Objectives: To identify the main causes of morbidity and mortality in patients with antiphospholipid syndrome (APS) during a 5-year-period and to determine clinical and immunologic parameters with prognostic significance.
Methods: We analyzed the clinical and immunologic features of a cohort of 1,000 patients with APS from 13 European countries that have been followed from 1999 to 2004.
Results: 200 (20%) patients developed APS-related manifestations during the 5-year study period. Recurrent thrombotic events appeared in 166 (16.6%) patients and the most common were strokes (2.4% of the total cohort), transient ischemic attacks (2.3%), deep vein thromboses (2.1%), and pulmonary embolism (2.1%). When the thrombotic events occurred, 90 patients were on oral anticoagulants and 49 were using aspirin. 31 out of 420 (7.4%) patients on oral anticoagulants presented with hemorrhage. 3 out of 121 (2.5%) women with only obstetric APS manifestations at the beginning of the study developed a new thrombotic event. A total of 77 women (9.4% of female patients) experienced one or more pregnancies and 63 (81.8% of pregnant patients) succeeded in having one or more live births. The most common fetal complications were early pregnancy loss (17.1% of pregnancies) and premature birth (35% of live births). 53 (5.3% of the total cohort) patients died. The most frequent causes of death were bacterial infection (21% of deaths), myocardial infarction (19%), and stroke (13%). No clinical or immunologic predictor of thrombotic events, pregnancy morbidity or mortality was detected.
Conclusion: APS patients still develop significant morbidity and mortality despite current therapy (oral anticoagulants and/or antiaggregants).