OPTIMA Tacrolimus-eluting Stent: A Twelve-month Clinical Follow up with Two Different Periods of Dual Antiplatelet Therapy; 2-month vs. 6-month Approach

Abstract

Introduction: There are limited data comparing long-term efficacy and safety of OPTIMA tacrolimus-eluting stent (TES) with Dual Antiplatelet Therapy (DAT) in daily practice. Therefore, we evaluated the safety and performance of OPTIMA TES with 2 or 6-month dual antiplatelet therapy in a 12-month follow up period. Methods: In a prospective, non-randomized single center registry in which 106 patients that underwent percutaneous coronary intervention with the OPTIMA TES between January 2010 and February 2011 were enrolled. After stenting, 62 patients received DAT for 2 months and the remainder for 6 months. Major Adverse Cardiac Events (MACE), stent thrombosis rate and target lesion revascularization (TLR) were evaluated in a 12-month follow-up period for 2-and 6-month DAT groups. Results: No cases with death, MI or stent thrombosis were observed within the 12-month follow-up period in either of the groups. TLR and MACE rates were higher in 6-month DAT group compared to 2-month group (6.8% vs. 3.2% respectively, P=0.001) which may be due to this group having more diffuse disease (23.60±5.69 vs. 20.88±5.14, P=0.018).Conclusions: OPTIMA tacrolimus-eluting stent is safe and efficient with short term DAT period. A randomized trial is needed for better evaluations of OPTIMA TES in daily clinical practice.

Keywords: Tacrolimus- eluting Stent, PCI, Stent Thrombosis, Dual Antiplatelet Therapy