Italian biolimus eluting stent registry in all comers: in hospital and one year outcomes

Abstract

Purpose: Drug-eluting stents constitute the current standard of care for the treatment of high-risk lesions. The prospective, multicenter NOBORI 2 trial has evaluated the performance of biolimus-A9 eluting stents (BES) in an unselected patient population. The trial suggests the good and sustained performance of this stent system in a real world scenario. Nevertheless, there is often discrepancy in terms of clinical event rates between randomized trials and everyday practice. Aim of this study is to evaluate clinical performance of BES in an unrestricted high-risk cohort of patients in seven major Italian cath labs. Methods: Unselected consecutive patients treated with BES were enrolled in an independent multicenter registry. Primary end-points of this registry were immediate procedural outcome, incidence of target lesion failure (TLF, defined as composite of cardiac death, myocardial infarction, and target lesion revascularization), ischemic-driven target lesion revascularization (TLR) and rate of definite stent thrombosis (ST) at 12-months follow-up. A subgroup analysis was also performed on stent implantation (acute myocardial infarction, left main coronary artery lesions, chronic total occlusions, bifurcation lesions, stent restenosis, bypass graft lesions, left ventricle ejection fraction less than 35%, ostial lesions, diffuse disease longer than 30 mm). Results: Between February 2008 and July 2012, 1067 patients (82% male sex; mean age 66±11 years), for a total of 1590 lesions treated with BES were identified. Clinical follow-up was available in 90% of patient at 12 months, with a mean follow up of 16±9 months. In-hospital major adverse cardiovascular event (MACE) rate was 2.1%, mainly due to peri-procedural myocardial infarction (MI). At 12 months follow-up, TLF was 4.9%, with a cardiac mortality rate of 1.9%. Clinically driven TLR rate was 2.4%. Definite ST was observed in 10 patients (0.9%). In 781 lesions (49%) BES was used off-label (27% bifurcation lesions, 13% acute myocardial infarction, 11% chronic total occlusions, 7% left main lesions). In this high-risk population the incidence of in hospital MACE was 2.8%. At 12 months follow-up the TLF and clinically driven TLR rate were 7% and 2.9%, respectively. Eight case of definite ST occurred (1.6%). Conclusions: Extensive use of BES was associated with favorable procedural and 12-month outcomes despite the treatment of unselected high-risk patients and complex lesions. Furthermore, Biolimus eluting stent showed excellent safety and efficacy profile also in indications, with a low rate of TVF, clinically driven TLR and ST.