Outcomes and optimal antithrombotic therapy in women undergoing fibrinolysis for ST-elevation myocardial infarction.
BACKGROUND
The manifestations, complications, and outcomes of cardiovascular disease differ between women and men. The safety and efficacy of pharmacological reperfusion therapy in women with ST-elevation myocardial infarction are of particular interest.


RESULTS
We investigated outcomes in the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 study, which randomized ST-elevation myocardial infarction patients with planned fibrinolysis to enoxaparin or unfractionated heparin. Compared with men (n=15,696), women (n=4783) were older and more likely to have hypertension and diabetes (P<0.001). The unadjusted 30-day mortality rate for women was >2-fold higher than for men (13.2% versus 5.4%; odds ratio, 2.66; 95% CI, 2.40 to 2.96). After adjustment for age, fibrinolytic therapy, revascularization, region, and elements of the TIMI Risk Score, women had a 1.25-fold-higher 30-day risk of death (95% CI, 1.08 to 1.46) but similar risk of intracerebral hemorrhage (adjusted odds ratio, 0.81; 95% CI, 0.52 to 1.26). The 30-day rate of death or nonfatal MI in women was reduced by enoxaparin compared with unfractionated heparin in women (15.4% versus 18.3%; P=0.007). Major bleeding was more frequent in women receiving enoxaparin compared with those receiving unfractionated heparin (2.3% versus 1.4%; P=0.022) but similar among women and men receiving enoxaparin (2.3% versus 2.0%; P=0.39). The rates of death, nonfatal myocardial infarction, or nonfatal major bleeding (net clinical benefit) were lower with enoxaparin (absolute risk reduction, 2.6% in women [P=0.02] and 1.6% in men [P=0.001]).


CONCLUSIONS
In ExTRACT-TIMI 25, women presented with a profile of higher baseline risk and increased short-term mortality. In this large, contemporary clinical trial, women had similar relative and greater absolute risk reductions than men when treated with enoxaparin compared with unfractionated heparin as adjunctive therapy with fibrinolysis.
Mega
Jessica L
JL
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Mass 02115, USA. jmega@partners.org
Morrow
David A
DA
Ostör
Erika
E
Dorobantu
Maria
M
Qin
Jie
J
Antman
Elliott M
EM
Braunwald
Eugene
E
D015906:Angioplasty, Balloon, Coronary; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012727:Sex Characteristics; D013300:Streptokinase / Q000627:therapeutic use; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use
D000933:Antifibrinolytic Agents; D017984:Enoxaparin; D011994:Recombinant Proteins; C087896:reteplase; D013300:Streptokinase; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase