| Outcomes |
No of Participants (studies) Follow up | Quality of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with anticoagulant alone post TAVI | Risk difference with Anticoagulant (VKA or DOAC) + clopidogrel (95% CI) | ||||
| All-cause mortality at ≤12 months |
313 (1 study) 12 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
RR 1.15 (0.67 to 1.98) | 134 per 1000 |
20 more per 1000 (from 44 fewer to 131 more) |
| Health-related quality of life at ≤12 months - not measured | 0 | Not estimable | |||
| Major bleeding at ≤12 months - VARC-2 life-threatening, disabling or major bleeding (major bleeding) at 12 months |
313 (1 study) 12 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
RR 1.87 (1.01 to 3.44) | 89 per 1000 |
77 more per 1000 (from 1 more to 217 more) |
| Minor bleeding at ≤12 months - VARC-2 minor bleeding (minor bleeding) at 12 months |
313 (1 study) 12 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
RR 1.41 (0.83 to 2.39) | 127 per 1000 |
52 more per 1000 (from 22 fewer to 177 more) |
| Stroke (arterial thromboembolic events) at ≤12 months |
313 (1 study) 12 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
RR 1.01 (0.41 to 2.47) | 57 per 1000 |
1 more per 1000 (from 34 fewer to 84 more) |
| Myocardial infarction (arterial thromboembolic events) at ≤12 months |
313 (1 study) 12 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
OR 1.01 (0.06 to 16.16) | 6 per 1000 |
0 more per 1000 (from 6 fewer to 83 more) |
| All-cause mortality at >12 months - not measured | 0 | Not estimable | |||
| Health-related quality of life at >12 months - not measured | 0 | Not estimable | |||
| Major bleeding at >12 months - not measured | 0 | Not estimable | |||
| Minor bleeding at >12 months - not measured | 0 | Not estimable | |||
| Arterial thromboembolic events at >12 months - not measured | 0 | Not estimable | |||
| Hospital readmission at 12 months - not measured | 0 | Not estimable | |||
| Withdrawal due to adverse events at 12 months - not measured | 0 | Not estimable | |||
| Thrombus on imaging at <12 months - not measured | 0 | Not estimable | |||
| Need for reintervention at 6-12 months - not measured | 0 | Not estimable | |||
| Need for reintervention at >12 months - not measured | 0 | Not estimable | |||
| Mean aortic valve gradient (valve degeneration - transvalvular gradient) at ≥12 months |
264 (1 study) 6 months |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
The mean aortic valve gradient (valve degeneration - transvalvular gradient) at ≥12 months in the control groups was 9 mmHg |
The mean aortic valve gradient (valve degeneration - transvalvular gradient) at ≥12 months in the intervention groups was 1.5 higher (0.29 to 2.71 higher) | |
Downgraded by 1 increment as the majority of the evidence was at high risk of bias
Anticoagulation includes a mixture of some receiving VKAs and some receiving DOACs, whereas ideally aimed to look at these groups separately
Downgraded by 2 increments as the confidence interval crossed both MIDs
Downgraded by 1 increment as the confidence interval crossed one MID
Downgraded by 2 increments as the majority of the evidence was at very high risk of bias
MIDs used to assess imprecision ±2.55
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