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.

Abstract

BACKGROUND:

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.

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 of target lesion failure and rate of definite or probable stent thrombosis.

RESULTS:

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.

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.

• Authors: Michael Haude, Ralph Toelg, Pedro Alves Lemos, Evald Høj Christiansen, Alexandre Abizaid, Clemens von Birgelen, Franz-Josef Neumann, William Wijns, Hüseyin Ince, Christoph Kaiser, Soo Teik Lim, Javier Escaned, Eric Eeckhout, Hector M Garcia-Garcia, Ron Waksman
• Journal: Cardiovascular revascularization medicine : including molecular interventions (Cardiovasc Revasc Med) Vol. 38 Pg. 106-110 (05 2022) ISSN: 1878-0938 [Electronic] United States
• PMID: 34364807 (Publication Type: Journal Article)
• Copyright: Copyright © 2021. Published by Elsevier Inc.

Chemical References

• Metals
• Sirolimus

Topics

• Absorbable Implants
• Coronary Artery Disease (diagnostic imaging, therapy)
• Humans
• Metals
• Myocardial Infarction
• Percutaneous Coronary Intervention (adverse effects, methods)
• Prospective Studies
• Sirolimus (adverse effects)
• Treatment Outcome