Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry')

Jonathan Thaler¹, Michael Parides¹, Danieli Castro Oliveira de Andrade², Diana Paredes Ruiz³, Maria G Tektonidou⁴, Vittorio Pengo⁵, Savino Sciascia⁶, Cecilia Nalli⁷, Guilherme de Jesús⁸, Paul R Fortin⁹, Maria Efthymiou¹⁰, H Michael Belmont¹¹, Michelle Petri¹², Ricard Cervera¹³, Leslie Skeith¹⁴, Tatsuya Atsumi¹⁵, Chary López-Pedrera¹⁶, Yu Zuo¹⁷, D Ware Branch¹⁸, Rohan Willis¹⁹, Nina Kello²⁰, Zhuoli Zhang²¹, Esther Rodriguez Almaraz²², Bahar Artim-Esen²³, Jose Pardos-Gea²⁴, Guillermo Pons-Estel²⁵, Giulia Pazzola²⁶, Hui Shi²⁷, Ali Duarte-Garcia²⁸, Medha Barbhaiya¹, Cecile Yelnik²⁹, Pierluigi Meroni³⁰, Robert Roubey³¹, Maria Laura Bertolaccini³², Hannah Cohen³³, Jacob H Rand³⁴, Doruk Erkan³⁵

Affiliations

¹ Hospital for Special Surgery, New York, New York, USA.
² University of Sao Paolo, Sao Paolo, Brazil.
³ Biobizkaia Health Research Institute, Barakaldo, Spain.
⁴ National and Kapodistrian University of Athens, Athens, Greece.
⁵ Padova University Hospital, Padova, Italy.
⁶ ASL Città Di Torino and University of Turin, Turin, Italy.
⁷ University of Brescia, Brescia, Italy.
⁸ Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
⁹ CHU de Quebec-Universite Laval, Quebec, QC, Canada.
¹⁰ University College London, London, UK.
¹¹ New York University Langone Medical Center, New York, New York, USA.
¹² Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹³ Hospital Clinic Barcelona, Barcelona, Catalonia, Spain.
¹⁴ University of Calgary, Calgary, Alberta, Canada.
¹⁵ Hokkaido University Hospital, Sapporo, Japan.
¹⁶ IMIBIC/Reina Sofia Hospital, University of Cordoba, Cordoba, Spain.
¹⁷ University of Michigan, Ann Arbor, Michigan, USA.
¹⁸ University of Utah and Intermountain Healthcare, Salt Lake City, Utah, USA.
¹⁹ University of Texas Medical Branch, Galveston, Texas, USA.
²⁰ Northwell Health, Great Neck, New York, USA.
²¹ Peking University First Hospital, Beijing, China.
²² Hospital Universitario 12 de Octubre, Madrid, Spain.
²³ Istanbul University School of Medicine, Istanbul, Turkey.
²⁴ Vall d'Hebron University Hospital Barcelona, Spain.
²⁵ Centro Regional de Enfermedades Autoinmunes y Reumaticas del Grupo Orono (GO-CREAR), Rosario, Argentina.
²⁶ Rheumatology Unit, Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy.
²⁷ Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
²⁸ Mayo Clinic, Rochester, Minnesota, USA.
²⁹ Lille University, Lille, France.
³⁰ Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
³¹ University of North Carolina, Chapel Hill, North Carolina, USA.
³² King's College London, London, UK.
³³ University College London Hospitals NHS Foundation Trust, London, UK.
³⁴ Weill Cornell Medical Center, New York, New York, USA.
³⁵ Hospital for Special Surgery, New York, New York, USA. Electronic address: erkand@hss.edu.

PMID: 41266210
DOI: 10.1016/j.ard.2025.10.019

Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry')

Jonathan Thaler et al. Ann Rheum Dis. 2026 Mar.

. 2026 Mar;85(3):497-506.

doi: 10.1016/j.ard.2025.10.019. Epub 2025 Nov 19.

Authors

Affiliations

¹ Hospital for Special Surgery, New York, New York, USA.
² University of Sao Paolo, Sao Paolo, Brazil.
³ Biobizkaia Health Research Institute, Barakaldo, Spain.
⁴ National and Kapodistrian University of Athens, Athens, Greece.
⁵ Padova University Hospital, Padova, Italy.
⁶ ASL Città Di Torino and University of Turin, Turin, Italy.
⁷ University of Brescia, Brescia, Italy.
⁸ Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
⁹ CHU de Quebec-Universite Laval, Quebec, QC, Canada.
¹⁰ University College London, London, UK.
¹¹ New York University Langone Medical Center, New York, New York, USA.
¹² Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹³ Hospital Clinic Barcelona, Barcelona, Catalonia, Spain.
¹⁴ University of Calgary, Calgary, Alberta, Canada.
¹⁵ Hokkaido University Hospital, Sapporo, Japan.
¹⁶ IMIBIC/Reina Sofia Hospital, University of Cordoba, Cordoba, Spain.
¹⁷ University of Michigan, Ann Arbor, Michigan, USA.
¹⁸ University of Utah and Intermountain Healthcare, Salt Lake City, Utah, USA.
¹⁹ University of Texas Medical Branch, Galveston, Texas, USA.
²⁰ Northwell Health, Great Neck, New York, USA.
²¹ Peking University First Hospital, Beijing, China.
²² Hospital Universitario 12 de Octubre, Madrid, Spain.
²³ Istanbul University School of Medicine, Istanbul, Turkey.
²⁴ Vall d'Hebron University Hospital Barcelona, Spain.
²⁵ Centro Regional de Enfermedades Autoinmunes y Reumaticas del Grupo Orono (GO-CREAR), Rosario, Argentina.
²⁶ Rheumatology Unit, Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy.
²⁷ Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
²⁸ Mayo Clinic, Rochester, Minnesota, USA.
²⁹ Lille University, Lille, France.
³⁰ Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
³¹ University of North Carolina, Chapel Hill, North Carolina, USA.
³² King's College London, London, UK.
³³ University College London Hospitals NHS Foundation Trust, London, UK.
³⁴ Weill Cornell Medical Center, New York, New York, USA.
³⁵ Hospital for Special Surgery, New York, New York, USA. Electronic address: erkand@hss.edu.

PMID: 41266210
DOI: 10.1016/j.ard.2025.10.019

Abstract

Objectives: There is a lack of high-quality data to inform risk-stratified long-term thrombosis prevention strategies in patients with persistently positive antiphospholipid antibodies (aPL). We aimed to determine independent clinical and biologic predictors of thrombosis among persistently aPL-positive patients.

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.

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Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry')

Affiliations

Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry')

Authors

Affiliations

Abstract

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous