Objective
Estimating the incidence of new thrombotic and hemorrhagic events in a single-center prospective cohort of Primary Antiphospholipid Syndrome (PAPS) patients over approximately 7.5 years and identifying risk factors associated with a first recurrent thrombotic and hemorrhagic event.
Methods
Incidence rates of thrombosis and hemorrhage were calculated considering that patients remained at continuous risk and could experience multiple events. For time-to-event analysis of the first thrombotic episode, patients were followed until their first thrombotic event or last outpatient visit, and baseline clinical and laboratory data were compared. Statistical analysis included Kaplan-Meier curves, log-rank test and Cox proportional hazards modeling.
Results
A total of 155 PAPS patients were included, 83.2 % were female. Hypertension was present in 43.9 %, and diabetes in 9 %. Lupus anticoagulant was the most common antibody (93.4 %). During 942 patient-years of follow-up, 32 thrombotic events (18 arterial, 12 venous, and 2 thrombotic microangiopathies) occurred in 26 patients, yielding an incidence rate of 3.4 per 100 patient-years. The INR was within the therapeutic target in 50 % of the 22 events. The incidence of a first thrombotic event was 3.2 per 100 patient-years, occurring at a mean of 3.2 ± 2.0 years. Diabetes was independently associated with increased thrombotic risk (HR 4.10, 95 % CI 1.72–9.78, p = 0.001). Eight first major hemorrhages were recorded (0.9 per 100 patient-years), with baseline microvascular involvement as associated risk factor (HR 9.04, 95 % CI 2.15–37.92, p = 0.003).
Conclusion
Thrombotic events were frequent in PAPS, even with therapeutic INR. Diabetes increased 4-fold the risk of a first thrombotic event.
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