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.