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Estudio Randomizado Argentino de Angioplastia vs. Cirugía (Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease) - ERACI
Description:
CABG vs. PTCA for mortality in multivessel coronary disease.
Hypothesis:
Patients with multivessel disease will exhibit similar mortality and cardiac event rates from either angioplasty or coronary artery bypass graft surgery.
Study Design
Study Design:
Patients Screened: 1,409
Patients Enrolled: 127
Mean Follow Up: 1 year and 3 years
Mean Patient Age: 58 ± 5 years
Female: 15
Patient Populations:
Severely limiting stable angina despite maximal medical therapy.
Rest unstable angina refractory to maximal medical therapy.
No or minimal symptoms, but a large area of myocardium at risk identified by exercise testing.
Severe coronary obstruction (> 70% in more than one major epicardial coronary artery).
All lesions must be equally amenable to either surgery or angioplasty.
Exclusions:
Dilated ischemic cardiomyopathy
An indication for coronary artery bypass surgery but not for angioplasty
Evolving acute myocardial infarction
Limited life expectancy because of terminal illness
Consent not given
Primary Endpoints:
Combined coronary cardiac events
Death
Myocardial infarction
Repeat revascularization procedures
Angina
Secondary Endpoints:
Completeness of revascularization
Cost of treatment during initial hospitalization and over a total of 5 years
Drug/Procedures Used:
CABG surgery
Standard techniques, under hypothermic arrest and using blood cardioplegia
Reverse saphenous vein grafts and left internal mammary artery used when possible (76.5% of patients)
PTCA
Standard techniques
Patients pretreated with aspirin, 325 mg/day and calcium channel blocker for 24 h before PTCA procedure.
Intravenous heparin, bolus of 10,000 IU, administered at start of procedure
Continuous infusion of heparin to maintain therapeutic partial thromboplastin time (70 to 80 seconds) for additional 24 h
Success defined as a gain in lumen diameter > 20% and a final residual stenosis < 50%.
Concomitant Medications:
Not stated.
Principal Findings:
In-hospital, no differences in death, frequency of periprocedure MI, or need for emergency revascularization between the two groups.
At 1 year, there was no significant difference in death or MI occurrence.
However, patients who had CABG surgery were more frequently free of angina, reinterventions, and combined cardiac events than the PTCA group. (83.5% vs. 63.7%, p < 0.005).
In-hospital cost and cumulative cost at 1 year were greater for CABG group than for the angioplasty group ($828,000 vs. $438,000 for all patients combined, including revascularizations required; p = 0.01).
At 3 years, freedom from combined cardiac events (death, Q-wave MI, angina, and repeat revascularization) was significantly greater for the CABG group than for the PTCA group (77% vs 47%; p < 0.001).
There were no differences in overall mortality (4.7% vs 9.5%; p = 0.5) or cardiac mortality (4.7% vs 4.7%; p = 0.8) between the two groups.
However, patients who had bypass surgery were more frequently free of angina (79% vs 59%; p < 0.001) and required fewer reinterventions (6.3% vs 37%; p < 0.001) than patients who had coronary angioplasty.
In-hospital cost and cumulative cost at 3 years were greater for CABG group than for the angioplasty group ($832,000 vs. $474,000 for all patients combined, including revascularizations required; p = 0.02).
Interpretation:
Patients with multivessel coronary artery disease were more free from combined cardiac events after 3 years than angioplasty patients, although their mortality rates were similar. However, the authors point out that second-generation PTCA procedures and devices might provide different results, and they urge continued study. Note that cost data was calculated using standard cost models, not actual charges.
References:
1. J Am Coll Cardiol 1993;22:1060-7. Final results (1-year)
2. J Am Coll Cardiol 1996;27:1178-84. Three-year follow-up
Keywords: Coronary Artery Disease, Angina, Stable, Heparin, Constriction, Pathologic, Myocardium, Angioplasty, Balloon, Coronary, Calcium Channel Blockers, Hospital Costs, Saphenous Vein, Mammary Arteries, Partial Thromboplastin Time, Coronary Artery Bypass, Heart Arrest, Induced
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