Table 1.
Characteristics of the landmark studies on transcatheter aortic valve replacement.
| Study | Year | Population | Arms | Age | Risk scores | Results | Complications |
|---|---|---|---|---|---|---|---|
| Extreme-risk | |||||||
| PARTNER B | 2010 | 358 pts with severe AS, NYHA II-IV, STS > 50% or critical conditions | TAVR with Edwards SAPIEN valve vs. standard therapy (usually balloon aortic valvuloplasty) | 83.1 ± 8.6 | STS score 11.2% EuroScore 26.4% | TAVR significantly reduces the rate of all-cause death (HR 0.55), CV death (HR 0.39), death + rehospitalization (HR 0.46), symptoms and 6MWD at 1 yr and non-significantly increases major stroke rate at 30 days (5.0 vs. 1.1%, p 0.06) and 1 yr (7.8 vs. 3.9%, p 0.18). | Paravalvular aortic regurgitation 3–4+ in TAVR: 11% at 30 days and 1 yr |
| CoreValve Extreme Risk | 2014 | 489 pts with severe AS, NYHA II-IV, STS > 50% or irreversible 30-days SAVR morbidity | TAVR with CoreValve vs. OPG (43% for all-cause death or stroke at 1 yr) | 83.2 ± 8.7 | STS score 10.3% EuroScore 22.6% | All-cause death or stroke at 1 yr 26.0% (upper 95%CI 29.9% < OPG 43%). Significant improvement in NYHA class | PM implantation: 21.6% at 30 days, 26.2% at 1 yr. Paravalvular aortic regurgitation 3–4+: 4% at 1 yr |
| High-risk | |||||||
| PARTNER A | 2011 | 699 pts with severe AS, NYHA II-IV, STS > 10% | TAVR with Edwards SAPIEN valve vs. SAVR | 83.6 ± 6.8 | STS score 11.8% EuroScore 29.3% | No difference in all-cause death at 1 yr (24.2% TAVR vs. 26.8% SAVR). More neurological events (strokes + TIA) in TAVR pts at 30 days and 1 yr (p 0.04). Shorter hospital stay and shorter ICU stay in TAVR patients | Higher rate of vascular complications at 30 days in TAVR. No difference in new PM implantation (4%). More major bleeding events and new-onset AF in SAVR |
| CoreValve High Risk | 2014 | 747 pts with severe AS, NYHA II-IV, STS 15–50% | TAVR with CoreValve vs. SAVR | 83.2 ± 7.1 | STS score 7.3% EuroScore 17.6% | TAVR reduces 1 yr all-cause death (14 vs. 19%, p 0.04) and neurological events (20 vs. 27%) | More PM implantations and major vascular complications in TAVR. More bleeding events, AKI and new or worsening AF in SAVR |
| Intermediate-risk | |||||||
| PARTNER 2A | 2016 | 2,032 pts with severe AS, NYHA II-IV, STS 4.0–8.0% | TAVR with SAPIEN XT vs. SAVR | 81.5 ± 6.7 | STS score 5.8% EuroScore N/A | No difference in primary composite endpoint (all-cause death + disabling stroke) at 2 yrs; similar single components of the primary endpoint. TF TAVR reduces the primary endpoint (HR 0.78, p 0.05) | More major vascular complications and paravalvular aortic regurgitation but less life-threatening bleeding, AKI, and new-onset AF in TAVR. Similar new PM implantation rates (8.5 vs. 6.9%, p 0.17) |
| SURTAVI | 2017 | 1,160 pts with severe AS, NYHA II-IV, STS 3–15% and non-traditional risk factors | TAVR with CoreValve or Evolut R vs. SAVR | 79.8 ± 6.2 | STS score 4.4% EuroScore 11.9% | TAVR non-inferior for composite primary endpoint (all-cause death + disabling stroke) at 2 yrs. No structural valve deterioration at 2 yrs in both groups | Higher aortic regurgitation (5%) and new PM implantation (26 vs. 7%) in TAVR. Higher AKI (4%), AF (43%) and blood transfusions in SAVR |
| Low-risk | |||||||
| NOTION | 2015 | 280 pts ≥ 70 years-old with severe AS | TAVR with CoreValve vs. SAVR | 79.2 ± 4.9 | STS score 2.9% EuroScore 8.4% | TAVR non-inferior for composite primary endpoint (all-cause death + stroke + MI) at 1 yr | TAVR showed fewer post-operative major bleedings, cardiogenic shock, AKI and new AF, and shorter hospital stay. At 1 yr, TAVR showed more PM implantations, total aortic regurgitation, and higher NYHA class |
| Evolut Low Risk | 2019 | 1,403 pts with severe AS, NYHA II-IV, STS < 3% | CoreValve or Evolut R or Evolut PRO TAVR vs. SAVR | 74.0 ± 5.9 | STS score 1.9% EuroScore N/A | TAVR non-inferior for composite primary endpoint (all-cause death + disabling stroke) at 2 yrs | TAVR shows fewer 30-days disabling strokes, bleeding complications, AKI, and AF but higher 3–4+ aortic regurgitation (3.5%) and new PM implantation rates (17%) |
| PARTNER 3 | 2019 | 1,000 pts with severe AS, NYHA II-IV, or asymptomatic pts with ejection fraction < 50%, STS < 4% | TF TAVR with SAPIEN 3 vs. SAVR. | 73.3 ± 5.8 | STS score 1.9% EuroScore II 1.5% | TAVR non-inferior for composite of all-cause death, stroke, and rehospitalizations at 2 yrs (HR 0.54, p 0.001). TAVI shows lower 30-days stroke (HR 0.25), death or stroke (HR 0.30) and new AF (HR 0.10), shorter index hospitalization, fewer major bleeding events (HR 0.12) but more new left bundle branch block (HR 3.43) | No difference in major vascular complications and new PM implantation rates at 30 days, nor in 3–4+ aortic regurgitation at 30 days or 1 yr |
| UK TAVI | 2020 | 913 pts with severe AS, aged ≥ 80 yrs or ≥ 70 yrs with intermediate/high surgical risk | TAVR vs. SAVR | 81.1 ± 4.4 | STS score 2.6% EuroScore N/A | TAVR non-inferior for all-cause death (HR 1.91, p 0.33), CV death (HR 2.22, p 0.27), stroke (HR 0.95, p 0.93), or the composite of all-cause death + stroke (HR 0.95, p 0.88) at 1 yr compared to SAVR | TAVR is associated with less major bleeding, shorter hospital stay, and more rapid improvement in NYHA class and QoL as well as more vascular complications, PM implantations, and mild or moderate aortic regurgitation than SAVR. |
| Direct comparison | |||||||
| CHOICE | 2014 | 241 pts with severe AS, NYHA II-IV, high surgical risk (≥ 75 yo or STS ≥ 10% or EuroScore ≥ 20%), suitable for TF access and contraindication to SAVR | TF TAVR with a first-generation balloon-expandable valve vs. first-generation self-expanding valve | 81.9 ± 6.7 | STS score 5.6% EuroScore 21.5% | Device success was more frequent in the balloon-expandable group compared to the self-expanding group (RR 1.24, p < 0.001). | Significantly lower moderate to severe aortic regurgitation, less frequent need for implanting more than 1 valve, and fewer PM implantations in the balloon-expandable valve group. Cardiovascular mortality and bleeding and vascular complications were not significantly different |
| SCOPE | 2019 | 739 pts ≥ 75 yo with symptomatic severe AS at increased surgical risk | ACURATE neo vs SAPIEN 3 TAVR systems | 82.8 ± 4.1 | STS score 3.5% EuroScore N/A | Non-inferiority of the ACURATE neo was not met as for the primary composite efficacy and safety endpoint (absolute risk difference 7.1%, p 0.42) at 30 days compared to SAPIEN 3. | More frequent AKI and moderate or severe aortic regurgitation with ACURATE neo. No difference in all-cause death and stroke between the study groups. |
| SCOPE II | 2020 | 796 pts ≥ 75 yo with indication to transfemoral TAVR | ACURATE neo vs Evolut R TAVR systems | 83.2 ± 4.3 | 4.6 ± 2.9% | Non-inferiority of the ACURATE neo was not met as for the primary composite endpoint (absolute risk difference 1.8%; p=0.0549) at 1 year compared to Evolut R | More frequent cardiac deaths, moderate or severe aortic regurgitation at 30 days while lower PM implant rate were observed in the ACURATE neo group |
| SOLVE-TAVI | 2020 | 438 pts ≥ 75 yo, severe AS, NYHA II-IV, STS>10%, or Euro Score>20% | TF TAVR with SAPIEN 3 vs. Evolut R | 81.7 ± 5.3 | STS score 4.7% EuroScore 15% | No difference in composite of all-cause death, stroke, 3–4+ paravalvular leak and permanent PM implantation at 30 days (28.4 vs. 26.1%, p 0.04 for equivalence). No difference in individual components of the primary endpoint | PM implantation rates SAPIEN 3 19% vs. Evolut R 23% (p 0.06 for equivalence). Numerically higher strokes with SAPIEN 3 (4.7 vs. 0.5%, p 0.003 for equivalence) |
6MWD, 6-min walking distance; AF, atrial fibrillation; AKI, acute kidney injury; AS, aortic stenosis; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; ICU, intensive care unit; MI, myocardial infarction; N/A, not available; NYHA, New York Heart Association; pts, patients; OPG, objective performance goal; PM, pace maker; QoL, quality of life; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; TF, transfemoral; TIA, transient ischemic attack; yo, years-old; yr, year.