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Randomized prospective trial comparing the native prothrombin antigen with
the prothrombin time for monitoring oral anticoagulant therapy
B Furie, CF Diuguid, M Jacobs, DL Diuguid and BC Furie
Center for Hemostasis and Thrombosis Research, New England Medical Center,
Boston, MA 02111.
The dosage of the anticoagulant warfarin sodium is based upon the
prolongation of the prothrombin time into an optimal therapeutic range. We
have developed a new assay for the native prothrombin antigen that measures
the fully gamma-carboxylated prothrombin using a radioimmunoassay. Based on
preliminary data that indicated that the native prothrombin antigen
predicted both bleeding and thrombotic complications more accurately than
the prothrombin time in patients anticoagulated with warfarin sodium, we
have performed a randomized prospective trial comparing the complication
rate in warfarin-treated patients monitored with the native prothrombin
antigen or the prothrombin time. Patients with indications for
anticoagulation were randomized to be monitored by the native prothrombin
antigen (therapeutic range, 12 to 24 micrograms/mL) or the prothrombin time
index (therapeutic range, 1.5 to 2.0). Of the prothrombin time group (N =
80), seven (8.8%) had bleeding or thrombotic complications, with a
complication rate of 9.5%/patient-year. In the native prothrombin antigen
group (N = 76), one subject (1.3%) had a bleeding complication. The
complication rate per patient-year was 1.5%. These results indicate an 85%
reduction in the complication rate of the native prothrombin antigen group
compared with the complication rate of the prothrombin time group. This
difference is statistically significant by the Fisher exact test (P = .037)
and by Kaplan Meier survival analysis (P = .040). This study suggests that
the use of the native prothrombin antigen assay has the potential to
decrease the complications associated with anticoagulation therapy with
warfarin sodium.
Volume 75,
Issue 2,
pp. 344-349,
01/15/1990
Copyright © 1990 by The American Society of Hematology
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