MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design
Por:
Brugaletta, S, Cequier, A, Alfonso, F, Iniguez, A, Romani, S, Serra, A, Salinas, P, Goicolea, J, Bordes, P, del Blanco, BG, Hernandez-Antolin, R, Pernigotti, A, Gomez-Lara, J, Sabate, M
Publicada:
1 ene 2019
Resumen:
Aim Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. Study design This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial ( number: NCT03234348). This trial will randomize similar to 148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. Conclusion This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
Filiaciones:
Brugaletta, S:
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Hosp Clin, Inst Clin Cardiovasc, Dept Cardiol, Barcelona, Spain
Cequier, A:
Hosp Bellvitge Princeps Espanya, Dept Cardiol, Barcelona, Spain
Alfonso, F:
Hosp La Princesa, Dept Cardiol, Madrid, Spain
Iniguez, A:
Hosp Alvaro Cunqueiro, Dept Cardiol, Vigo, Spain
Romani, S:
Hosp San Pedro Alcantara, Dept Cardiol, Caceres, Spain
Serra, A:
Hosp Santa Creu & Sant Pau, Dept Cardiol, Barcelona, Spain
Salinas, P:
Hosp Clin San Carlos, Dept Cardiol, Madrid, Spain
Goicolea, J:
Hosp Puerta Hierro Majadahonda, Dept Cardiol, Madrid, Spain
Bordes, P:
Hosp Gen Alicante, Dept Cardiol, Alicante, Spain
del Blanco, BG:
Hosp Valle De Hebron, Dept Cardiol, Barcelona, Spain
Hernandez-Antolin, R:
Hosp Ramon & Cajal, Dept Cardiol, Madrid, Spain
Pernigotti, A:
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Hosp Clin, Inst Clin Cardiovasc, Dept Cardiol, Barcelona, Spain
Gomez-Lara, J:
Hosp Bellvitge Princeps Espanya, Dept Cardiol, Barcelona, Spain
Sabate, M:
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Hosp Clin, Inst Clin Cardiovasc, Dept Cardiol, Barcelona, Spain
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