Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited. Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome: The Italian Elderly ACS study Stefano Savonitto a , Stefano De Servi b , Anna Sonia Petronio c , Leonardo Bolognese d , Claudio Cavallini e , Cesare Greco f , Ciro Indolfi g , Luigi Oltrona Visconti h , Federico Piscione i , Giuseppe Ambrosio l , Marcello Galvani m , Antonio Marzocchi n , Ignazio Santilli o , Giuseppe Steffenino p and Attilio Maseri q Background Elderly patients represent one-third of all admissions for non-ST-elevation acute coronary syndrome (NSTEACS) in the coronary care units. Despite their high- risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments, also due to less clear evidence regarding the most effective treatment strategy. Purpose The Italian Elderly ACS study includes patients older than 74 years of age with NSTEACS in a multicenter randomized clinical trial, comparing an early aggressive and an initially conservative approach. Patients not enrolled due to specific exclusion criteria or any other reason will be enrolled in a Registry. Centers Centers with on-site interventional cathlab and centers without on-site cathlab refering patients to a cathlab within a consolidated percutaneous coronary intervention network. Patients Patients admitted within 48 h of the most recent ischemic symptoms are eligible if they show transient ischemic ECG changes and/or CKMB/Tn elevation. Patients with secondary ischemia, ongoing ischemia, or heart failure, despite optimal therapy or recent coronary intervention, serum creatinine more than 2.5 mg/dl, high bleeding risk, and severe concomitant disease, are excluded from the study. Design Central randomization to a systematic early aggressive approach (coronary angiography within 48 h of admission and, when indicated, coronary revascularization) or an initially conservative approach (optimal medical therapy with coronary angiography in selected cases with refractory ischemia). Follow-up will include patient visits and ECG at 30 days, 6 months, and 1 year, post randomization. Primary end point The composite of all-cause mortality, myocardial (re)infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months. Sample size Expected primary end point rates of 30% in the conservative arm vs. 20% in the invasive arm. According to these estimates, with two-tailed a of 0.05, power will be 80, 85, or 90% with 252, 289, and 338 patients per group, respectively. The goal is to enroll 700 patients from 50 centers. J Cardiovasc Med 9:217–226 Q 2008 Italian Federation of Cardiology. Journal of Cardiovascular Medicine 2008, 9:217–226 Keywords: acute coronary syndrome, elderly, randomized clinical trial, registry a ‘‘Angelo De Gasperis’’ Department of Cardiology, Niguarda Ca Granda Hospital, Milan, b Department of Cardiology, Civil Hospital, Legnano, c Cardiothoracic Department, University of Pisa, Pisa, d Department of Cardiology, San Donato Hospital, Arezzo, e Department of Cardiology, Silvestrini Hospital, Perugia, f Department of Cardiology, San Giovanni Hospital, Rome, g Institute of Cardiology, University of Magna Grecia, Catanzaro, h Department of Cardiology, San Martino Hospital, Genoa, i Department of Cardiology, University of Naples Federico II, Naples, l Chair of Cardiology at the University of Perugia, Perugia, m Division of Cardiology, Forli Hospital, Forli, n Institute of Cardiology, Polyclinic Sant’Orsola, Bologna, o Stroke Unit, Department of Neurosciences, Niguarda Ca Granda Hospital, Milan, p Santa Croce and Carle Hospital, Cuneo and q Department of Cardiology, San Raffaele Hospital, Milan, Italy Correspondence and request for reprints to Dr Stefano Savonitto, Dipartimento Cardiologico ‘A. De Gasperis’, Ospedale Niguarda Ca’ Granda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy Tel: +39 0335 6056565; fax: +39 02 6883804; e-mail: stefano.savonitto@fastwebnet.it Received 23 November 2007 Revised 8 January 2008 Accepted 11 January 2008 Introduction Non-ST-elevation acute coronary syndrome (NSTEACS) is the most common presentation of acute ischemic heart disease in elderly patients. According to the Euro Heart Survey [1–3], 53 out of 100 patients admitted to a hospital for NSTEACS in European countries are older than 74 years of age. Data from a large sample of the Italian coronary care units (CCUs), collected in the BLITZ [4], Research trial protocol A nationwide trial of the Italian Federation of Cardiology (FIC) promoted by the Italian Society of Interventional Cardiology (SICI-GISE) 1558-2027 ß 2008 Italian Federation of Cardiology