Three-year clinical outcome after primary scenting of totally occluded native coronary arteries: A randomized comparison of bare-metal stem implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (Primary Stenting of Totally Occluded Native Coronary Arteries [PRISON] II study)

Background The purpose of this study was to examine the 3-year clinical outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II study. Methods Patients with totally occluded coronary arteries randomized to either sirolimus-eluting Cypher stents (SESs) (Cordis, a Johnson & Joshson Company, Miami Lakes, FL) (100 patients) or bare-metal BxVelocity stents (BMSs) (Cordis) (100 patients) were followed clinically for 3 years. Results Between 1 and 3 years, there were infrequent additional clinical events that were equally distributed between the SES and the BMS group. After: 3 years, target lesion revascularization was 7% in the SES group versus 27% in the BMS group (P < .001); and target vessel revascularization was seen in 11% in the SES group versus 30% in the BMS group (P = .002). Major adverse cardiac events were noted in 10% of the SES group versus 34% in the BMS group (P < .001). There were no statistically significant differences in death, myocardial infarction, and stent thrombosis according to the Academic Research Consortium criteria between the 2 groups. Conclusions Clinical outcome up to 3 years after implantation of SESs for total coronary occlusions continues to demonstrate a significant reduction in adverse clinical events compared with BMSs without the evidence for either disproportionate late restenosis or late stent thrombosis. (Am Heart J 2009;157:149-55.)