Adikesava Naidu Otikunta1, Uday Kumar Hosad2, Y V Subba Reddy3, Srikanth Eruvaram4, Ravi Srinivas5, Rajeev Garg6, Limmy Loret Lobo7. 1. Associate Professor, Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana, India. 2. Senior Consultant Interventional Cardiologist, Department of Cardiology, Yashoda Hospital, Secunderabad, Telangana, India. 3. Professor and Head, Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana, India. 4. Senior Resident, Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana, India. 5. Assistant Professor, Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana, India. 6. Senior Interventional Cardiologist, Department of Cardiology, Yashoda Hospital, Malakpet, Hyderabad, Telangana, India. 7. Clinical Researcher, Department of Cardiology, Yashoda Hospital, Secunderabad, Telangana, India.
Abstract
INTRODUCTION: In the era of drug-eluting stents, Bare Metal Stent (BMS) has worked its way up to be recognized in several indications. Moreover, literature suggests that strut thickness has been directly related to the restenosis rate. AIM: We intended to evaluate the clinical performance of the ultrathin (60 μm) Flexinnium stent (Sahajanand Medical Technologies Pvt. Ltd. Surat, India) for treatment of a wide range of patients with coronary artery disease in routine clinical practice. MATERIALS AND METHODS: This was an observational, non-randomized, retrospective, single-arm study carried out in real-world patients at three clinical centres of India. A total of 419 consecutive patients' data was collected for the study, who underwent treatment for coronary lesions by implantation of Flexinnium stent, between April 2013 and December 2014. The primary 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 incidence of Stent Thrombosis (ST) was also observed as safety endpoint. These endpoints were observed during in-hospital stay, at 30 days, six months and at 12 months follow up. All data were analysed using the Statistical Package for Social Sciences (SPSS; Chicago, IL, USA) program, version 15. RESULTS: A total of 491 lesions were treated in 419 patients having mean age of 54.1 years. A total of 525 Flexinnium stents were implanted. There were 243 (58.0%) patients with hypertension. At 12 months the total incidences of MACE were 14 (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 of definite ST at 12 months follow up. CONCLUSION: Our results demonstrate that the Flexinnium stent is associated with a low 12 months incidence of MACE in a wide range of real-world population. Long-term follow up would further confirm its clinical performance profile.
INTRODUCTION: In the era of drug-eluting stents, Bare Metal Stent (BMS) has worked its way up to be recognized in several indications. Moreover, literature suggests that strut thickness has been directly related to the restenosis rate. AIM: We intended to evaluate the clinical performance of the ultrathin (60 μm) Flexinnium stent (Sahajanand Medical Technologies Pvt. Ltd. Surat, India) for treatment of a wide range of patients with coronary artery disease in routine clinical practice. MATERIALS AND METHODS: This was an observational, non-randomized, retrospective, single-arm study carried out in real-world patients at three clinical centres of India. A total of 419 consecutive patients' data was collected for the study, who underwent treatment for coronary lesions by implantation of Flexinnium stent, between April 2013 and December 2014. The primary 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 incidence of Stent Thrombosis (ST) was also observed as safety endpoint. These endpoints were observed during in-hospital stay, at 30 days, six months and at 12 months follow up. All data were analysed using the Statistical Package for Social Sciences (SPSS; Chicago, IL, USA) program, version 15. RESULTS: A total of 491 lesions were treated in 419 patients having mean age of 54.1 years. A total of 525 Flexinnium stents were implanted. There were 243 (58.0%) patients with hypertension. At 12 months the total incidences of MACE were 14 (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 of definite ST at 12 months follow up. CONCLUSION: Our results demonstrate that the Flexinnium stent is associated with a low 12 months incidence of MACE in a wide range of real-world population. Long-term follow up would further confirm its clinical performance profile.
Authors: Michael H Sketch; Michael Ball; Barry Rutherford; Jeffrey J Popma; Catherine Russell; Dean J Kereiakes Journal: Am J Cardiol Date: 2005-01-01 Impact factor: 2.778
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Authors: John C Wang; Didier Carrié; Monica Masotti; Andrejs Erglis; David Mego; Matthew W Watkins; Paul Underwood; Dominic J Allocco; Christian W Hamm Journal: Cardiovasc Revasc Med Date: 2014-12-23
Authors: Arturo Giordano; Michele Polimeno; Nicola Corcione; Luciano Fattore; Luigi Di Lorenzo; Giuseppe Biondi-Zoccai; Paolo Ferraro; Maria Fiammetta Romano Journal: Curr Cardiol Rev Date: 2012-02