Five-Year Follow-Up of the Argentine Randomized Trial of Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease (ERACI II)

ObjectivesThe purpose of the present study is to report the five-year follow-up results of the ERACI II trial.BackgroundImmediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG).MethodsA total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up.ResultsAt five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina.ConclusionsAt five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE

Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: The EUCATAX trial

Objectives: The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention. Background: Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. Methods: Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. Results: At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P = 0.02), and MACE rate was 10% in PES and 19% in BMS arm (P = 0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. Conclusions: The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.Fil: Rodriguez, Alfredo E.. Sanatorio "Otamendi y Miroli S. A."; ArgentinaFil: Vigo, Cesar F.. Sanatorio del Salvador S. A.; ArgentinaFil: Delacasa, Alejandro. Sanatorio Belgrano; ArgentinaFil: Mieres, Juan. Sanatorio "Otamendi y Miroli S. A."; ArgentinaFil: Fernandez Pereira, Carlos. Sanatorio "Otamendi y Miroli S. A."; ArgentinaFil: Bernardi, Victor. Clinica del Sol;Fil: Bettinoti, Marcelo. Sanatorio Guemes Sociedad Anonima.; ArgentinaFil: Rodriguez Granillo, Gaston Alfredo. Sanatorio "Otamendi y Miroli S.A.". Servicio de Diagnóstico por Imágenes. Departamento de Imágenes en Cardiología. Centro de Investigaciones Cardiovasculares; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Curotto, Valeria. Sanatorio "Otamendi y Miroli S. A."; ArgentinaFil: Rubilar, Bibiana. Sanatorio "Otamendi y Miroli S. A."; ArgentinaFil: Tronge, Jorge. No especifíca;Fil: Palacios, Igor F.. Massachusetts General Hospital; Estados UnidosFil: Antoniucci, David. Careggi Hospital; Itali