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I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results G. M ONTALESCOT, DISCLOSURE : Research Grants to the Institution.

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Presentation on theme: "I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results G. M ONTALESCOT, DISCLOSURE : Research Grants to the Institution."— Presentation transcript:

1 I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results G. M ONTALESCOT, DISCLOSURE : Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular, Astra-Zeneca, Bayer, Biotronik, Boehringer-Ingelheim, Boston Scientific, Cleveland Clinic Foundation, Cardiovascular Research Foundation, Cordis, Daiichi-Sankyo, Duke institute, Eli-Lilly, Europa, Fédération Française de Cardiologie, Fondation de France, GSK, ICM, INSERM, Lead-up, Medtronic, Menarini, Nanospheres, Novartis, Pfizer, Sanofi-Aventis Group, Servier, Société Française de Cardiologie, The Medicines Company, TIMI group. ATOLL: Acute STEMI Treated with primary PCI and intravenous enoxaparin Or UFH to Lower ischemic and bleeding events at short- and Long-term follow-up (Investigator-driven study) G. Montalescot, M. Cohen, P. Goldstein, K. Huber, C. Pollack, U. Zeymer, E. Vicaut for the ATOLL investigators for the ATOLL investigators

2 Intravenous enoxaparin vs. UFH in PCI  57% Major Bleeding (p=0.004)  23% Death or re-MI (p<0.001) Montalescot G et al. N Engl J Med 2006;355:1006 –17 Gibson MC et al. J Am Coll Cardiol 2007;49:2238–46 ?

3 ATOLL Trial design STEMI  Primary PCI 30-day and 6-month results Randomization as early as possible (MICU +++) Real life population (shock, cardiac arrest included) No anticoagulation and no lytic before Rx Similar antiplatelet therapy in both groups ENOXAPARIN IV 0.5 mg/kg with or without GPIIbIIIa UFH IV IU with GP IIbIIIa IU without GP IIbIIIa (Dose ACT-adjusted) IVRS Primary PCI ENOXAPARIN SC UFH IV or SC

4 Trial organization ACTION Study Group (Academic Research Organization, Paris): 1-Coordinating Center: 1-Coordinating Center: Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris 2-Sponsor: 2-Sponsor: AP-HP (Assistance Publique-Hôpitaux de Paris) 3-Data center, Statistics: Unité Recherche Clinique, Lariboisière Hospital, Paris 4-International CRO: Pierrel-Hyperphar 4-International CRO: Pierrel-Hyperphar 5-Funding: AP-HP and unrestricted research grant from Sanofi-Aventis Group 5-Funding: AP-HP and unrestricted research grant from Sanofi-Aventis Group Steering Committee: G. Montalescot (Chair, France), M. Cohen (USA), P. Goldstein (France), K. Huber (Austria), C. Pollack (USA), E. Vicaut (France), U. Zeymer (Germany) Data Safety Monitoring Board: A. Cohen (Chair, France), M. Cucherat (France), A. Gitt (Germany) Core Laboratory: R. Dumaine, A. Samadi Clinical Event Committee: F. Philippe, P. Sabouret, F. Boccara, A. Bellemain, O. Gournay

5 Main objectives 1° EP: –All-cause mortality at D30, –Complications of MI at D30 [resuscitated cardiac arrest, recurrent MI/ACS, urgent revascularization, stroke, peripheral or pulmonary embolism], –Procedure failure [definite stent thrombosis; B.O. use of GpIIB/IIIa; Non-TIMI 3 flow after PCI; ST resolution < 50% after PCI], –Non-CABG major bleeding during hospitalization Main 2° EP: All-cause mortality, Recurrent ACS or Urgent revascularization at D30 Main safety EP: Non-CABG major bleeding (STEEPLE definition) during hospitalization

6 FINAL 30-DAY RESULTS

7 Selected Baseline Characteristics UFH (n=460) ENOXAPARIN (n=450) Age, median (Q1;Q3) Age > (52; 70) 17% (80) 59 (52; 71) 19% (85) Pre-hospital randomization71% (325)71% (318) Shock and/or cardiac arrest before sheath, % (n)5% (24)4% (17) Time from symptom onset to randomization—hr, median (Q1;Q3) 2h19 (1h26; 4h37) 2h33 (1h29; 4h50) Radial artery access, % (n) Other artery access, % (n) 66% (305) 34% (155) 69% (309) 31% (141) Glycoprotein IIb/IIIa inhibitors,% (n) 83% (382)77% (347) Clopidogrel < 300mg > 300 and < 600mg > 600 and < 900mg > 900mg 37% (171) 37% (172) 25% (113) 1% (4) 37% (168) 39% (174) 22% (101) 2% (7)

8 Primary Endpoint Death, Complication of MI, Procedure Failure or Major Bleeding

9 Main Secondary Endpoint (ischemic) Death, Recurrent ACS or Urgent Revascularization

10 Consistent therapy Pre-specified analysis: no protocol violation (88%)

11 Death or Complication of MI Death, resuscitated cardiac arrest, recurrent ACS, Urg Revasc, stroke, peripheral or pulmonary embolism

12 Death or resuscitated cardiac arrest Death (any)

13 Safety Endpoints Protocole definitions (STEEPLE) NS

14 Death, Complication of MI or Major bleeding Net clinical benefit

15 6-month Follow-up

16 6-month results Follow-up on mortality 100% follow-up We used a Cox regression model to identify independent predictors of death at 6 months. We firstly performed univariate analysis and significant variables were introduced into a stepwise cox regression model

17 Death over 6 months Months Death ENOX UFH Log Rank Test: p= % 7.0% 7.2% 3.8% 4.5% 4.7%  =2.5%

18 Independent correlates of death at 6 months Beta blockers, yes vs. no0.16 [0.08;0.32]<.0001 KILLIP II,III,IV vs. I3.87 [2.02;7.4]<.0001 Age >75 vs. < [2.2;7.29]<.0001 ACE yes vs. no0.32 [0.16;0.66] MI location, anterior vs. other2.24 [1.27;3.94] Prior heart failure, yes vs. no4.57 [1.37;15.31] Prior COPD, yes vs. no3.15 [1.05;9.39] Systolic BP [mmHg] (10 units increase)0.87 [0.77;0.97] Prior stroke, yes vs. no3.10 [1.14;8.48]0.0273

19 Conclusions In this 1 st head-to-head comparison between two anticoagulants in primary PCI, i.v. enoxaparin: Reduced serious ischemic events, on top of intense antiplatelet therapy Had a good safety profile, with a superior net clinical benefit Tended to reduce mortality over 6 months

20 Special Thank to: INVESTIGATORS – Austria: WR. Benzer, K. Huber, F. Leisch, F. Weidinger – France: F. Adnet, M. Angioi, B. Barberon, JF. Benezet, JL. Bonnet, J. Boschat, B. Boulanger, D. Carrie, T. Chouihed, P. Coste, Y. Cottin, H. Courcoux, C. Cuvier, N. Danchin, JL. Ducasse, F. Duclos, P. Ecollan, S. Elhadad, E. Filippi, M. Freysz, F. Funck, S. Gallula, B. Gelée, A. Greffet, P. Henry, A. Jacquemin, T. Joseph, JM. Lablanche, H. Lardoux, H. Le Breton, B. Lederman, A. Margenet, G. Mehu, O. Nallet, F. Paganelli, M. Pansieri, L. Payot, C. Pouges, E. Salengro, C. Spaulding, G. Steg, O. Stibbe, E. Teiger, M. Thicoipe, C. Thuaire, J. Treuil, O. Wittenberg, O. Wolf – Germany: D. Andresen, C. Axthelm, Fischer, E. Girth, E. Hauptmann, U. Zeymer – USA: M.Cohen, F. Shamoon COMMITTEES – A Appaix-Bellemain, F Boccara, A Cohen, M. Cohen, M Cucherat, R Dumaine, A Gitt, P Goldstein, O Gournay, K Huber, F Philippe, C Pollack, P Sabouret, A Samadi, E Vicaut, U Zeymer PIERREL Research– L. Basso, L. Merlini, M. Mazzoleni ACTION study Group – ME. Assossou, M. Aout, B. Bertin, D. Brugier, JP. Collet, M. Courreges-Viaud, V. Gallois, P. Gallula, V. Jouis, S. Kabla, C. Misse, G. Ngouala, A. Pena, S. Paulsrud, N. Vignolles


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