Two-year outcomes after deployment of XIENCE v everolimus-eluting stents in patients undergoing percutaneous coronary intervention of bifurcation lesions: A report from the SPIRIT v single arm study

Abstract

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi-vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30-day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non-bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.