Coronary interventions

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

EuroIntervention 2022;18:e389-e396. DOI: 10.4244/EIJ-D-21-00651

Luis Ortega-Paz
Luis Ortega-Paz1, MD, PhD; Salvatore Brugaletta1, MD, PhD; Josep Gomez-Lara2, MD, PhD; Fernando Alfonso3, MD, PhD; Angel Cequier2, MD, PhD; Sebastián Romaní4, MD; Pascual Bordes5, MD; Antonio Serra6, MD; Andrés Iñiguez7, MD; Pablo Salinas8, MD; Bruno García del Blanco9, MD, PhD; Javier Goicolea10, MD; Rosana Hernández-Antolín11, MD; Javier Cuesta2, MD; Joan Antoni Gómez-Hospital2, MD, PhD; Manel Sabaté1,12, MD, PhD
1. Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; 2. Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain; 3. Hospital Universitario de La Princesa, Madrid, Spain; 4. Hospital San Pedro de Alcántara, Cáceres, Spain; 5. Hospital General de Alicante, Alicante, Spain; 6. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 7. Hospital Alvaro Cunqueiro, Vigo, Spain; 8. Hospital Clínico San Carlos, Madrid, Spain; 9. Hospital Vall d’Hebrón, Barcelona, Spain; 10. Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain; 11. Hospital Ramón y Cajal, Madrid, Spain; 12. Centro de Investigacíon Biomédica en Red. Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain

Background: The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.

Aims: The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial.

Methods: 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.

Results: 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).

Conclusions: 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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