The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial.

Abstract

AIMS:

The aim of this study was to assess the relationship between sex and clinical outcomes and treatment-related complications in patients with ST-elevation or non-ST-elevation acute coronary syndromes (ACS) randomized to treatment with ticagrelor or clopidogrel in the PLATelet inhibition and patient Outcomes (PLATO) trial.

METHODS:

The associations between sex subgroup and the primary composite outcomes, secondary outcomes, and major bleeding endpoints as well as interaction of sex subgroup with treatment effects were analysed using Cox proportional-hazards models.

RESULTS:

Sex was not significantly associated with the probability of the primary composite endpoint [adjusted hazard ratio (HR): 1.02 (0.91-1.16)], or other adverse cardiovascular endpoints. Ticagrelor was similarly more effective than clopidogrel in reducing rates of the primary endpoint in women 11.2 vs. 13.2% [adjusted HR: 0.88 (0.74-1.06)] and men 9.4 vs. 11.1% [adjusted HR: 0.86 (0.76-0.97)] (interaction P-value 0.78), all-cause death in women 5.8 vs. 6.8% [adjusted HR: 0.90 (0.69-1.16)] and men 4.0 vs. 5.7% [adjusted HR: 0.80 (0.67-0.96)] (interaction P-value 0.49), and definite stent thrombosis in women 1.2 vs. 1.4% [adjusted HR: 0.71 (0.36-1.38)] and men 1.4 vs. 2.1% [adjusted HR: 0.63 (0.45-0.89)] (interaction P-value 0.78). The treatments did not differ for PLATO-defined overall major bleeding complications in women [adjusted HR: 1.01 (0.83-1.23)] or men [adjusted HR: 1.10 (0.98-1.24)]. Sex had no significant association with these outcomes (interactions P = 0.43-0.88).

CONCLUSION:

Female sex is not an independent risk factor for adverse clinical outcomes in moderate-to-high risk ACS patients. Ticagrelor has a similar efficacy and safety profile in men and women.

• Authors: Steen Husted, Stefan K James, Richard G Bach, Richard C Becker, Andrzej Budaj, Magda Heras, Anders Himmelmann, Jay Horrow, Hugo A Katus, Riita Lassila, Joao Morais, José C Nicolau, Ph Gabriel Steg, Robert F Storey, Daniel Wojdyla, Lars Wallentin, PLATO study group
• Journal: European heart journal (Eur Heart J) Vol. 35 Issue 23 Pg. 1541-50 (Jun 14 2014) ISSN: 1522-9645 [Electronic] England
• PMID: 24682844 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

Chemical References

• Platelet Aggregation Inhibitors
• Purinergic P2Y Receptor Antagonists
• Clopidogrel
• Ticagrelor
• Adenosine
• Ticlopidine

Topics

• Acute Coronary Syndrome (drug therapy)
• Adenosine (administration & dosage, adverse effects, analogs & derivatives)
• Aged
• Clopidogrel
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Graft Occlusion, Vascular (prevention & control)
• Hemorrhage (chemically induced)
• Humans
• Male
• Myocardial Infarction (etiology)
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Prospective Studies
• Purinergic P2Y Receptor Antagonists (administration & dosage, adverse effects)
• Recurrence
• Sex Factors
• Stents
• Stroke (etiology)
• Ticagrelor
• Ticlopidine (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome