Long Term Outcome of Patients with Bifurcated Lesions Randomized to Sirolimus or Everolimus Eluting Stent: The Sea-Corp BC Study

Abstract

Background Different drug-eluting stents may have different clinical efficacy in bifurcation interventions. Thus, we sought to compare the long term efficacy of sirolimus (SES) and everolimus (EES) eluting stents in patients with bifurcation lesions. Methods We realized a cooperative, non-sponsored, pooled analysis on (previously ever unreported) long term outcome data from 2 prospective randomized trials with similar methodology (SEASIDE and CORPAL). In these trials, patients with all types of bifurcations were randomly assigned to treatment with either a SES (n=220) or EES (n=223) according to the provisional side-branch stenting technique. Primary end-point of the study was the occurrence of major adverse cardiac events (MACE) (death of any cause, acute myocardial infarction or repeat revascularization) during 3-year follow-up. Landmark analysis for late (>12 months) events was planned. Results A total of 443 patients with bifurcated lesions were randomized to a SES (n=220) or EES (n=223). The two study group did not differed and, overall, 70.1% of patients had target bifurcation located in the distal left main or left anterior descending artery, 60.9% presented with acute coronary syndromes and 37.2% had Medina 1,1,1 lesion. Three-year follow-up was available in 439 (99.1%) of patients. At 3 years, MACE occurred in 7.7% of patients and were non-significantly lower in patients randomized to EES vs. SES: 6.8% vs. 8.7% (p=0.16). Interestingly, total mortality rate was 4.1% in SES group vs. 1.8% of EES group (p=0.14). At landmark analysis for late events, MACE occurring after 12-month were significantly reduced in patients randomized to EES compared to SES: 1.4% vs. 5.4% (p=0.02). Conclusions Provisional side branch stenting with SES or EES in bifurcation lesions is associated with low rates of major adverse events at 3-year follow-up. Patients randomized to EES, as compared with SES, exhibited a numerically lower incidence of adverse events during the 3-year follow-up and a significantly lower rate of adverse late (beyond 1 year) adverse events.