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Arterial Revascularization Therapies Study - ARTS
Description:
Stenting vs CABG surgery in multivessel CAD.
Hypothesis:
How does coronary stenting compare with coronary artery bypass grafting in patients undergoing coronary revascularization?
Study Design
Study Design:
Patients Screened: Not reported
Patients Enrolled: 1205
NYHA Class: Not reported
Mean Follow Up: 1 year
Mean Patient Age: 30-83 (average 61)
Female: 24%
Mean Ejection Fraction: Average 61%
Patient Populations:
Patients who had not undergone bypass urgery or angioplasty with stable angina, unstable angina or silent ischemia AND ≥2 de novo lesions in different vessels and territories that were amenable to stent implantation.
Exclusions:
LVEF of 30% or less, overt congestive heart failure, history of cerebrovascular accident, transmural MI in previous week, severe hepatic or renal disease, diseased saphenous veins, neutropneia or thrombocytopenia, intolerance or contraindication to aspirin or ticlopidine, need for major surgery.
Primary Endpoints:
Freedom from death, myocardial infarction, any cerebrovascular even, and any repeat coronary revascularization, and at 1 year.
Secondary Endpoints:
Angina status, cost, cost effectiveness, use of medications, quality of life, death + MI + stroke, death, MI, stroke, revascularization.
Drug/Procedures Used:
Coronary artery stenting or CABG surgery. The average interval between randomization and treatment was 27 days for patients in surgery group and 11 days for stenting group.
Concomitant Medications:
< 4% were treated with glycoprotein IIb/IIIa inhibitors
Principal Findings:
At one year, surgery was associated with a higher event-free survival compared to stenting (87.8% vs 73.8%, p<0.001). This difference was due to primarily to the much higher rate of repeat revascularization in the stenting group --> among those without a stroke or MI, the incidence was 16.8% vs 3.5% in surgery group. There was no significant difference between the two groups in the incidence of death (2.8% vs 2.5%), stroke (2.0% vs 1.5%), or MI (4.0% vs 5.3%). The costs for the initial procedure were $4,212 less per patient for the stenting group but this difference narrowed to $2,973 per patient by one-year follow-up. A subsequent report revealed that diabetics who underwent stenting had the lowest event-free survival (63.4% vs 84.4% diabetes and CABG, 76.2% no-diabetes and stenting, and 88.4% no diabetes plus CABG). The lower event-free survival in the diabetes plus stenting group was due to an increased incidence of repeat revascularization. There was a non-significant trend toward a lower mortality rate in the diabetes plus CABG group compared to the diabetes plus stenting group (3.1% vs. 6.3%).
Interpretation:
At one year, in patients with multivessel disease coronary stenting was associated with a higher rate of repeat revascularization compared to CABG surgery, especially in diabetics. There was no significant difference between the groups in the incidence of death, MI, and stroke. These results are similar to prior randomized trials comparing CABG with PTCA that showed higher rates of revascularization with PTCA. It appears that the introduction of coronary stents without the use of glycoprotein IIb/IIIa inhibitors (<4% use in ARTS) has not offset these differences. Outcomes in the modern era of glycoprotein inhibition, clopidogrel, and coated stents and with longer follow-up to detect late graft failure is not known.
References:
N Engl J Med 2001; 344: 1117-24. Circulation 2001;104:533-8. Diabetes subgroup analysis.
Keywords: Coronary Artery Disease, Stroke, Angina, Stable, Disease-Free Survival, Ticlopidine, Coronary Artery Bypass, Angioplasty, Diabetes Mellitus, Stents
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