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.

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.
Competing Interests: Declaration of competing interest MH reports study grants and personal fees from Biotronik, Abbott Vascular, Cardiac Dimensions, Orbus Neich, and Philips, RT reports personal fees from Biotronik and Abbott Vascular, PAL reports grants from Biotronik, EHC reports grants from Biotronik, AA is a proctor for TAVR implantation for Boston Scientific, CvB reports grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic, FJN reports lectures fees paid to his institution from Amgen, Bayer Healthcare, Biotronic, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, consultancy fees paid to his institution from Boehringer Ingelheim, and grant support from Bayer Healthcare, and Boston Scientific, WW reports institutional grants from Biotronik and MicroPort, is a co-founder of Argonauts Partners, and received speaker fees from MicroPort, JE reports speaker fee honoraria from Abbott, Biotronik, Bostoms Scientific and Philips, LST received honoraria and conference support from Terumo, Kaneka, Abbott, Medtronic, Alvimedia, Boston Scientific, Biotronik and Asahi Intecc., EE reports speaker honoraria and research grants from Biotronik. HGG reports that MedStar was the core laboratory of the study, RW reports that MedStar was the core laboratory of the study and reports grants and personal fees from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi, personal fees of Amgen, Corindus, Lifetech Medical, Medtronic, Philips Volcano, Pi-Cardia LTD, is an investor of MedAlliance, and grants from Edwards Lifesciences. All other authors have no conflict of interest to declare.
(Copyright © 2021. Published by Elsevier Inc.)