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Preliminary Results A Multicenter Randomized Trial of Immediate Versus Delayed Invasive Strategy Immediate Versus Delayed Invasive Strategy in Patients with Non-ST Elevation ACS in Patients with Non-ST Elevation ACS Angioplasty to Blunt the rise Of troponin in Acute coronary syndromes Randomized for an immediate or Delayed intervention Funded by the Programme Hospitalier de Recherche Clinique (French Ministry of Health) Sponsored by Assistance Publique-Hopitaux de Paris (AP-HP) Led by the A.C.T.I.O.N. group (Academic Research Organization) Coordinating Center: Piti-Salptrire University Hospital Data Management and Statistics: URC Lariboisire University Hospital Additional support from Eli-Lilly G. Montalescot, on behalf of the ABOARD investigators G. Montalescot, disclosure: research grant, consulting or speaker fee from BMS, Boston scientific, Cordis, Daiichi Sankyo, Eli Lilly, GSK, SAG, MSD, The Medicines Company, Medtronic, Novartis, Portola, Schering. Slide 2 Preliminary Results BackgroundBackground Randomized trials have demonstrated that an invasive strategy is superior to a conservative strategy in NSTE-ACS Randomized trials have demonstrated that an invasive strategy is superior to a conservative strategy in NSTE-ACS The optimal timing of intervention remains a matter of debate The optimal timing of intervention remains a matter of debate A primary PCI approach of NSTE-ACS has not been tested yet A primary PCI approach of NSTE-ACS has not been tested yet Slide 3 Preliminary Results Time to catheterization (hrs) EARLYLATE FRISC 2 (1999)96408 TRUCS (2000)48120 TIMI-18 (2001)2279 VINO (2002)61464 RITA 3 (2002)481020 ELISA (2003)650 ISAR-COOL (2003)386 ICTUS (2005)23283 TIME-ACS (2008)1450 ABOARD (2009)ImmediateNext morning Slide 4 Preliminary Results Study objective To determine whether immediate intervention (primary PCI strategy) is superior to delayed intervention (next day strategy) in patients with moderate-to-high risk (TIMI score > 3) non-ST segment elevation ACS. Slide 5 Preliminary Results ABOARD study design NSTE-ACS 2 of 3 Criteria: Ischemic symptom, ST-T change, troponin rise with TIMI score > 3 Immediate cath Next day cath All PCIs on abciximab 1-month Follow-up IVRS RANDOMIZATION Slide 6 Preliminary Results Troponin during hospitalization The preferred biomarker for myocardial necrosis is cardiac troponin ACS PCI 1.35 (1.13-1.60) ALL Antman EM et al NEJM 1996 Nienhuis MB et al - CCI 2008 Slide 7 Preliminary Results Outcomes Primary Primary MI: defined as the peak of troponin I during hodpitalizationMI: defined as the peak of troponin I during hodpitalization Secondary Secondary 1. Death (any), new MI (CK-MB) or urgent revascularization (PCI or CABG) 2. Death, new MI, urgent revascularization or recurrent ischemia 3. Individual parameters Slide 8 Preliminary Results Statistical Analysis Study Power: 352 patients: 80% power to detect an effect size equal to 0.3 Study Power: 352 patients: 80% power to detect an effect size equal to 0.3 Randomization: Central 24 hour IVRS Randomization: Central 24 hour IVRS Analysis: Intention to treat; Tests: Mann- Whitney test for non-gaussian quantitative parameters, Chi-square or Fishers exact probability tests for qualitative parameters. Analysis: Intention to treat; Tests: Mann- Whitney test for non-gaussian quantitative parameters, Chi-square or Fishers exact probability tests for qualitative parameters. Follow-up: 100% Follow-up: 100% Slide 9 Preliminary Results Top-10 Recruiting Centers 1- G. Montalescot Piti, Paris 2- G. Cayla Nimes 3- S. Elhadad Lagny 4- H. Lebreton Rennes 5- F. Leclercq Montpellier 6- F. Duclos Argenteuil 7- J.L. Dubois-Rand Crteil 8- P.G. Steg Bichat, Paris 9- L. Payot Montreuil 10- P. Henry Lariboisire, Paris Slide 10 Preliminary Results Baseline Characteristics Characteristic Immediate (N=175) Delayed (N=177) Age, mean sd, y65 12 Female sex, %27.429.4 Weight, mean sd, kg77 1676 15 Current smoking, %32.033.9 Diabetes mellitus, %21.732.2 Previous CABG, %5.16.8 Previous MI, %16.618.6 Previous PCI, %24.630.5 Previous Stroke, %5.24.5 Cardiac Insufficiency, %4.0 Slide 11 Preliminary Results Index ACS event Entry criteria, (%) Immediate (N=175) Delayed (N=177) Ischemic symptom98.297.7 ST-T segment changes69.776.8 Elevated Troponin I75.472.9 TIMI score, (%) > 395.495.5 > 522.930.5 Slide 12 Preliminary Results In-hospital medications Immediate (N=175) Delayed (N=177) Aspirin, (%) 99.4100 Clopidogrel, (%)96.698.9 Loading dose, mean sd, mg660 268 663 267 Maintenance dose, mean sd, mg111 40111 39 Abciximab, (%)65.157.4 Unfractionated heparin only, (%)5.13.4 Low Molecular Weight Heparin only, (%)68.667.2 Both UFH and LMWH, (%)22.928.8 Neither UFH nor LMWH, (%)2.90.6 Beta-blocker, (%)87.485.3 Statin, (%)94.395.5 ACE inhibitor or ARB, (%)84.580.2 Slide 13 Preliminary Results Time to catheterization (hrs) IMMEDIATEDELAYED FRISC 2 (1999)96408 TRUCS (2000)48120 TIMI-18 (2001)2279 VINO (2002)61464 RITA 3 (2002)481020 ELISA (2003)650 ISAR-COOL (2003)386 ICTUS (2005)23283 TIME-ACS (2008)1450 ABOARD (2009) median (IQR), hr.min 1.10 (0.51-2.03) 20.48 (17.30-24.36) Slide 14 Preliminary Results InterventionsInterventions IMMEDIATEDELAYED Radial access (%)87.481.8 Culprit artery Left main trunk, (%)4.17.3 Left anterior descending artery, (%)48.645.0 Circumflex artery, (%)24.729.1 Right coronary artery, (%)24.725.2 Coronary bypass graft, (%)2.12.0 Percutaneous Coronary Intervention, (%)80.169.5 Stent (at least one), (% of PCI)94.096.2 DES (at least one), (% of PCI)47.955.2 Number of stents/patient, meansd1.2 0.91.2 1.0 CABG surgery, (%)11.011.3 Slide 15 Preliminary Results Primary EP (peak of troponin I) Median, IQR 2.1 (0.3-7.1) 1.7 (0.3-7.2) Peak values of troponin I in the 2 groups p = 0.70 Slide 16 Preliminary Results Composite Ischemic Endpoints at 1 month % Key secondary EP P=0.31 P=0.94 Slide 17 Preliminary Results Individual Ischemic Endpoints at 1 month % P=0.28 P=0.09 P=0.32 P=0.57 P=0.62 P=0.08 Slide 18 Preliminary Results Safety outcomes at 1 month ImmediateDelayedP Major bleeding at 1 month, (%) 4.06.80.25 Non-CABG related major bleeding, Non-CABG related major bleeding, 2.35.10.26 CABG-related major bleeding CABG-related major bleeding 1.7 1.00 Transfusion > 2 units Transfusion > 2 units 3.45.60.32 Transfusion > 5 units Transfusion > 5 units 1.1 1.00 Thrombocytopenia at 1 month, (%) 2.94.50.41 Non-CABG thrombocytopenia, (%) Non-CABG thrombocytopenia, (%) 2.34.00.54 Post-CABG thrombocytopenia, (%) Post-CABG thrombocytopenia, (%) 0.6 1.00 Slide 19 Preliminary Results Sites of Major Bleedings 1- Gastro-Intestinal 4 2- Puncture-related 4 3- Hemopericardium 2 4- Intracranial 1 5- Epistaxis 1 6- Hematoma (not puncture-related) 1 unknown7 One patient had 2 bleeding events n Slide 20 Preliminary Results Subgroup analysis (primary EP) Immediate betterDelayed better Median differences and Hodges-Lehmann CI for the primary end point (peak of troponin) Slide 21 Preliminary Results Hospital stay Immediate Median, IQR, hrs 55 ( 30; 98) Delayed Median, IQR, hrs 77 ( 49; 145) P