Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study.

Abstract

BACKGROUND:

In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.

OBJECTIVES:

This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis.

METHODS:

We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis.

RESULTS:

At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012).

CONCLUSIONS:

During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

• Authors: Jung-Min Ahn, Jae-Hyung Roh, Young-Hak Kim, Duk-Woo Park, Sung-Cheol Yun, Pil Hyung Lee, Mineok Chang, Hyun Woo Park, Seung-Whan Lee, Cheol Whan Lee, Seong-Wook Park, Suk Jung Choo, CheolHyun Chung, JaeWon Lee, Do-Sun Lim, Seung-Woon Rha, Sang-Gon Lee, Hyeon-Cheol Gwon, Hyo-Soo Kim, In-Ho Chae, Yangsoo Jang, Myung-Ho Jeong, Seung-Jea Tahk, Ki Bae Seung, Seung-Jung Park
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 65 Issue 20 Pg. 2198-206 (May 26 2015) ISSN: 1558-3597 [Electronic] United States
• PMID: 25787197 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Sirolimus

Topics

• Aged
• Coronary Artery Bypass
• Coronary Artery Disease (drug therapy, surgery)
• Coronary Stenosis (drug therapy, surgery)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Middle Aged
• Percutaneous Coronary Intervention
• Prospective Studies
• Sirolimus (administration & dosage)
• Time Factors
• Treatment Outcome