were 12.6 +/- 4.5 mm long and 2.7 +/- 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischemia. Target lesion failure rate was 8.0% [95% CI:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarction, and 6 clinically-driven target lesion revascularizations. Only one target lesion failure occurred beyond 3 years; a target-vessel myocardial infarction with clinically-driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed.
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