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Argentine Randomized Study: Coronary Angioplasty With Stenting vs. Coronary Artery Bypass Surgery in Patients With Multiple-Vessel Disease (ERACI II): 30-Day and One Year Follow-Up Results - ERACI II
Description:
Argentine Randomized Study: Coronary Angioplasty With Stenting vs. Coronary Artery Bypass Surgery in Patients With Multiple-Vessel Disease (ERACI II): 30-Day and One Year Follow-Up Results
Hypothesis:
Previous studies performed in the pre-stent era have shown equivalent acute and long-term results with percutaneous transluminal coronary revascularization (PTCR) when compared with CABG in patients with multivessel coronary disease. The objective of this study was to determine if PTCR with stent implantation results in better early outcomes when compared with CABG in patients with symptomatic multivessel coronary artery disease.
Study Design
Study Design:
Patients Enrolled: 450
Mean Follow Up: 1, 3, and 5 years
Drug/Procedures Used:
A total of 450 patients were randomized to undergo either PTCR (225 patients) or CABG (225 patients). Stenting of the target lesions was performed using the Gianturco Roubin II (GR-II) stent. The primary end point was a combined Major Adverse Cardiac Event (MACE) end point of death, Q-wave myocardial infarction (Q-MI) and stroke at 30 days. Follow-up data at 1, 3 and 5 years were obtained. Secondary end points included angina status at 1, 3 and 5 years, completeness of revascularization assessed by angiography or functional testing and follow-up costs of both techniques.
Principal Findings:
At 30 days, the composite MACE rate was significantly higher in the CABG group when compared to the PTCR group (12.3% vs. 3.6%, P = 0.002). This difference was due to a significantly higher incidence in the CABG group of death (5.7% vs. 0.9%, P = 0.012), of Q-MI (5.7% vs. 0.9%, P = 0.012), and of death or Q-MI (11.4 vs. 1.8%, p < 0.0001). In the surgically treated group, the mortality rate was 0% in patients with chronic stable angina, 5.6% in patients with unstable angina class II, and 7.9% in patients with unstable angina class III. At a mean follow-up of 18.5 +/- 6.4 months, survival was significantly better in the PTCR group (96.9% vs. 92.5%, p < 0.017). Freedom from myocardial infarction was also better in the PTCR group (97.7% vs. 93.7%, p < 0.017), while freedom from repeat procedure and freedom from angina were significantly better in the CABG group (95.2% vs. 83.2%, p < 0.001 for repeat procedures; 92% vs. 84.5%, P = 0.01 for freedom from angina).
PTCR with stent implantation results in better survival and freedom from MI than surgical revascularization.
Interpretation:
This study has several limitations. First, the GR-II stent used in this study was recently shown to result in significantly worse acute and long-term outcomes when compared to the "gold standard" Palmaz-Schatz stent. Second, there was a very high mortality rate in the CABG group. The authors attribute the high mortality rate to high-risk patient characteristics. Providing a risk-adjusted mortality rate using available risk-adjustment models for CABG mortality could have clarified this issue. An important finding is the high surgical mortality in patients with acute coronary syndromes. It confirms findings from the VANQWISH trial and from other registries, and it suggests a potential role for a strategy of pharmacological stabilization and/or percutaneous "culprit lesion" revascularization, followed by non-urgent surgical revascularization in patients with acute coronary syndromes where surgical revascularization is indicated.
References:
1. Rodriguez A , Bernardi V, Navia J, et al. J Am Coll Cardiol 2001;37:51–8.
Keywords: Coronary Artery Disease, Myocardial Infarction, Stroke, Angina, Stable, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Stents
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