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Five year clinical follow-up of the arterial revascularisation therapy study - ARTS I - Five year follow-up
Description:
The goal of the study was to evaluate treatment with coronary artery bypass surgery (CABG) compared with stenting on long-term events in patients with multivessel coronary artery disease.
Study Design
Study Design:
Patients Enrolled: 1,205
Mean Follow Up: Five years
Mean Patient Age: Mean age 61 years
Female: 23
Mean Ejection Fraction: Mean 61% at baseline
Patient Populations:
Patients who had not undergone bypass surgery 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:
Left ventricular ejection fraction ≤30%, overt congestive heart failure, history of cerebrovascular accident, transmural MI in previous week, severe hepatic or renal disease, diseased saphenous veins, neutropenia or thrombocytopenia, intolerance or contraindication to aspirin or ticlopidine, or need for major surgery
Primary Endpoints:
Freedom from MACE (defined as death, MI, any cerebrovascular event, and any repeat coronary revascularization) at one year
Secondary Endpoints:
Freedom from MACE at 30 days, three years, and five years; angina status, cost, cost-effectiveness, use of medications, quality of life, death + MI + stroke, death, MI, stroke, and revascularization
Drug/Procedures Used:
Patients were randomized to CABG (n=605) or stent (n=600). Freedom from major adverse cardiac events (MACE), anginal status, and medication use was assessed at five years.
Principal Findings:
Follow-up through five years was available in 96.5% of patients in the CABG group (n=584) and 98.3% of patients in the stent group (n=590). There were six crossovers in the stent group and 19 in the CABG group. Unstable angina was present in 35% of patients in the CABG group and 37% of patients in the stent group. Triple-vessel disease was reported in 33% in the CABG group and 30% in the stent group, and two-vessel disease in 67% and 68%, respectively.
At five years, CABG was associated with an improvement in the primary composite endpoint of freedom from death, myocardial infarction (MI), stroke, or revascularization (58.3% for stent vs. 78.2% for CABG, relative risk [RR] 1.91, p<0.001). The improvement in the primary endpoint in the CABG arm was driven primarily by the need for repeat revascularization, which was higher in the stent group (30.3% for stent vs. 8.8%, RR 3.46, p<0.001). There was no difference between the groups in mortality (8.0% for stent vs. 7.6% for CABG, p=0.83), stroke (3.8% vs. 3.5%, p=0.83), or Q wave MI (6.7% vs. 5.6%, p=0.47) but non-Q wave MI trended lower in the CABG group (1.8% vs. 0.8%, p=0.14), as did the composite of death, stroke, or MI (18.2% for stent vs. 14.9%, p=0.14).
Presence of angina at five years was higher in the stent group compared with the CABG group (21.2% vs. 15.5%, p=0.08), with higher rates of Canadian Angina Class I (9.5% vs. 7.0%) and Class II (9.0% vs. 6.1%). More patients in the stent group were on short-acting nitrates (6.1% vs. 2.4%, p=0.003), long-acting nitrates (19.6% vs. 11.6%, p<0.001), beta-blocker therapy (53.9% vs. 46.5%, p=0.016), and calcium channel blockers (29.1% vs. 18.9%, p<0.001).
Interpretation:
Among patients with multivessel coronary artery disease, treatment with CABG was associated with an improvement in the primary composite endpoint of freedom from MACE at five years compared with stenting.
The present analysis of the five-year follow-up data is the longest follow-up for studies comparing multivessel CABG with stenting, although other studies have followed patients comparing CABG with balloon angioplasty. Given the time of enrollment of the present study, all patients in the stent arm received bare metal stents. The upcoming SYNTAX trial is being designed to compare CABG with drug-eluting stents for noninferiority in patients with triple-vessel disease.
References:
Serruys PW, et al. Five-Year Outcomes After Coronary Stenting Versus Bypass Surgery for the Treatment of Multivessel Disease: The Final Analysis of the Arterial Revascularization Therapies Study (ARTS) Randomized Trial. J Am Coll Cardiol 2005 46: 575-581.
Serruys PW. ARTS 1: Five year clinical follow-up of the Arterial Revascularisation Therapy Study. Paper presented at the European Society of Cardiology Congress 2004, 29 August-1 September, Munich, Germany.
Keywords: Coronary Artery Disease, Myocardial Infarction, Stroke, Angina, Stable, Drug-Eluting Stents, Nitrates, Canada, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Calcium Channel Blockers
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