Analysis of 12 Months Clinical Outcomes Associated with Implantation of Ultrathin (60 μm) Bare Metal Stent in an Unselected Real-world Population with Coronary Artery Disease

摘要

Introduction: In the era of drug-eluting stents, Bare MetalStent (BMS) has worked its way up to be recognized in severalindications. Moreover, literature suggests that strut thicknesshas been directly related to the restenosis rate.Aim: We intended to evaluate the clinical performance ofthe ultrathin (60 μm) Flexinnium stent (Sahajanand MedicalTechnologies Pvt. Ltd. Surat, India) for treatment of a widerange of patients with coronary artery disease in routine clinicalpractice.Materials and Methods: This was an observational, nonrandomized, retrospective, single-arm study carried out in realworld patients at three clinical centres of India. A total of 419consecutive patients’ data was collected for the study, whounderwent treatment for coronary lesions by implantation ofFlexinnium stent, between April 2013 and December 2014. Theprimary endpoint of the study was Major Adverse Cardiac Events(MACE), a conglomerate of cardiac death, Myocardial Infarction(MI) (Q-wave and non-Q-wave), Target Lesion Revascularization(TLR) and Target Vessel Revascularization (TVR). Any incidenceof Stent Thrombosis (ST) was also observed as safety endpoint.These endpoints were observed during in-hospital stay, at 30days, six months and at 12 months follow up. All data wereanalysed using the Statistical Package for Social Sciences(SPSS; Chicago, IL, USA) program, version 15.Results: A total of 491 lesions were treated in 419 patientshaving mean age of 54.1 years. A total of 525 Flexinniumstents were implanted. There were 243 (58.0%) patients withhypertension. At 12 months the total incidences of MACE were14 (3.5%). These included 9 (2.3%) cardiac deaths, 1 (0.3%) MI,3 (0.8%) TLRs and 1 (0.3%) TVR. There was one incidence ofdefinite ST at 12 months follow up.Conclusion: Our results demonstrate that the Flexinnium stentis associated with a low 12 months incidence of MACE in awide range of real-world population. Long-term follow up wouldfurther confirm its clinical performance profile.