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Arterial Revascularization Therapies Study II: Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions - ARTS II: 5-Year Results
Description:
The goal of the trial was to evaluate in a nonrandomized, open-label study, treatment with sirolimus-eluting stents (SES) compared with historical controls in the ARTS I trial of patients undergoing revascularization with coronary artery bypass graft surgery (CABG) or bare-metal stents (BMS) in patients with multivessel disease.
Hypothesis:
The efficacy and safety of SES would compare favorably with CABG and BMS.
Study Design
Study Design:
Patients Enrolled: 607
Mean Follow Up: 5 years
Mean Patient Age: 63 years
Female: 23
Mean Ejection Fraction: 60
Patient Populations:
Patients who had not undergone bypass surgery or angioplasty with stable angina, unstable angina, or silent ischemia AND de novo lesions in different vessels and territories that were amenable to stent implantation
Exclusions:
Left ventricular ejection fraction 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, neutropenia or thrombocytopenia, intolerance or contraindication to aspirin or clopidogrel, or need for major surgery
Primary Endpoints:
MACCE at 1 year for the comparison of CABG-treated patients in the ARTS I trial with SES patients in the ARTS II study.
MACCE included death, cerebrovascular event, nonfatal MI, and repeat revascularization (either percutaneous or surgical).
Secondary Endpoints:
MACCE at 30 days, 6 months, and 3 and 5 years; total cost at 30 days; and cost, cost-effectiveness, and quality of life at 6 months, and 1, 3, and 5 years
Drug/Procedures Used:
Patients were enrolled in the registry in a nonrandomized, open-label manner and treated with SES (n = 607). Patients were compared to historical controls from the ARTS I CABG and BMS arms.
Concomitant Medications:
Glycoprotein IIb/IIIa receptor antagonists (33%)
Principal Findings:
Baseline differences were found when comparing ARTS II to ARTS I. In ARTS II, patients were more frequently diabetic (26.2% vs. 18.2%) and they more often had three-vessel disease present (54% vs. 28%). Lesions were more frequently complex (13.9% vs. 7.5% for Type C lesions). More stents were implanted per patient than in ARTS I BMS (3.7 vs. 2.8), and longer lengths of stent were implanted (73 mm vs. 48 mm).
At 1 year, there was no difference in the incidence of major adverse cardiac and cerebrovascular events (MACCE) comparing the ARTS II SES registry patients with the CABG randomized patients in the ARTS I trial (10.4% vs. 11.6%, p = 0.46), but MACCE was lower in ARTS II SES compared with BMS patients in ARTS I (26.5%). There was also no difference in 1-year death (1.0% for ARTS II registry SES patients vs. 2.7% for ARTS I CABG patients), cerebrovascular events (0.8% vs. 1.8%), myocardial infarction (MI) (1.2% vs. 3.5%), or revascularization with CABG (2.0% vs. 0.7%) or percutaneous coronary intervention (PCI) (5.4% vs. 3.0%).
At 5 years, the composite outcome of death, MI, or stroke was 12.7% with SES, 13.8% with CABG, and 17.8% with BMS (p = 0.42 for SES vs. CABG and p = 0.008 for SES vs. BMS). Freedom from revascularization was 79.2% for SES, 91.0% for CABG, and 69.1% for BMS (p
Interpretation:
Among patients suitable for either CABG or PCI, this registry experience demonstrates that SES placement was associated with a low need for repeat revascularization. However, given the registry, nonrandomized nature of the study, and the comparison to historical controls, conclusions cannot be made about the superiority of one approach over another.
The low revascularization rates and clinical adverse events were evident despite the increased length and complexity of lesions treated. Despite attempts to control for confounding variables by using similar inclusion and exclusion criteria between the registry and the much earlier trial, unidentified modifiers may affect these results. Conclusions regarding superiority of a given therapy would need to be addressed in randomized trials.
Despite higher-risk coronary anatomy compared with an historical control, 5-year death, MI, or stroke rates appear to be similar between SES vs. CABG, and lower with SES vs. BMS. However, the 5-year cumulative incidence of SES-thrombosis is not insignificant. The authors estimated that stent thromboses were attributable for approximately one-third of death, MI, or stroke events.
References:
Serruys PW, Onuma Y, Garget S, al. 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. J Am Coll Cardiol 2010;Feb 17:[Epub ahead of print].
Presented by Dr. Patrick W. Serruys at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Daemen J, Kuck KH, Macaya C, et al., on behalf of the ARTS-II Investigators. Multivessel Coronary Revascularization in Patients With and Without Diabetes Mellitus: 3-Year Follow-Up of the ARTS-II (Arterial Revascularization Therapies Study–Part II) Trial. J Am Coll Cardiol 2008;52:1957-67.
Keywords: Stroke, Myocardial Infarction, Coronary Artery Disease, Angina, Stable, Drug-Eluting Stents, Sirolimus, Angioplasty, Percutaneous Coronary Intervention, Stents, Thrombosis, Coronary Artery Bypass, Diabetes Mellitus
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