Recurrent thrombosis and hemorrhagic events in a large single-center primary antiphospholipid syndrome cohort: Results from APS-Rio cohort after nearly 1,000 patient-years of follow-up

Signorelli, F; Balbi, GGM; Bastos, VP; Reis-Carvalho, T; Klumb, EM; Levy, RA

doi:10.1016/j.semarthrit.2025.152873

Lupus & antiphospholipid syndrome

Recurrent thrombosis and hemorrhagic events in a large single-center primary antiphospholipid syndrome cohort: Results from APS-Rio cohort after nearly 1,000 patient-years of follow-up

Semin Arthritis RheumPublished 8 Nov 2025Prospective cohort study

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Authors' conclusion

Thrombotic events were frequent in PAPS, even with therapeutic INR. Diabetes increased 4-fold the risk of a first thrombotic event.

Study context

Population: Primary APS (Primary Antiphospholipid Syndrome (PAPS)) patients, single-centre prospective cohort (APS-Rio), followed ≈7.5 years
Participants: 155 participants942 patient-years

Outcome: Incidence of new thrombotic and hemorrhagic events

Methodological detailssingle-centre, Kaplan-Meier curves, log-rank test and Cox proportional hazards modeling

Single-centre
Kaplan-Meier curves, log-rank test and Cox proportional hazards modeling

Main finding

As reported in the abstract

Thrombotic events (all), incidence rate

32 thrombotic events (18 arterial, 12 venous, 2 thrombotic microangiopathies) in 26 patients; incidence rate per 100 patient-years

3.4

Observational data: associations, not effects.

Further findings

Risk factor for first thrombotic event: diabetes

	← Lower risk ←→ Higher risk →	HR (95 % CI)	P value
DiabetesIndependently associated	0.10.31310	4.10 (1.72–9.78)	P = 0.001
	0.10.31310Hazard ratio (log scale)

First thrombotic event, incidence per 100 patient-years · mean 3.2 ± 2.0 years

Incidence of first thrombotic event per 100 patient-years: 3.2

Safety

First major hemorrhages

	← Lower risk ←→ Higher risk →	HR (95 % CI)	P value
Baseline microvascular involvementAssociated risk factor	0.050.21520	9.04 (2.15–37.92)	P = 0.003
	0.050.21520Hazard ratio (log scale)

First major hemorrhages — First major hemorrhages recorded: 8
First major hemorrhages — Incidence per 100 patient-years: 0.9

Original publication

Recurrent thrombosis and hemorrhagic events in a large single-center primary antiphospholipid syndrome cohort: Results from APS-Rio cohort after nearly 1,000 patient-years of follow-up. Semin Arthritis Rheum. Published 8 November 2025. doi:10.1016/j.semarthrit.2025.152873

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