0097: Transient Ischemic Attack in Antiphospholipid Antibody-positive Patients: Retrospective and Prospective Results from the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository (“Registry”)
SUNY Downstate Medical Center brooklyn, NY, United States
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Zeynep Belce Erton1, Jonathan Thaler2, Danieli Andrade3, Megan Barber4, Maria Tektonidou5, Savino Sciascia6, Vittorio Pengo7, Jose Pardos-Gea8, Guillermo Ruiz-Irastorza9, Chary Lopez-Pedrera10, H Michael Belmont11, Kello Nina12, Paul R. Fortin13, Stéphane Zuily14, Cecilia Chighizola15, Flavio Victor Signorelli16, Zhuoli Zhang17, Tatsuya Atsuma18, Maria Efthymiou19, D. Ware Branch20, Cecilia Nalli21, Esther Rodriguez almaraz22, Michelle Petri23, Giulia Pazzola24, Ricard Cervera25, Bahar Artim Esen26, Hui Shi27, Yu Zuo28, Rosana M Quintana29, Rohan Willis30, Ali Duarte-Garcia31, Maria Laura Bertolaccini32, Hannah Cohen33, Doruk Erkan2 and On Behalf Of APS ACTION34, 1SUNY Downstate Medical Center, Brooklyn, NY, 2Hospital for Special Surgery, New York, NY, 3University of São Paulo, São Paulo, Brazil, 4University of Calgary, Division of Rheumatology, Cumming School of Medicine, Calgary, AB, Canada, 5Joint Academic Rheumatology Program, First Department of Propedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece, 6University of Turin, Torino, Italy, 7Department of Cardiac-Thoracic-Vascular Sciences and Public Health University of Padova, Padova, Italy, 8Vall d'Hebron University Hospital, Barcelona, Spain, 9Hospital Universitario Cruces, Barakaldo, Spain, 10IMIBIC - Reina Sofia Hospital, Córdoba, Spain, 11NYU School of Medicine, New York, NY, 12Northwell Health, Brooklyn, NY, 13Centre ARThrite - CHU de Québec - Université Laval, Quebec City, QC, Canada, 14Lorraine University, Vandoeuvre-lès-Nancy, France, 15University of Milan, Milan, Italy, 16University of São Paulo, Rio De Janeiro, Brazil, 17Peking University First Hospital, Rheumatology and Immunology Department, Beijing, China, 18Hokkaido University, Department of Rheumatology, Endocrinology and Nephrology, Sapporo, Japan, 19University College London, London, United Kingdom, 20University of Utah, Salt Lake City, UT, 21Rheumatology and Clinical Immunology, ASST Spedali Civili of Brescia, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy, 22Hospital Universitario 12 de Octubre, Madrid, Spain, 23Department of Medicine, Division of Rheumatology, Johns Hopkins University School of Medicine, Timonium, MD, 24Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy, 25Hospital Clínic de Barcelona, Barcelona, Spain, 26Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, 27Rijin Hospital, Shanghai, China, 28University of Michigan, Ann Arbor, MI, 29Centro Regional de Enfermedades Autoinmunes y Reumticas (CREAR), Grupo Oroño, Rosario, Argentina, 30University of Texas Medical Branch, Galveston, TX, 31Mayo Clinic, Rochester, MN, 32King's College London, London, United Kingdom, 33University College London Hospitals NHS Foundation Trust, London, United Kingdom, 34on behalf of APS ACTION, New York, NY
Background/Purpose: APS ACTION Registry aims to study the course of disease in antiphospholipid antibody (aPL)-positive patients. Although transient ischemic attack (TIA) can develop in aPL-positive patients, the ascertainment of TIA can be challenging due to the need to exclude other conditions, e.g., complex migraine with aura or seizure. Our primary objective was to analyze the clinical characteristics of persistently aPL-positive patients who were reported to have had "TIA" prior to recruitment and/or during prospective follow-up.
Methods: The registry inclusion criteria are positive aPL based on the Updated Sapporo APS Classification Criteria within one year prior to enrollment. Patients are followed every 12±3m with clinical data and blood collection. Firstly, we retrospectively compared the baseline characteristics of patients with a history of TIA among those without or with a history of imaging-confirmed thrombosis (at any time prior to registry entry). Secondly, in patients who completed 1-10 year follow up, we prospectively analyzed those with new onset TIA, which was defined as "a transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction lasting less than 24 hours" (confirmation status by a neurologist is also recorded).
Results: As of April 2023, 1,166 patients were included in the registry and 92 (8%) had a history of TIA at enrollment: 22/92 (24%) without and 70/92 (76%) with history of imaging confirmed arterial/venous thrombosis. Of 22 TIA patients without history of thrombosis (mean age 54.8 ± 11, female 17 [77%], White: 20 [91%]), 15 (68%) were confirmed by a neurologist. Of 70 TIA patients with history of imaging-confirmed thrombosis (mean age 56.7 ± 11, female 39 [56%], White: 48 [69%], arterial thrombosis 59 [84%], and venous thrombosis 29 [41%]), 46 [66%] were confirmed by a neurologist. At baseline, TIA patients without thrombosis were more likely to receive antiplatelet agent alone and have single LA positivity, whereas TIA patients with history of imaging-confirmed thrombosis were more likely to have hypertension and receive warfarin (Table 1). During the prospective follow up of 92 patients with a history of TIA (mean follow-up: 4.5 ± 3.0 years), seven new TIA were reported: a) two (9%) in 22 patients with no history of thrombosis (1.41 per 100 patient-years), and b) five (7%) in 70 patients with history of thrombosis (2.71 per 100 patient-years) (Table 2). In addition, four of 759 (0.5%) patients with no history of TIA at baseline and who completed at least one year follow-up developed a TIA during the mean follow-up of 5.12 years (0.09 per 100-patient years).
Conclusion: In our large international cohort of persistently aPL-positive patients, 8% were reported to have history of "TIA" at the registry entry. The TIA recurrence rate during follow-up was 7-8%; however, the new TIA rate was less than one percent. Approximately two-thirds of patients without a history of imaging-confirmed thrombosis were treated with anticoagulation; all patients with recurrent/new TIA during the follow-up were on anticoagulation. Our findings underscore the need for well-designed controlled studies of TIA in aPL-positive patients with strict definitions.
Z. Erton: None; J. Thaler: None; D. Andrade: None; M. Barber: AbbVie/Abbott, 2, AstraZeneca, 2, GlaxoSmithKlein(GSK), 2, 5, Janssen, 2, Sanofi Genzyme, 2; M. Tektonidou: None; S. Sciascia: None; V. Pengo: Werfen group, Milan, Italy, 6; J. Pardos-Gea: Roche, 6; G. Ruiz-Irastorza: None; C. Lopez-Pedrera: None; H. Belmont: Alexion, 6, Aurinia, 6; K. Nina: None; P. Fortin: AbbVie, 1, AstraZeneca, 1, 6, GlaxoSmithKlein(GSK), 1, 6, Roche-Genentech, 1; S. Zuily: None; C. Chighizola: None; F. Signorelli: None; Z. Zhang: None; T. Atsuma: AbbVie, 5, 6, Alexion, 5, 6, Astellas, 5, 6, Boehringer-Ingelheim, 2, Bristol-Myers Squibb, 6, Chugai, 5, 6, Daiichi Sankyo, 5, 6, Eisai, 5, 6, Eli Lilly, 5, 6, Gilead, 5, 6, GSK, 2, 5, Merck Sharp & Dohme, 2, 6, Mitsubishi Tanabe Pharma, 5, 6, Otsuka, 5, 6, Pfizer, 5, 6, Sanofi/Genzyme, 2, 6, Takeda, 5, 6, UCB, 5, 6; M. Efthymiou: Alexion, 1, Immune Tolerance Network (ITN), 1; D. Branch: UCB Pharmaceuticals, 5; C. Nalli: None; E. Rodriguez almaraz: None; M. Petri: Alexion, 1, Amgen, 1, AnaptysBio, 1, Annexon Bio, 1, Argenx, 1, Arhros-Focus Med/Ed, 6, AstraZeneca, 1, 5, Aurinia, 1, 5, 6, Axdev, 1, Biogen, 1, Boxer Capital, 2, Cabaletto Bio, 2, Caribou Biosciences, 2, CVS Health, 1, Eli Lilly, 1, 5, Emergent Biosolutions, 1, Exagen, 5, Exo Therapeutics, 2, Gilead Biosciences, 2, GlaxoSmithKlein(GSK), 1, 5, 6, Horizon Therapeutics, 2, Idorsia Pharmaceuticals, 2, IQVIA, 1, Janssen, 1, 5, Kira Pharmaceuticals, 2, MedShr, 6, Merck/EMD Serono, 1, Momenta Pharmaceuticals, 2, Nexstone Immunology, 2, Nimbus Lakshmi, 2, Proviant, 2, Sanofi, 2, Sinomab Biosciences, 2, Thermofisher, 5, UCB, 2; G. Pazzola: None; R. Cervera: None; B. Artim Esen: None; H. Shi: None; Y. Zuo: None; R. Quintana: None; R. Willis: None; A. Duarte-Garcia: None; M. Bertolaccini: None; H. Cohen: argenx, 1, Roche, 1, Technoclone (paid to University College London Hospital (UCLH) Charity), 6, UCB Biopharma (paid to UCLH Charity), 2; D. Erkan: Abbvie, 1, ACR/EULAR, 5, APS ACTION, 12, Executive Committee Co-chair, Argenx, 1, Aurinia, 6, Chugai, 1, Exagen, 5, GSK, 5, 6, NIH-NIAID, 5, Up-To-Date, 9; O. Of APS ACTION: None.