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:
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
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 ?
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 50-70 IU with GP IIbIIIa 70-100IU without GP IIbIIIa (Dose ACT-adjusted) IVRS Primary PCI ENOXAPARIN SC UFH IV or SC
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
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-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
Death over 6 months 0123456 0.00 0.02 0.04 0.06 0.08 0.10 Months Death ENOX UFH Log Rank Test: p=0.11 6.3% 7.0% 7.2% 3.8% 4.5% 4.7% =2.5%
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. <754.01 [2.2;7.29]<.0001 ACE yes vs. no0.32 [0.16;0.66]0.0021 MI location, anterior vs. other2.24 [1.27;3.94]0.0052 Prior heart failure, yes vs. no4.57 [1.37;15.31]0.0137 Prior COPD, yes vs. no3.15 [1.05;9.39]0.0401 Systolic BP [mmHg] (10 units increase)0.87 [0.77;0.97]0.0149 Prior stroke, yes vs. no3.10 [1.14;8.48]0.0273
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
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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