Abstract 16000: Randomized Study Between Everolimus-Eluting Stent and Sirolimus-Eluting Stent in Patients With Bifurcation Lesions Treated by Provisional Side-Branch Stenting.
Introduction: The efficacy of Everolimus eluting stents in bifurcation lesions has been poorly tested, and randomized comparisons with other drug-eluting stents in this lesion subset have not yet been reported. We compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated by provisional side branch stenting.
Methods: Between February 2007 and December 2008, 293 patients with all types of Medina bifurcation lesions were enrolled in a prospective study. Eligible patients were randomly assigned in a 1:1 ratio to treatment with either a sirolimus (n=145) or everolimus stent (n=148). We included patients with main vessel diameter over 2.5 mm and side branch over 2.25 mm. Patients with diffuse side-branch stenosis were excluded. The incidence of major events (death, target lesion revascularization or acute myocardial infarction) at 1 year follow-up was the primary end-point of our study.
Results: There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or left ventricular ejection fraction. Main vessel (3.1±0.4 vs 3.1± 0.4 mm) and side-branch (2.4±0.3 vs 2.4±0.4 mm) diameters were almost identical in both groups. Immediate results and in-hospital outcome were also similar in both groups of patients. Four patients suffered acute non-Q-wave myocardial infarction in hospital: 2 from the sirolimus group (1.3%) and 2 from the everolimus group (1.3%). In-hospital death occurred in 2 patients, 1 from each group. Four patients were lost at follow-up. The remaining patients completed 1-year follow-up. Target lesion revascularization was required in 9 patients : 4 (3%) from the sirolimus group and 5 (3%) from the everolimus group. Late mortality occurred in 4 patients from the sirolimus group and in 1 patient from the everolimus group. Major event rates at one year were similar in both groups: 11 (8%) in the sirolimus group and 9 (6%) from the everolimus group (p: ns).
Conclusions: In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus and everolimus-eluting stent groups.
- © 2010 by American Heart Association, Inc.