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.

Details

Serval ID
serval:BIB_1B0E25B20B12
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
Cardiovascular revascularization medicine
Author(s)
Haude M., Toelg R., Lemos P.A., Christiansen E.H., Abizaid A., von Birgelen C., Neumann F.J., Wijns W., Ince H., Kaiser C., Lim S.T., Escaned J., Eeckhout E., Garcia-Garcia H.M., Waksman R.
ISSN
1878-0938 (Electronic)
ISSN-L
1878-0938
Publication state
Published
Issued date
05/2022
Peer-reviewed
Oui
Volume
38
Pages
106-110
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Permanent drug-eluting stents are associated with a steady increase in 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.
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 of target lesion failure and rate of definite or probable stent thrombosis.
A total of 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 ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). 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.
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.
Keywords
Absorbable Implants, Coronary Artery Disease/diagnostic imaging, Coronary Artery Disease/therapy, Humans, Metals, Myocardial Infarction, Percutaneous Coronary Intervention/adverse effects, Percutaneous Coronary Intervention/methods, Prospective Studies, Sirolimus/adverse effects, Treatment Outcome, Bioresorbable scaffolds, De novo coronary lesions, Scaffold thrombosis, Target lesion failure
Pubmed
Web of science
Create date
24/08/2021 12:51
Last modification date
04/11/2023 7:08
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