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.

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I v enoxaparin or unfractionated heparin in primary pci acute and long term results

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.


Intravenous enoxaparin vs ufh in pci
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
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
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



Selected baseline characteristics
Selected Baseline Characteristics


Primary endpoint
PrimaryEndpoint

Death, Complication of MI, ProcedureFailure or Major Bleeding


Main secondary endpoint ischemic
Main SecondaryEndpoint (ischemic)

Death, RecurrentACS or Urgent Revascularization


Consistent therapy pre specified analysis no protocol violation 88
Consistent therapyPre-specifiedanalysis: no protocol violation (88%)


Death or complication of mi
Death or Complication of MI

Death, resuscitatedcardiacarrest, recurrentACS, UrgRevasc,

stroke, peripheral or pulmonaryembolism


Death or resuscitated cardiac arrest
Deathorresuscitatedcardiacarrest

Death (any)


Safety endpoints
SafetyEndpoints

NS

Protocole definitions (STEEPLE)


Death complication of mi or major bleeding
Death, Complication of MI or Major bleeding

Net clinicalbenefit



6 month results
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
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


Special thank to
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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