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

• Published in: European heart journal Vol. 35; no. 23; pp. 1541 - 1550
• Main Authors: Husted, Steen, James, Stefan K, Bach, Richard G, Becker, Richard C, Budaj, Andrzej, Heras, Magda, Himmelmann, Anders, Horrow, Jay, Katus, Hugo A, Lassila, Riita, Morais, Joao, Nicolau, José C, Steg, Ph Gabriel, Storey, Robert F, Wojdyla, Daniel, Wallentin, Lars
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 14.06.2014
• Subjects: Acute Coronary Syndrome - drug therapy; Acute coronary syndromes; Adenosine - administration & dosage; Adenosine - adverse effects; Adenosine - analogs & derivatives; Aged; Clinical Research; Dose-Response Relationship, Drug; Double-Blind Method; Female; Graft Occlusion, Vascular - prevention & control; Hemorrhage - chemically induced; Humans; Male; Myocardial Infarction - etiology; P2Y receptor; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Platelets; Prospective Studies; Purinergic P2Y Receptor Antagonists - administration & dosage; Purinergic P2Y Receptor Antagonists - adverse effects; Recurrence; Sex; Sex Factors; Stents; Stroke - etiology; Thrombosis; Ticagrelor; Ticlopidine - administration & dosage; Ticlopidine - adverse effects; Ticlopidine - analogs & derivatives; Treatment Outcome; P2Y12 receptor; Acute coronary syndromes; Platelets; Ticagrelor; Thrombosis; Sex
• DOI: 10.1093/eurheartj/ehu075
• ISSN: 0195-668X; 1522-9645

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. 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. 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). 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.