Antiphospholipid Syndrome Alliance for Clinical Trials & International Networking Clinical Database and Repository Analysis: Determinants of Thrombosis in Patients Presenting with Obstetric APS

Guilherme Ramires de Jesus¹, STEPHANE ZUILY², Doruk Erkan³, Roger A. Levy⁴ and on Behalf of APS ACTION, ¹Department of Obstetrics, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, ²CHU de Nancy, Regional Competence Centre For Rare Vascular And Systemic Autoimmune Diseases, Vascular Medicine Division, NANCY, France, ³Rheumatology, Hospital for Special Surgery, New York, NY, ⁴Rheumatology, Department of Rheumatology, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Antiphospholipid, pregnancy and thrombosis

Session Information

Date: Tuesday, November 10, 2015

Title: Antiphospholipid Syndrome: Clinical

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: APS ACTION Clinical Database and Repository (“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. The natural post-partum course of APS patients presenting with pure obstetric APS can be complicated by thrombosis; however, the incidence rate as well as the determinants of thrombosis are not well determined. Therefore, our objective was to compare the clinical and laboratory characteristics of the obstetric APS patients with or without thrombosis.

Methods: A web-based data capture system is used to store patient demographics, aPL-related history, and medications. The inclusion criteria are positive aPL based on the Updated Sapporo Classification Criteria at least twice within one year prior to enrollment. For the purpose of this cross-sectional baseline data analysis, we included obstetric APS patients with or without thrombosis after the initial diagnosis of pregnancy morbidity (PM) . We compared variables using Chi-Square and T-test, or non-parametric tests accordingly.

Results: Of 550 patients included in the registry as of May 2015, 173/419 (41.2%) women had any PM and 126/173 (72.8%) fulfilled the obstetric APS criteria, 74/126 (58.7%) with thrombotic APS (venous: 43; arterial: 22; and both: 9). Thrombosis occurred in 47/74 (63.5%) patients following the obstetric APS diagnosis (mean time between PM and first non-gravid thrombosis: 7.6±8.2 years). Table shows the clinical and laboratory characteristics of patients with pure obstetric APS, compared to those with presenting with obstetric APS followed by non-gravid thrombosis. Patients with obstetric APS only, compared to those with obstetric and thrombotic APS, were more likely to “ever” use aspirin and hydroxychloroquine (data not shown).

Conclusion: The cross sectional analysis of the baseline characteristics of a large scale aPL/APS registry demonstrates that: a) approximately 60% of thrombotic APS patients present initially with pregnancy morbidity; and b) earlier age during the first pregnancy morbidity, selected cardiovascular risk factors and non-criteria aPL manifestations, and lupus anticoagulant test positivity may increase the risk of future thrombosis after an aPL-related pregnancy morbidity.

Variables, n (%)	Obstetric APS only (n=52)	Obstetric APS followed by Thrombosis (n=47)	P value
Demographics Age of first pregnancy morbidity	28.94 + 6.77	26.25 + 5.52	0.03
Associated Autoimmune Disease No SLE	28 (53.8%) 12 (23.0%)	29 (61,7%) 8 (17.0%)	0.21 0.22
Lupus-like disease	6 (11.5%)	2 (4.2%)	0.09
Other	6 (11.5%)	8 (17.0%)	0.43
Vascular Events
Venous Thrombosis	NA	25 (53.1%)	NA
Arterial Thrombosis	NA	17 (36.1%)	NA
Venous and Arterial Thrombosis	NA	5 (10.6%)	NA
Cardiovascular Risk Factors*
Hypertension on medication	11 (21.1%)	20 (42.5)	0.01
Diabetes on medication	1 (1.9%)	3 (6.3%)	0.13
Hyperlipidemia on medication	3 (5.7%)	8 (17.0%)	0.03
Obesity (BMI > 30)	6 (11.5%)	11 (23.4%)	0.059
Smoking (ever)	9 (17.3%)	18 (38.2%)	0.009
First Pregnancy Morbidity
> Three (pre)-embryoic loss	4 (7.6%)	5 (10.6%)	0.30
Fetal Loss	34 (65.3%)	30 (63.8%)	0.43
Premature Birth < 34 week	14 (26.9%)	12 (25.5%)	0.43
Non-Criteria Manifestations
Superficial Vein Thrombosis	1 (1.9%)	6 (12.7%)	0.01
Transient Ischemic Attack	4 (7.6%)	7 (14.8%)	0.12
Livedo	6 (11.5%)	11 (23.4%)	0.059
Thrombocytopenia	12 (23.0%)	10 (21.2%)	0.41
Hemolytic Anemia	3 (5.7%)	4 (8.5%)	0.29
Heart Valve Disease	1 (1.9%)	6 (12.7%)	0.01
Skin Ulcer	0	4 (8.5%)	NA
aPL-Nephropathy	2 (3.8%)	0	NA
Cognitive Dysfunction	0	0	NA
Laboratory parameters
Lupus Anticoagulant (alone or with other autoantibodies)	35 (67.3%)	42 (89.3%)	0.004
Triple Positivity	17 (32.6%)	13 (27.6%)	0.29

*at the time of the registry entry

Disclosure: G. Ramires de Jesus, None; S. ZUILY, None; D. Erkan, Lupus Clinical Trials Consortium, 2,New York Community Trust, 2,Alexion Pharmaceuticals, Inc., 2,Alexion Pharmaceuticals, Inc., 5,EMD Serono, 2; R. A. Levy, None.

To cite this abstract in AMA style:

Ramires de Jesus G, ZUILY S, Erkan D, Levy RA. Antiphospholipid Syndrome Alliance for Clinical Trials & International Networking Clinical Database and Repository Analysis: Determinants of Thrombosis in Patients Presenting with Obstetric APS [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/antiphospholipid-syndrome-alliance-for-clinical-trials-international-networking-clinical-database-and-repository-analysis-determinants-of-thrombosis-in-patients-presenting-with-obstetric-aps/. Accessed .

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