Effect of enoxaparin versus unfractionated heparin in diabetic patients with ST-elevation myocardial infarction in the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) trial.
BACKGROUND
Patients with diabetes mellitus (DM) are at higher risk for complications after ST-elevation myocardial infarction (STEMI) than patients without DM. Potent antithrombotic therapies may offer particular benefit for these high-risk patients and must be balanced against the potential for increased bleeding.


METHODS
We performed a prospectively planned analysis of efficacy and safety in patients with DM among 20,479 patients with STEMI treated with fibrinolysis and randomized to a strategy of enoxaparin (up to 8 days) or unfractionated heparin (UFH) (48 hours) in ExTRACT-TIMI 25.


RESULTS
Patients with DM (n = 3060) were older and more likely to be women and to present with heart failure (P < .0001 for each) than those without DM. After adjustment for the TIMI Risk Score, sex, and renal function, patients with DM were at 30% higher risk for death or myocardial infarction (MI) by 30 days (OR(adj) 1.29, 95% CI 1.14-1.46). Among patients with DM, the enoxaparin strategy reduced mortality (9.5% vs 11.8%, relative risk [RR] 0.81, 95% CI 0.66-0.99), death/MI (13.6% vs 17.1%, RR 0.80; 95% CI 0.67-0.94), and death/MI/urgent revascularization (16.0% vs 19.7%, RR 0.81, 95% CI 0.70-0.94). The enoxaparin strategy was associated with a trend toward higher major bleeding (2.6% vs 1.6%, RR 1.63, 95% CI 0.99-2.69). Taking efficacy and safety into account, the enoxaparin strategy offered superior net clinical benefit (death/MI/major bleed, 14.8% vs 18.0%, RR 0.83, 95% CI 0.70-0.97) compared with UFH in patients with DM.


CONCLUSIONS
In a subgroup analysis, a reperfusion strategy including enoxaparin significantly improved outcomes compared with UFH among high-risk STEMI patients with DM undergoing fibrinolysis.
Morrow
David A
DA
Department of Medicine, Harvard Medical School, Boston, MA, USA. dmorrow@partners.org
Antman
Elliott M
EM
Murphy
Sabina A
SA
Qin
Jie
J
Ruda
Mikhail
M
Guneri
Sema
S
Jacob
Ashok Joseph
AJ
Budaj
Andrzej
A
Braunwald
Eugene
E
D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D048909:Diabetes Complications / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies
D017984:Enoxaparin; D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D001241:Aspirin