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Author, year [Ref] | Type of study | patients | Sapporo criteria | Thrombotic events A/V | Treatments | Observation time | Recurrence rate | Main findings |
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Rosove and Brewer, 1992 [33] | RC | 70 | No | 31/39 | None LDASA Warfarin INR <2.0 Warfarin INR 2.0–2.9 Warfarin INR >3.0 | 161.2 pt.-years 37.8 pt.-years 11.3 pt.-years 40.9 pt.-years 110.2 pt.-years | 0.19/pt.-year 0.32/pt.-year 0.57/pt.-year 0.07/pt.-year 0 | Intermediate-high intensity warfarin conferred better antithrombotic protection than low-intermediate warfarin and LDASA |
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Derksen et al., 1993 [35] | RC | 19 | Yes | 0/19 | None Warfarin INR 2.5–4.0 | 8–248 months | NA | Anticoagulation was effective in preventing thrombosis compared to placebo |
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Khamashta et al., 1995 [34] | RC | 147 | Yes | 67/80 | None LDASA Warfarin INR <3.0 (+LDASA) Warfarin INR >3.0 (+LDASA) | 280.6 pt.-years 240.3 pt.-years 141.3 pt.-years 197.3 pt.-years | 0.29/pt.-year 0.18/pt.-year 0.23/pt.-year 0.015/pt.-year | Warfarin INR >3.0 ± LDASA was significantly more effective than warfarin INR <3.0 ± LDASA in preventing thrombotic recurrences |
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Krnic-Barrie et al., 1997 [15] | RC | 61 | No | 38/23 | None LDASA Warfarin Warfarin + LDASA | 124.9 pt.-years 36.6 pt.-years 63.0 pt.-years 30.6 pt.-years | A: 0.192/V: 0.11/pt.-year A: 0.082/V: 0.027/pt.-year A: 0.048/V: 0/pt.-year A: 0/V: 0/pt.-year | Warfarin treatment, with or without LDASA, was more effective than placebo and LDASA alone in preventing recurrence |
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Munoz-Rodríguez et al., 1999 [40] | RC | 47 | Yes | 19/28 | None LDASA Warfarin INR 2.5–3.5 | 4–50 months | 91% 41% 19% | Warfarin was more effective than placebo and LDASA in preventing thrombotic recurrences |
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Ruiz-Irastorza et al., 2002 [14] | RC | 66 | Yes | 51/32 | Warfarin INR 3.0–4.0 | 66 pt.-years | 0.09/pt.-year | Despite high-intensity warfarin, the risk of thrombotic recurrences was high |
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Wittkowsky et al., 2006 [39] | RC | 36 | Yes | 14/16 | Warfarin INR 2.0–3.0 Warfarin INR >3.0 | 62.5 pt.-years | 0.096/pt.-year | 67% of the recurrences occurred at INR <3.0 |
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Girón-González et al., 2004 [41] | PC | 158 | Yes | 70/106 | Warfarin INR 2.5–3.5 | 624 pt.-years | 0.005/pt.-year | Thrombotic recurrence was associated with INR below target |
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Ames et al., 2005 [27] | PC | 67 | Yes | 17/50 | Warfarin INR <2.0 Warfarin INR 2.0–3.0 Warfarin INR 3.1–4.0 Warfarin INR >4.0 | 9 weeks 122 weeks 9 weeks 5 weeks | 0 0.04/pt.-year 0.1/pt.-year 0 | Recurrence rates were higher in patients receiving high-intensity than low-intensity anticoagulation |
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Ginsberg et al., 1995 [30] | PC subgroup analysis | 16 | No | 0/16 | None Warfarin INR 2.0–3.0 | 8.7 months 3 months | 18% 0 | No recurrence was observed with warfarin INR 2.0–3.0 |
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Prandoni et al., 1996 [29] | RC subgroup analysis | 15 | Yes | 0/15 | None Warfarin INR 2.0–3.0 | 1–10 years | 0.038/pt.-year 0 | No recurrence was observed with warfarin INR 2.0–3.0 |
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Rance et al., 1997 [31] | RC subgroup analysis | 27 | No | 0/27 | None Warfarin INR 2.0–3.0 | 1–4 years | NA 0 | No recurrence was observed with warfarin INR 2.0–3.0 |
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Schulman et al., 1998 [32] | RCT subgroup analysis | 68 | No | 0/68 | None Warfarin INR 2.0–2.8 | 4 years | 0.01/pt.-year 0 | No recurrence was observed with warfarin INR 2.0–2.8 |
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Levine et al., 2004 [42] | RCT subgroup analysis | 720 | No | 720/0 | ASA Warfarin INR 1.4–2.8 | 2 years | 22.18% 26.15% | ASA and low-intensity anticoagulation were equally effective for secondary stroke prevention |
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Crowther et al., 2003 [19] | RCT | 114 | Yes | 27/87 | Warfarin INR 2.0–3.0 Warfarin INR 3.1–4.0 | 2.7 years | 0.013/pt.-year 0.032/pt.-year | Warfarin at INR 2.0–3.0 was as effective as warfarin at INR 3.1–4.0 in secondary prevention of thrombosis |
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Finazzi et al., 2005 [20] | RCT | 109 | Yes | 44/75 | Warfarin INR 2.0–3.0 Warfarin INR 3.0–4.5 | 3.3 years 3.5 years | 0.016/pt.-year 0.031/pt.-year | Warfarin at INR 2.0–3.0 was as effective as warfarin at INR 3.1–4.5 in secondary prevention of thrombosis |
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Tan et al., 2009 [16] | RC | 59 | Yes | 29/30 | Warfarin INR 2.0–3.0 Warfarin INR 3.1–4.0 | 8.8 years | 23.7% | Warfarin at INR 2.0–3.0 is as effective as warfarin at INR >3 in preventing venous rethromboses and less effective in preventing arterial rethromboses |
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Cervera et al., 2009 [2] | PC | 1000 | Yes | | LDASA Warfarin | 5 years | 14% 21.4% | Antiaggregation and anticoagulation are associated with a significant recurrence rate |
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Pengo et al., 2010 [18] | RC | 160 | Yes | 76/69 | No treatment Warfarin (median INR 2.3) | 10 years | 44.2% | Oral anticoagulation was the only predictor of thromboembolic events |
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Okuma et al., 2010 [43] | RCT | 20 | No | 0/20 | LDASA Warfarin INR 2.0–3.0 + LDASA | 3.9 years | NA | Warfarin + LDASA was more effective that LDASA alone in secondary prevention of stroke |
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Fujieda et al., 2012 [44] | RC | 82 | Yes | 82/0 | Warfarin Antiplatelet Warfarin + antiplatelet Dual antiplatelet | 8.5 years | 3.4/100/pt.-year 0 | Dual antiplatelet regimen was beneficial in preventing recurrences in refractory APS |
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