Five-Year ARTS II Outcomes Reported for SES

March 16, 2010—Patrick W. Serruys, MD, PhD, et al published findings from a study that sought to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass grafting (CABG) and bare-metal stents (BMS) from the ARTS I study. The background of the study is that the long-term outcome after SES implantation in patients with multivessel disease had yet to be established. The findings were published in the Journal of the American College of Cardiology (2010;55:1093–1101).

ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis Corporation, Bridgewater, NJ), applying the same inclusion and exclusion criteria, endpoints, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with three-vessel disease.

As detailed by the investigators, the rate of death/stroke/myocardial infarction event-free survival at 5 years was 87.1% in the ARTS II SES group versus 86% (P = .1) and 81.9% (P = .007) in the ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event rate in ARTS II (27.5%) was significantly higher than in the ARTS I CABG group (21.1%; P = .02) and lower than in the ARTS I BMS group (41.5%; P < .001). The cumulative incidence of definite stent thrombosis was 3.8%. At 5 years, 32% (56 of 176) of major adverse cardiac events were related to possible, probable, or definite stent thrombosis.

The investigators concluded that at 5 years, SES had a safety record comparable to CABG and superior to BMS, and a major adverse cardiac and cerebrovascular event rate that was higher than in patients treated with CABG and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.