Percutaneous versus Surgical Intervention for Severe Aortic Valve Stenosis: A Systematic Review
Table 2
RCTs evaluating safety and efficacy of balloon- and self-expanded TAVR. For each study, total population, follow-up, and treatment type are reported. Primary and secondary endpoints are expressed in the number of patients. The main results are summarized in the right column as hazard ratios or incidence rates. Studies evaluating transcatheter heart valve therapies. An evaluation of THVT and anticoagulant regimen is reported. Studies are summarized according to the main finding in terms of treatment and prevention. The number of total TAVR implantations per study is reported.
Author/year # Type of study
Study completion date
Total number
Treatment ()
Follow-up (yrs)
Primary endpoint ()
Secondary endpoints ()
Finding
Makkar 2020 (23) Lancet RCT
2025
358
TAVR
SAPIEN
2
All-cause mortality or disabling stroke
Severe aortic regurgitation
At 2 yrs, death () and stroke () similar between groups. Portico no advantage
Portico
CoreValve
381
369
Portico
Others
Portico
Others
55
48
1/269
0/269
Lanz 2019 Lancet RCT
2022
739
TAVR SAPIEN 3
TAVR ACURATE neo
30 days
Composite early safety and clinical efficacy
Individual components of primary endpoint, procedural complications, and clinical safety
30 days’ safety and clinical efficacy better for SAPIEN 3 vs. ACURATE neo. PEP RD 7.1% (1.3-12.9)
367
372
SAPIEN 3 60
ACURATE neo 87
SAPIEN 3 255
ACURATE neo 287
Mack 2019 (11) NEJM RCT
2029
950
TAVR
SAVR
1
Death from any cause, stroke, and rehospitalization at 1 year
Death or stroke at 30 days
At 1 year, the rates of the composite of death, stroke, and rehospitalization lower for TAVR. PEP HR 0.54 (0.37 to 0.79)
496
454
TAVR
SAVR
TAVR
SAVR
42
68
5
15
Popma 2019 (26) NEJM RCT
2026
1468
TAVR
SAVR
2
Composite of death from any cause or stroke
Composite of death, stroke, bleeding, major vascular complication, and others
At 2 yrs, TAVR noninferior with respect to death from any cause or stroke. PEP incidence difference: -1.8 (BCI -4.0-0.4)
734
734
TAVR
SAVR
39
49
TAVR 381
SAVR 633
Thyregod 2019 (27) Circulation RCT
2023
280
TAVR 145
SAVR 135
5
Death from any cause, stroke, or MI
Cardiac death, stroke, TIA, MI, AF, pacemaker, reintervention, and endocarditis
Higher rates of prosthetic regurgitation and pacemaker implantation higher for TAVR PEP,
TAVR 55
SAVR 49
TAVR 167
SAVR 155
Feldman, 2018 (28) JAMA RCT
2025
912
TAVR MEV 607
TAVR SEV 305
1
Composite of all-cause mortality, stroke, and moderate or greater paravalvular leak noninferiority
1-year moderate or greater paravalvular leak, superiority testing
Higher rates of new pacemaker implants and valve thrombosis higher for MEV. Higher rates of repeat procedures, valve-in-valve and valve malpositioning for SEV. PEP for noninferiority
MEV 5
SEV 21
MEV 93
SEV 78
Reardon 2017 (25) NEJM RCT
2026
1660
TAVR 864
SAVR 796
2
Death from any cause and stroke
MACE and cerebrovascular events
SAVR higher acute kidney injury, AF, and blood transfusion. TAVR higher rates of residual AR and PM implantation. PEP 95% credible interval posterior probability of
TAVR 109
SAVR 111
—
—
Leon 2016 (35) NEJM RCT
2024
2032
TAVR 1011
SAVR 1021
2
Death from any cause or disabling stroke
Death, stroke, or rehospitalization
TAVR similar to SAVR for primary endpoint of death or disabling stroke. PEP HR 0.89 (0.73 to 1.09)
TAVR 192
SAVR 202
TAVR 344
SAVR 326
Mack 2015 (10) Lancet RCT
2017
699
TAVR 348
SAVR 351
5
Death from any cause
Death or stroke at 5 yrs
TAVR similar clinical outcomes in high surgical risk patients. PEP HR 1.04, 95% CI 0.86–1.24;
TAVR 229
SAVR 198
TAVR 236
SAVR 200
Kapadia 2015 (9) Lancet RCT
2017
358
TAVR 179
SAVR 179
5
Death from any cause
Cardiovascular death, stroke, vascular complications, major bleeding, and functional status
At 2 yrs rates of cardiovascular mortality lower for TAVR. PEP HR 0.50, 95% CI 0.39–0.65;
TAVR 127
SAVR 143
TAVR 84
SAVR 118
Adams 2014 (24) NEJM RCT
2019
795
TAVR 394
SAVR 401
1
Rate of death from any cause at 1 year
Composite of death from any cause, myocardial infarction, stroke, and reintervention
At 1 yr. survival higher for TAVR. Adverse event more frequent for TAVR. PEP for noninferiority
TAVR 14.2%
SAVR 19.1%
TAVR 90
SAVR 211
Kodali 2012 (96) NEJM RCT
2017
699
TAVR 348
SAVR 351
2
Death from any cause
Cardiovascular mortality, stroke, rehospitalization, AKI, vascular complications, bleeding, and NYHA
PVL higher for TAVR and associated with increased late mortality. PEP HR 0.90; 95% CI, 0.71 to 1.15;
TAVR 116
SAVR 114
TAVR 295
SAVR 266
Makkar 2012 (3) NEJM RCT
2017
358
TAVR 179
MT 179
2
Death from any cause
Death or stroke at 2 yrs
At 2 years, TAVR reduced the rates of death and hospitalization. PEP HR 0.95 (0.91 to 0.98);
