Literature DB >> 33867409

Efficacy and Safety of Ticagrelor Versus Prasugrel in Women and Men with Acute Coronary Syndrome: A Pre-specified, Sex-Specific Analysis of the ISAR-REACT 5 Trial.

Senta Gewalt1, Shqipdona Lahu1, Gjin Ndrepepa1, Costanza Pellegrini1, Isabell Bernlochner2,3, Franz-Josef Neumann4, Maurizio Menichelli5, Tanja Morath1, Bernhard Witzenbichler6, Jochen Wöhrle7, Katharina Hoppe1, Gert Richardt8, Karl-Ludwig Laugwitz2,3, Heribert Schunkert1,2, Adnan Kastrati1,2, Stefanie Schüpke1,2, Katharina Mayer1.   

Abstract

AIM: Sex-specific analyses of direct head-to-head comparisons between newer P2Y12 inhibitors are limited. This study was conducted to assess the efficacy and safety of ticagrelor versus prasugrel in women and men with acute coronary syndromes (ACS) planned for an invasive strategy.
METHODS: This pre-specified analysis of the ISAR-REACT 5 trial included 956 women and 3,062 men with ACS randomly assigned to either ticagrelor or prasugrel. The primary endpoint was the 12-month incidence of death, myocardial infarction, or stroke; the safety endpoint was the 12-month incidence of bleeding (type 3-5 according to the Bleeding Academic Research Consortium [BARC]).
RESULTS: The primary endpoint occurred in 42 women (8.9%) in the ticagrelor group and 39 women (8.3%) in the prasugrel group (hazard ratio [HR]=1.10, 95% confidence interval [CI] 0.71-1.70, P=0.657) and in 142 men (9.4%) in the ticagrelor group and 98 men (6.5%) in the prasugrel group (HR=1.47 [1.13-1.90], P=0.004; P for interaction [Pint]=0.275). BARC type 3-5 bleeding occurred in 36 women (9.7%) in the ticagrelor group and 34 women (9.7%) in the prasugrel group (HR=1.04 [0.65-1.67], P=0.856) and in 59 men in the ticagrelor group (4.4%) and 46 men (3.6%) in the prasugrel group (HR=1.24 [0.85-1.83], P=0.266; Pint=0.571).
CONCLUSIONS: Although there was no significant interaction between sex and treatment effect of study drugs, the superior efficacy of prasugrel was more evident among men. No difference in bleeding between the two study groups was seen for both women and men.

Entities:  

Keywords:  Acute coronary syndrome; Percutaneous coronary intervention; Prasugrel; Sex; Ticagrelor

Mesh:

Substances:

Year:  2021        PMID: 33867409      PMCID: PMC9135658          DOI: 10.5551/jat.62776

Source DB:  PubMed          Journal:  J Atheroscler Thromb        ISSN: 1340-3478            Impact factor:   4.394


  31 in total

1.  Statistics in medicine--reporting of subgroup analyses in clinical trials.

Authors:  Rui Wang; Stephen W Lagakos; James H Ware; David J Hunter; Jeffrey M Drazen
Journal:  N Engl J Med       Date:  2007-11-22       Impact factor: 91.245

2.  Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials.

Authors:  Jeffrey S Berger; Maria C Roncaglioni; Fausto Avanzini; Ierta Pangrazzi; Gianni Tognoni; David L Brown
Journal:  JAMA       Date:  2006-01-18       Impact factor: 56.272

Review 3.  Platelet function and long-term antiplatelet therapy in women: is there a gender-specificity? A 'state-of-the-art' paper.

Authors:  Giuseppe Patti; Raffaele De Caterina; Rosanna Abbate; Felicita Andreotti; Luigi Marzio Biasucci; Paolo Calabrò; Gabriele Cioni; Giovanni Davì; Germano Di Sciascio; Enrica Golia; Paolo Golino; Gelsomina Malatesta; Fabio Mangiacapra; Rossella Marcucci; Annunziata Nusca; Vito Maurizio Parato; Vittorio Pengo; Domenico Prisco; Fabio Pulcinelli; Giulia Renda; Elisabetta Ricottini; Benedetta Ruggieri; Francesca Santilli; Francesco Sofi; Marco Zimarino
Journal:  Eur Heart J       Date:  2014-07-14       Impact factor: 29.983

4.  Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Authors:  Roxana Mehran; Sunil V Rao; Deepak L Bhatt; C Michael Gibson; Adriano Caixeta; John Eikelboom; Sanjay Kaul; Stephen D Wiviott; Venu Menon; Eugenia Nikolsky; Victor Serebruany; Marco Valgimigli; Pascal Vranckx; David Taggart; Joseph F Sabik; Donald E Cutlip; Mitchell W Krucoff; E Magnus Ohman; Philippe Gabriel Steg; Harvey White
Journal:  Circulation       Date:  2011-06-14       Impact factor: 29.690

5.  Gender Differences in Platelet Reactivity in Patients Receiving Dual Antiplatelet Therapy.

Authors:  Monica Verdoia; Patrizia Pergolini; Roberta Rolla; Matteo Nardin; Lucia Barbieri; Veronica Daffara; Paolo Marino; Giorgio Bellomo; Harry Suryapranata; Giuseppe De Luca
Journal:  Cardiovasc Drugs Ther       Date:  2016-04       Impact factor: 3.727

6.  Is there Sex-related Outcome Difference According to oral P2Y12 Inhibitors in Patients with Acute Coronary Syndromes? A Systematic Review and Meta-Analysis of 107,126 Patients.

Authors:  Oliver Brown; Jennifer Rossington; Gill Louise Buchanan; Giuseppe Patti; Angela Hoye
Journal:  Curr Vasc Pharmacol       Date:  2019       Impact factor: 2.719

Review 7.  Some thoughts on the vasculopathy of women with ischemic heart disease.

Authors:  Carl J Pepine; Richard A Kerensky; Charles R Lambert; Karen M Smith; Gregory O von Mering; George Sopko; C Noel Bairey Merz
Journal:  J Am Coll Cardiol       Date:  2006-02-07       Impact factor: 24.094

8.  Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation.

Authors:  S Yusuf; F Zhao; S R Mehta; S Chrolavicius; G Tognoni; K K Fox
Journal:  N Engl J Med       Date:  2001-08-16       Impact factor: 91.245

9.  A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.

Authors:  Paul M Ridker; Nancy R Cook; I-Min Lee; David Gordon; J Michael Gaziano; Joann E Manson; Charles H Hennekens; Julie E Buring
Journal:  N Engl J Med       Date:  2005-03-07       Impact factor: 91.245

10.  Gender-Related Differences in Antiplatelet Therapy and Impact on 1-Year Clinical Outcome in Patients Presenting With ACS: The START ANTIPLATELET Registry.

Authors:  Plinio Cirillo; Luigi Di Serafino; Giuseppe Patti; Emilia Antonucci; Paolo Calabrò; Paolo Gresele; Gualtiero Palareti; Vittorio Pengo; Pasquale Pignatelli; Rossella Marcucci
Journal:  Angiology       Date:  2018-07-03       Impact factor: 3.619

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