Positive Outcomes Reported With Supralimus Sirolimus-Eluting Stent With Biodegradable Polymer
October 1, 2009 – The six-month clinical outcome of Sahajanand Medical Technologies Supralimus Sirolimus-Eluting Stent with a bioabsorbable polymer was highlighted by the company at TCT 2009. The results were released at EuroPCR 2009 earlier this year and demonstrated excellent results in high risk patients with complex coronary lesions, including high procedural success rate (greater than 97 percent), and sustained safety.
Dr. Ricardo A. Costa, of the Cardiovascular Research Center, Brazil, offered preliminary clinical results at six months from the Multicenter E-Series Registry. He said the stent demonstrated clinical effectiveness of Supralimus in preventing revascularization, with only 2 percent target vessel revascularization (TVR) rate. There were no thrombosis events and no TVR/TLR in the Supralimus treated patient’s in-hospital. The stent thrombosis rate (definite/probable, ARC) up to six months was less than 1 percent.
Out-of Hospital adverse events (N=718) included 2 percent cardiac death, 0.5 percent myocardial infarction (MI) and 4.5 percent of major adverse cardiac event (MACE). Thus the preliminary data with the Supralimus Sirolimus-Eluting Stent has shown promising results, Dr. Costa said.
The study was conducted by Dr. Alexandre Abizaid, Dr. Costa and others from Jan 2007, which involved 1,181 patients with 1,260 lesions and prospectively enrolled in 50 cities of Brazil, Venezuela and India. The included patients were real world scenario with routine or emergency PCI. Mean age of patients was 64 years and risk factors included 79 percent hypertension, 38 percent diabetes, 31 percent smoker, 23 percent with previous MI, 64 percent with dyslipidemia, 34 percent with previous PCI and 46 percent with family history of CAD.
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