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Duke University Clinical Cardiology Study - 1 - DUCCS-1
Description:
Withholding heparin following anistreplase to reduce MI complications.
Hypothesis:
To examine whether withholding heparin following anistreplase thrombolytic therapy reduces complications of myocardial infarction.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 250
Mean Follow Up: 5 days
Patient Populations:
Acute MI within 6 hours
Primary Endpoints:
Death, reinfarction, recurrent ischemia, occlusion of infarct related artery
Drug/Procedures Used:
Heparin (15 U/kg 4 hours after anistreplase) or no heparin
Concomitant Medications:
Anistreplase (APSAC), aspirin, beta blockers, nitrates
Principal Findings:
Of the 250 patients enrolled, 128 patients were randomized to receive heparin and 122 were randomized to no heparin.
There was no difference detected in the primary endpoint between patients who received heparin and those who did not (42% vs 43%, respectively).
Bleeding complications were more frequent for the heparin group (32% vs 17.2%, p = 0.006), with life-threatening bleeds in 4.7% of heparin-treated patients compared to 0.8% of patients not receiving heparin.
Interpretation:
The DUCCS-1 trial showed that combining heparin with APSAC therapy was associated with a significant increase in hemorrhagic complications, without additional benefit. Although not powered to exclude a benefit in ischemic complications, the benefit of heparin with APSAC was likely to be small compared to the risk of bleeding. Concomitant heparin therapy has been of net benefit in the setting of other thrombolytic agents (ISIS-3, GUSTO-1).
References:
1. J Am Coll Cardiol 1994;23:11-8.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Streptokinase, Heparin, Anistreplase, Fibrinolytic Agents
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