Studies reporting thrombotic outcomes in APS patients treated with DOACs
References . | Study design . | N . | Treatment . | Follow-up (range) . | Thrombosis % (n/N) . | Recurrent thrombosis by history of ATE, % (n/N) . | Recurrent thrombosis by triple antibody positivity, % (n/N) . | ||
---|---|---|---|---|---|---|---|---|---|
+Hx . | −Hx . | +tAb . | −tAb . | ||||||
113 | Retrospective | 26 | R: 15; D: 11; initial, 6 | Mean 19 mo (8-29) | 3.8 (1/26) | 0 (0/13) | 7.7 (1/13) | 0 (0/19) | 14.3 (1/7) |
114 | Retrospective | 35 | R: 35 | Median 10 mo (6-24) | 0 (0/35) | — (Excluded) | 0 (0/35) | NR | NR |
43 | Retrospective | 8 | R: 8 | 5-365 d* | 75 (6/8) | 50 (1/2) | 83.3 (5/6) | 66.7 (2/3) | 80 (4/5) |
115 | Retrospective | 8 | R: 7; A: 1 | Mean 19 mo (2-36) | 0 (0/8) | 0 (0/6) | 0 (0/2) | 0 (0/1) | 0 (0/7) |
116 | Registry | 19 | R: 17; D: 2; initial: 2 | Mean 23.3 mo (1-84) | 31.6 (6/19)† | NR | NR | NR | NR |
117 | Retrospective | 23 | R: 23; initial: 3 | Median 20 mo | 4.3 (1/23) | NR | NR | NR | NR |
44 | RCT | 54 | R: 54 | 210 d | 0 (0/54) | — (Excluded) | 0 (0/54) | 0 (0/14) | 0% (0/40) |
118 | Prospective/registry | 23 | R: 23; initial: 6 | Mean 35.6 (29-40) | 26.1 (6/23) | 100 (3/3) | 15 (3/20) | 50 (1/2) | 23.8 (5/21) |
116,119 | Prospective‡ | 56 | R: 49; A: 3; D: 4 | Mean 22.1 mo (2-43) | 10.7 (6/56);5.8/100 patient-years | 25 (2/8)§ | 8.3 (4/48) | 25 (4/16)§ | 5 (2/40) |
120 | Retrospective | 24 | NR | Median 31 mo | 8.3 (2/24) | NR | NR | NR | NR |
121 | Retrospective | 41 | R: 29; A: 7; D: 5; initial: 14 | Median 48 mo (14-62) | 12.2 (5/41) | NR | NR | NR | NR |
Crowther and Legault 2018 | Prospective | 82 | R: 82 | Mean 18.8 mo | 4.9 (4/82);4.0/129.8 patient-years | 20 (1/5) | 3.9 (3/77) | — (0/0) | 4.9 (4/82) |
37 | RCT‖ | 59 | R: 59 | Mean 569 d | 12 (7/59) | 19 (4/21) | 7.9 (3/38) | 12 (7/59) | — (0/0) |
Pooled: 9.6 (44/458) (95% CI, 7.2-12.7) | Pooled: 19.0 (11/58) (95% CI, 10.9-30.9) | Pooled: 6.5 (19/293) (95% CI, 4.2-9.9) | Pooled: 12.3 (14/114) (95% CI, 7.5-19.6) | Pooled 10.0 (16/202) (95% CI, 4.9-12.5) |
References . | Study design . | N . | Treatment . | Follow-up (range) . | Thrombosis % (n/N) . | Recurrent thrombosis by history of ATE, % (n/N) . | Recurrent thrombosis by triple antibody positivity, % (n/N) . | ||
---|---|---|---|---|---|---|---|---|---|
+Hx . | −Hx . | +tAb . | −tAb . | ||||||
113 | Retrospective | 26 | R: 15; D: 11; initial, 6 | Mean 19 mo (8-29) | 3.8 (1/26) | 0 (0/13) | 7.7 (1/13) | 0 (0/19) | 14.3 (1/7) |
114 | Retrospective | 35 | R: 35 | Median 10 mo (6-24) | 0 (0/35) | — (Excluded) | 0 (0/35) | NR | NR |
43 | Retrospective | 8 | R: 8 | 5-365 d* | 75 (6/8) | 50 (1/2) | 83.3 (5/6) | 66.7 (2/3) | 80 (4/5) |
115 | Retrospective | 8 | R: 7; A: 1 | Mean 19 mo (2-36) | 0 (0/8) | 0 (0/6) | 0 (0/2) | 0 (0/1) | 0 (0/7) |
116 | Registry | 19 | R: 17; D: 2; initial: 2 | Mean 23.3 mo (1-84) | 31.6 (6/19)† | NR | NR | NR | NR |
117 | Retrospective | 23 | R: 23; initial: 3 | Median 20 mo | 4.3 (1/23) | NR | NR | NR | NR |
44 | RCT | 54 | R: 54 | 210 d | 0 (0/54) | — (Excluded) | 0 (0/54) | 0 (0/14) | 0% (0/40) |
118 | Prospective/registry | 23 | R: 23; initial: 6 | Mean 35.6 (29-40) | 26.1 (6/23) | 100 (3/3) | 15 (3/20) | 50 (1/2) | 23.8 (5/21) |
116,119 | Prospective‡ | 56 | R: 49; A: 3; D: 4 | Mean 22.1 mo (2-43) | 10.7 (6/56);5.8/100 patient-years | 25 (2/8)§ | 8.3 (4/48) | 25 (4/16)§ | 5 (2/40) |
120 | Retrospective | 24 | NR | Median 31 mo | 8.3 (2/24) | NR | NR | NR | NR |
121 | Retrospective | 41 | R: 29; A: 7; D: 5; initial: 14 | Median 48 mo (14-62) | 12.2 (5/41) | NR | NR | NR | NR |
Crowther and Legault 2018 | Prospective | 82 | R: 82 | Mean 18.8 mo | 4.9 (4/82);4.0/129.8 patient-years | 20 (1/5) | 3.9 (3/77) | — (0/0) | 4.9 (4/82) |
37 | RCT‖ | 59 | R: 59 | Mean 569 d | 12 (7/59) | 19 (4/21) | 7.9 (3/38) | 12 (7/59) | — (0/0) |
Pooled: 9.6 (44/458) (95% CI, 7.2-12.7) | Pooled: 19.0 (11/58) (95% CI, 10.9-30.9) | Pooled: 6.5 (19/293) (95% CI, 4.2-9.9) | Pooled: 12.3 (14/114) (95% CI, 7.5-19.6) | Pooled 10.0 (16/202) (95% CI, 4.9-12.5) |
Included studies of ≥5 patients. Thrombosis outcomes included VTE, ATE, or definite microthrombosis. Possible microthrombosis (recurrent migraine in 1 patient113 and cognitive alterations/refractory headaches in 2 patients43 ) were not included in the thrombotic episodes.
A, apixaban; D, dabigatran; Hx, history; initial, initial anticoagulant treatment with a DOAC; NR, not reported; R, rivaroxaban; RCT, randomized controlled trial; tAb, triple-positive antibody status; Tmt, treatment.
Time to recurrence reported.
Included 2 patients on DOACs for primary prevention.
All patients switched to a DOAC after a minimum of 3 months and d-dimer <500 ng/mL.
One patient with a recurrent VTE had both a history of ATE and triple antibody positivity.
Reported based on an on-treatment per protocol analysis.