Men Versus Women

Although women represent a large segment of our cardiovascular patients, adequate, high-quality clinical trial data on women remains scarce and disproportionally lower than what is needed to guide practice decisions.A recent analysis from the Food and Drug Administration highlighted that there is significant underrepresentation of women in clinical trials involving coronary disease, acute coronary syndrome, and myocardial infarction. 1 Because women present at older ages, often have different disease manifestations, and may differ in response to treatments, the Food and Drug Administration and others have provided formal guidance on the inclusion of women in clinical trials, but this issue remains far from resolved.Women with coronary disease and acute coronary syndrome present an additional challenge to researchers and clinicians.There are multiple examples in the literature suggesting that women may have differential responses to cardiovascular therapies, but this has often been later disproven on further study and improved patient risk stratification.For example, GP IIb/IIIa (glycoprotein IIb/IIIa) inhibitors were initially thought to increase the risk of bleeding for women presenting with non-ST-segment-elevation myocardial infarction and were thus widely underused, despite evidence about the potential ischemic benefits.Much of this sex difference in bleeding may have been attributable to more frequent overdosing of GP IIb/IIIa inhibitors in women compared with men. 2 Importantly, despite some early observations that women might benefit less than men treated with potent platelet inhibition, when analyses were done among troponin positive patients, GP IIb/IIIa inhibitors were found to be equally efficacious in men and women. 3This is an example of the importance of better defining the patient population-for both men and women-that is most likely to benefit from aggressive pharmacological interventions.The 2014 American College of Cardiology/American Heart Association non-ST-elevation acute coronary syndromes guidelines explicitly recommend that women presenting with acute coronary syndrome should be treated with the same pharmacological interventions as men (Class I recommendation). 4n this issue of Circulation: Cardiovascular Interventions, Berry et al 5 once again demonstrate the importance of establishing clear inclusion criteria (ie, which patients will benefit) when studying antithrombotic therapies for patients with coronary disease.Using data from the DAPT study (Dual Antiplatelet Therapy), the authors examined whether the risks/benefits of prolonged dual antiplatelet therapy differed by sex.The DAPT study assessed the effectiveness of dual antiplatelet therapy (clopidogrel or prasugrel in combination with aspirin) beyond 12 months after coronary stenting.Of 7175 enrolled women, 2925 (40.7%) met the inclusion criteria for randomization, which included good adherence to 12 months of DAPT Fatima Rodriguez, MD, MPH