Six months clinical outcomes of Sahajanand Medical Technologies’s supralimus-sirolimus-eluting stent with bioabsorbable polymer were presented at EuroPCR 2009, in Barcelona. This analysis was performed as a part of the prospective of E-Series Multicenter Registry. The dataset demonstrated excellent results in high-risk patients with complex coronary lesions, including high procedural success rate (>97%), and sustained safety.
Presented by Ricardo A Costa, of Cardiovascular Research Center, Brazil, preliminary clinical results at six months (60%) demonstrated clinical effectiveness of supralimus in preventing revascularisation, with only 2% target vessel revascularisation rate. There were no thrombosis events and no target vessel revascularisation /target lesion revascularisation in the supralimus treated patients in-hospital. The stent thrombosis rate (definite/probable, ARC) up to six months was less than 1%.
Out-of-hospital adverse events (n=718) included only 2% cardiac death, 0.5% myocardial infarction and 4.5% major adverse cardiac events. Thus the preliminary data with the Supralimus sirolimus-eluting Stent has shown promising results.
The study was conducted by Alexandre Abizaid, Ricardo Costa and others from January 2007 and involved 1,181 patients with 1,260 lesions prospectively enrolled in 50 cities of Brazil, Venezuela and India. The patients were part of real-world scenario with routine or emergency percutaneous coronary intervention. Mean age of patients was 64 years and risk factors included 79% hypertension, 38% diabetes, 31% were smokers, 23% with previous infarction, 64% with dyslipidemia, 34% with previous percutaneous coronary intervention and 46% with family history of coronary artery disease. Clinical follow-up was scheduled at one, six, 12 and 24 months. Final analysis of this registry is awaited.