Table 2.

Summary of findings for DOACs vs LMWHs for the treatment of cancer-associated thrombosis

OutcomeNo. of participants (studies)Certainty of the evidence (GRADE)RR (95% CI)Observed risk with LMWHAnticipated absolute effects
Risk with DOACs*Absolute risk difference
Recurrent VTE 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.68 (0.39 to 1.17) 8.3% 5.6% −2.7% (–5.1 to 1.4) 
Major bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.36 (0.55 to 3.35) 3.5% 4.8% 1.3% (–1.6 to 8.3) 
Composite outcome of first recurrent VTE and major bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.86 (0.60 to 1.23) 11.1% 9.5% −1.6% (–4.4 to 2.6) 
Clinically relevant nonmajor bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.63 (0.73 to 3.64) 6.5% 10.6% 4.1% (–1.8 to 17.2) 
All-cause mortality 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.96 (0.68 to 1.36) 25.7% 24.7% −1.0% (–8.2 to 9.3) 
On-treatment analyses       
 Recurrent VTE (on-treatment) 2440 (3 RCTs) ⊕⊕⊕⊕ HIGH 0.60 (0.38 to 0.95) 8.1% 4.9% −3.2% (–5.0 to −0.4) 
 Major bleeding (on-treatment) 2440 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.43 (0.46 to 4.45) 3.2% 4.6% 1.4% (–1.7 to 11.0) 
 Clinically relevant nonmajor bleeding (on-treatment) 2440 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.93 (0.70 to 5.31) 4.6% 8.9% 4.3% (–1.4 to 19.7) 
OutcomeNo. of participants (studies)Certainty of the evidence (GRADE)RR (95% CI)Observed risk with LMWHAnticipated absolute effects
Risk with DOACs*Absolute risk difference
Recurrent VTE 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.68 (0.39 to 1.17) 8.3% 5.6% −2.7% (–5.1 to 1.4) 
Major bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.36 (0.55 to 3.35) 3.5% 4.8% 1.3% (–1.6 to 8.3) 
Composite outcome of first recurrent VTE and major bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.86 (0.60 to 1.23) 11.1% 9.5% −1.6% (–4.4 to 2.6) 
Clinically relevant nonmajor bleeding 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.63 (0.73 to 3.64) 6.5% 10.6% 4.1% (–1.8 to 17.2) 
All-cause mortality 2607 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 0.96 (0.68 to 1.36) 25.7% 24.7% −1.0% (–8.2 to 9.3) 
On-treatment analyses       
 Recurrent VTE (on-treatment) 2440 (3 RCTs) ⊕⊕⊕⊕ HIGH 0.60 (0.38 to 0.95) 8.1% 4.9% −3.2% (–5.0 to −0.4) 
 Major bleeding (on-treatment) 2440 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.43 (0.46 to 4.45) 3.2% 4.6% 1.4% (–1.7 to 11.0) 
 Clinically relevant nonmajor bleeding (on-treatment) 2440 (3 RCTs) ⊕⊕⊕◯ MODERATE due to imprecision 1.93 (0.70 to 5.31) 4.6% 8.9% 4.3% (–1.4 to 19.7) 

GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate (the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different). Low certainty: our confidence in the effect estimate is limited (the true effect may be substantially different from the estimate of the effect). Very low certainty: we have very little confidence in the effect estimate (the true effect is likely to be substantially different from the estimate of effect). RCTs, randomized controlled trials.

*

The risk in the DOAC group (and its 95% CI) is based on the observed risk in the LMWH group and the relative effect of the intervention (and its 95% CI).

Graded down for imprecision due to a broad 95% CIs with a possible positive and negative effect of DOAC vs LMWH.

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