The management of thrombosis in the antiphospholipid-antibody syndrome
Open accessAbstract
BACKGROUND: The antiphospholipid-antibody syndrome is a thrombophilic disorder in which venous or arterial thrombosis, or both, may occur in patients with antiphospholipid antibodies. The optimal treatment of these patients is unclear. We assessed the efficacy of warfarin, low-dose aspirin, or both in the secondary prevention of thrombosis in patients with the syndrome. METHODS: One hundred forty-seven patients (124 [84 percent] of whom were female) with the antiphospholipid-antibody syndrome and a history of thrombosis were studied retrospectively. The syndrome was primary in 62 patients and was associated with systemic lupus erythematosus in 66 patients and lupus-like disease in 19. Each patient's history was reviewed. RESULTS: One hundred one patients (69 percent) had a total of 186 recurrences of thrombosis. The median time between the initial thrombosis and the first recurrence was 12 months (range, 0.5 to 144 months). Treatment with high-intensity warfarin (producing an international normalized ratio of > or = 3) with or without low-dose aspirin (75 mg per day) was significantly more effective (P < 0.001 by the log-rank test) than treatment with low-intensity warfarin (producing an international normalized ratio of < 3) with or without low-dose aspirin or treatment with aspirin alone in preventing further thrombotic events (recurrence rates per patient-year, 0.013, 0.23, and 0.18, respectively). The rate of recurrence of thrombosis was highest (1.30 per patient-year) during the first six months after the cessation of warfarin therapy. Complications involving bleeding occurred in 29 patients during warfarin therapy and were severe in 7 (0.071 and 0.017 occurrence per patient-year, respectively). CONCLUSIONS: The risk of recurrent thrombosis in patients with the antiphospholipid-antibody syndrome is high. Long-term anticoagulation therapy in which the international normalized ratio is maintained at or above 3 is advisable in these patients.
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In patients with antiphospholipid syndrome and first venous thrombosis, there is no additional benefit of a vitamin K antagonist target INR of 3-4 versus 2-3, based on an RCT and pooled data from five studies that included a majority with venous events.
“Data from an RCT21 reporting exclusively on patients with venous events and pooled data from five studies that included a majority with venous events21–25 showed no additional benefit of a target INR of 3–4 vs INR of 2–3.”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [24]
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Experimental — accuracy not yet measuredPooled data from two retrospective studies and two RCTs showed no statistically significant difference in thrombosis recurrences between vitamin K antagonist target INR 3-4 and INR 2-3 (relative risk 0.46 (0.06-3.52)).
“Pooled data from two retrospective studies and two RCTs21–24 showed that there was no statistically significant difference in thrombosis recurrences between treatment with VKA with a target INR of 3–4 and treatment with INR of 2–3 (relative risk (RR) 0.46 (0.06–3.52)).”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [24]
Table 3 (p. 995) reports fewer recurrent events during warfarin treatment at INR ≥3 than at INR <3: 0.015 versus 0.23 events per patient-year. The Discussion (p. 996) says INR 2–3 did not prevent thrombotic events and recommends maintaining INR above 3, contrary to the claimed finding of no significant difference. This paper does not report the pooled RR of 0.46; its Table 3 relative risks compare each treatment with no treatment, not the two INR targets with each other. (LLM, conf=0.86)
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- Authors
- Khamashta, M. A., Cuadrado, M. J., Mujic, F., Taub, N. A., Hunt, B. J., & Hughes, G. R. V.
- Affiliations
- St Thomas' Hospital (GB)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-04-13
- Volume
- 332
- Issue
- 15
- Pages
- 993-997
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2327141264
- Cited by
- 1,450
- References
- 37
- Citations by year
- 2026: 9 · 2025: 11 · 2024: 13 · 2023: 17 · 2022: 10 · 2021: 14 · 2020: 26 · 2019: 24 · 2018: 21 · 2017: 32 · 2016: 18 · 2015: 24 · 2014: 41 · 2013: 28 · 2012: 36
- FWCI
- 63.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Jean Shanks Foundation
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- antiphospholipid syndrome, thrombosis, warfarin, low-dose aspirin, anticoagulation, recurrent thrombosis, secondary prevention, systemic lupus erythematosus, bleeding complications, international normalized ratio
- MeSH terms
- Adolescent, Adult, Anticoagulants, Aspirin, Female, Follow-Up Studies, Humans, Lupus Erythematosus, Systemic, Male, Middle Aged, Recurrence, Retrospective Studies, Thrombosis, Warfarin, Antiphospholipid Syndrome
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