Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.

Acute Coronary Syndrome / drug therapy Aged Coronary Thrombosis / epidemiology Female Hemorrhage / chemically induced Humans Incidence Kaplan-Meier Estimate Male Middle Aged Myocardial Infarction / epidemiology Percutaneous Coronary Intervention Platelet Aggregation Inhibitors / adverse effects Prasugrel Hydrochloride / adverse effects Purinergic P2Y Receptor Antagonists / adverse effects Stents Stroke / epidemiology Ticagrelor / adverse effects

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
17 10 2019

Historique:

pubmed: 3 9 2019

medline: 2 11 2019

entrez: 3 9 2019

Statut: ppublish

Résumé

The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

Sections du résumé

BACKGROUND

The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain.

METHODS

In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding.

RESULTS

A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46).

CONCLUSIONS

Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

Identifiants

DOI: 10.1056/NEJMoa1908973 PMID: 31475799

pubmed: 31475799

doi: 10.1056/NEJMoa1908973

doi:

Substances chimiques

Platelet Aggregation Inhibitors 0

Purinergic P2Y Receptor Antagonists 0

Prasugrel Hydrochloride G89JQ59I13

Ticagrelor GLH0314RVC

Banques de données

ClinicalTrials.gov

['NCT01944800']

Types de publication

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

Langues

eng

Sous-ensembles de citation

Pagination

1524-1534

Subventions

Organisme : United States

ID : FKZ 81X1600501

Pays : United States

Organisme : United States

ID : FKZ 81X1600501

Pays : United States

Investigateurs

Stefanie Schüpke (S)

Raphaela Hilz (R)

Katharina Mayer (K)

Stephanie Ast (S)

Sara Ates (S)

Anja Batrice (A)

Janika Bohner (J)

Felix Bourier (F)

Christof Burgdorf (C)

Robert Byrne (R)

Salvatore Cassese (S)

Antoinette de Waha (A)

Julia Ellert (J)

Massimiliano Fusaro (M)

Senta Gewalt (S)

Christian Grebmer (C)

Philipp Groha (P)

Friederike Gusmini (F)

Christian Hengstenberg (C)

Katrin Huber (K)

Oliver Husser (O)

Henning Jansen (H)

Johannes Jehle (J)

Michael Karl (M)

Adnan Kastrati (A)

Thorsten Kessler (T)

Martin Klügl (M)

Katharina Koch-Büttner (K)

Marielouise Kornmayer (M)

Marc Kottmaier (M)

Sebastian Kufner (S)

Vivien Kujath (V)

Constantin Kuna (C)

Anna Lena Lahmann (AL)

Clarissa Lanig (C)

Carsten Lennerz (C)

Elke Lorenz (E)

Amadea Erben (A)

Tanja Morath (T)

Jonathan Nadjiri (J)

Suzan Nasifoglu (S)

Philipp Nicol (P)

Ilka Ott (I)

Costanza Pellegrini (C)

Vanessa Pfetsch (V)

Tilko Reents (T)

Tobias Rheude (T)

Stefanie Rosner (S)

Elena Risse (E)

Dennis Rubach (D)

Philipp Moritz Rumpf (PM)

Veronika Sanin (V)

Dominique Sauter (D)

Anna-Katharina Schmidt (AK)

Raphael Schmieder (R)

Friederike Schürmann (F)

Verena Kantenwein (V)

Iva Simunovic (I)

Carolin Sonne (C)

Susanne Tholen (S)

Kerstin Trappe (K)

Teresa Trenkwalder (T)

Felix Voll (F)

Moritz von Scheidt (M)

Severin Weigand (S)

Simon Wernhart (S)

Jens Wiebe (J)

Fritz Wimbauer (F)

Janina Winogradow (J)

Isabel Wustrow (I)

Erion Xhepa (E)

Bettina Harrer (B)

Kerstin Maisburger (K)

Daniela Schemmer (D)

Franz-Josef Neumann (FJ)

Dietmar Trenk (D)

Michael Amann (M)

Torqa Aurel (T)

Johannes Bremicker (J)

Heinz-Joachim Büttner (HJ)

Marco Cederqvist (M)

Christian Claus (C)

David De Pasquale (D)

Felix Gaiser (F)

Samuel Hemmerling (S)

Willibald Hochholzer (W)

Julia Hromek (J)

Stefan Leggewie (S)

Matthias Lippert (M)

Nikolaus Löffelhardt (N)

Sebastian Merz (S)

Björn Müller-Edenborn (B)

Thomas Nührenberg (T)

Florian Riede (F)

Roland Schmitz (R)

Undine Schulz (U)

Christian Stratz (C)

Jochen Strübin (J)

Christian Valina (C)

Vera von Kapherr (V)

Valentin Wennekes-Neagu (V)

Markus Zwigart (M)

Erik de Frenne (E)

Cornelia Ebel (C)

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Commentaires et corrections

Type : CommentIn