Figure 1 details the study selection process, illustrating a total of 2389 retrieved articles with 963 duplicates, deleted by the Endnote X9 software. After reviewing the titles and abstracts, 1394 repetitive literature reviews, case reports, meta-analyses, and unrelated articles were excluded. Twenty-nine items were further excluded based on the inclusion criteria, resulting in the final 3 articles. Table 1 comprises the details of the included studies, as 2633 patients with AS across the 3 cohorts were enrolled (EVOLUT[8], NOTION[9, 14], and PARTNER III[11]). In the assessment of deviation risk, due to specific study designs, it is impossible to blind operators or patients (Supplement Figs A. and B.). Summary of findings and strength of evidence (GRADE) are shown in Supplement ( Table B. C. and D.), the quality of evidence for the most results is evaluated as high. Because fewer than 10 studies were included, we did not perform tests to assess publication bias.
Table 1
Characteristics of studies and patients
Study | | NOTION | PARTNER III | EVOLUT |
Number of centers | | 3 | 71 | 86 |
Recruitment period | | 2011–2013 | 2012–2016 | 2016–2018 |
Valve Type | | CoreValve, Evolut R, or Evolut PRO | Sapien 3 | CoreValve |
sample size | TAVI | 145 | 496 | 725 |
SAVR | 135 | 454 | 678 |
male -no. (%) | TAVI | 78(53.8) | 335(67.5) | 464(64.0) |
SAVR | 71(52.6) | 323(71.1) | 449(66.2) |
Mean year | TAVI | 79.2 ± 4.9 | 73.3 ± 5.8 | 74.1 ± 5.8 |
SAVR | 79 ± 4.7 | 73.6 ± 6.1 | 73.6 ± 5.9 |
Mean STS-PROM score | TAVI | 2.9 ± 1.6 | 1.9 ± 0.7 | 1.9 ± 0.7 |
SAVR | 3.1 ± 1.7 | 1.9 ± 0.6 | 1.9 ± 0.7 |
Prior cerebrovascular accident -no. (%) | TAVI | 24 (16.6) | 17 (3.4) | 74 (10.2) |
SAVR | 22 (16.3) | 23 (5.1) | 80 (11.8) |
Prior myocardial infarction -no. (%) | TAVI | 8 (5.5) | 28 (5.7) | 48 (6.6) |
SAVR | 6 (4.4) | 26 (5.8) | 33 (4.9) |
Peripheral vascular disease -no. (%) | TAVI | 6 (4.1) | 34 (6.9) | 54 (7.5) |
SAVR | 9 (6.7) | 33 (7.3) | 56 (8.3) |
Chronic lung disease -no. (%) | TAVI | 17 (11.7) | 25 (5.1) | 104 (15.0) |
SAVR | 16 (11.9) | 28 (6.2) | 117 (18.0) |
Diabetes mellitus -no. (%) | TAVI | 26 (17.9) | 155 (31.2) | 228 (31.4) |
SAVR | 28 (20.7) | 137 (30.2) | 207 (30.5) |
Creatinine level > 2 mg/dl -no. (%) | TAVI | 2 (1.4) | 1 (0.2) | 3 (0.4) |
SAVR | 1 (0.7) | 1 (0.2) | 1 (0.1) |
TAVI: transcatheter aortic valve implantation |
SAVR: surgical aortic valve replacement |
Table 2 displays the results of all outcome analyses. The EVOLUT trial has yet to complete a two-year follow-up of all participants, so we did not include the trial in our analysis of the 2-year results to avoid bias in the analysis. The results of the 30-day, 1-year, and 2-year follow-ups are shown in Fig. 2, Fig. 3, and Fig. 4 respectively. At the 30-day follow-up of the low-risk surgical patients with AS, TAVI was associated with a lower incidence of all-cause mortality (RR, 0.44; 95% CI, 0.20 to 0.98; P = 0.04), acute kidney injury (stage 2 or 3) (RR, 0.27; 95% CI, 0.14 to 0.56; P = 0.0003), life-threatening or significant bleeding (RR, 0.29; 95% CI, 0.14 to 0.61; P = 0.001), and NAF (RR, 0.21; 95% CI, 0.14 to 0.31; P<0.00001), but an increased risk of PPI (RR, 3.59; 95% CI, 1.43 to 9.03; P = 0.006).
Table 2
Subgroup analyses at the 30-day, 1-year and 2-year follow-up.
Research end point | Research number | Heterogeneity test | Outcome |
Low-risk group | | P value | I2(%) | RR | 95%CI | P value |
30-days | | | | | | |
All-cause mortality | 3 | 0.92 | I2 = 0 | 0.44 | [0.20, 0.98] | 0.04 |
Cardiovascular mortality | 3 | 0.95 | I2 = 0 | 0.47 | [0.21, 1.03] | 0.06 |
Stroke | 3 | 0.11 | I2 = 54 | 0.57 | [0.22, 1.48] | 0.25 |
Transient ischemic attack | 3 | 0.25 | I2 = 27 | 0.75 | [0.17, 3.37] | 0.71 |
Myocardial infarction | 3 | 0.81 | I2 = 0 | 0.65 | [0.34, 1.22] | 0.18 |
Acute kidney injury ( stage 2 or 3) | 3 | 0.54 | I2 = 0 | 0.27 | [0.14, 0.56] | 0.0003 |
Life-threatening or disabling bleeding | 3 | 0.002 | I2 = 83 | 0.29 | [0.14, 0.61] | 0.001 |
Permanent pacemaker implantation | 3 | 0.002 | I2 = 84 | 3.59 | [1.43, 9.03] | 0.006 |
New-atrial fibrillation | 3 | 0.03 | I2 = 72 | 0.21 | [0.14, 0.31] | <0.00001 |
1-year | | | | | | |
All-cause mortality | 3 | 0.52 | I2 = 0 | 0.69 | [0.43, 1.10] | 0.12 |
Cardiovascular mortality | 3 | 0.83 | I2 = 0 | 0.56 | [0.33, 0.94] | 0.03 |
Stroke | 3 | 0.24 | I2 = 0 | 0.71 | [0.40, 1.25] | 0.23 |
Transient ischemic attack | 3 | 0.91 | I2 = 0 | 0.98 | [0.52, 1.83] | 0.94 |
Myocardial infarction | 3 | 0.57 | I2 = 0 | 0.74 | [0.43, 1.27] | 0.28 |
Life-threatening or disabling bleeding | 2 | 0.53 | I2 = 0 | 0.32 | [0.24, 0.42] | <0.00001 |
Permanent pacemaker implantation | 3 | 0.0002 | I2 = 88 | 3.42 | [1.33, 8.82] | 0.01 |
New-atrial fibrillation | 3 | 0.03 | I2 = 69 | 0.25 | [0.18, 0.36] | <0.00001 |
2-years | | | | | | |
All-cause mortality | 2 | 0.99 | I2 = 0 | 0.79 | [0.46, 1.35] | 0.38 |
Cardiovascular mortality | 2 | 0.83 | I2 = 0 | 0.66 | [0.36, 1.20] | 0.17 |
Stroke | 2 | 0.96 | I2 = 0 | 0.68 | [0.37, 1.26] | 0.22 |
Transient ischemic attack | 2 | 0.21 | I2 = 36 | 1.09 | [0.39, 3.04] | 0.87 |
Myocardial infarction | 2 | 0.99 | I2 = 0 | 0.79 | [0.46, 1.35] | 0.38 |
Permanent pacemaker implantation | 2 | <0.0001 | I2 = 94 | 3.58 | [0.45, 28.74] | 0.23 |
New-atrial fibrillation | 2 | 0.009 | I2 = 85 | 0.27 | [0.14, 0.51] | <0.0001 |
At the 1-year follow-up of the low-risk surgical patients with AS, the cardiovascular mortality (RR, 0.56; 95% CI, 0.33 to 0.94; P = 0.03), life-threatening or significant bleeding (RR, 0.32; 95% CI, 0.24 to 0.42; P<0.00001) and the NAF (RR, 0.25; 95% CI, 0.18 to 0.36; P<0.00001) results in the TAVI group were superior to those in the SAVR group, but TAVI group was inferior to the SAVR group for the incidence of PPI (RR, 3.42; 95% CI, 1.33 to 8.82; P = 0.01).
At the 2-year follow-up of low-risk surgical patients with AS, only the NAF results (RR, 0.27; 95% CI, 0.14 to 0.51; P<0.0001) in the TAVI group were superior to those in the SAVR group. The differences in all-cause mortality, cardiovascular mortality, stroke, TIA, MI, and PPI between the TAVI and SAVR groups were not statistically significant.