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 - 16/08/11
, Elliott M. Antman, MD a, Sabina A. Murphy, MPH a, Jie Qin, MS a, Mikhail Ruda, MD b, Sema Guneri, MD c, Ashok Joseph Jacob, MD d, Andrzej Budaj, MD e, Eugene Braunwald, MD afrom the TIMI Study GroupCardiovascular Division, Brigham and Women's Hospital, Boston, MA
Résumé |
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 20479 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 (ORadj 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.
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| ExTRACT-TIMI 25 was supported by Sanofi-Aventis. |
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| The TIMI Study Group has received research grant support from Sanofi-Aventis, Bridgewater, NJ. Drs Morrow, Antman, and Braunwald have received honoraria for educational presentations and have served as consultants to Sanofi-Aventis. Drs Budaj, Guneri, Jacob, and Ruda have received research grant support from Sanofi-Aventis. Ms Murphy has no additional disclosures. |
Vol 154 - N° 6
P. null - décembre 2007 Retour au numéro
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- Giuseppe De Luca, Paolo Marino
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