One-Year Clinical Outcomes of Forty-Eight Millimeter Everolimus-Eluting Stent Implanted in Very Long Lesions: A Propensity-Matched Comparison (The FREIUS Study).

Background. Long coronary lesions still remain a challenge, with poor immediate results and suboptimal outcomes when compared to class A/B1 lesions. The presence of overlapped segments of metal struts and polymer might trigger an abnormal inflammatory reaction, resulting in a higher restenosis rate. The aim of our study was to evaluate the safety, feasibility, and cost effectiveness of a 48 mm everolimus-eluting stent [EES] during treatment of very long coronary lesions. Methods and Results. The FREIUS study is a prospective data collection of consecutive patients undergoing 48 mm EES implantation in six high-volume European centers. Each patient was matched through a propensity score to a comparable patient treated with two or more second-generation overlapped drug-eluting stents. The primary endpoint was the combined incidence of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization [device-oriented composite endpoint [DOCE]]. The secondary endpoints were all-cause death, each individual component of the primary endpoint, and definite/probable stent thrombosis. From January 2014 to April 2015, a total of 218 patients were treated with at least one 48 mm EES and were compared with 218 matched controls. Overall, 9% of patients reached the primary endpoint. Cumulative survival free from DOCE incidence did not differ between the two groups [7% in the cases vs 10.5% in the controls: P=.10]. After multivariable analysis, only clinical presentation with myocardial infarction [hazard ratio [HR], 1.8: 95% confidence interval [CI], 1.5-2.1: P=.01] and stent number [HR, 1.4: 95% CI, 1.1-1.8: P=.02] emerged as independent predictors of DOCE. Conclusion. The use of 48 mm EES offers a safe and effective strategy for the treatment of very long coronary lesions.