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)

Rahel, Braim M.; Laarman, Gerrit J.; Kelder, Johannes C.; ten Berg, Juriën M.; Suttorp, Maarten J.

doi:10.1016/j.ahj.2008.08.025

« Previous Next »American Heart Journal
Volume 157, Issue 1 , Pages 149-155, January 2009

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)

Braim M. Rahel, MD, PhD
- Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
Gerrit J. Laarman, MD, PhD
- Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
Johannes C. Kelder, MD
- Department of Research and Statistics, St. Antonius Hospital Nieuwegein, The Netherlands
Juriën M. ten Berg, MD, PhD
- Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
Maarten J. Suttorp, MD, PhD, FACC
- Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
- Reprint requests: Maarten J. Suttorp, MD, PhD, FESC, FACC, Department of Interventional Cardiology, St. Antonius Hospital Nieuwegein, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.

Received 22 May 2008; accepted 20 August 2008. published online 07 November 2008.

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.