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

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)106-110
Number of pages5
JournalCardiovascular Revascularization Medicine
Volume38
DOIs
Publication statusPublished - May 2022
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • De novo coronary lesions
  • Scaffold thrombosis
  • Target lesion failure
  • n/a OA procedure

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