Table 2 GRADE evidence profile.
Quality assessment | No of patients | Effect | Quality* | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Rivaroxaban | Enoxaparin | Relative (95% CI) | Absolute | ||
Symptomatic venous thromboembolism (follow-up 28–75 days) | ||||||||||||
9 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 38/8781 (0.4%) | 72/7048 (1%) | RR 0.44 (0.29 to 0.67) | 6 fewer per 1000 (from 3 fewer to 7 fewer) | ⊕⊕ΟΟ LOW | CRITICAL |
0.9% | 5 fewer per 1000 (from 3 fewer to 6 fewer) | |||||||||||
Major bleeding (follow-up 35–75 days) | ||||||||||||
8 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious3 | none | 185/8679 (2.1%) | 92/6936 (1.3%) | RR 1.37 (1.05 to 1.78) | 5 more per 1000 (from 1 more to 10 more) | ⊕⊕ΟΟ LOW | CRITICAL |
1.5% | 6 more per 1000 (from 1 more to 12 more) | |||||||||||
All-cause mortality (follow-up 35–75 days) | ||||||||||||
8 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 10/8679 (0.1%) | 15/6936 (0.2%) | RR 0.63 (0.27 to 1.44) | 1 fewer per 1000 (from 2 fewer to 1 more) | ⊕⊕⊕Ο MODERATE | CRITICAL |
0.1% | 0 fewer per 1000 (from 1 fewer to 0 more) | |||||||||||
Symptomatic deep vein thrombosis (follow-up 28–75 days) | ||||||||||||
9 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 19/8781 (0.2%) | 53/7048 (0.8%) | RR 0.36 (0.21 to 0.61) | 5 fewer per 1000 (from 3 fewer to 6 fewer) | ⊕⊕⊕Ο MODERATE | CRITICAL |
0.6% | 4 fewer per 1000 (from 2 fewer to 5 fewer) | |||||||||||
Symptomatic pulmonary embolism (follow-up 28–75 days) | ||||||||||||
9 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 19/8781 (0.2%) | 19/7048 (0.3%) | RR 0.79 (0.35 to 1.79) | 1 fewer per 1000 (from 2 fewer to 2 more) | ⊕⊕⊕Ο MODERATE | CRITICAL |
0% | — | |||||||||||
Clinically relevant non-major bleeding (follow-up 35–75 days) | ||||||||||||
8 | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious4 | none | 251/8679 (2.9%) | 156/6936 (2.2%) | RR 1.23 (1 to 1.51) | 5 more per 1000 (from 0 more to 11 more) | ⊕⊕ΟΟ LOW | IMPORTANT |
2.3% | 5 more per 1000 (from 0 more to 12 more) | |||||||||||
Postoperative wound infection (follow-up 40–75 days) | ||||||||||||
4 | randomised trials | serious5 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 27/6356 (0.4%) | 28/6373 (0.4%) | RR 0.97 (0.57 to 1.66) | 0 fewer per 1000 (from 2 fewer to 3 more) | ⊕⊕⊕Ο MODERATE | CRITICAL |
0.4% | 0 fewer per 1000 (from 2 fewer to 3 more) | |||||||||||
