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Men, women medically managed after ACS show similar bleeding, ischemic outcomes
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Among patients with ACS who were medically managed and did not undergo revascularization, there was little difference by sex in long-term bleeding and ischemic outcomes, according to new data from the TRILOGY ACS study.
“These findings suggest that the natural history of ACS is similar between women vs. men when not confounded by the differential use of revascularization procedures and that individualized dosing of antiplatelet agents may mitigate previously documented higher risks of bleeding among women with ACS vs. men,” the researchers wrote.
Peter Clemmensen, MD, DMSc, and colleagues analyzed data from 9,326 patients (39% women) from the TRILOGY ACS study, which compared prasugrel (Effient, Daiichi Sankyo/Eli Lilly) 10 mg/day (5 mg/day for older or lighter patients) with clopidogrel 75 mg/day for patients with ACS not undergoing revascularization.
The researchers determined sex-specific differences in long-term bleeding and ischemic outcomes. They also analyzed sex-specific differences in platelet reactivity in the 27% of patients who were enrolled in a platelet function substudy.
At baseline, women were older, weighed less and had less prior MI or revascularization, lower creatinine clearance and lower hemoglobin levels compared with men, Clemmensen, from the department of medicine, division of cardiology, Nykoebing F Hospital and Rigshospitalet Copenhagen University Hospital, Denmark, and colleagues reported.
Outcomes similar by sex
At 30 months, unadjusted rates of the primary outcome of CV death, MI or stroke were similar between the sexes (women, 20.2%; men, 19.1%; HR = 1.03; 95% CI, 0.92-1.16), as were the rates of all-cause mortality (women, 12.2%; men, 11.7%; HR = 1.01; 95% CI, 0.88-1.07) and Global Use of Strategies to Open Occluded Arteries (GUSTO) severe, life-threatening or moderate bleeding (women, 3.8%; men, 2.8%; HR = 1.06; 95% CI, 0.77-1.45).
They observed no significant treatment effect for prasugrel vs. clopidogrel for the primary endpoint for both women (HR = 1; 95% CI, 0.84-1.19) and men (HR = 0.94; 95% CI, 0.81-1.08; P for interaction = .56).
According to the researchers, when the full TRIOGY ACS adjustment model was applied, women had a lower risk for the primary endpoint (HR = 0.86; 95% CI, 0.75-0.99) and all-cause mortality (HR = 0.7; 95% CI, 0.59-0.83) compared with men. The primary endpoint was driven by CV death (HR = 0.69; 95% CI, 0.57-0.83), while there was no difference between the sexes in MI or stroke, they noted.
Thirty-day platelet reactivity was lower with prasugrel vs. clopidogrel, but those results did not differ by sex, the researchers wrote.
Role of medical management
Results from previous studies have indicated that women were more likely than men to have in-hospital mortality after ACS, but the TRILOGY ACS findings may be different because all patients were medically managed and most were taking secondary prevention medications, the researchers wrote.
“Our findings also provide conformation that the 5-mg dose of prasugrel is appropriate for patients aged [75 years or older] or weighing < 60 kg and suggest a possible influence of revascularization with its more intensive antithrombotic therapies,” Clemmensen and colleagues wrote. – by Erik Swain
Disclosures: TRILOGY ACS was funded by Daiichi Sankyo and Eli Lilly. Clemmensen reports receiving research grants from Daiichi Sankyo and Eli Lilly; speakers’ bureau payments from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo and Eli Lilly; and consulting fees or other payments from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Pfizer and WebMD. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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