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).

Abstract

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.

• Authors: Braim M Rahel, Gerrit J Laarman, Johannes C Kelder, Juriën M Ten Berg, Maarten J Suttorp
• Journal: American heart journal (Am Heart J) Vol. 157 Issue 1 Pg. 149-55 (Jan 2009) ISSN: 1097-6744 [Electronic] United States
• PMID: 19081412 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Sirolimus

Topics

• Combined Modality Therapy
• Coronary Occlusion (therapy)
• Drug-Eluting Stents
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Prospective Studies
• Single-Blind Method
• Sirolimus (administration & dosage)
• Stents
• Time Factors
• Treatment Outcome