Shirish Hiremath1, Praveen Chandra2, Devang Desai3, R Sivakumar4, S Selvamani4, Anand Srinivasan5, Madhu Paulose5, Sajy Jose5, B C Kalmath6, Vilas P Magarkar7, Abhijeet Pathak8, Tushar Mhetre9. 1. Ruby Hall Clinic and Research Centre, Pune, India. 2. Max Hospital, New Delhi, India. 3. Shree B. D. Mehta Mahavir Heart Institute, Surat, India. 4. Meenakshi Mission Hospital, Madurai, India. 5. St. Gregorios Cardio-Vascular Center Parumala, Kerala, India. 6. Zynova Hospital, Mumbai, India. 7. Seth Nandlal Dhoot Hospital, Aurangabad, India. 8. Anand Rishiji Hospital, Ahmednagar, India. 9. Assistant Manager, Clinical Research Department, Biosensors Interventional Technologies (India) Pvt. Ltd, India. Electronic address: t.mhetre@biosensorsindia.com.
Abstract
OBJECTIVES: This study aims to assess the safety and efficacy of a biodegradable polymer-coated Rapamycin-Eluting Stent (Excel) used in conjunction with six-month dual antiplatelet therapy in daily practice. BACKGROUND: The polymeric material of cardiac stents has been reported to adversely affect the safety profile of the drug-eluting stents and is also suspected to cause serious long-term complications. It has been proposed that the biodegradable polymer coatings may reduce such late-stage adverse effects. METHODS: This is a prospective, multi-center registry of 654 patients from across 9 cardiology centers in India, who were enrolled and exclusively treated with Excel stents between February 2008 and May 2010. The recommended antiplatelet regimen included clopidogrel and aspirin for 6 months period, followed by lifelong aspirin therapy. RESULTS: The study population included 46.94% diabetics, 24.31% smokers, 48.93% hypertensives and 14.98% hyperlipidemics. The cumulative rates of major adverse cardiac events were 0.153% at discharge and 1.38% at 12 months. The mean percentage of stenosis was 88.24 ± 9.17% No events occurred between 6 and 12 months. CONCLUSIONS: This multi-center registry study on "real world, all comers" has, thus, showed that EXCEL™ stent which is PLA-coated biodegradable Rapamycin-Eluting Stent exhibited high efficacy and safety profile in treatment of patients undergoing PCI as evidenced by significantly lower rates of MACE and no case of stent thrombosis. There was no event even after DAPT was discontinued after 6 months.
OBJECTIVES: This study aims to assess the safety and efficacy of a biodegradable polymer-coated Rapamycin-Eluting Stent (Excel) used in conjunction with six-month dual antiplatelet therapy in daily practice. BACKGROUND: The polymeric material of cardiac stents has been reported to adversely affect the safety profile of the drug-eluting stents and is also suspected to cause serious long-term complications. It has been proposed that the biodegradable polymer coatings may reduce such late-stage adverse effects. METHODS: This is a prospective, multi-center registry of 654 patients from across 9 cardiology centers in India, who were enrolled and exclusively treated with Excel stents between February 2008 and May 2010. The recommended antiplatelet regimen included clopidogrel and aspirin for 6 months period, followed by lifelong aspirin therapy. RESULTS: The study population included 46.94% diabetics, 24.31% smokers, 48.93% hypertensives and 14.98% hyperlipidemics. The cumulative rates of major adverse cardiac events were 0.153% at discharge and 1.38% at 12 months. The mean percentage of stenosis was 88.24 ± 9.17% No events occurred between 6 and 12 months. CONCLUSIONS: This multi-center registry study on "real world, all comers" has, thus, showed that EXCEL™ stent which is PLA-coated biodegradable Rapamycin-Eluting Stent exhibited high efficacy and safety profile in treatment of patients undergoing PCI as evidenced by significantly lower rates of MACE and no case of stent thrombosis. There was no event even after DAPT was discontinued after 6 months.
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