I v enoxaparin or unfractionated heparin in primary pci acute and long term results
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I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results PowerPoint PPT Presentation


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G. Montalescot, M. Cohen, P. Goldstein, K. Huber, C. Pollack, U. Zeymer , E. Vicaut for the ATOLL investigators. I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results.

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I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results

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G. Montalescot, M. Cohen, P. Goldstein,

K. Huber, C. Pollack, U. Zeymer, E. Vicaut

for the ATOLL investigators

I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results

ATOLL: Acute STEMI Treated with primary PCI and intravenous enoxaparinOr UFH to Lower ischemic and bleeding events at short- and Long-term follow-up (Investigator-driven study)

G. Montalescot, 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, FédérationFrançaise de Cardiologie, Fondation de France, GSK, ICM, INSERM, Lead-up, Medtronic, Menarini, Nanospheres, Novartis, Pfizer, Sanofi-Aventis Group, Servier, SociétéFrançaise de Cardiologie, The Medicines Company, TIMI group.


Intravenousenoxaparinvs. 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

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

PrimaryPCI

ENOXAPARIN SC

UFH IV or SC

30-day and 6-monthresults


Trial organization

ACTION Study Group (Academic Research Organization, Paris):

1-Coordinating Center: Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris

2-Sponsor:AP-HP (Assistance Publique-Hôpitaux de Paris)

3-Data center, Statistics: Unité Recherche Clinique, Lariboisière Hospital, Paris

4-International CRO: Pierrel-Hyperphar

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


FINAL 30-DAY RESULTS


Selected Baseline Characteristics


PrimaryEndpoint

Death, Complication of MI, ProcedureFailure or Major Bleeding


Main SecondaryEndpoint (ischemic)

Death, RecurrentACS or Urgent Revascularization


Consistent therapyPre-specifiedanalysis: no protocol violation (88%)


Death or Complication of MI

Death, resuscitatedcardiacarrest, recurrentACS, UrgRevasc,

stroke, peripheral or pulmonaryembolism


Deathorresuscitatedcardiacarrest

Death (any)


SafetyEndpoints

NS

Protocole definitions (STEEPLE)


Death, Complication of MI or Major bleeding

Net clinicalbenefit


6-month Follow-up


6-monthresults

  • Follow-up on mortality

  • 100% follow-up

  • Weused a Cox regression model to identifyindependentpredictors of deathat 6 months. Wefirstlyperformedunivariateanalysis and significant variables wereintroducedinto a stepwisecoxregression model


0.10

UFH

0.08

0.06

Death

ENOX

0.04

0.02

Log Rank Test: p=0.11

0.00

0

1

2

3

4

5

6

Months

Death over 6 months

7.2%

7.0%

6.3%

r=2.5%

r=2.5%

r=2.5%

4.7%

4.5%

3.8%


Independentcorrelates of deathat 6 months


Conclusions

  • In this1sthead-to-headcomparisonbetweentwo anticoagulants in primary PCI, i.v. enoxaparin:

    • Reducedseriousischemicevents, on top of intense antiplatelettherapy

    • Had a good safety profile, with a superior net clinicalbenefit

    • Tended to reducemortalityover 6 months


SpecialThank 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

PIERRELResearch– 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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