Lupus & antiphospholipid syndrome
Thrombosis recurrence and major bleeding in non-anticoagulated thrombotic antiphospholipid syndrome patients: Prospective study from antiphospholipid syndrome alliance for clinical trials and international networking (APS ACTION) clinical database and repository (“Registry”)
Main finding · 5-year thrombosis recurrenceResult — go to the resultHazard ratio 1.38 95% CI 0.53–3.56Authors' conclusion
Fourteen percent of the TAPS patients were not anticoagulated at recruitment. Their recurrent thrombosis risk did not differ compared to matched anticoagulated TAPS patients
Study context
- Population
- Thrombotic APS patients in the APS ACTION international registry; 94 (14 %) of 662 not anticoagulatedmedian follow-up 5 years [IQR 3 to 8]
- Participants
- 93 vs 181
- Exposure
- Non-anticoagulated vs anticoagulated thrombotic APS
- Non-anticoagulatedn = 93
- Anticoagulatedn = 181reference
- Outcome
- Thrombosis recurrence and major bleeding
- Follow-up
- Median 5 years
Methodological detailsinternational registry, matched on gender, age, type of previous thrombosis and associated autoimmune disease, Kaplan-Meier method, marginal Cox regression model
- International registry
- Matched on gender, age, type of previous thrombosis and associated autoimmune disease
- Kaplan-Meier method
- Marginal Cox regression model
Main finding
5-year thrombosis recurrence
Hazard ratio
1.38
95% CI 0.53–3.56
P = 0.50
Non-anticoagulatedvs Anticoagulated
HR 1.38 (95% CI 0.53–3.56); P = 0.50
As reported in the abstract
- 5-year thrombosis recurrence rates, as printed (abstract does not state which rate belongs to which group)
- 12 % versus 10 %
Observational data: associations, not effects.
Further findings
Features of non-anticoagulated vs anticoagulated patients
- Non-anticoagulated more likely to receive antiplatelet therapy
- P < 0.001
- Non-anticoagulated less likely to have >1 previous thrombosis
- P < 0.001
- Non-anticoagulated less likely to have lupus anticoagulant positivity
- P = 0.01
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| 5-year major bleeding · median 5 yearsMarginal Cox's regression model · matched cohort | 0.53 (0.15–1.86) | P = 0.32 | |
| 0.10.31310Hazard ratio (log scale) |
- 5-year major bleeding — 5-year major bleeding rates, as printed (abstract does not state which rate belongs to which group)
- 6 % versus 7 %
Original publication
Thrombosis recurrence and major bleeding in non-anticoagulated thrombotic antiphospholipid syndrome patients: Prospective study from antiphospholipid syndrome alliance for clinical trials and international networking (APS ACTION) clinical database and repository (“Registry”). Semin Arthritis Rheum. Published 20 December 2023. doi:10.
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