Enoxaparin versus unfractionated heparin in diabetic patients
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.
Diabetes mellitus (DM) is a growing global health challenge marked by a steady increase in the worldwide prevalence of the disease and substantial associated cardiovascular morbidity and mortality. Cardiovascular disease is the most frequent cause of death among patients with DM. In addition to a higher prevalence of coronary artery disease, patients with DM have significantly higher mortality after presenting with an acute coronary syndrome (ACS). They also experience more frequent complications of procedures used during management of ACS, even after accounting for other associated differences in medical comorbidity compared with patients without DM. Disturbingly, evidence-based treatments are underused in patients with DM. For these reasons, there is an important clinical need to identify medical interventions that are safe and effective in diabetic patients with ACS, providing evidence directly supporting use in this high-risk group. In this regard, potent antiplatelet therapy for ACS appears to offer particular benefit in patients with DM.
A strategy using enoxaparin has been shown to reduce the risk of death or recurrent ischemic events compared with a strategy using unfractionated heparin (UFH) in patients with ST-elevation myocardial infarction (STEMI) treated with fibrinolysis, with a concurrent increase in the risk of bleeding. It is plausible that patients with DM may derive particular benefit from more potent antithrombotic therapy. However, this potential for benefit must be weighed against a possible higher risk for bleeding. We prospectively planned to evaluate the efficacy and safety of enoxaparin in patients with DM among the 20479 patients enrolled in the double-blind, placebo-controlled ExTRACT-TIMI 25 trial.
Abstract and Introduction
Abstract
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.
Introduction
Diabetes mellitus (DM) is a growing global health challenge marked by a steady increase in the worldwide prevalence of the disease and substantial associated cardiovascular morbidity and mortality. Cardiovascular disease is the most frequent cause of death among patients with DM. In addition to a higher prevalence of coronary artery disease, patients with DM have significantly higher mortality after presenting with an acute coronary syndrome (ACS). They also experience more frequent complications of procedures used during management of ACS, even after accounting for other associated differences in medical comorbidity compared with patients without DM. Disturbingly, evidence-based treatments are underused in patients with DM. For these reasons, there is an important clinical need to identify medical interventions that are safe and effective in diabetic patients with ACS, providing evidence directly supporting use in this high-risk group. In this regard, potent antiplatelet therapy for ACS appears to offer particular benefit in patients with DM.
A strategy using enoxaparin has been shown to reduce the risk of death or recurrent ischemic events compared with a strategy using unfractionated heparin (UFH) in patients with ST-elevation myocardial infarction (STEMI) treated with fibrinolysis, with a concurrent increase in the risk of bleeding. It is plausible that patients with DM may derive particular benefit from more potent antithrombotic therapy. However, this potential for benefit must be weighed against a possible higher risk for bleeding. We prospectively planned to evaluate the efficacy and safety of enoxaparin in patients with DM among the 20479 patients enrolled in the double-blind, placebo-controlled ExTRACT-TIMI 25 trial.
SHARE
