A two year analysis of Diabetic subset ‘e-BioMatrix’ prospective, multicentric, all comers registry in India

Abstract Objective The objective of this analysis is to study safety and efficacy of BioMatrix, Biolimus A9-eluting stent in diabetic patients. Background Patients with diabetes mellitus (DM) are at high risk for restenosis, myocardial infarction, and cardiac mortality after coronary stenting. Long-term safety of drug-eluting stents (DES) in DM is relatively uncertain. Interim report of the BioMatrix dedicated diabetic registry showed significantly lowered MACE rates. Thus, a diabetic cohort was analyzed from the all comers Biomatrix registry to confirm its safety and efficacy at large. Methods In the BioMatrix all comers registry, 1189 patients were enrolled prospectively between December 2008 and February 2012. This subgroup analysis consists of 485 diabetic patients from this registry. We analyzed the incidence of Major Adverse Cardiac Events (MACE) and Stent Thrombosis (ST) at 1, 6, and 12 months with an extended follow-up of two years. At the time of this analysis, all patients had completed two-year follow-up. Results The mean age was 58.38 ± 10.03 years (range 31–87), average LVEF was 50.98 ± 11.87% (range 19–95). The mean age was 58.38 ± 10.03 years. 14.4% patients were insulin dependent (IDDM). 58.7% were hypertensive, 10.7% had family history of CAD, 20% had hypercholesterolemia and 7.4% had suffered previously with MI, 64.53% presented with acute coronary syndrome. STEMI patients comprised of 34.02%. 15.67% had total occlusion. 10.51% were patients with Multi Vessel Disease At two-year follow-up, very low MACE rate of 0.62% was observed. There was only a single case of probable ST. Conclusion This analysis continues to confirm clinical safety and efficacy of BioMatrix stent in diabetic patients along with additional risk factors. The two-year result shows that BioMatrix stent is a suitable alternative as compared to contemporary DESs which are currently available in the market for simple as well complex disease.