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Guillaume Cayla , Service de Cardiologie CHU Nîmes-Pr Messner

Pourquoi la Bivaluridine et pourquoi pas les IIb - IIIa ?. Guillaume Cayla , Service de Cardiologie CHU Nîmes-Pr Messner Unité INSERM 937 La Pitié Salpetrière Pr Montalescot. COI: AstraZeneca , Abbott Vascular , Biotronik , CLS Behring, Daiichi Sankyo , Eli Lilly, Iroko Cardio.

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Guillaume Cayla , Service de Cardiologie CHU Nîmes-Pr Messner

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  1. Pourquoi la Bivaluridine et pourquoi pas les IIb-IIIa? Guillaume Cayla, Service de Cardiologie CHU Nîmes-Pr Messner Unité INSERM 937 La Pitié Salpetrière Pr Montalescot COI: AstraZeneca, Abbott Vascular, Biotronik, CLS Behring, DaiichiSankyo, Eli Lilly, Iroko Cardio

  2. Les Questions • Bivalirudine: Forces et Faiblesses? • HNF/IIbIIIa comparateur, quid Enoxaparine? • IIb/IIIa molécules anciennes, nouvelles données? • Conclusion: les questions en suspens….

  3. HORIZON MI Harmonizing Outcomes with Revascularization and Stents in AMI ≥3400* pts with STEMI with symptom onset ≤12 hours Aspirin, thienopyridine UFH + GP IIb/IIIa inhibitor (abciximab or eptifibatide) Bivalirudin monotherapy (± provisional GP IIb/IIIa) Emergent angiography, followed by triage to… R 1:1 R 1:3 CABG – – Primary PCI Medical Rx 3000 pts eligible for stent randomization Bare metal stent TAXUS paclitaxel-eluting stent Clinical FU at 30 days, 6 months, 1 year, and then yearly through 5 years *To rand 3000 stent pts

  4. @ 1 month Diff = -3.3% [-5.0, -1.6] RR = 0.60 [0.46, 0.77] PNI ≤ 0.0001 Psup ≤ 0.0001 Diff = 0.0% [-1.6, 1.5] RR = 0.99 [0.76, 1.30] Psup = 1.00 Diff = -2.9% [-4.9, -0.8] RR = 0.76 [0.63, 0.92] PNI ≤ 0.0001 Psup = 0.006 Stone et al, NEJM 2008

  5. Cardiacmortality @ 3 years Heparin + GPIIb/IIIa(n=1802) Bivalirudin alone (n=1800) 6 0.56 (0.40, 0.80) 3-yr HR (95%CI) 5 5.1% P=0.001 4 3.8% 3 Cardiac Mortality (%) 2.9% 2 2.1% 1 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Months Stone et al, Lancet 2011

  6. * « Administration if No Reflow or Giant Thrombus post PCI » Stone et al, NEJM 2008

  7. Thrombose aigue de stent? Impact de l’administration HNF Impact de la dose de charge de clopidogrel

  8. HORIZON MI Les Points positifs Les Points négatifs Large population (3602 patients) Thrombose aigue stent? Réduction hémorragies+++ Impact de la coadministration héparine Dose de clopidogrel Bénéfice mortalité court et long terme Pas de réduction événements ischémiques Bail out IIB/IIIA 7% Utilisation radiale: 6%....

  9. Bivalirudine ESC STEMI 2010 AHA 2011

  10. Les Questions • Bivalirudine: Forces et Faiblesses? • HNF(+IIbIIIa) comparateur, quid Enoxaparine? • IIb/IIIa molécules anciennes, nouvelles données? • Conclusion: les questions en suspens….

  11. ATOLL Trial design Randomization as early as possible (MICU +++) Real life population (shock, cardiacarrestincluded) No anticoagulationand no lyticbeforeRx Similarantiplatelettherapy in both groups STEMI  Primary PCI ENOXAPARIN IV 0.5 mg/kg with or withoutGPIIbIIIa UFH IV 50-70 IU with GP IIbIIIa 70-100IU without GP IIbIIIa (Dose ACT-adjusted) IVRS Primary PCI ENOXAPARIN SC UFH IV or SC 30-dayresults Montalescot et al Lancet 2011; 378: 693-703

  12. ATOLL study Death, Complication of MI, ProcedureFailure or Major Bleeding RRR=17% P=0.063

  13. Death, Recur MI/ACS or Urgent Revasc Main SecondaryEndpoint (ischemic)

  14. Enoxaparine: ATOLL trial Death, MI, Major bleeding Montalescot G Lancet 2011; 378: 693-703

  15. Les Questions • Bivalirudine: forces et faiblesses? • HNF/IIbIIIa comparateur, quid Enoxaparine? • IIb/IIIa molécules anciennes, nouvelles données? • Conclusion: les questions en suspens….

  16. Amélioration flux TIMI-3 Abciximab Test for heterogeneity: Chi² = 3.56, df = 5 (P = 0.61), I² = 0% Test for overall effect: Z = 4.38 (P < 0.0001) Tirofiban Test for heterogeneity: Chi² = 1.84, df = 2 (P = 0.40), I² = 0% Test for overall effect: Z = 2.11 (P=0.03) Eptifibatide Test for heterogeneity: Chi² = 3.74, df = 1 (P = 0.05), I² = 73.3% Test for overall effect: Z = 2.35 (P=0.02) Test for heterogeneity: Chi² = 12.53, df = 10 (P = 0.25), I² = 20.2% Test for overall effect: Z = 5.08 (P < 0.00001) Favours Late GP IIb-IIIa inhibitors Favours Early GP IIb-IIIa inhibitors 0.1 0.2 0.5 1 2 5 10 Adapted from De Luca et al. Heart 2008; Epub ahead of print

  17. High Risk and short delay EUROTRANSFER FINESSE High Risk and long delay FINESSE substudy RELAX-AMI On Time-2 Low Risk and longdelay MISTRAL BRAVE-3 Low Risk and short delay IIb/IIIa Données Récentes: Impact du temps et du risque du patient Risk Profile High Intermediate Low 60 120 180 240 300 360 Ischemic Time (min) (Symptom Onset - TTT) Studies with benefit of IIbIIIa inhibitors Studies withoutbenefit of IIbIIIa inhibitors

  18. Les questions en 2012 ? Voie intracoronaire?→ AIDA STEMI Nouveaux P2Y12 inhibiteurs?

  19. Guidelines 2010 Utilisation plus sélective

  20. Les Questions • Bivalirudine: forces et faiblesses? • HNF/IIbIIIa comparateur, quid Enoxaparine? • IIb/IIIa molécules anciennes, nouvelles données? • Conclusion: les questions en suspens….

  21. Conclusion Radiale? (RIVAL/RIFLE) Enoxaparine Bivalirudine UFH Prasugrel/Ticagrelor? Utilisation + selectiveIIb/IIIa? Ischemic complications : ATOLL Study Enoxaparine? Enoxaparine/IIb/IIIa Bivalirudine UFH/IIbIIIa Bleeding complications: HORIZON

  22. BACK UP SLIDE

  23. Euromax

  24. RIVAL S Jolly et al Lancet 2011; 377:1409-20

  25. RIFLE STEAACS p = 0.003 N=1001 21.0% p = 0.029 p = 0.026 13.6% 12.2% 11.4% 7.8% 7.2% • Net Adverse Clinical Event (NACE) = MACCE + bleeding • Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac death, myocardial infarction, target lesion revascularization, stroke 30-day NACE rate

  26. RIFLE STEAACS N=1001 p = 0.026 p = 1.000 p = 0.002 12.2% 7.8% 6.8% 5.4% 5.2% 2.6% 30-day bleeding rate

  27. HORIZON MI Transradial:n=200!!!

  28. 2-Year Stent Thrombosis(ARC Definite/Probable) Bivalirudin alone (n=1800) Heparin + GPIIb/IIIa (n=1802) 6 5 4.6% 4.3% 4 Stent Thrombosis (%) 3 HR [95%CI]= 0.94 [0.67, 1.32] 2 p= 0.73 1 0 0 3 6 9 12 15 18 21 24 Months Number at risk Bivalirudin alone 1611 1509 1475 1444 1206 Heparin+GPIIb/IIIa 1591 1482 1449 1386 1153

  29. Thrombose de stent Bivalirudin monotherapy Heparin + GPIIb/IIIa inhibitor 3.5 HR [95%CI] = 5.93 [2.06-17.04] P = 0.0002 3.0% 3.0 2.5 2.2% 2.0 Def/Prob Stent Thrombosis (%) 1.5% 1.5 HR [95%CI] = 1.73 [0.47-1.13] P = 0.06 1.0 0.3% 0.5 0.0 0 1 30 90 180 270 365 Time in Days Number at risk Bivalirudin 1611 1600 1562 1525 1506 1485 1355 UFH+GPIIb/IIIa 1591 1587 1521 1495 1476 1457 1315

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