Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry').
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Thaler Jonathan, Parides Michael, de Andrade Danieli Castro Oliveira, Ruiz Diana Paredes, Tektonidou Maria G, Pengo Vittorio, Sciascia Savino, Nalli Cecilia, de Jesús Guilherme, Fortin Paul R, Efthymiou Maria, Belmont H Michael, Petri Michelle, Cervera Ricard, Skeith Leslie, Atsumi Tatsuya, López-Pedrera Chary, Zuo Yu, Branch D Ware, Willis Rohan, Kello Nina, Zhang Zhuoli, Almaraz Esther Rodriguez, Artim-Esen Bahar, Pardos-Gea Jose, Pons-Estel Guillermo, Pazzola Giulia, Shi Hui, Duarte-Garcia Ali, Barbhaiya Medha, Yelnik Cecile, Meroni Pierluigi, Roubey Robert, Bertolaccini Maria Laura, Cohen Hannah, Rand Jacob H, Erkan Doruk
Аннотация
METHODS: Patients positive for aPL according to the Revised Sapporo Classification Criteria are eligible for inclusion in the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Registry. Registrants with at least 1 year of follow-up were included in this study. We fit Cox proportional hazards models to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for independent predictors of thrombosis.
RESULTS: In unadjusted analyses, based on 1067 patients with a mean follow-up of 4.43 years (4,727 person-years), history of thrombosis, hematologic disease (autoimmune haemolytic anaemia and/or thrombocytopenia), microvascular disease, obesity, renal disease, sedentary lifestyle, baseline anticoagulant use, and family history of early cardiovascular disease occurred more frequently (P < .05) among patients with new thrombosis (n = 93) than among those without new thrombosis (n = 974). After adjustment, independent predictors of new thrombosis were history of thrombosis (HR 2.34, 95% CI 1.14 to 4.81, P = .02) and hematologic disease (HR 1.95, 95% CI 1.19 to 3.18, P = .01); there was a trend for history of microvascular disease (P = .06) and obesity (P = .08).
CONCLUSIONS: In this prospective analysis, history of thrombosis and hematologic disease each conferred an approximately twofold increased risk of new thrombosis in persistently aPL-positive patients. These findings can guide future clinical trial designs and inform patient management decisions.