Table 2.

Studies reporting thrombotic outcomes in APS patients treated with DOACs

ReferencesStudy designNTreatmentFollow-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 R: 8 5-365 d* 75 (6/8) 50 (1/2) 83.3 (5/6) 66.7 (2/3) 80 (4/5) 
115  Retrospective 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) 
ReferencesStudy designNTreatmentFollow-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 R: 8 5-365 d* 75 (6/8) 50 (1/2) 83.3 (5/6) 66.7 (2/3) 80 (4/5) 
115  Retrospective 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.

Close Modal

or Create an Account

Close Modal
Close Modal