Supplement Table 1C.
TAVI Compared to SAVR for Low-Risk Surgical Patients with Aortic Stenosis | ||||||
Patient or population: low-risk surgical patients with aortic stenosis Settings: Intervention: TAVI1 Comparison: SAVR2 | ||||||
Outcomes | Illustrative Comparative Risks* (95% CI) | Relative Effect (95% CI) | No of Participants (Studies) | Quality of the Evidence (GRADE) | Comments | |
Assumed Risk | Corresponding Risk | |||||
SAVR | TAVI | |||||
All-cause mortality
Follow-up: 1 year |
Study population | RR 0.66 (0.41-1.06) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
32 per 1000 | 21 per 1000 (13-34) | |||||
Moderate | ||||||
30 per 1000 | 21 per 1000 (12-32) | |||||
Cardiovascular mortality
Follow-up: 1 year |
Study population | RR 0.56 (0.33-0.94) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
29 per 1000 | 16 per 1000 (10-27) | |||||
Moderate | ||||||
27 per 1000 | 15 per 1000 (9-25) | |||||
Stroke
Follow-up: 1 year |
Study population | RR 0.71 (0.4-1.25) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
39 per 1000 | 27 per 1000 (15-48) | |||||
Moderate | ||||||
43 per 1000 | 31 per 1000 (17-54) | |||||
Transient ischemic attack
Follow-up: 1 year |
Study population | RR 0.98 (0.52-1.83) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
15 per 1000 | 15 per 1000 (8-27) | |||||
Moderate | ||||||
15 per 1000 | 15 per 1000 (8-27) | |||||
Myocardial infarction
Follow-up: 1 year |
Study population | RR 0.74 (0.43-1.27) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
23 per 1000 | 17 per 1000 (10-29) | |||||
Moderate | ||||||
22 per 1000 | 16 per 1000 (9-28) | |||||
Life-threatening or disabling bleeding
Follow-up: 1 year |
Study population | RR 0.32 (0.24-0.42) | 2353 (2 studies) | ⊕⊕⊕⊕ High | ||
156 per 1000 | 50 per 1000 (38-66) | |||||
Moderate | ||||||
173 per 1000 | 55 per 1000 (42-73) | |||||
Permanent pacemaker implantation
Follow-up: 1 year |
Study population | RR 3.42 (1.33-8.82) | 2633 (3 studies) | ⊕⊕⊕⊝ Moderate3,4 | ||
57 per 1000 | 194 per 1000 (76-501) | |||||
Moderate | ||||||
53 per 1000 | 181 per 1000 (70-467) | |||||
New-atrial fibrillation
Follow-up: 1 year |
Study population | RR 0.25 (0.18-0.36) | 2633 (3 studies) | ⊕⊕⊕⊕ High3,4 | ||
386 per 1000 | 96 per 1000 (69-139) | |||||
Moderate | ||||||
384 per 1000 | 96 per 1000 (69-138) | |||||
*The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). RR, risk ratio. | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1Transcatheter aortic valve implantation; 2surgical aortic valve replacement; 3inconsistency; 4large effect. |