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Italian Elderly ACS Study

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Early Aggressive vs Initially Conservative Therapy in Elderly Patientswith Non-ST-Elevation Acute Coronary SyndromeThe Italian elderly-ACS studyA nationwide trial of the Italian Federation of Cardiology (FIC)promoted by the Italian Society of Interventional Cardiology SICI-GISE Steering committee Chairmen: S. Savonitto, S. De Servi Members: A.S. Petronio, L. Bolognese, C. Greco, C. Cavallini, C. Indolfi, L. Oltrona Visconti, F Piscione Registry coordinator: G. Steffenino Event adjudication committee: G. Ambrosio, M. Galvani, A. Marzocchi, I. Santilli ClinicalTrials.gov ID: NCT00510185 website: http://elderly.altavianet.it

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Design of the study Patients >74 years with NSTEACS Early invasive (angio within 48 hours) Initially conservative (angio for refractory ischemia) 12-month follow-up 12-month follow-up Primary endpoint the composite of all-cause mortality, myocardial (re)MI, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 6 months Central random Registry of excluded pts with simplified CRF 12-month follow-up 700 pts 40 centers RCT Registry Savonitto S, J Cardiovasc Med 2008;9:217

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Centers Centers without onsite cathlab operating in network with a nearby cathlab able to perform coronary angiography within 48 hours after patient enrolment, or earlier in case of emergency Centers with onsite cathlab and a program of nonsistematic angiography in the study population Savonitto S, J Cardiovasc Med 2008;9:217

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Patients Inclusion criteria Be >74 year old Have had symptoms suggestive of acute myocardial ischemia at rest within 48 h prior to randomization, together with a) ischemic ECG changes and/or b) elevated biochemical markers of myocardial damage. Provide written informed consent before randomization. Savonitto S, J Cardiovasc Med 2008;9:217

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Patients Exclusion criteria - I Secondary causes of myocardial ischemia Ongoing ischemia despite maximally titrated anti-ischemic therapy Ongoing signs of heart failure despite treatment PCI or surgery within 30 days prior to randomization Savonitto S, J Cardiovasc Med 2008;9:217

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Patients Exclusion criteria - 2 Serum creatinine level >2.5 mg/dL Active internal bleeding, history of hemorrhagic diathesis or recent transfusion of RBC, whole blood or platelets Cerebrovascular accident within the previous month Known platelet count of <90,000 cells/mL Ongoing oral anticoagulant treatment or an INR >1.5 at the time of screening . Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization Savonitto S, J Cardiovasc Med 2008;9:217

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Patients Exclusion criteria, 3 Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol Participation in any phase of another clinical research study involving the evaluation of an investigational drug or device within 30 days prior to randomization Inability to give at least verbal informed consent to the study Savonitto S, J Cardiovasc Med 2008;9:217

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Endpoints The composite of all-cause mortality, myocardial (re)MI, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding at 6 months Primary endpoint CV mortality at 1 year All-cause mortality and (re)MI at 6 months All-cause mortality and (re)MI at 1 year The composite of death, myocardial (re)MI, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding at 1 year Major bleeding within 6 months Any stroke within 6 months Total n° of days spent in hospital within 6 months after index admission QoL evaluated at 6 months Secondary endpoints Savonitto S, J Cardiovasc Med 2008;9:217

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Randomised treatment strategies Patients >74 years With NSTEACS Early invasive (angio within 48 hours) Initially conservative (angio for refractory ischemia) Web random Refractory ischemia: recurrent symptoms and ECG changes >12 hrs after admission despite maximal therapy Post-admission (re)MI Heart failure Malignant ventricular arrhythmia Recurrent ischemic symptoms (CCS III-IV) after index discharge despite optimal antianginal therapy, particularly if ischemia is documented on provocative testing Angio During index admission Angio After index discharge Savonitto S, J Cardiovasc Med 2008;9:217

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Recommended drug therapy Aspirin, 325 mg p.o on admission, then 75-100 mg throughout follow-up Clopidogrel, 300 mg on admission, then 75 mg throughout follow-up GPIIb/IIIa RB: invasive arm (and conservative arm in case of angio) - either upstream eptifibatide-tirofiban if delay to angio >4 hrs - or post-angio abciximab, particularly if delay to angio <4hrs UFH: 2500 i.v. bolus, then start infusion of 7U/kg/hr nomogram-adjusted to a target aPTT of 50-70 seconds up to 30 minutes prior to angiography Enoxaparin: i.v. bolus of 3000 U, followed by sq administration of 75U/kg (max 6000 U) b.i.d. for 3-5 days. Latest dose >8 hrs prior to angio No further UFH/enoxa post-angio, except for patients laying in bed (50 U o.d.) Bivalirudin as anticoagulant during PCI, according to REPLACE-2 dosing: - i.v. bolus 0.75 mg/kg - 1.75 mk/kg/hour infusion during PCI All other medications as recommended by current practice guidelines Savonitto S, J Cardiovasc Med 2008;9:217

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Follow-up RCT 1month: visit and ECG 6 months: visit and ECG 12 months: visit and ECG Registry 1month: visit or phone 6 months: visit and ECG 12 months: visit or phone Savonitto S, J Cardiovasc Med 2008;9:217

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Sample size Sample size calculations are based on the primary-endpoint rates at 6 months in pts >75y observed in the retrospective analysis of the TACTICS-TIMI 18 trial. In this study, the rates of the primary endpoint of death + MI + rehospitalization were 30% in the conservative arm vs 20% in the invasive arm. According to these estimates, the following figures are given, based upon the logrank test for survival curves. Savonitto S, J Cardiovasc Med 2008;9:217

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5 5 3 1 4 6 1 2 1 8 11 2 2 6 Countrywide distribution of the participating Centers 1 Savonitto S, J Cardiovasc Med 2008;9:217

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	stefano.savonitto@fastwebnet.it 1 Years ago. Category: Cardiology

Tags:	Cardiology

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