Supplement Table 1B.
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: 30 days |
Study population | RR 0.44 (0.2-0.98) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
15 per 1000 | 7 per 1000 (3-15) | |||||
Moderate | ||||||
13 per 1000 | 6 per 1000 (3-13) | |||||
Cardiovascular mortality
Follow-up: 30 days |
Study population | RR 0.47 (0.21-1.03) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
14 per 1000 | 7 per 1000 (3-15) | |||||
Moderate | ||||||
13 per 1000 | 6 per 1000 (3-13) | |||||
Stroke
Follow-up: 30 days |
Study population | RR 0.57 (0.22-1.48) | 2633 (3 studies) | ⊕⊕⊕⊝ Moderate3 | ||
30 per 1000 | 17 per 1000 (7-44) | |||||
Moderate | ||||||
30 per 1000 | 17 per 1000 (7-44) | |||||
Transient ischemic attack
Follow-up: 30 days |
Study population | RR 0.75 (0.17-3.37) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
6 per 1000 | 5 per 1000 (1-21) | |||||
Moderate | ||||||
7 per 1000 | 5 per 1000 (1-24) | |||||
Myocardial infarction
Follow-up: 30 days |
Study population | RR 0.65 (0.34-1.22) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
18 per 1000 | 12 per 1000 (6-22) | |||||
Moderate | ||||||
13 per 1000 | 8 per 1000 (4-16) | |||||
Acute kidney injury (stage 2 or 3)
Follow-up: 30 days |
Study population | RR 0.27 (0.14-0.56) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
28 per 1000 | 8 per 1000 (4-16) | |||||
Moderate | ||||||
28 per 1000 | 8 per 1000 (4-16) | |||||
Life-threatening or disabling bleeding
Follow-up: 30 days |
Study population | RR 0.29 (0.14-0.61) | 2633 (3 studies) | ⊕⊕⊕⊝ Moderate3 | ||
150 per 1000 | 43 per 1000 (21-91) | |||||
Moderate | ||||||
207 per 1000 | 60 per 1000 (29-126) | |||||
Permanent pacemaker implantation
Follow-up: 30 days |
Study population | RR 3.59 (1.43-9.03) | 2633 (3 studies) | ⊕⊕⊕⊕ High | ||
48 per 1000 | 173 per 1000 (69-435) | |||||
Moderate | ||||||
40 per 1000 | 144 per 1000 (57-361) | |||||
New-atrial fibrillation
Follow-up: 30 days |
Study population | RR 0.21 (0.14-0.31) | 2633 (3 studies) | ⊕⊕⊕⊕ High3,4 | ||
365 per 1000 | 77 per 1000 (51-113) | |||||
Moderate | ||||||
354 per 1000 | 74 per 1000 (50-110) | |||||
*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. |