ARTS II, a 45-center, 607-patient registry, intended to compare 1-year outcomes of the sirolimus-eluting stent against the historical results of the two arms of ARTS I.51 Patients were stratified to ensure that at least one third had three-vessel disease to achieve a number of treatable lesions per patient comparable to ARTS I. Compared with ARTS I, ARTS II comprised a higher-risk cohort: 53.5% had three-vessel disease, and diabetes was present in 26.2%. Mean stented length was 72.5 mm, with 3.7 stents implanted per patient. The 1-year survival rate was 99.0%, the composite of death/stroke and MI-free survival was 96.9%, and freedom from revascularization was 91.5%. In the unadjusted comparison with the historical control arms of ARTS I-CABG and ARTS I-PCI, the respective relative risks and 95% CIs for the end points were (1) freedom from repeat revascularization, 2.03 (1.23-3.34) and 0.44 (0.31-0.61), respectively; and (2) freedom from death, stroke, MI, and revascularization, 0.89 (0.65-1.23) and 0.39 (0.300.51), respectively. The authors concluded that surgery still afforded a lower need for repeat revascu-larization, although overall event rates in ARTS II approached those of the surgical results and were significantly better than bare stenting in ARTS I. The three year clinical outcome of ARTS II (presented at the 56th Annual Scientific Session, American College of Cardiology, New Orleans, 2007) confirmed the favorable results during long-term follow-up. In the unadjusted comparison of ARTS II with ARTS I-CABG and ARTS I-PCI, freedom from death, stroke, and MI until three years was 92.0%, 89.1%, and 87.2%, respectively (for ARTS II versus ARTS I-CABG, log rank P = .07; for ARTS II versus ARTS I-PCI, log rank P = .004), and freedom from death, stroke, MI and repeat revascularization up to three years was 80.6%, 83.8%, and 66.0%, respectively (for ARTS II versus ARTS I-CABG, log rank P = .22; for ARTS II versus ARTS I-PCI, log rank P < .001). So the overall major adverse event rate of ARTS II at three years is noninferior to ARTS I-CABG.
The promising results of ARTS II have to be interpreted cautiously, because ARTS II did not account for advances in surgical technique that may have occurred since the days of ARTS I. Despite this limitation, there is currently no evidence-based reason for withholding the benefit of drug-eluting stents with respect to reintervention from patients with multi-vessel disease. Randomized studies that clarify the role of drug eluting-stents compared with CABG for multivessel disease are currently underway.
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