Arterial Revascularisation Therapies Study Part II - Sirolimus-eluting stents for the treatment of patients with multivessel de novo coronary artery lesions.

Abstract

To determine the safety and effectiveness of CYPHER(R) sirolimus-eluting stent implantation in patients with multivessel disease; and to compare outcomes against the historical results of the two arms of the Arterial Revascularisation Therapies Study (ARTS I). ARTS II is a 45 center, 607 patient single arm trial; the1-year outcomes were compared to the historical controls of the ARTS I trial, using conventional and Bayesian statistical methods. Patients were stratified by clinical site to ensure that at least one-third had 3-vessel disease to achieve the number of treatable lesions per patient comparable to ARTS I. Multivessel stenting was performed with sirolimus-eluting stents according to local institutional practice with the goal of achieving complete revascularisation. The majority of patients (53.5%) had 3-vessel disease and diabetes was present in 26.2%. Mean stented length was 72.5mm, 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%, freedom from revascularisation was 91.5% and the composite endpoint of MACCE-free survival was 89.5% (the primary endpoint). Diabetic patients treated with sirolimus-eluting stents were more likely to undergo repeat revascularisation (RR 1.97, 95% CI 1.16 - 3.34) and experience a MACCE (RR 1.85, 95% CI 1.16 - 2.97) than non-diabetics at 1-year. In the unadjusted comparison with the historical control arms of ARTS-I-CABG and ARTS-I-PCI, the respective relative risks (RR) and associated 95% confidence intervals (CI) for the endpoints were: (1) freedom from repeat revascularisation RR 2.03 (1.23-3.34) and RR 0.44 (0.31-0.61) respectively; and (2) MACCE free survival RR 0.89 (0.65-1.23) and RR 0.39 (0.30-0.51) respectively. The low incidence of MACCE and repeat revascularisation in ARTS II suggests that contemporary PCI with sirolimus-eluting stents is safe and efficacious for the treatment of multivessel coronary artery disease. Compared to the historical population of ARTS I, surgery still afforded a lower need for repeat revascularisation although overall MACCE rates in ARTS II approached the surgical results and were significantly better than bare stenting in ARTS I.