Multicenter International Registry of Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention with Everolimus-Eluting Stents

Volume 24 - Issue 7 - July 2012
Posted on: 6/29/12
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Author(s):

Michael S. Lee, MD^*1, Kyung Woo Park, MD^*2, Si-Hyuck Kang, MD², Imad Sheiban, MD³, Ehtisham Mahmud, MD⁸, Khalid Bin Thani, MD⁸, Richard Cheng, MD¹, Jang-Hyun Cho, MD⁵, Dong-Kyu Jin, MD⁷, Hyeon-Cheol Gwon, MD⁶, In-Ho Chae, MD⁴, Joseph Aragon, MD⁹, Kyle Gillis, BS⁹, Gregg W. Stone, MD¹⁰, Hyo-Soo Kim, MD²

Abstract: Objective. The aim of this study was to assess the clinical outcomes of percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES) for the treatment of unprotected left main coronary artery (ULMCA) disease. Background. The standard of care for the treatment of ULMCA disease is coronary artery bypass grafting (CABG). Data suggest that PCI with drug-eluting stents is a viable alternative to CABG for the treatment of ULMCA disease. Randomized trials demonstrated superior event-free survival with EES compared with paclitaxel-eluting stents in non-ULMCA lesions. However, data with ULMCA PCI with EES are limited. Methods. This multicenter international registry included 178 patients from the United States, South Korea, and Italy who underwent ULMCA PCI with EES from 2008 to 2010. The primary endpoint was freedom from target lesion failure (TLF), defined as cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) at 1 year. Results. At 30 days, 4 patients (2.2%) died from cardiac causes, and no patient experienced MI or TLR. One-year freedom from TLF was 94.4%. One-year freedom from cardiac death, MI, and ischemia-driven TLR was 96.6%, 98.9%, and 98.3%, respectively. Two patients (1.1%) had definite or probable stent thrombosis. Conclusion. PCI with EES is safe and effective and may be a viable option for the treatment of ULMCA disease.

J INVASIVE CARDIOL 2012;24(7):316-319

Key words: drug-eluting stents, ULMCA PCI

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Coronary artery bypass graft (CABG) surgery is the standard of care for the treatment of unprotected left main coronary artery (ULMCA) disease, and percutaneous coronary intervention (PCI) is reserved for patients who are poor surgical candidates.¹ ULMCA PCI is a class IIa indication and may be considered in patients who are at low risk for procedural complications and are at increased risk of adverse surgical outcomes.²

The cobalt chromium everolimus-eluting stent (EES; XIENCE V; Abbott Vascular, also distributed as Promus; Boston Scientific) reduced the rates of angiographic and clinical restenosis, myocardial infarction (MI), and stent thrombosis compared with the paclitaxel-eluting stent (PES) in non-ULMCA lesions.^3-9 We report the clinical outcomes of patients who underwent ULMCA PCI with EES in a multicenter international registry.

Methods

Baseline demographic, procedural, angiographic, and clinical outcomes data of 178 patients who underwent ULMCA PCI with EES from May 2008 to September 2010 were collected from 22 institutions. The data collected from the South Korean patients were a part of the prospective Efficacy of XIENCE/Promus versus Cypher to Reduce Late Loss after Stenting (EXCELLENT) registry (n = 139). The data collected from the University of Turin-San Giovanni Batista “Molinette” Hospital, Turin, Italy (n = 14), University of California, Los Angeles Medical Center (n = 8), and Santa Barbara Cottage Hospital (n = 8) were collected in a prospective manner. The data from the University of California, San Diego Medical Center (n = 9) were collected retrospectively. Institutional review board approval was obtained at each institution to obtain patient data.