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.
Por:
Ortega-Paz L, Brugaletta S, Gomez-Lara J, Alfonso F, Cequier A, Romaní S, Bordes P, Serra A, Iñiguez A, Salinas P, García Del Blanco B, Goicolea J, Hernández-Antolín R, Cuesta J, Gómez-Hospital JA and Sabaté M
Publicada:
5 ago 2022
Ahead of Print:
5 ago 2022
Resumen:
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.
Filiaciones:
Ortega-Paz L:
Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
Brugaletta S:
Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
Gomez-Lara J:
Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain
Alfonso F:
Hospital Universitario de La Princesa, Madrid, Spain
Cequier A:
Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain
Romaní S:
Hospital San Pedro de Alcántara, Cáceres, Spain
:
Hospital General de Alicante, Alicante, Spain
Serra A:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Iñiguez A:
Hospital Alvaro Cunqueiro, Vigo, Spain
Salinas P:
Hospital Clínico San Carlos, Madrid, Spain
García Del Blanco B:
Hospital Vall d'Hebron, Barcelona, Spain
Goicolea J:
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
Hernández-Antolín R:
Hospital Ramón y Cajal, Madrid, Spain
Cuesta J:
Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain
Gómez-Hospital JA:
Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain
Sabaté M:
Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
Centro de Investigacíon Biomédica en Red. Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
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