Table 2.

Primary and secondary outcome analysis by risk category and whether anticoagulants were continued or discontinued in events (%) per 100 patient years (95% confidence intervals)

Groups	Low risk women* who discontinued oral anticoagulants (n=591)	Men and high risk women*		High risk* women who discontinued oral anticoagulants (n=101)
		Discontinued oral anticoagulants (n=323)	Continued oral anticoagulants (n=1802)
Primary outcome:
Risk of recurrent major† VTE	3.0 (1.8 to 4.8)	8.1 (5.2 to 11.9)	1.6 (1.1 to 2.3)	7.4 (3.0 to 15.2)
Secondary outcomes:
Risk of major‡ bleed	0.2 (0 to 1.0)	0.6 (0 to 2.3)	1.2 (0.8 to 1.8)	2.1 (0.3 to 7.6)
Recurrent PE death	0	0	0.1 (0 to 0.3)	0
Non-PE death	0.2 (0 to 1.0)	0.1.0 (0.2 to 2.8)	0.4 (0.2 to 0.8)	2.1 (0.3 to 7.6)

VTE=venous thromboembolism; PE=pulmonary embolism.

Not shown are results in low risk women who continued anticoagulants (n=31), patients with no follow-up (n=32), or not classifiable owing to missing D-dimer result (n=6).

*HERDOO2 criteria: hyperpigmentation, oedema, or redness in either leg at 5-12 months at baseline or enrolment visit, VIDAS D-dimer ≥250 μg/L during anticoagulant treatment, obesity with body mass index ≥30, or older age, ≥65 years. Low risk=0 or 1 of the criteria present; high risk=≥2 or the criteria present.

†Proximal deep vein thrombosis and segmental or greater PE.

‡According to definition by International Society on Thrombosis and Haemostasis.²³