Bleeding events in thrombotic antiphospholipid syndrome: prevalence, severity, and associated damage accrual

Research and Practice in Thrombosis and Haemostasis · 4 authors, 5 centres

AI SUMMARY

FIDELITY 100%

POPULATION197 patients with thrombotic APS (2006 Sydney criteria), median age at onset 40 years, 71.1% female, 65.9% primary APS, followed for median 10 years (2412 patient-years)

INTERVENTIONAntithrombotic therapy (98.5% anticoagulation, 26.4% antiplatelet, 24.9% both)

COMPARISONNo formal comparison group; descriptive analysis of bleeding events and damage

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

In a retrospective study of 197 patients with thrombotic antiphospholipid syndrome (APS) followed for up to 43 years, 40.6% experienced at least one bleeding event, with an incidence of 6.9 events per 100 patient-years. Major bleeding occurred in 15.7% of patients (1.6 events per 100 patient-years), and 7.6% of all patients sustained permanent organ damage from bleeding, most commonly affecting the central nervous system. These findings highlight that bleeding-related damage is not captured by the current Damage Index for Antiphospholipid Syndrome (DIAPS), suggesting a need for its revision.

Full summary

2,559 CHARS

**Background:** Thrombotic antiphospholipid syndrome (APS) is a multisystemic autoimmune thrombophilia requiring lifelong anticoagulation, which increases bleeding risk. The Damage Index for Antiphospholipid Syndrome (DIAPS) does not include bleeding-related damage. This study aimed to characterize the prevalence, severity, and damage associated with bleeding events in patients with thrombotic APS.

**Methods:** This single-center retrospective analysis included 197 patients with thrombotic APS (2006 Sydney criteria) attending rheumatology/hematology clinics at University College London Hospital until December 2019. Patient files were reviewed for up to 43 years. Bleeding events were classified according to ISTH definitions into major bleedings and nonmajor bleedings (minor and clinically relevant nonmajor [CRNM] bleedings). Damage was defined as a bleeding event resulting in permanent (>6 months) decrease in organ function or total/partial organ resection. Data were collected by two physicians and analyzed using STATA version 16.

**Key Results:** Among 197 patients (2412 patient-years [PYs] of follow-up), all exposed to antithrombotic therapy, 40.6% (80/197) experienced 167 bleeding events (6.9 events per 100 PYs). Of these, 61.3% (49/80) had nonmajor bleedings (77.2% of bleedings: 42.6% minor, 57.4% CRNM) and 38.8% (31/80) had major bleedings (22.8% of bleedings; 1.6 events per 100 PYs). Soft/connective tissue was affected in 44.3% of bleedings (94.6% nonmajor), central nervous system (CNS) in 20.9% (62.9% major), genitourinary in 22.2%, and abdominal in 10.8%. Bleeding was spontaneous in 90.4% of cases. Thrombocytopenia was present in 28.1% of bleedings and likely involved in 62.2% of those. Damage occurred in 11.4% of bleedings (19/167), affecting 7.6% of patients (15/197). Most damage (73.7%) was CNS-related (8.4% of all bleedings), leading to permanent motor/sensory deficits, seizures, or death. Gynecologic damage (hysterectomy for abnormal uterine bleeding) occurred in 3 patients, and abdominal damage (organ resection) in 2 patients. No damage was observed in soft/connective tissue.

**Clinical Implications:** Approximately 40% of thrombotic APS patients experience bleeding, and nearly 8% sustain permanent organ damage not captured by the current DIAPS. The CNS is the most common site of major bleeding and damage. These findings underscore the need to include bleeding-related damage in future revisions of the DIAPS and to carefully balance thrombotic and bleeding risks when managing anticoagulation in APS.

PICO

PPOPULATION

197 patients with thrombotic APS (2006 Sydney criteria), median age at onset 40 years, 71.1% female, 65.9% primary APS, followed for median 10 years (2412 patient-years)

IINTERVENTION

Antithrombotic therapy (98.5% anticoagulation, 26.4% antiplatelet, 24.9% both)

OOUTCOME

Prevalence and severity of bleeding events (ISTH definitions), damage accrual (permanent organ function decrease ≥6 months or organ resection)

STUDY TYPE

cohort

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10879794

Bleeding events in thrombotic antiphospholipid syndrome: prevalence, severity, and associated damage accrual

Research and Practice in Thrombosis and Haemostasis

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ABSTRACT

Abstract Background Life-long anticoagulation increases bleeding risk in patients with antiphospholipid syndrome (APS). The Damage Index for Antiphospholipid Syndrome does not include bleeding events in damage accrual. Objectives We aimed to characterize the prevalence, severity, and damage associated with bleeding events in patients with APS. Methods This was a single-center retrospective analysis of patients with thrombotic APS (2006 Sydney criteria). Bleeding events were reviewed up to 43 years and classified according to the ISTH definitions into 2 groups: 1) major bleedings and 2) nonmajor bleedings (minor bleedings and clinically relevant nonmajor bleedings). Damage events were recorded as bleeding events a) resulting in permanent (>6 months) decrease in organ function and b) complicated by total/partial organ resection. Results Among 197 patients (2412 patient-years [PYs] of follow-up), all of whom had been exposed to antithrombotic therapy, 40.6% experienced 167 bleedings (6.9 events per 100 PYs), of whom 61.3% had nonmajor bleedings (77.2% of bleedings: 42.6% minor, 57.4% clinically relevant nonmajor) and 38.8% had major bleedings (22.8% of bleedings; 1.6 events per 100 PYs). Soft/connective tissue was affected in 44.3% of bleedings, and 94.6% were nonmajor bleedings. Central nervous system was affected in 20.9% of bleedings, and 62.9% were major bleedings. Bleeding events were spontaneous in 90.4% of cases, and thrombocytopenia was likely involved in 62.2% of bleedings. Damage occurred in 11.4% of bleedings and affected 7.6% of patients. Most of the damage was associated with central nervous system events (8.4% of all bleedings). Conclusion Approximately 40% of patients experienced at least 1 bleeding, and almost 8% of patients were left with organ damage not recognized by the current version of the Damage Index for Antiphospholipid Syndrome. Keywords: anticoagulants, antiphospholipid syndrome, antithrombotic agents, bleeding, damage, prevalence

CITATION EXPORT

Pedro Gaspar, Prabal Mittal, Hannah Cohen et al.. Bleeding events in thrombotic antiphospholipid syndrome: prevalence, severity, and associated damage accrual. Research and Practice in Thrombosis and Haemostasis. (2024). https://doi.org/10.1016/j.rpth.2024.102327

AUTHORS

4 · 5 CENTRES

Pedro Gaspar, Prabal Mittal, Hannah Cohen, David A Isenberg

1Department of Internal Medicine, Hospital Santa Maria, Unidade Local de Saúde Santa Maria, Lisbon, Portugal
2Instituto de Medicina Molecular João Lobo Antunes, Centro Académico de Medicina de Lisboa, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
3Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK
4Haemostasis Research Unit, Department of Haematology, University College London, London, UK
5Centre for Rheumatology, Division of Medicine, University College London, London, UK