CLINICAL RESEARCH: CLINICAL TRIALS
Five-Year Follow-Up of the Argentine Randomized Trial of Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease (ERACI II)
Alfredo E. Rodriguez, MD, PhD, FACC*,
Julio Baldi, MD, PhD*,
Carlos Fernández Pereira, MD*,
Jose Navia, MD*,
Máximo Rodriguez Alemparte, MD*,
Alejandro Delacasa, MD ,
Federico Vigo, MD*,
Daniel Vogel, MD*,
William O'Neill, MD, FACC ,
Igor F. Palacios, MD, FACC, ,* on behalf of the ERACI II Investigators
* Otamendi Hospital, Buenos Aires, Argentina
Sanatorio Belgrano, Mar del Plata, Argentina
William Beaumont Hospital, Royal Oak, Michigan
Massachusetts General Hospital, Boston, Massachusetts
Manuscript received October 11, 2004;
revised manuscript received December 13, 2004,
accepted December 20, 2004.
* Reprint requests and correspondence: Dr. Igor F. Palacios, Cardiac Catheterization Laboratory, Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts 02114
(Email: ipalacios{at}partners.org).
OBJECTIVES: The purpose of the present study is to report the five-year follow-up results of the ERACI II trial.
BACKGROUND: Immediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG).
METHODS: A total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up.
RESULTS: At five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina.
CONCLUSIONS: At five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE.
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Abbreviations and Acronyms
| | AMI = acute myocardial infarction | | ARTS = Artery Revascularization Therapies Study | | CABG = coronary artery bypass grafting | | CAD = coronary artery disease | | ERACI II = Argentine Randomized Study: Coronary Angioplasty with Stenting Versus Coronary Bypass Surgery in Multi-Vessel Disease | | LAD = left anterior descending | | LIMA = left internal mammary artery graft | | MACE = major adverse cardiovascular events | | PCI = percutaneous coronary intervention | | PTCA = percutaneous transluminal coronary angioplasty |
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