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(Circulation. 2001;103:1838.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Argatroban Anticoagulant Therapy in Patients With Heparin-Induced Thrombocytopenia
From Loyola University Medical Center, Maywood, Ill (B.E.L., J.F., J.M.W., J.M.); Midwest Heart Specialists, Downers Grove, Ill (D.E.W.); Duke University Medical Center, Durham, NC (S.D.B.); University of Pennsylvania, Philadelphia (W.H.M.); the Cleveland Clinic, Cleveland, Ohio (J.B.); Rochester General Hospital, Rochester, NY (R.S.); Westchester Medical Center, Valhalla, NY (R.G.L.); West Pennsylvania Hospital, Pittsburgh (Z.R.Z.); University of Alabama, Birmingham (P.K.R.); Massachusetts General Hospital, Boston (I.K.J.); Northwest Medical Specialists, Arlington Heights, Ill (S.D.R.); Texas Biotechnology Corporation, Houston (M.J.H., as consultant); and McMaster University, Hamilton, Ontario, Canada (J.G.K.).
Correspondence to Dr Bruce E. Lewis, Loyola University Medical Center, 2160 S First Ave, Maywood, IL 60153. E-mail blewis{at}LUMC.edu
Background—Heparin-induced thrombocytopenia (HIT) is an immune-mediated syndrome caused by heparin. Complications range from thrombocytopenia to thrombocytopenia with thrombosis. We report a prospective, historical- controlled study evaluating the efficacy and safety of argatroban, a direct thrombin inhibitor, as anticoagulant therapy in patients with HIT or HIT with thrombosis syndrome (HITTS).
Methods and Results—Patients with HIT (isolated thrombocytopenia, n=160) or HITTS (n=144) received 2 µg · kg-1 · min-1 IV argatroban, adjusted to maintain the activated partial thromboplastin time 1.5 to 3.0 times baseline value. Treatment was maintained for 6 days, on average. Clinical outcomes over 37 days were compared with those of 193 historical control subjects with HIT (n=147) or HITTS (n=46). The incidence of the primary efficacy end point, a composite of all-cause death, all-cause amputation, or new thrombosis, was reduced significantly in argatroban-treated patients versus control subjects with HIT (25.6% versus 38.8%, P=0.014). In HITTS, the composite incidence in argatroban-treated patients was 43.8% versus 56.5% in control subjects (P=0.13). Significant between-group differences by time-to-event analysis of the composite end point favored argatroban treatment in HIT (P=0.010) and HITTS (P=0.014). Argatroban therapy, relative to control subjects, also significantly reduced new thrombosis and death caused by thrombosis (P<0.05). Argatroban-treated patients achieved therapeutic activated partial thromboplastin times generally within 4 to 5 hours of starting therapy and, compared with control subjects, had a significantly more rapid rise in platelet counts (P=0.0001). Bleeding events were similar between groups.
Conclusions—Argatroban anticoagulation, compared with historical control subjects, improves clinical outcomes in patients who have heparin-induced thrombocytopenia, without increasing bleeding risk.
Key Words: anticoagulants • inhibitors • heparin • thrombosis • platelets
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