Table 2.
GRADE analysis for quality of evidence.
| Outcome | Certainty Assessment | Patients | Anticipated effects | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | DOAC | Other AC | Relative risk (95% CI) | Absolute risk reduction with DOAC (95% CI) | ||
| DOAC compared to VKA/LMWH | ||||||||||||
| VTE | 10 | RCT | Not serious | Not serious | Not serious | Not serious | None | 5.6% (119/2125) | 9.0% (187/2068) | 0.63 (0.51–0.79) | 33 fewer per 1000 (44 fewer to 19 fewer) |
⊕ ⊕ ⊕ ⊕ High |
| MB | 9 | RCT | Not serious | Not serious | Not serious | Not serious | None | 4.3% (86/2008) | 4.0% (78/1958) | 1.01 (0.65–1.56) | 0 fewer per 1000 (14 fewer to 22 more) |
⊕ ⊕ ⊕ ⊕ High |
| CRNMB | 9 | RCT | Not serious | Not serious | Not serious | Not serious | None | 11.7% (235/2008) | 8.9% (174/1958) | 1.28 (0.95–1.73) | 25 more per 1000 (4 fewer to 65 more) |
⊕ ⊕ ⊕ ⊕ High |
| All bleed | 10 | RCT | Not serious | Not serious | Not serious | Not serious | None | 16.1% (341/2117) | 13.5% (277/2057) | 1.11 (0.84–1.46) | 15 more per 1000 (22 fewer to 62 more) |
⊕ ⊕ ⊕ ⊕ High |
| DOAC compared to LMWH | ||||||||||||
| VTE | 4 | RCT | Not serious | Not serious | Not serious | Not serious | None | 5.9% (86/1446) | 9.9% (143/1448) | 0.57 (0.40–0.83) | 42 fewer per 1000 (59 fewer to 17 fewer) |
⊕ ⊕ ⊕ ⊕ High |
| MB | 4 | RCT | Not serious | Not serious | Not serious | Not serious | None | 4.8% (69/1446) | 3.7% (53/1448) | 1.31 (0.78–2.18) | 11 more per 1000 (8 fewer to 43 more) |
⊕ ⊕ ⊕ ⊕ High |
| CRNMB | 4 | RCT | Not serious | Not serious | Not serious | Not serious | None | 11.2% (162/1446) | 7.3% (106/1448) | 1.6 (1.13–2.26) | 44 more per 1000 (10 more to 92 more) |
⊕ ⊕ ⊕ ⊕ High |
| All bleed | 4 | RCT | Not serious | Not serious | Not serious | Not serious | None | 16.0% (231/1446) | 11.0% (159/1448) | 1.49 (1.1–2.01) | 54 more per 1000 (11 more to 111 more) |
⊕ ⊕ ⊕ ⊕ High |
| DOAC compared to VKA | ||||||||||||
| VTE | 6 | RCT | Not serious | Not serious | Not serious | Not serious | None | 4.9% (33/679) | 7.1% (44/620) | 0.69 (0.44– 1.06) | 22 fewer per 1000 (40 fewer to 4 more) |
⊕ ⊕ ⊕ ⊕ High |
| MB | 5 | RCT | Not serious | Not serious | Not serious | Not serious | None | 3.0% (17/562) | 4.9% (25/510) | 0.62 (0.34– 1.14) | 19 fewer per 1000 (32 fewer to 7 more) |
⊕ ⊕ ⊕ ⊕ High |
| CRNMB | 5 | RCT | Not serious | Not serious | Not serious | Not serious | None | 13.0% (73/562) | 13.3% (68/510) | 0.95 (0.63– 1.41) | 7 fewer per 1000 (49 fewer to 55 more) |
⊕ ⊕ ⊕ ⊕ High |
| All bleed | 6 | RCT | Not serious | Not serious | Not serious | Not serious | None | 16.4% (110/671) | 19.4% (118/609) | 0.84 (0.65– 1.08) | 31 fewer per 1000 (68 fewer to 16 more) |
⊕ ⊕ ⊕ ⊕ High |
VTE (recurrent) venous thromboembolism, MB major bleeding, CRNMB clinically relevant non major bleeding, all bleeding MB + CRNMB, DOAC direct oral anticoagulant, other AC other anticoagulant (VKA or LMWH).