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Bleeding and Recurrent Thrombosis in Definite Antiphospholipid Syndrome
Analysis of a Series of 66 Patients Treated With Oral Anticoagulation to a Target International Normalized Ratio of 3.5
Guillermo Ruiz-Irastorza, MD, PhD;
Munther A. Khamashta, MD, MRCP, PhD;
Beverley J. Hunt, MD, FRCP, FRCPath;
Alejandro Escudero, MD;
Maria J. Cuadrado, MD, PhD;
Graham R. V. Hughes, MD, FRCP
Arch Intern Med. 2002;162:1164-1169.
Background Prolonged anticoagulation is the treatment of choice for patients with
thrombosis and the antiphospholipid syndrome. However, there is still debate
about the optimum intensity of anticoagulation.
Methods The study included 66 patients with antiphospholipid syndrome (Sapporo
criteria) and previous thrombosis. All were receiving oral anticoagulation
to a target international normalized ratio of 3.5. Every patient was individually
interviewed to recall major bleeding and thrombotic episodes during the previous
12 months.
Results Patients were mainly women and white. The rate of major bleeding was
6 cases per 100 patient-years (95% confidence interval [CI] 1.6-15.0). The
rate of intracranial bleed was 1.5 per 100 patient-years (95% CI, 0.04-8.4).
None of the bleeding episodes was fatal. The rate of thrombotic recurrences
was 9.1 cases per 100 patient-years (95% CI, 3.3-19.6). Most recurrences took
place in the same vascular bed as the original thrombosis. Age, time receiving
anticoagulant therapy, primary vs secondary antiphospholipid syndrome, positivity
for anticardiolipin antibodies, positivity for lupus anticoagulant, previous
arterial thrombosis, previous stroke, previous venous thrombosis, and previous
thrombocytopenia were not predictive of bleeding events. However, the risk
of thrombotic recurrences was independently higher in patients who were receiving
anticoagulation for longer periods.
Conclusions The risk of intracranial and fatal bleeding in patients with definite
antiphospholipid syndrome and previous thrombosis treated with oral anticoagulation
to a target international normalized ratio of 3.5 is similar than in groups
of patients treated to lower target ratios. The risk of thrombotic recurrences,
even during anticoagulation, was high. Most recurrences took place in the
same territory as original thromboses.
From the Lupus Research Unit, St Thomas' Hospital, London, England
(Drs Ruiz-Irastorza, Khamashta, Hunt, Escudero, Cuadrado, and Hughes), and
Service of Internal Medicine, Hospital de Cruces, Bizkaia, the Basque Country,
Spain (Dr Ruiz-Irastorza).
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