| Autor: |
Patrick W, Serruys, Andrew T L, Ong, Marie-Claude, Morice, Bernard, De Bruyne, Antonio, Colombo, Carlos, Macaya, Gert, Richardt, Jean, Fajadet, Christian, Hamm, Keith, Dawkins, A James, O'Malley, Marco, Bressers, Dennis, Donohoe |
| Rok vydání: |
2009 |
| Zdroj: |
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 1(2) |
| ISSN: |
1774-024X |
| Popis: |
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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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