Long-term (beyond 5 years) clinical impact of Xience everolimus-eluting stent implantation.

Objects: We aim at examining the long-term clinical outcome after Xience everolimus-eluting stent (X-EES) implantation.

Background: Long-term clinical outcomes beyond 5 years after X-EES implantation remain unclear.

Methods: This retrospective study has collected data from 1184 consecutive patients, corresponding to 1463 lesions, who were treated with X-EES alone in the Nagoya Heart Center between January 2010 and December 2013. The primary endpoint was the 10-year cumulative incidence of target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Definite/probable stent thrombosis (ST) was evaluated as a secondary outcome.

Results: At 10 years, the cumulative incidence of TLF was recorded to be 12.4%, whereas that of cardiac death, target vessel MI, and clinically indicated TLR was at 4.4%, 4.1%, and 7.8%, respectively. The cumulative rate of definite/probable ST was observed to remain low (0.3% at 30 days; 0.3% at 1 year; 0.6% at 5 years; and 1.1% at 10 years). In the multivariate analysis, the risk factors of TLF were insulin-treated diabetes (hazard ratio (HR), 1.93; 95% confidence interval (CI), 1.13-3.29;  = .02), left ventricular dysfunction (HR, 2.28; 95% CI, 1.43-3.62;  < .01), hemodialysis (HR, 2.22; 95% CI, 1.39-3.56;  < .01), prior percutaneous coronary intervention (HR, 1.68; 95% CI, 1.18-2.41;  < .01), peripheral vascular disease (HR, 1.70; 95% CI, 1.07-2.69;  < .01), severe calcification (HR, 2.08; 95% CI, 1.36-3.09;  < .01), and in-stent restenosis (HR, 2.93; 95% CI, 1.64-4.89;  < .01).

Conclusions: The incidence rates of the long-term adverse effects after X-EES implantation, such as late TLR and ST, were determined to be low in this study; however, they increased over time until 10 years after stent implantation.