Argatroban anticoagulation in conjunction with glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention: An open-label, nonrandomized pilot study

Background. Argatroban, a direct thrombin inhibitor, blocks clot-bound thrombin more effectively than does heparin. This multicenter, prospective pilot study evaluated the efficacy and safety of argatroban in combination with glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. Methods: Patients (N = 152) received argatroban as a 250- or 300-mug/kg bolus, followed by a 15-mug/kg/min infusion during percutaneous coronary intervention. An additional 150-mug/kg bolus was administered if activated clotting times 5-15 min after initiating argatroban were <275 s. Abciximab (N = 150) or double-bolus eptifibatide (N = 2) was administered simultaneously. Results: Median activated clotting times at the beginning and end of the procedure were approximately 300 s. The primary efficacy endpoint-a composite of death, myocardial infarction, or urgent revascularization at 30 days occurred in 4 (2.6%) patients (no death, 4 myocardial infarctions, and 2 revascularizations). Two (1.3%) patients had major bleeding by the Thrombolysis in Myocardial Infarction criteria (1 retroperitoneal, 1 groin hematoma). Conclusions: Argatroban in combination with glycoprotein IIb/IIIa inhibition appears to provide adequate anticoagulation and be well tolerated with an acceptable bleeding risk for patients undergoing percutaneous coronary intervention. Additional studies are warranted. Abbreviated Abstract. We describe a multicenter, prospective pilot study of the efficacy and safety of argatroban anticoagulation in conjunction with glycoprotein IIb/IIIa inhibition in 152 patients undergoing elective percutaneous coronary intervention. The primary efficacy composite endpoint of death, myocardial infarction or urgent revascularization at 30 days occurred in 2.6% of patients (no death, 4 myocardial infarctions, and 2 urgent revascularizations), and major bleeding occurred in 1.3% of patients.