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Abstract Number: 2760

Antiphospholipid Syndrome Alliance for Clinical Trials & International Networking (APS ACTION) Clinical Database and Repository (“Registry”) Analysis: First and Recurrent Thrombosis Risk after 1201 Patient-Years of Follow-up

Ozan Unlu1, Danieli Andrade2, Alessandra Banzato3, D. Ware Branch4, Paul R. Fortin5, Maria Gerosa6, Roger A. Levy7, Michelle Lopes8, Michelle Petri9, Ignasi Rodriguez10, Maria Tektonidou11, Amaia Ugarte12, Rohan Willis13, Doruk Erkan14 and , on Behalf of APS ACTION .15, 1Barbara Volcker Center for Women and Rheumatic Diseases, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, 2Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR., Sao Paulo, Brazil, 3Department of Cardiac Thoracic and Vascular Sciences, Clinical Cardiology, Thrombosis Centre, University of Padova, Padova, Italy, 4Obstetrics and Gynecology, University of Utah and Intermountain Healthcare, Salt Lake City, UT, 5Medicine, CHU de Quebec - Universite de Laval, Quebec, QC, Canada, 6Istituto Ortopedico Gaetano Pini, University of Milan, Milano, Italy, 7Rheumatology, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, 8Rheumatology, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, 9Medicine (Rheumatology), Division of Rheumatology, Johns Hopkins University School of Medicine, MD, USA, Baltimore, MD, 10Rheumatology, Hospital Clinica, Barcelona, Spain, 11First Department of Internal Medicine, School of Medicine, National University of Athens, Athens, Greece, 12Autoimmune Diseases Research Unit, Department of Internal Medicine, BioCruces Health Research Institute, Hospital Universitario Cruces, University of the Basque Country, Biscay, Spain, 13Rheumatology/Dept Int Med, University of Texas Medical Branch, Galveston, TX, 14Rheumatology, Hospital for Special Surgery- Weill Cornell Medicine, New York, NY, 15., New York, NY

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Antiphospholipid antibodies, prevention, risk and thrombosis

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Session Information

Date: Tuesday, November 7, 2017

Title: Antiphospholipid Syndrome

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: APS ACTION Registry was created to study the natural course of disease over 10 years in persistently antiphospholipid antibody (aPL)-positive patients with/without other systemic autoimmune diseases. Previously, based on 16 new thrombotic events, we reported the annual recurrent and first thrombosis risk in persistently aPL-positive patients as 2.38 and 1.86%, respectively (Arthritis Rheumatol. 2016; 68 [suppl 10]).)

Methods: A web-based data capture system is used to store patient demographics, history, and medications. Inclusion criteria are positive aPL based on the Updated Sapporo Classification Criteria at least twice within one year prior to enrollment. Patients are followed every 12±3 months with clinical data and blood collection; they also receive advice on cardiovascular disease and thrombosis prevention at each visit. In this descriptive analysis, we report additional thrombotic events based on patients who completed one-, two-, three-, and four-year follow-up visits.

Results: As of 4/2017, 671 patients were included (aPL/APS without any other autoimmune disease [AIDx]: 436 [no thrombosis: 88; thrombotic APS [TAPS]: 241; obstetric APS [OAPS]: 47; and TAPS+OAPS: 60]; and aPL/APS associated with another AIDx: 235 [no thrombosis: 67; TAPS: 118; OAPS: 18; and TAPS+OAPS: 32]). Of 671 patients, 515 (77%), 391 (58%), 243 (36%), and 52 (8%) completed their one-, two-, three-, and four-year follow-up visits, respectively. Mean follow up were 2.38 years (844 patient-years [pt-y]) and 2.23 years (357 pt-y) for those with and without a history of thrombosis, respectively. Table demonstrates the demographic, clinical, and laboratory characteristics of 13 patients who had new thrombosis since our most recent analysis. Based on a total of 22 recurrent events (10 events during the 1st year; 5 during the 2nd; 6 during the 3rd; and 1 during 4th) and six initial (3 events during the 1st year; 2 during the 2nd; and 1 during the 3rd) since the inception of the registry, the incident thrombosis risk was 2.60 and 1.68 per 100 pt-y in patients with and without history of thrombosis, respectively (annual thrombosis risk 2.63% and 1.68%, respectively). In a subgroup analysis, the incident thrombosis risk was: a) 3.13 and 1.50 per 100 pt-y in patients with and without history of thrombosis, respectively for those with other AIDx and b) 2.38 and 1.79 per 100 pt-y in patients with and without history of thrombosis, respectively for those without other AIDx.

Conclusion: The incident thrombosis risk remains relatively low and commonly associated with LA- and/or triple aPL-positivity as well as non-aPL thrombosis risk factors. The risk is similar between aPL- positive patients with and without other AIDx. Annual and risk stratified analysis of APS ACTION registry will better determine the risk of thrombosis in persistently aPL-positive patients based on different risk profiles.

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Disclosure: O. Unlu, None; D. Andrade, None; A. Banzato, None; D. W. Branch, None; P. R. Fortin, None; M. Gerosa, None; R. A. Levy, None; M. Lopes, None; M. Petri, Exagen, 2; I. Rodriguez, None; M. Tektonidou, None; A. Ugarte, None; R. Willis, None; D. Erkan, None; O. B. O. A. A. ., None.

To cite this abstract in AMA style:

Unlu O, Andrade D, Banzato A, Branch DW, Fortin PR, Gerosa M, Levy RA, Lopes M, Petri M, Rodriguez I, Tektonidou M, Ugarte A, Willis R, Erkan D, . OBOAA. Antiphospholipid Syndrome Alliance for Clinical Trials & International Networking (APS ACTION) Clinical Database and Repository (“Registry”) Analysis: First and Recurrent Thrombosis Risk after 1201 Patient-Years of Follow-up [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/antiphospholipid-syndrome-alliance-for-clinical-trials-international-networking-aps-action-clinical-database-and-repository-registry-analysis-first-and-recurrent-thrombosis-ri/. Accessed .
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