OBJECTIVETo investigate the anticoagulant efficacy and safety of argatroban for patients undergoing elective percutaneous coronary intervention (PCI).

METHODSA total of 300 consecutive patients with coronary heart disease undergoing elective PCI were enrolled and randomized into heparin group (100 U/kg via artery sheaths, n = 150) and argatroban group (200 µg/kg bolus, followed by 350 µg·kg(-1)·h(-1) i.v. infusion, n = 150). The primary efficacy endpoint was the activated clotting time (ACT) results (10 min and 60 min after anticoagulant administration and at the point at the end of PCI). The additional dosage of heparin or argatroban was given if the ACT value during PCI procedure < 250 s. Activated partial thromboplastin time (APTT) was also measured at pre-procedure, 10 min after anticoagulant injection and 60 min after PCI. The primary safety endpoint was thrombosis and hemorrhagic events during PCI procedure and hospital stay.

RESULTSAll patients in the two groups attained the target ACT ( ≥ 250 s), and ACT in heparin group was significantly prolonged [(343.32 ± 44.70) s vs. (289.60 ± 20.88) s, P < 0.01], at 10 min after anticoagulation injection. ACT was similar between the two groups at 60 min after anticoagulation injection [(291.26 ± 46.79) s vs. (288.40 ± 21.61) s, P > 0.05]. The ACT value in argatroban group was similar at 10 min and 60 min after injection (P > 0.05). Supplemental anticoagulant was needed for 13 (8.7%) patients in heparin group and 2 (1.3%) patients in argatroban group because of ACT under 250 s (P < 0.05) . At the end of PCI procedure, ACT in heparin group was significantly shorter than in argatroban group [(247.16 ± 41.38)s vs. (278.65 ± 20.51) s, P < 0.01]. APTT in heparin group was significantly prolonged than in argatroban group not only at 10 min point [(182.16 ± 4.37) s vs. (81.69 ± 21.49) s, P < 0.01] after anticoagulant injection but also at the point of 60 min after PCI procedure[(169.13 ± 6.35)s vs. (56.21 ± 15.68) s, P < 0.01]. There was no thrombus event in two groups and no bleeding event in argatroban group, and there was three bleeding events in heparin group [2.0% (3/150) vs.0, P > 0.05].

CONCLUSIONArgatroban is an effective and safe anticoagulation agent during elective PCI procedure, anticoagulant efficacy and risk of bleeding side effects of argatroban are similar to heparin.