Three-year clinical outcome after primary stenting of totally occluded native coronary arteries: a randomized comparison of bare-metal stent 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.
Rahel
Braim M
BM
Department of Interventional Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.
Laarman
Gerrit J
GJ
Kelder
Johannes C
JC
Ten Berg
Juriën M
JM
Suttorp
Maarten J
MJ
D003131:Combined Modality Therapy; D054059:Coronary Occlusion / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D020123:Sirolimus