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The funding source was the Spanish Heart Foundation. The promoter of the study had no role in the study design, providing only funds for independent data management (Effice SL, Madrid) and a core laboratory analysis centre (Barcicore, Cardiac Imaging Corelab, Barcelona) for database management and all statistical analyses. The authors had unrestricted access to the data and vouch for the accuracy and completeness of the data and analyses and for the fidelity of the study to the protocol. The corresponding author had final responsibility for the decision to submit for publication.

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Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial

Publicated to:Eurointervention. 18 (5): e389-e396 - 2022-08-01 18(5), DOI: 10.4244/eij-d-21-00651

Authors: Ortega-Paz, Luis; Brugaletta, Salvatore; Gomez-Lara, Josep; Alfonso, Fernando; Cequier, Angel; Romani, Sebastian; Bordes, Pascual; Serra, Antonio; Iniguez, Andres; Salinas, Pablo; Garcia del Blanco, Bruno; Goicolea, Javier; Hernandez-Antolin, Rosana; Cuesta, Javier; Antoni Gomez-Hospital, Joan; Sabate, Manel

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Abstract

Long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.To report the 3-year clinical outcomes of the MAGSTEMI trial.This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee.Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000).At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

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