Follow Up

Patient Population

■ HIT with thrombosis

Up to 14 Days

Argatroban

IV infusion starting at 2.0 ig/kg/min

Clinical Outcomes Assessed

Death

Amputation

New Thrombosis

Bleeding

FIGURE 4 Schematic of the study design for ARG-911, ARG-915, and ARG-915X. Patients with a clinical diagnosis of HIT with or without thrombosis were eligible. The starting dose of argatroban, 2.0 mg/kg/min, was titrated to achieve an aPTT 1.5-3.0 times the baseline aPTT (not to exceed 100 s). Outcomes over a 37-day period were compared with those of a historical control group. Abbreviations: aPTT, activated partial thromboplastin time; HIT, heparin-induced thrombocytopenia; iv, intravenous.

absence of thrombocytopenia. Patients were excluded if they had an unexplained aPTT greater than two times control at baseline, documented coagulation disorder, or bleeding diathesis unrelated to HIT, a lumbar puncture within the prior 7 days, or a history of previous aneurysm, hemorrhagic stroke, or recent (within 6 mo) thrombotic stroke unrelated to HIT. Reentry of patients into studies ARG-915 and ARG-915X was allowed, although outcomes from initial entries only were included in the primary analyses to avoid potential bias.

The historical control group of ARG-911 consisted of patients at the participating centers who met the same inclusion-exclusion criteria for the study and who were seen prior to the initiation of the study. Controls were treated according to the local standard of practice at the time of HIT diagnosis, with typical treatments being heparin discontinuation and/or oral anticoagulation (Lewis et al., 2001).

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