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

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 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, 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. 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)

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

6. ACS Antman EM et al – NEJM 1996 Nienhuis MB et al - CCI 2008 1.35 (1.13-1.60) ALL PCI Troponin during hospitalization « The preferred biomarker for myocardial necrosis is cardiac troponin »

7. Outcomes Primary MI: defined as the peak of troponin I during hodpitalization Secondary Death (any), new MI (CK-MB) or urgent revascularization (PCI or CABG) Death, new MI, urgent revascularization or recurrent ischemia Individual parameters

8. Statistical Analysis Study Power: 352 patients: 80% power to detect an effect size equal to 0.3 Randomization: Central 24 hour IVRS Analysis: Intention to treat; Tests: Mann-Whitney test for non-gaussian quantitative parameters, Chi-square or Fisher’s exact probability tests for qualitative parameters . Follow-up: 100%

9. Top-10 Recruiting Centers

10. Baseline Characteristics

11. Index ACS event

12. In-hospital medications

13. Time to catheterization (hrs)

14. Interventions

15. Peak values of troponin I in the 2 groups Median, IQR 2.1 (0.3-7.1) 1.7 (0.3-7.2) p = 0.70 Primary EP (peak of troponin I)

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

17. % P=0.08 P=0.09 P=0.32 P=0.57 P=0.28 P=0.62 Individual Ischemic Endpoints at 1 month

18. Safety outcomes at 1 month

19. Sites of Major Bleedings n One patient had 2 bleeding events

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

21. Hospital stay P<0.001

22. 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

23. Thank you