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Introduction and objectives: Clinical evidence on the bioresorbable magnesium scaffolds (BRS) is still scarce. We aim to assess clinical outcomes after magnesium BRS deployment in a real-world cohort of patients. Methods: We included in a non-randomized, prospective, single-center registry of all patients treated with at least one Magmaris device in our cath lab. Pre and postdilatation with optical coherence tomography guidance, as part of the 4Ps strategy, were performed in all cases. The primary endpoint was target lesion failure (TLF) at 12 months. Results: 42 patients (with 42 lesions) underwent Magmaris percutaneous coronary intervention (PCI) between June 2016 to April 2017. PCI was performed in an acute setting in 54.76% cases; the most treated vessel was the anterior descending artery, with a mean diameter of 3.30±0.25 mm. All lesions underwent predilatation and postdilatation, with a mean postdilatation pressure of 19.2 atm. Procedural success rate was 100%. TLF rate was 4.7% at 12 months. None of our patients died or suffered myocardial infarction. Two patients (4.7%) underwent clinically-driven target lesion revascularization due to in-stent restenosis. No stent thrombosis was detected. Conclusion: 12-months clinical outcomes after Magmaris PCI demonstrate its safety and feasibility when deployed in a 4Ps strategy. Resumo: Introdução e objetivos: A evidência clínica dos suportes vasculares restaurativos biorreabsorbíveis de magnésio é ainda escassa. O objetivo deste estudo consistiu na avaliação dos resultados clínicos após a implantação dos SVR (suportes vasculares restaurativos) de magnésio numa coorte de doentes do mundo real. Métodos: Incluímos num registo não aleatório, prospetivo e unicêntrico todos os doentes tratados com pelo menos um dispositivo Magmaris, no nosso laboratório de hemodinâmica. A pré e a pós-dilatação, sob a orientação de TCO como parte da estratégia dos 4 Ps, foram efetuadas em todos os casos. O objetivo primário foi a falência da lesão alvo (FLA) aos 12 meses. Resultados: Foram submetidos 42 doentes (com 42 lesões) a ICP com Magmaris entre junho de 2016 e abril de 2017. A ICP foi efetuada num contexto agudo em 54,76% dos casos, sendo a artéria descendente anterior alvo do maior número de tratamentos, com um diâmetro médio de vaso de 3,30±0,25 mm. Todas as lesões foram submetidas a pré e pós-dilatação, com uma pressão média de pós-dilatação de 19,2 atm. A taxa de sucesso do procedimento foi de 100%. A taxa da FLA foi de 4,7% aos 12 meses. Nenhum dos doentes faleceu ou sofreu enfarte do miocárdio. Dois doentes (4,7%) foram submetidos a revascularização da lesão alvo devido a restenose intra stent. Não foi detetada trombose de stent. Conclusão: Os resultados clínicos a 12 meses após a ICP com Magmaris demonstraram segurança e viabilidade quando desenvolvidos sob uma estratégia de 4 Ps.

Introduction and Objectives: Clinical evidence on the bioresorbable magnesium scaffolds (BRS) is still scarce. We aim to assess clinical outcomes after magnesium BRS deployment in a real-world cohort of patients., Methods: We included in a non-randomized, prospective, single-center registry of all patients treated with at least one Magmaris device in our cath lab. Pre and postdilatation with optical coherence tomography guidance, as part of the 4Ps strategy, were performed in all cases. The primary endpoint was target lesion failure (TLF) at 12 months., Results: 42 patients (with 42 lesions) underwent Magmaris percutaneous coronary intervention (PCI) between June 2016 to April 2017. PCI was performed in an acute setting in 54.76% cases; the most treated vessel was the anterior descending artery, with a mean diameter of 3.30±0.25 mm. All lesions underwent predilatation and postdilatation, with a mean postdilatation pressure of 19.2 atm. Procedural success rate was 100%. TLF rate was 4.7% at 12 months. None of our patients died or suffered myocardial infarction. Two patients (4.7%) underwent clinically-driven target lesion revascularization due to in-stent restenosis. No stent thrombosis was detected., Conclusion: 12-months clinical outcomes after Magmaris PCI demonstrate its safety and feasibility when deployed in a 4Ps strategy., (Copyright © 2020 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.)