| |
USA |
742 TAVI (n = 389) SAVR (n = 353) |
Randomized clinical trial |
Patients with severe aortic stenosis and heart failure symptoms of the New York Heart Association (NYHA) class II |
TAVI |
SAVR conventional open-heart techniques with the use of cardiopulmonary bypass. |
Mortality |
|
| Adams et al. 201410
|
| Søndergaard et al. 201611
|
Denmark and Sweden |
276 TAVI (n = 142) SAVR (n = 134) |
Randomized clinical trial |
Severe native aortic valve stenosis |
TF-TAVI |
SAVR |
Mortality |
-
Mortality
-
At 2 years
-
8.0% in the TAVI group
-
9.8% in the SAVR group
-
p=0.54.
|
| Skelding et al. 201612
|
USA |
353 TAVI (n = 183) SAVR (n = 170) |
Randomized clinical trial |
Female patients with New York Heart Association (NYHA) class II or greater symptoms and severe aortic stenosis |
TAVI |
SAVR conventional surgery |
Mortality and Postoperative Complications |
-
Mortality at 30 days
-
All-cause mortality
-
3.8% in the TAVI group
-
4.7% in the SAVR group
-
p = 0.70
-
Stroke:
-
5.6% in the TAVI group
-
6.5% in the SAVR group
-
p = 0.73
-
Myocardial infarction:
-
1.6% in the TAVI group
-
0.6% in the SAVR group
-
p = 0.35
-
Cardiac perforation
-
2.7% in the TAVI group
-
0.0% in the SAVR group
-
p = 0.03
|
| Grayburn et al. 201813
|
USA |
739 TAVI (n = 386) SAVR (n = 353) |
Randomized clinical trial |
Patients were stratified by the severity of baseline AR (aortic regurgitation) into those with none and/or trace and those with mild AR |
TAVI |
SAVR |
Mortality |
|
| Conte et al. 201714
|
USA |
790 TAVI (n = 391) SARV (n = 359) |
Randomized clinical trial |
Severe aortic stenosis |
TAVI iliofemoral or non-iliofemoral access ports |
SAVR |
Postoperative Complications, mortality |
-
Mortality at 2 years
-
8.0% in the TAVI group
-
9.8% in the SAVR group
-
p = 0.54
-
Major Vascular Complications:
-
Significantly higher in the TAVI group during the periprocedural period (5.4% vs. 1.4%, p = 0.003)
|
| Leon et al. 202115
|
USA |
950 TAVI (n = 496) Surgery (n = 454) |
Randomized clinical trial |
Patients with severe aortic stenosis |
TAVI transfemoral |
Minimally invasive surgery |
Mortality |
|
| Durko et al. 201816
|
Europe, USA, Canada |
1660 TAVI (n = 864) Surgery (n = 796) |
Randomized controlled trials |
Patients with severe, symptomatic aortic stenosis at intermediate surgical risk |
TAVI |
SAVR conventional surgery |
Complications |
-
Early strokes:
-
TAVI: 3.3%
-
SAVR: 5.4%
-
p = 0.031
-
Early encephalopathy:
-
TAVI: 1.6%
-
SAVR: 7.8%
-
p < 0.001
|
| Thyregod et al. 201317
|
Scandinavia |
280 TAVI (n = 140) SAVR (n = 140) |
Randomized clinical trial |
Patients 70 years or older with severe degenerative AV stenosis with symptoms or without symptoms but with left ventricular systolic dysfunction and/or hypertrophy |
TAVI |
SAVR complete median sternotomy |
Complications or all-cause mortality (primary outcome) |
|
| Gleason et al. 201618
|
USA |
750 TAVI (n = 391) SAVR (n = 359) |
Randomized clinical trial |
High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis |
TAVI |
SAVR |
Mortality and complications |
|
| Kapadia et al. 201819
|
USA |
5637 TAVI (n = 4389) SAVR (n = 1248) |
Randomized clinical trial |
Patients with aortic stenosis |
TF-TAVI |
SAVR |
Complications and quality of life |
-
30-day Stroke:
-
TF-TAVI: 5.1%
-
SAVR: 3.7%
-
p = 0.09
-
30-day Major Stroke:
-
TF-TAVI: 3.9%
-
SAVR: 2.2%
-
p = 0.018
-
SAVR (KCCQ score):
-
Without major stroke: 79 [53, 94]
-
With major stroke: 64 [30, 94] p = 0.03
-
TF-TAVI (KCCQ score):
-
Without major stroke: 78 [49, 96]
-
With major stroke: 60 [8, 99] p = 0.04
|
| Mack et al. 201520
|
USA |
699 TAVI (n = 348) SAVR (n = 351) |
Randomized controlled trial |
Patients with severe aortic stenosis |
TF-TAVI |
SAVR type of surgery not specified |
Mortality |
-
Mortality
-
At 5 years
-
67.8% in the TAVI group
-
62.4% in the SAVR group
-
p=0.76.
|
| Deeb et al. 201621
|
USA |
750 TAVI (n = 391) SAVR (n = 359) |
Randomized clinical trial |
Patients with severe aortic stenosis |
TAVI |
SAVR procedure at the discretion of the cardiac surgeon |
Mortality and complications |
-
Three-year outcomes
-
All-cause mortality or stroke
-
37.3% in the TAVI group
-
46.7% in the SAVR group
-
p=0.006 All-cause mortality
-
32.9% in the TAVI group
-
39.1% in the SAVR group
-
p=0.068 All stroke
-
12.6% in the TAVI group
-
19.0% in the SAVR group
-
p=0.034 Major adverse cardiovascular or cerebrovascular events
-
40.2% in the TAVI group
-
47.9% in the SAVR group
-
p=0.025
|
| Kapadia et al. 201522
|
USA |
358 TAVI (n = 179) SAVR (n = 179) |
Randomized clinical trial |
Patients with severe symptomatic inoperable aortic stenosis (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 54% female). |
TF-TAVI |
Balloon aortic valvuloplasty |
Mortality |
-
Five-year outcomes
-
All-cause mortality
-
71.8% in the TAVI group
-
93.6% in the SAVR group
-
p<0.0001
|
| Thyregod et al. 201523
|
Denmark and Sweden |
274 TAVI (n = 139) SAVR (n = 135) |
Randomized clinical trial |
Patients ≥70 years of age with severe degenerative aortic valve stenosis |
TF-TAVI |
SAVR underwent conventional open heart surgery with the use of cardiopulmonary bypass |
Mortality and complications |
-
One-year outcomes
-
Death from any cause, stroke, or MI (primary outcome)
-
13.1% in the TAVI group
-
16.3% in the SAVR group
-
−3.2% absolute difference; p=0.43 for superiority
|
| Gleason et al. 201824
|
USA |
750 TAVI (n = 391) SAVR (n = 359) |
Randomized clinical trial |
Patients with severe, symptomatic (New York Heart Association [NYHA] functional class II or greater) aortic stenosis |
TAVI |
SAVR |
Mortality and complications |
|
| Toff et al. 202225
|
UK |
866 TAVI (n = 450) SAVR (n = 416) |
Randomized clinical trial |
Patients were aged 70 years or older with severe, symptomatic aortic stenosis and increased operative risk due to comorbidity or age. |
TAVI |
SAVR (midline sternotomy and minimally invasive surgery |
Mortality |
|
| Généreux et al. 201426
|
USA |
657 SARV (n = 313) TAVI-TF (n = 240) TARV-TA (n = 104) |
Randomized clinical trial |
Patients with severe symptomatic aortic stenosis |
TF-TAVI OR TA-TAVI |
SAVR |
Postoperative Complication |
|
| Amrane et al. 201927
|
Canada, Europe, USA |
936 SARV (n = 438) TAVI (n = 498) |
Randomized clinical trial |
Patients with severe symptomatic AS are considered to be of intermediate surgical risk. |
TF-TAVI |
SAVR |
Mortality |
-
One-year outcomes
-
All-cause mortality
-
6.5% after TAVI
-
6.7% after SAVR
|
| Leon et al. 201628
|
USA |
2032 TAVI (n = 1011) SAVR (n = 1021) |
Randomized clinical trial |
Intermediate-risk patients with severe aortic stenosis |
TF-TAVI OR TA-TAVI |
SAVR transthoracic or transaortic access |
Postoperative Complications and Mortality |
-
Death from any cause or a disabling stroke
-
Overall: Similar rates between TAVI and surgery
-
p=0.001 for noninferiority
|
| Reardon et al. 201129
|
USA, Canada, Europe |
1657 TAVI (n = 863) SAVR (n = 794) |
Randomized clinical trial |
Intermediate-risk patients with severe symptomatic aortic stenosis |
TF-TAVI |
SAVR |
Postoperative Complications, life quality, and mortality |
-
24-month outcomes
-
All-cause mortality
-
11.4% in the TAVI group
-
11.6% in the surgery group
-
95% confidence interval for difference, −3.8% to 3.3% Disabling stroke
-
Similar rates in both groups Quality of life (KCCQ summary score) Significant improvement in both groups over 24 months A greater proportion of patients improved at 1 month in the TAVI group compared to the surgery group
|
| Smith et al. 201130
|
EUA, Canada, Germany |
699 SARV (n = 351) TAVI-TF (n = 244) TARV-TA (n = 104) |
Randomized clinical trial |
Patients with severe aortic stenosis and cardiac symptoms (New York Heart Association [NYHA] class II function or worse) |
TF-TAVI OR TA-TAVI |
SAVR conventional surgery |
Postoperative Complications and mortality |
-
30-day and 1-year outcomes
-
All-cause death
-
30 days: 3.4% in transcatheter group vs. 6.5% in surgical group (p=0.07)
-
1 year: 24.2% in transcatheter group vs. 26.8% in surgical group (p=0.44) Reduction of 2.6 percentage points in the transcatheter group
-
Upper limit of 95% CI for difference: 3.0 percentage points
-
Predefined margin: 7.5 percentage points; p=0.001 for noninferiority
-
Major stroke
-
30 days: 3.8% in transcatheter group vs. 2.1% in surgical group (p=0.20)
-
1 year: 5.1% in transcatheter group vs. 2.4% in surgical group (p=0.07)
-
Major vascular complications 30 days: 11.0% in transcatheter group vs. 3.2% in surgical group (p<0.001)
|
| Makkar et al. 202031
|
USA |
2032 TARV- TF (n = 1550) SAVR (n = 482) |
Randomized clinical trial |
Intermediate-risk patients with severe symptomatic aortic stenosis |
TF-TAVI |
SAVR in the transthoracic region |
Mortality, Postoperative Complications, Quality Of Life |
-
Five-year outcomes
-
All-cause mortality 4
-
7.9% in the TAVI group
-
43.4% in the surgery group p=0.21
-
At least mild paravalvular aortic regurgitation
-
33.3% in the TAVI group
-
6.3% in the surgery group
-
Health status improvement Similar improvement in both TAVI and surgery groups at 5 years
|
| Kapadia et al. 201432
|
USA |
449 TAVI (n = 220) SAVR (n = 229) |
Randomized clinical trial |
Inoperable patients with severe aortic stenosis |
TAVI TF |
SAVR TF |
Mortality |
-
Three-year mortality
-
54.1% in the TAVI group
-
80.9% in the SAVR group
-
p<0.001
|
| Baron et al. 201933
|
USA |
943 TAVI (n = 494) SAVR (n = 449) |
Randomized clinical trial |
Patients with severe aortic stenosis (AS) of low surgical risk |
Transfemoral TAVI using a balloon-expandable valve |
SAVR |
Quality of life |
-
At 1 month
-
TAVI showed better health status than SAVR Mean difference in KCCQ-OS: 16.0 points,
-
p<0.001
-
At 6 months
-
TAVI remained better than SAVR, though with a reduced effect
-
Mean difference in KCCQ-OS: 2.6 points,
-
p<0.04
-
At 12 months TAVI still showed better health status, with a further reduced effect
-
Mean difference in KCCQ-OS: 1.8 points,
-
p<0.04 Proportion of patients with KCCQ-OS ≥75 and no significant decline from baseline
-
At 6 months: 90.3% in TAVI vs. 85.3% in SAVR, p=0.03
-
At 12 months: 87.3% in TAVI vs. 82.8% in SAVR,
-
p=0.07
|
| Garcia et al. 202134
|
USA |
1524 TAVI (n = 1045) SAVR (n = 479) |
Randomized clinical trial |
Patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing TAVI or SAVR |
TAVI |
SAVR |
Complication |
|
| Vandermolen et al. 202135
|
USA |
322 TAVI (n = 220) SAVR (n = 102) |
Randomized clinical trial |
Patients with classic low-flow, low-gradient aortic stenosis |
TAVI |
SAVR |
Mortality |
-
Median follow-up of 2.7 years (range 1.5–4.1 years)
-
99 patients had died:
-
70 (31.8%) in the TAVI group
-
29 (28.4%) in the SAVR group
|
| Forrest et al. 202236
|
USA |
1414 TAVI (n = 730) SAVR (n = 684) |
Randomized clinical trial |
Patients with aortic stenosis in low-risk patients |
TAVI |
SAVR |
Mortality and complications |
-
All-cause mortality rates
-
3.5% in the TAVI group
-
4.4% in the SAVR group p=0.366 Disabling stroke rates
-
1.5% in the TAVI group
-
2.7% in the SAVR group , p=0.119
|
| Kapadia et al. 201523
|
USA |
358 TAVI (n = 179) SAVR (n = 179) |
Randomized clinical trial |
Patients with severe inoperable aortic stenosis |
TAVI |
SAVR |
Mortality |
-
Five-year outcomes
-
All-cause mortality
-
71.8% in the TAVI group
-
93.6% in the SAVR group
-
p<0.0001
|
| Forrest et al. 202337
|
USA |
1414 TAVI (n = 730) SAVR (n = 684) |
Randomized clinical trial |
Low-Risk Patients with Aortic Stenosis |
TAVI with self-expanding supraannular valve |
SAVR |
Mortality and complications |
-
Mortality rates (all-cause or disabling stroke)
-
Year 1: −1.8% difference (TAVI vs. Surgery)
-
Year 2: −2.0% difference
-
Year 3: −2.9% difference Incidence of mild paravalvular regurgitation
-
20.3% in the TAVI group
-
2.5% in the surgery group Pacemaker placement 23.2% in the TAVI group
-
9.1% in surgery group p<0.001 Moderate or greater paravalvular regurgitation
-
<1% in both groups No significant difference
|