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ORIGINAL ARTICLE
Year : 2016  |  Volume : 4  |  Issue : 1  |  Page : 5-9

Clinical performance of biodegradable polymer coated Sirolimus-eluting stent in multivessel disease: Results from MULTIDES study


1 Department of Cardiology, Heart and Brain Centre, Lalitha Super Speciality Hospital Pvt. Ltd., Guntur, Andhra Pradesh, India
2 Department of Cardiology, Apollo Hospitals, Ahmedabad, Gujarat, India
3 Department of Cardiology, Yashfeen Cardiac Hospital, Navsari, Gujarat, India
4 Department of Clinical Trials, Sahajanand Medical Technologies Pvt. Ltd., Surat, Gujarat, India

Correspondence Address:
Ashok Thakkar
Department of Clinical Trials, Sahajanand Medical Technologies Pvt. Ltd., Surat - 395 004, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2321-449X.178118

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Context: The role of percutaneous coronary intervention in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. Aim: The aim of this study was to examine the incidence of clinical outcomes after utilization of Indolimus, biodegradable polymer coated sirolimus-eluting stent (SES), in multivessel coronary stenting in an unselected patient population. Settings and Design: From April-2012 to June-2014, patients with multivessel (≥2 vessels) disease were examined in the retrospective, nonrandomized, observational, multicenter MULTIDES study. Materials and Methods: A total of 151 patients, exclusively treated with Indolimus SES in multivessel, were included in the study. The study was conducted in accordance with the Declaration of Helsinki and country-specific regulatory requirements. All patients signed informed consent form. Statistical Analysis Used: Continuous variables are presented as mean ± standard deviation and categorical variables as counts and percentages. All data were analyzed using Statistical Package for Social Sciences program. Results: The mean age was 53.7 ± 10.7 years; male gender represented 108 (71.5%) patients. A total of 314 Indolimus stents were implanted. Clinical follow-up was performed at 30-day, at 6-month, and at 9-month. The primary endpoint, major adverse cardiac events (MACEs) at 9-month follow-up, occurred in 5 (3.3%) patients, consisting of 1 (0.7%) cardiac death, 2 (1.3%) myocardial infarction, 2 (1.3%) target lesion revascularization, 0 (0%) target vessel revascularization, and 0 (0%) stent thrombosis. Conclusion: The present study describes that Indolimus implantation is safe and effective treatment in multivessel CAD, showing low rates of MACEs during 9-month follow-up.


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