Abstract 20266: Five-Year Clinical and Angiographic Outcome After Primary Stenting of Totally Occluded Native Coronary Arteries (PRISON II- Late Study) : A Randomized Comparison of Bare Metal Stent Implantation With Sirolimus-Eluting Stent Implantation for the Treatment of Total Coronary Occlusions
Objectives: The purpose of this study was to examine the five-year clinical and angiographic outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II) study.
Methods: Patients with totally occluded coronary arteries were randomized to either sirolimus-eluting Cypher stents (SES) (n=100) or bare-metal BxVelocity stents (BMS) (n=100). Complete clinical follow-up at 5 year was available in 91% of the patients. Angiographic follow-up could be obtained in 48% of the patients in the BMS-group and in 63% of the patients in the SES-group.
Results: After five years, patients in the SES-group had significantly lower rates of target vessel revascularization, target vessel failure, and major adverse cardiac events, which was driven by a larger in-segment minimal lumen diameter (1.98±1.03 mm vs 1.43±0.88 mm, p=0.004) with less residual diameter stenosis (37.5% vs 54.1%, p=0.003) and less very late loss (post-PCI — 5 year) (0.02±0.98 mm vs 0.62±1.02 mm, p=0.002) in the SES-group. There were no significant differences in death and myocardial infarction between the two groups. Eight (8%) cases of stent thrombosis (7 definite, 1 probable; 1 subacute, 1 late, 6 very late) were noticed in the SES-group versus 3 cases (3%, all possible; all very late) in the BMS-group (p=0.21).
Conclusions: The results of the present study show that the documented superior short-term angiographic and clinical results of SES in patients with total coronary occlusions are maintained during long-term 5-year follow-up as compared with BMS. On the other hand, there is a trend to a higher stent thrombosis rate in the SES-group.
- © 2010 by American Heart Association, Inc.