Efficacy and safety of optimized antithrombotic therapy with aspirin, clopidogrel and enoxaparin in patients with non-ST segment elevation acute coronary syndromes in clinical practice.

In randomized clinical trials enoxaparin in non ST-elevation acute coronary syndromes (NSTE-ACS) has been shown to be more effective than unfractionated heparin in preventing the combined endpoint of death and myocardial infarction. Clopidogrel in combination with aspirin reduced the combined endpoint of death, myocardial infarction and stroke in NSTE-ACS patients compared to aspirin alone. Aim of the present study was to determine the clinical impact of optimized antithrombotic therapy with enoxaparin, clopidogrel and aspirin compared to standard therapy with unfractionated heparin (UFH) and aspirin in NSTE-ACS in clinical practice. We analyzed data of 2,956 consecutive patients with NSTE-ACS and either antithrombotic therapy with enoxaparin, clopidogrel and aspirin or with aspirin and UFH, which were prospectively enrolled in the acute coronary syndromes registry (ACOS) from July 2000 until the end of November 2002. After adjustment for baseline characteristics and PCI the combined endpoint of hospital death and non-fatal reinfarctions was lower in the group with optimized antithrombotic therapy including clopidogrel, enoxaparin and aspirin compared to the control-group with aspirin and UFH (odds ratio 0.30, 95% confidence interval 0.16-0.53). There was no significant difference in major bleedings between the two treatment groups (1.5% vs. 0.9%, P = 0.35), while overall there were more bleeding complications in the group with optimized antithrombotic therapy (4.9% vs. 2.0%, P = 0.005). In clinical practice optimized antithrombotic therapy with aspirin, clopidogrel and enoxaparin in NSTE-ACS is associated with a reduction in the combined endpoint of death and non-fatal reinfarctions compared to standard therapy with aspirin and UFH without increase in major bleeding complications.