Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study.

Abstract

OBJECTIVES:

This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis.

BACKGROUND:

The clinical benefit of second-generation DES for ULMCA stenosis has not been determined.

METHODS:

The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272).

RESULTS:

EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16).

CONCLUSIONS:

Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG.

• Authors: Young-Hak Kim, Duk-Woo Park, Jung-Min Ahn, Sung-Cheol Yun, Hae Geun Song, Jong-Young Lee, Won-Jang Kim, Soo-Jin Kang, Seung-Whan Lee, Cheol Whan Lee, Seong-Wook Park, Yangsoo Jang, Myung-Ho Jeong, Hyo-Soo Kim, Seung-Ho Hur, Seung-Woon Rha, Do-Sun Lim, Sung-Ho Her, Ki Bae Seung, In-Whan Seong, Seung-Jung Park, PRECOMBAT-2 Investigators
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 5 Issue 7 Pg. 708-17 (Jul 2012) ISSN: 1876-7605 [Electronic] United States
• PMID: 22814775 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Immunosuppressive Agents
• Everolimus
• Sirolimus

Topics

• Confidence Intervals
• Coronary Artery Bypass
• Coronary Restenosis (drug therapy, surgery, therapy)
• Coronary Vessels (pathology)
• Drug-Eluting Stents
• Everolimus
• Female
• Humans
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Incidence
• Male
• Middle Aged
• Risk
• Sirolimus (administration & dosage, analogs & derivatives, therapeutic use)