12-month clinical outcomes after Magmaris percutaneous coronary intervention in a real-world cohort of patients: Results from the CardioHULA registry

Abstract

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.

Keywords: Bioresorbable scaffolds; ICP; Magnesium; Magnésio; PCI; Suportes vasculares restaurativos transitórios biorreabsorbíveis.