Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction.


Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
05 03 2019
Historique:
received: 30 10 2018
revised: 24 11 2018
accepted: 25 11 2018
entrez: 2 3 2019
pubmed: 2 3 2019
medline: 24 1 2020
Statut: ppublish

Résumé

In the ACCOAST (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction) trial, the prasugrel pre-treatment strategy versus placebo was associated with excess bleeding complications and no improved ischemic outcome in non-ST-segment elevation myocardial infarction (MI). Whether patients with the longest pre-treatment duration had an ischemic benefit is unknown. This pre-specified analysis of the ACCOAST trial aimed to assess the effect of pre-treatment duration with prasugrel (time from randomization to angiography) on outcomes. Within the 4,033 patients randomized in the ACCOAST trial, pre-treatment duration was available in 4,001 patients (99.2%). The population of the trial was divided into quartiles of pre-treatment duration (0.1 to 2.5 h, 2.5 to 3.9 h, 3.9 to 13.6 h, and >13.6 h) with an evaluation of the primary efficacy endpoint of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use. Secondary efficacy outcomes including cardiovascular death, MI, or stroke; all-cause death; stent thrombosis and safety outcomes (all coronary artery bypass graft [CABG] or non-CABG TIMI [Thrombolysis In Myocardial Infarction] major bleeding) were also evaluated at 7 days. The primary efficacy outcome of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use did not differ between the quartiles of pre-treatment duration in the trial population (p = 0.17 for interaction). None of the secondary efficacy outcomes were found to be dependent on pre-treatment duration. The safety outcome of all CABG or non-CABG TIMI major bleeding did not differ between the quartiles of pre-treatment duration (p = 0.37 for interaction). In non-ST-segment elevation MI patients, the excess risk of bleeding and the absence of ischemic benefit were consistent across the quartiles of increasing duration of prasugrel pre-treatment. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).

Sections du résumé

BACKGROUND
In the ACCOAST (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction) trial, the prasugrel pre-treatment strategy versus placebo was associated with excess bleeding complications and no improved ischemic outcome in non-ST-segment elevation myocardial infarction (MI). Whether patients with the longest pre-treatment duration had an ischemic benefit is unknown.
OBJECTIVES
This pre-specified analysis of the ACCOAST trial aimed to assess the effect of pre-treatment duration with prasugrel (time from randomization to angiography) on outcomes.
METHODS
Within the 4,033 patients randomized in the ACCOAST trial, pre-treatment duration was available in 4,001 patients (99.2%). The population of the trial was divided into quartiles of pre-treatment duration (0.1 to 2.5 h, 2.5 to 3.9 h, 3.9 to 13.6 h, and >13.6 h) with an evaluation of the primary efficacy endpoint of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use. Secondary efficacy outcomes including cardiovascular death, MI, or stroke; all-cause death; stent thrombosis and safety outcomes (all coronary artery bypass graft [CABG] or non-CABG TIMI [Thrombolysis In Myocardial Infarction] major bleeding) were also evaluated at 7 days.
RESULTS
The primary efficacy outcome of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use did not differ between the quartiles of pre-treatment duration in the trial population (p = 0.17 for interaction). None of the secondary efficacy outcomes were found to be dependent on pre-treatment duration. The safety outcome of all CABG or non-CABG TIMI major bleeding did not differ between the quartiles of pre-treatment duration (p = 0.37 for interaction).
CONCLUSIONS
In non-ST-segment elevation MI patients, the excess risk of bleeding and the absence of ischemic benefit were consistent across the quartiles of increasing duration of prasugrel pre-treatment. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).

Identifiants

pubmed: 30819358
pii: S0735-1097(19)30095-6
doi: 10.1016/j.jacc.2018.11.055
pii:
doi:

Substances chimiques

Platelet Aggregation Inhibitors 0
Prasugrel Hydrochloride G89JQ59I13

Banques de données

ClinicalTrials.gov
['NCT01015287']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

906-914

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Johanne Silvain (J)

Sorbonne University, ACTION Study Group, INSERM UMRS 1166, ICAN, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: https://twitter.com/Docjohanne.

Tomasz Rakowski (T)

Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Benoit Lattuca (B)

Sorbonne University, ACTION Study Group, INSERM UMRS 1166, ICAN, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France; Service de Cardiologie, Centre Hospitalier Universitaire Nîmes, ACTION Study Group, Université Montpellier, Montpellier, France.

Zhenyu Liu (Z)

Department of Cardiology, Peking Union Medical College Hospital, Beijing, China.

Leonardo Bolognese (L)

Cardiovascular and Neurological Department, Azienda Ospedaliera, Arezzo, Italy.

Patrick Goldstein (P)

SAMU and Emergency Department, Lille University Hospital, Lille, France.

Christian Hamm (C)

Kerckhoff Heart and Thorax Center, Bad Nauheim and Medical Clinic I, University of Giessen, Giessen, Germany.

Jean-Francois Tanguay (JF)

Montreal Heart Institute, Montreal University, Montreal, Quebec, Canada.

Jur Ten Berg (J)

Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.

Petr Widimsky (P)

Third Medical Faculty of Charles University and University Hospital Royal Vineyards, Prague, Czech Republic.

Debra Miller (D)

Eli Lilly and Company, Indianapolis, Indiana.

Jean-Jacques Portal (JJ)

Methodology and Statistical Unit, Centre Hospitalier Universitaire Lariboisière (ACTION Study Group, AP-HP, Université Paris 7), Paris, France.

Jean-Philippe Collet (JP)

Sorbonne University, ACTION Study Group, INSERM UMRS 1166, ICAN, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.

Eric Vicaut (E)

Methodology and Statistical Unit, Centre Hospitalier Universitaire Lariboisière (ACTION Study Group, AP-HP, Université Paris 7), Paris, France.

Gilles Montalescot (G)

Sorbonne University, ACTION Study Group, INSERM UMRS 1166, ICAN, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@psl.aphp.fr.

Dariusz Dudek (D)

Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

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