A Multicenter Randomized Trial of Immediate Versus Delayed Invasive Strategy in Patients with Non-ST Elevation ACS

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1 Angioplasty to Blunt the rise Of troponin in Acute coronary syndromes Randomized for an immediate or Delayed intervention A Multicenter Randomized Trial of Immediate Versus Delayed Invasive Strategy in Patients with Non-ST Elevation ACS G. Montalescot, on behalf of the ABOARD investigators Funded by the Programme Hospitalier de Recherche Clinique (French Ministry of Health) Sponsored by Assistance Publique Hopitaux Hopitaux de Paris (AP HP) Led by the A.C.T.I.O.N. group (Academic Research Organization) Coordinating Center: Pitié Salpêtri Salpêtrièrere University Hospital Data Management and Statistics: URC Lariboisière re University Hospital Additional support from Eli Lilly Lilly

2 Background 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 A primary PCI approach of NSTE-ACS has not been tested yet

3 Time to catheterization (hrs) EARLY LATE FRISC 2 (1999) TRUCS (2000) TIMI-18 (2001) VINO (2002) RITA 3 (2002) ELISA (2003) 6 50 ISAR-COOL (2003) 3 86 ICTUS (2005) TIME-ACS (2008) ABOARD (2009) Immediate Next morning

4 Study objective To determine whether immediate intervention ( primary( PCI strategy ) ) is superior to delayed intervention ( next( day strategy ) ) in patients with moderate-to to-high risk (TIMI score > 3) non-st segment elevation ACS.

5 2 of 3 Criteria ABOARD study design NSTE-ACS Criteria: Ischemic symptom,, ST-T T change, troponin rise with TIMI score > 3 IVRS RANDOMIZATION Immediate cath Next day cath All PCIs on abciximab 1-month Follow-up

6 Troponin during hospitalization «The preferred biomarker for myocardial necrosis is cardiac troponin» ACS % 1.7 % 3.4 % 3.7% 6.0% 7.5% <0.4 <1.0 <2.0 <5.0 < Cardiac Troponin 1 (ng/ml) 2007 Antman EM et al NEJM 1996 Nienhuis MB et al - CCI 2008 ALL PCI 1.35 ( )

7 Outcomes Primary MI: defined as the peak of troponin I during hospitalization Secondary 1. Death (any), new MI (CK-MB) or urgent revascularization (PCI or CABG), at 1 month 2. Death, new MI, recurrent ischemia (with or without urgent revascularization), at 1 month 3. Individual parameters, at 1 month

8 Characteristic Baseline Characteristics Immediate (N=175) Delayed (N=177) Age, mean ± sd, y 65 ± 12 65± 12 Female sex, % Weight, mean ± sd, kg 77 ± ± 15 Current smoking, % Diabetes mellitus, % Previous CABG, % Previous MI, % Previous PCI, % Previous Stroke, % Cardiac Insufficiency, %

9 Index ACS event Entry criteria, (%) Immediate (N=175) Delayed (N=177) Ischemic symptom ST-T segment changes Elevated Troponin I TIMI score, (%) > >

10 In-hospital medications Immediate (N=175) Delayed (N=177) Aspirin, (%) Clopidogrel, (%) Loading dose, mean ± sd, mg 660 ± ± 267 Maintenance dose, mean ± sd, mg 111 ± ± 39 Abciximab, (%) Unfractionated heparin only, (%) Low Molecular Weight Heparin only, (%) Both UFH and LMWH, (%) Neither UFH nor LMWH, (%) Beta-blocker, (%) Statin, (%) ACE inhibitor or ARB, (%)

11 Time to catheterization (hrs) EARLY LATE FRISC 2 (1999) TRUCS (2000) TIMI-18 (2001) VINO (2002) RITA 3 (2002) ELISA (2003) 6 50 ISAR-COOL (2003) 3 86 ICTUS (2005) TIME-ACS (2008) ABOARD (2009) median (IQR), hr.min 1.10 ( ) ( )

12 Interventions Immediate Delayed Radial access (%) Culprit artery Left main trunk, (%) Left anterior descending artery, (%) Circumflex artery, (%) Right coronary artery, (%) Coronary bypass graft, (%) Percutaneous Coronary Intervention, (%) Stent (at least one), (% of PCI) DES (at least one), (% of PCI) Number of stents/patient, mean±sd 1.2 ± ± 1.0 CABG surgery, (%)

13 Primary EP (peak( of troponin I) Density Peak values of troponin I in the 2 groups Distribution curves of the peaks values of troponin in the immediate and delayed groups immediate group delayed group Troponin I (ng/ml) Median, IQR 2.1 ( ) 1.7 ( ) p = 0.70

14 Composite Ischemic Endpoints at 1 month % Immediate Delayed P= P= Death / MI / UR Key secondary EP Death / MI / UR / RI

15 Safety outcomes at 1 month Immediate Delayed P Major bleeding at 1 month, (%) Non-CABG related major bleeding, CABG-related major bleeding Transfusion > 2 units Transfusion > 5 units Thrombocytopenia at 1 month, (%) Non-CABG thrombocytopenia, (%) Post-CABG thrombocytopenia, (%)

16 Sites of Major Bleedings 1- Gastro-Intestinal 4 2- Puncture-related related 4 3- Hemopericardium 2 4- Intracranial 1 5- Epistaxis 1 6- Hematoma (not puncture-related related) 1 unknown 7 One patient had 2 bleeding events n

17 Hospital stay Immediate Median,, IQR, hrs Delayed Median,, IQR, hrs 55 ( 30; 98) 77 ( 49; 145) P<0.001

18 Conclusions A «primary PCI strategy» in NSTE-ACS (compared( with a rapid intervention on the next day): is feasible,, but does not reduce the risk of MI (primary( outcome) is not associated with significant differences in other efficacy or safety outcomes does not benefit to a particular subgroup of patients shortens significantly hospital stay

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