The MeRes-1 Extend Trial: 2-year clinical and 6-month imaging outcomes of thin-strut sirolimus-eluting brs in patients with de novo coronary artery lesions
Abizaid, Alexandre; Kedev, Sasko; Ali, Rosli Bin Mohd; Santoso, Teguh; Cequier, Angel; Van Geuns, R. J. M; Chevalier, Bernard; Hellig, Farrel; Costa, Ricardo; Onuma, Yoshinobu; Costa JR, Jose; Serruys, Patrick; Bangalore, Sripal.
J. Am. Coll. Cardiol
; 76(17 suppl. b): 118-118, Oct., 2020.
Artigo
Inglês
| CONASS, SES-SP, SES SP - Instituto Dante Pazzanese de Cardiologia, SES-SP | ID: biblio-1343470
BACKGROUND The long- term clinical outcomes of percutaneous coronary intervention can be improved by replacing metallic drug eluting stents with bioresorbable vascular scaffolds. The MeRes-1 Extend trial was designed to assess the safety and efficacy of a novel thin-strut MeRes100 bioresorbable vascular scaffold (Meril Life Sci ences) in a diverse patient population. METHODS The MeRes-1 Extend was a prospective, multicenter, sin gle-arm study that enrolled 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. Major adverse cardiac events, consisting of cardiac death, myocardial infarction, and ischemia driven target lesion revascularisation, were the safety endpoint. At baseline and 6-month follow-up, quantitative coronary angiography and optical coherence tomography were performed. RESULTS Of all patients enrolled (mean age 58.30 9.02 years), 76.56% had hypertension, 26.56% had diabetes mellitus, 48.44% had dyslipidemia, and 28.13% had a previous myocardial infarction; 68.75% of patients presented with stable angina, 9.38% with unstable angina, and 21.88% with silent ischemia. A total of 69 target lesions (mean length 14.37 5.89 mm) were detected of which 71.01% were type B2/C. Procedural and device success were achieved in 64 and 62 patients, respectively. Major adverse cardiac events rate was reported in 1 patient (1.61%) in the form of ischemia-driven target lesion revascularization; there were no cases of myocardial infarction, car diac death, or scaffold thrombosis. At 6-month angiographic follow-up (n » 32), mean in-scaffold late lumen loss was 0.18 0.31 mm. Optical coherence tomography analysis (n » 21) showed 97.95 3.69% strut coverage and mean scaffold area of 7.56 1.79 mm2, with no strut malapposition. Updated data will be presented during Transcatheter Cardiovascular Therapeutics 2020 annual meeting. CONCLUSION Two-year clinical and 6-month imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of novel thin-strut MeRes100 sirolimus-eluting bioresorbable vascular scaffolds in patients with de novo coronary artery lesions.
Biblioteca responsável:
BR79.1
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