Abstract 3298: Effect of Enoxaparin vs Unfractionated Heparin in Diabetic Patients with ST-Elevation MI in the ExTRACT-TIMI 25 Trial
Patients with diabetes mellitus (DM) are at significantly higher risk of complications after an acute myocardial infarction than are patients without DM. Thus, it is important to identify interventions that reduce the risks associated with DM.
METHODS: We compared the outcomes of patients with and without DM among 20,479 patients with STEMI treated with fibrinolysis and randomized to enoxaparin (ENOX) or unfractionated heparin (UFH) in the ExTRACT-TIMI 25 Trial.
RESULTS: Patients with DM (N=3060) were older, more likely to be female, and to present with signs of heart failure (p<0.001 for each). After adjustment for the TIMI Risk Index (an integrated measure of age, HR and BP), gender and treatment allocation, pts with DM were at 30% higher risk of death or MI by 30 days (Adj RR 1.3; 95% CI 1.2–1.5). TIMI major bleeding tended toward being higher among pts with DM (2.1% vs. 1.7%, p=0.08), with no difference in minor bleeding (2.3% vs. 2.2%, p=0.55). Among patients with DM, ENOX reduced mortality (Fig⇓ Left, 9.5% vs. 11.8%, RR 0.81; 95% CI 0.66 – 0.99), and death or MI (Fig⇓ Right, 13.6% vs. 17.1%, RR 0.80; 95% CI 0.67– 0.94). With respect to safety in pts with DM, ENOX 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, ENOX offered superior net clinical benefit (D/MI/major bleed, 14.8% vs. 18.0%, RR 0.83; 95% CI 0.70 – 0.97) compared with UFH in pts with DM.
CONCLUSIONS: Adjunctive antithrombin therapy for STEMI with ENOX significantly improves outcomes compared with UFH among patients with DM, who are at significantly higher risk of death and recurrent ischemia.