Summary of findings of DOAC compared to VKA in morbidly obese patient (BMI ≥ 40 kg/m2) with AF
| Outcomes . | No. of participants (studies) Follow-up . | Certainty of the evidence (GRADE) . | Relative effect (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|
| Risk with VKA . | Risk difference with DOAC . | ||||
Stroke/SE Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁◯◯◯ VERY LOWa,b | RR 0.85 (0.56–1.29) | 26 per 1000 | 4 fewer per 1000 (11 fewer to 7 more) |
Major bleeding Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁⨁◯◯ LOWb,c | RR 0.62 (0.48–0.80) | 45 per 1000 | 17 fewer per 1000 (23 fewer to 9 fewer) |
Stroke/SE (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁⨁◯◯ LOWb,d,e,f | RR 0.86 (0.77–0.96) | No data | No data |
Major bleeding (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁◯◯◯ VERY LOWb,d,f,g | RR 0.73 (0.67–0.79) | No data | No data |
| Outcomes . | No. of participants (studies) Follow-up . | Certainty of the evidence (GRADE) . | Relative effect (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|
| Risk with VKA . | Risk difference with DOAC . | ||||
Stroke/SE Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁◯◯◯ VERY LOWa,b | RR 0.85 (0.56–1.29) | 26 per 1000 | 4 fewer per 1000 (11 fewer to 7 more) |
Major bleeding Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁⨁◯◯ LOWb,c | RR 0.62 (0.48–0.80) | 45 per 1000 | 17 fewer per 1000 (23 fewer to 9 fewer) |
Stroke/SE (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁⨁◯◯ LOWb,d,e,f | RR 0.86 (0.77–0.96) | No data | No data |
Major bleeding (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁◯◯◯ VERY LOWb,d,f,g | RR 0.73 (0.67–0.79) | No data | No data |
Sensitivity analysis was performed using pooled effect size from studies that reported the outcome of interest without complete raw data. 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.
AF, atrial fibrillation; BMI, body mass index; CI, confidence interval; DOAC, direct oral anticoagulant; RCT, randomized controlled trial; RR, Risk ratio; stroke/SE, stroke and systemic embolism.
Two studies with apixaban showed a non-significant increase in the risk of stroke/SE while the other three studies suggest that DOAC decreased the risk of stroke/SE. This resulted in moderate heterogeneity with I2 = 42.8%.
Post hoc analysis of RCT for edoxaban was done to assess for outcomes in morbidly obese patients with AF but this is not the primary focus to include morbid obesity group.
Low heterogeneity was detected with I2 = 29.3%.
NOS was used to assess the selection bias of five observational studies with scores of 4/4. Two post hoc analysis of RCT has low-risk selection bias in ROB.
Low heterogeneity was detected in pooled effect size analysis with I2 = 17.5%.
Post hoc analysis of RCT for apixaban was done to assess for outcomes in morbidly obese patients with AF but this is not the primary focus to include morbid obesity group.
High heterogeneity was detected in pooled effect size analysis with I2 = 79.9%.
Summary of findings of DOAC compared to VKA in morbidly obese patient (BMI ≥ 40 kg/m2) with AF
| Outcomes . | No. of participants (studies) Follow-up . | Certainty of the evidence (GRADE) . | Relative effect (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|
| Risk with VKA . | Risk difference with DOAC . | ||||
Stroke/SE Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁◯◯◯ VERY LOWa,b | RR 0.85 (0.56–1.29) | 26 per 1000 | 4 fewer per 1000 (11 fewer to 7 more) |
Major bleeding Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁⨁◯◯ LOWb,c | RR 0.62 (0.48–0.80) | 45 per 1000 | 17 fewer per 1000 (23 fewer to 9 fewer) |
Stroke/SE (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁⨁◯◯ LOWb,d,e,f | RR 0.86 (0.77–0.96) | No data | No data |
Major bleeding (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁◯◯◯ VERY LOWb,d,f,g | RR 0.73 (0.67–0.79) | No data | No data |
| Outcomes . | No. of participants (studies) Follow-up . | Certainty of the evidence (GRADE) . | Relative effect (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|
| Risk with VKA . | Risk difference with DOAC . | ||||
Stroke/SE Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁◯◯◯ VERY LOWa,b | RR 0.85 (0.56–1.29) | 26 per 1000 | 4 fewer per 1000 (11 fewer to 7 more) |
Major bleeding Follow-up: range 0.8 years to 2.8 years | 9274 (5 observational studies) | ⨁⨁◯◯ LOWb,c | RR 0.62 (0.48–0.80) | 45 per 1000 | 17 fewer per 1000 (23 fewer to 9 fewer) |
Stroke/SE (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁⨁◯◯ LOWb,d,e,f | RR 0.86 (0.77–0.96) | No data | No data |
Major bleeding (sensitivity analysis) assessed with: pooled effect size Follow-up: range 0.5 years to 2.8 years | (7 observational studies) | ⨁◯◯◯ VERY LOWb,d,f,g | RR 0.73 (0.67–0.79) | No data | No data |
Sensitivity analysis was performed using pooled effect size from studies that reported the outcome of interest without complete raw data. 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.
AF, atrial fibrillation; BMI, body mass index; CI, confidence interval; DOAC, direct oral anticoagulant; RCT, randomized controlled trial; RR, Risk ratio; stroke/SE, stroke and systemic embolism.
Two studies with apixaban showed a non-significant increase in the risk of stroke/SE while the other three studies suggest that DOAC decreased the risk of stroke/SE. This resulted in moderate heterogeneity with I2 = 42.8%.
Post hoc analysis of RCT for edoxaban was done to assess for outcomes in morbidly obese patients with AF but this is not the primary focus to include morbid obesity group.
Low heterogeneity was detected with I2 = 29.3%.
NOS was used to assess the selection bias of five observational studies with scores of 4/4. Two post hoc analysis of RCT has low-risk selection bias in ROB.
Low heterogeneity was detected in pooled effect size analysis with I2 = 17.5%.
Post hoc analysis of RCT for apixaban was done to assess for outcomes in morbidly obese patients with AF but this is not the primary focus to include morbid obesity group.
High heterogeneity was detected in pooled effect size analysis with I2 = 79.9%.
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