Characteristics of studies
| Source . | Design . | Participants . | Centers . | APLA testing . | . | ||
|---|---|---|---|---|---|---|---|
| Tests done . | Central/local . | Positivity predefined (minimum number of occasions with positive test) . | Any follow-up on therapy . | ||||
| Bank, 2003 (Europe) | RCT | 64 | 2 | ACLA (IgG and IgM) and LA*† | Central | Yes (1) | Yes (3 mo Idra in half of patients; 3 mo VKA in half of patients) |
| ACLA cutoff: not described | |||||||
| Ginsberg, 1995 (N. America) | Cohort | 65 | 1 | ACLA (IgG) and LA*‡ | 1 center | Yes (1) | Time on, and after, VKA analyzed separately |
| ACLA cutoff: >3 SD above mean (30 GPL units) | |||||||
| Kearon, 1999 (N. America) | RCT | 77 | 22 | ACLA (IgG + IgM) and LA*†‡ | Central | Yes (1) | No |
| ACLA cutoff not described | |||||||
| Kearon, 2004 (N. America) | RCT | 141 | 15 | ACLA (IgG + IgM) and LA*†‡ | Central | Yes (1) | Yes (2 mo VKA in half of patients) |
| ACLA cutoff not described | |||||||
| Rodger, 2008 (N. America, Europe) | Cohort | 619 | 12 | ACLA (IgG+ IgM)§ and LA†‡ | Central | No (1) | No |
| ACLA cutoff: 6 U/mL for men, 4 U/mL for women§ | |||||||
| Wahlander, 2005 (N. and S. America, Europe, Africa) | RCT | 1041 | 142 | ACLA only (IgG, IgM + IgA) | Central | Yes (1) | Yes (18 mo ximelagatran in half of patients; 18 mo placebo in half of patients) |
| ACLA cutoff: “ratio ≥1 according to assay specifications” | |||||||
| Taliani, 2009 (Europe) | 2 RCTs | 297∥ | ∼15 | Not described | Local | Not standardized | No |
| Schulman, 2006 (Europe) | RCT | ∼810 | 16 | ACLA only (IgG) | 4 central | Yes (1) | Yes (6 mo in half of patients; 6 wk in half of patients) |
| ACLA cutoff: 5 GPL units | |||||||
| Source . | Design . | Participants . | Centers . | APLA testing . | . | ||
|---|---|---|---|---|---|---|---|
| Tests done . | Central/local . | Positivity predefined (minimum number of occasions with positive test) . | Any follow-up on therapy . | ||||
| Bank, 2003 (Europe) | RCT | 64 | 2 | ACLA (IgG and IgM) and LA*† | Central | Yes (1) | Yes (3 mo Idra in half of patients; 3 mo VKA in half of patients) |
| ACLA cutoff: not described | |||||||
| Ginsberg, 1995 (N. America) | Cohort | 65 | 1 | ACLA (IgG) and LA*‡ | 1 center | Yes (1) | Time on, and after, VKA analyzed separately |
| ACLA cutoff: >3 SD above mean (30 GPL units) | |||||||
| Kearon, 1999 (N. America) | RCT | 77 | 22 | ACLA (IgG + IgM) and LA*†‡ | Central | Yes (1) | No |
| ACLA cutoff not described | |||||||
| Kearon, 2004 (N. America) | RCT | 141 | 15 | ACLA (IgG + IgM) and LA*†‡ | Central | Yes (1) | Yes (2 mo VKA in half of patients) |
| ACLA cutoff not described | |||||||
| Rodger, 2008 (N. America, Europe) | Cohort | 619 | 12 | ACLA (IgG+ IgM)§ and LA†‡ | Central | No (1) | No |
| ACLA cutoff: 6 U/mL for men, 4 U/mL for women§ | |||||||
| Wahlander, 2005 (N. and S. America, Europe, Africa) | RCT | 1041 | 142 | ACLA only (IgG, IgM + IgA) | Central | Yes (1) | Yes (18 mo ximelagatran in half of patients; 18 mo placebo in half of patients) |
| ACLA cutoff: “ratio ≥1 according to assay specifications” | |||||||
| Taliani, 2009 (Europe) | 2 RCTs | 297∥ | ∼15 | Not described | Local | Not standardized | No |
| Schulman, 2006 (Europe) | RCT | ∼810 | 16 | ACLA only (IgG) | 4 central | Yes (1) | Yes (6 mo in half of patients; 6 wk in half of patients) |
| ACLA cutoff: 5 GPL units | |||||||
ACLA, anti-cardiolipin antibody; GPL, arbitrary unit of ACLA (IgG isotype) measurement; Idra, idraparinux; Ig, immunoglobulin; LA, lupus anticoagulant; RCT, randomized, controlled trial; SD, standard deviation; VKA, vitamin K antagonist.
Activated partial thromboplastin time.
Dilute Russell viper venom time.
Confirmatory hexagonal phospholipid assay.
Cutoff to categorize ACLA as positive was picked to maximize predictive value, and a different value was used for men (≥6 U/mL) and women (≥4 U/mL); “positive” APLA (ACLA or LA) was associated with a higher risk of recurrence in men and a trend to a lower risk of recurrence in women.
Of 448 total patients, 297 were included in APLA analysis. The decision to perform APLA testing appears to have been at the discretion of the clinical center and the reason why some patients were not tested is not provided.