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. 2022 Nov 1;26(11):802–809. doi: 10.5152/AnatolJCardiol.2022.1665

Supplement Table 1B.

Summary of Findings and Strength of Evidence (GRADE) for 30-Day Results

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.