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Preliminary Results A Multicenter Randomized Trial of Immediate Versus Delayed Invasive Strategy Immediate Versus Delayed Invasive Strategy in Patients.

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Presentation on theme: "Preliminary Results A Multicenter Randomized Trial of Immediate Versus Delayed Invasive Strategy Immediate Versus Delayed Invasive Strategy in Patients."— Presentation transcript:

1 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: Pitié-Salpêtrière University Hospital Data Management and Statistics: URC Lariboisière 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.

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

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) ELISA (2003)650 ISAR-COOL (2003)386 ICTUS (2005)23283 TIME-ACS (2008)1450 ABOARD (2009)ImmediateNext morning

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.

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

6 Preliminary Results Troponin during hospitalization « The preferred biomarker for myocardial necrosis is cardiac troponin »ACS PCI 1.35 ( ) ALL Antman EM et al – NEJM 1996 Nienhuis MB et al - CCI 2008

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

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%

9 Preliminary Results Top-10 Recruiting Centers 1- G. Montalescot – Pitié, 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-Randé – Créteil 8- P.G. Steg – Bichat, Paris 9- L. Payot – Montreuil 10- P. Henry – Lariboisière, Paris

10 Preliminary Results Baseline Characteristics Characteristic Immediate (N=175) Delayed (N=177) Age, mean ± sd, y65 ± 12 Female sex, % Weight, mean ± sd, kg77 ± 1676 ± 15 Current smoking, % Diabetes mellitus, % Previous CABG, % Previous MI, % Previous PCI, % Previous Stroke, % Cardiac Insufficiency, %4.0

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

12 Preliminary Results In-hospital medications Immediate (N=175) Delayed (N=177) Aspirin, (%) Clopidogrel, (%) Loading dose, mean ± sd, mg660 ± ± 267 Maintenance dose, mean ± sd, mg111 ± ± 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, (%)

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) ELISA (2003)650 ISAR-COOL (2003)386 ICTUS (2005)23283 TIME-ACS (2008)1450 ABOARD (2009) median (IQR), hr.min 1.10 ( ) ( )

14 Preliminary Results InterventionsInterventions IMMEDIATEDELAYED 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±sd1.2 ± ± 1.0 CABG surgery, (%)

15 Preliminary Results Primary EP (peak of troponin I) Median, IQR 2.1 ( ) 1.7 ( ) Peak values of troponin I in the 2 groups p = 0.70

16 Preliminary Results Composite Ischemic Endpoints at 1 month % Key secondary EP P=0.31 P=0.94

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

18 Preliminary Results Safety outcomes at 1 month ImmediateDelayedP Major bleeding at 1 month, (%) Non-CABG related major bleeding, Non-CABG related major bleeding, CABG-related major bleeding CABG-related major bleeding Transfusion > 2 units Transfusion > 2 units Transfusion > 5 units Transfusion > 5 units Thrombocytopenia at 1 month, (%) Non-CABG thrombocytopenia, (%) Non-CABG thrombocytopenia, (%) Post-CABG thrombocytopenia, (%) Post-CABG thrombocytopenia, (%)

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

20 Preliminary Results Subgroup analysis (primary EP) Immediate betterDelayed better Median differences and Hodges-Lehmann CI for the primary end point (peak of troponin)

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

22 Preliminary Results ConclusionsConclusions 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 feasible, but does not reduce the risk of MI (primary outcome) is not associated with significant differences in other efficacy or safety outcomesis not associated with significant differences in other efficacy or safety outcomes does not benefit to a particular subgroup of patientsdoes not benefit to a particular subgroup of patients shortens significantly hospital stayshortens significantly hospital stay

23 Preliminary Results Thank you

24 Preliminary Results Subgroup analysis (Key secondary EP) Delayed better OR [95% CI] for the key secondary EP (Death, MI or Urg Revasc)


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