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aSignificance level of p < 0.05 for the primary endpoint (composite) and bleeding and p < 0.0125 for secondary endpoints (components of composite, and death due to thrombosis). bAll-cause death, all-cause amputation, or new thrombosis within 37-day study period.

cOutcome categories are not mutually exclusive; within a given category, a patient is counted only once if >1 event.

dPatients with > 1 event are counted only once. Abbreviation: HIT, heparin-induced thrombocytopenia.

aSignificance level of p < 0.05 for the primary endpoint (composite) and bleeding and p < 0.0125 for secondary endpoints (components of composite, and death due to thrombosis). bAll-cause death, all-cause amputation, or new thrombosis within 37-day study period.

cOutcome categories are not mutually exclusive; within a given category, a patient is counted only once if >1 event.

dPatients with > 1 event are counted only once. Abbreviation: HIT, heparin-induced thrombocytopenia.

Consistent with ARG-911, the positive benefits on the composite endpoint were driven in main part by significant reductions in new thrombosis (p < 0.001 in each study arm) (Table 2). There were no significant between-group differences in all-cause mortality or amputation. Argatroban therapy significantly reduced the incidence of death due to thrombosis in patients having HITTS (p = 0.002).

Similar, predictable aPTT responses occurred in patients with HIT or HITTS. The target aPTT was typically achieved by first assessment, and mean aPTT values remained generally constant throughout the infusion. Platelet counts recovered more rapidly in argatroban-treated patients than controls (p < 0.001 for each study arm).

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