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. 2019 Apr 28;5(1):e000924. doi: 10.1136/rmdopen-2019-000924

Table 3.

Studies of intensity of oral anticoagulation treatment in patients with antiphospholipid syndrome and previous arterial thrombosis

Reference Design Comparison Percentage with arterial thrombosis history Intervention Control Number of patient-years, intervention Number of patient-years, control Events, intervention Events, control Relative effect (95% CI) Study quality
Recurrent thrombosis
Crowther et al 200325 RCT Direct 100 Warfarin INR 3–4 Warfarin INR 2–3 35 py 38 py 8.6/100 py 2.6/100 py HR 3.1 (0.3 to 30.0) Low risk of bias*
Finazzi et al 200526 RCT Indirect 32 Warfarin INR 3–4.5 Warfarin INR 2–3 189 py 181 py 3.1/100 py 1.6/100 py High risk of bias*
Rosove and Brewer 199227 Retrospective cohort Indirect 44 Warfarin INR 3–4 Warfarin INR 2–3 110.2 py 40.9 py 0 7/100 py Intermediate quality
Khamashta et al 199528 Retrospective cohort Indirect 46 Warfarin ≥INR 3.0 Warfarin INR <3.0 197.3 py 141.3 py 1.5/100 py 23/100 py High quality
Total Direct and indirect RR 0.46 (0.06 to 3.52)
I2=83%
Major bleeding
Crowther et al 200325 RCT Direct 100 Warfarin INR 3–4 Warfarin INR 2–3 111 py 133 py 2.7/100 py 3.0/100 py HR 1.0 (0.02 to 4.8) Low risk of bias*
Finazzi et al 200526 RCT Indirect 32 Warfarin INR 3–4.5 Warfarin INR 2–3 189 py 181 py 1.0/100 py 1.6/100 py High risk of bias*
Khamashta et al 199528 Retrospective cohort Indirect 46 Warfarin ≥3.0 Warfarin <3.0 197.3 py 141.3 py 1.7/100 py 0 High quality
Total Direct and indirect RR 0.86 (0.28 to 2.67)
I2=0%

*Risk of bias for randomised controlled trials using the Cochrane tool.

INR, international normalised ratio; RCT, randomised controlled trial; py, patient-years.