Table 2.
Results of comparison studies of ACURATE neo with SAPIEN 3 and Evolut R/PRO
| Study design Author (year) |
Baseline of ACURATE-arm | Valve performance | Clinical outcome | |||||
|---|---|---|---|---|---|---|---|---|
| N | Age | Surgical score | Hemodynamic results | PVL | Pacemaker implantation | AKI stage 2 or 3 | 30-day mortality | |
| Versus SAPIEN 3 | ||||||||
|
PS-matched comparison Husser et al. (2017) [25] |
311 | 81 ± 6 | LES: 18 ± 10% |
9 ± 5 vs. 13 ± 5 mmHg (P < 0.001) |
4.8% vs. 1.8% (P = 0.008) |
10.2% vs. 16.4% (P = 0.018) |
3.2% vs. 2.7% (P = 0.679) |
2.3% vs. 1.9% (P = 0.742) |
|
PS-matched comparison*1 Mauri et al. (2017) [23] |
92 | 83 ± 7 | LES: 16.2 ± 8.8% |
9.3 ± 3.9 vs. 14.5 ± 5.5 mmHg (P < 0.001) |
4.5% vs. 3.6% (P = 0.208) |
12.0% vs. 15.2% (P = 0.678) |
NA |
1.1% vs. 2.2% (P = 1.000) |
|
PS-matched comparison Schaefer et al. (2017) [26] |
104 | 82 ± 6 |
LES: 15.9 ± 9.3% STS: 5.8 ± 3.8% |
7.3 ± 2.8 vs. 11.8 ± 3.5 mmHg (P < 0.001) |
4.8% vs. 1.9% (P = 0.257) |
10.6% vs. 16.4% (P = 0.239) |
2.9% vs. 1.9% (P = 0.655) |
3.9% vs. 0.9% (P = 0.317) |
|
PS-matched comparison*2 Husser et al. (2019) [27] |
65 |
81 (77–84) |
LES: 14.3% (9.8–21.5) |
7(5–10) vs. 11(9–12, 13•, 14•) mmHg (P < 0.001) |
4.6% vs. 0% (P = 0.244) |
23.1% vs. 44.6% (P = 0.016) |
1.5% vs. 7.7% (P = 0.208) |
3.1% vs. 6.2% (P = 0.680) |
|
PS-matched comparison Barth et al. (2019) [28] |
329 | 81 ± 5 | LES: 18.8 ± 14.7% |
8.6 ± 4.6 vs. 10.9 ± 4.2 mmHg (P < 0.001) |
12.0% vs. 3.1% (P < 0.001) |
11.9% vs. 18.5% (P = 0.020) |
NA |
4.6% vs. 2.1% (P = 0.134) |
|
Randomized clinical trial+ Lanz et al. (2019) [5••] |
372 | 83 ± 4 |
STS: 3.7% (2.5–4.9) |
7(1–15) vs. 11(2–23) mmHg (P < 0.0001) |
9.4% vs. 2.8% (P < 0.0001) |
10% vs. 9% (P = 0.76) |
3% vs. 1% (P = 0.0340) |
2% vs. 1% (P = 0.09) |
| Versus Evolut PRO | ||||||||
|
PS-matched comparison Pagnesi et al. (2019) [29•] |
251 | 81 ± 7 |
ES II: 6.34 ± 5.21% STS: 5.08 ± 3.05% |
8.3 ± 4.0 vs. 7.3 ± 3.6 mmHg (P = 0.003) |
7.3% vs. 5.7% (P = 0.584) |
11.0% vs. 12.8% (P = 0.565) |
2.4% vs. 1.6% (P = 0.543) |
3.2% vs. 1.2% (P = 0.221) |
| Versus SAPIEN 3 versus Evolut R | ||||||||
|
PS-matched comparison Costa et al. (2020) [30] |
48 | 82 (80–85) | STS: 4.0 ± 3.3% |
8.4 ± 3.5 vs. 9.7 ± 7.5 vs. 6.1 ± 2.4 mmHg (P < 0.001) |
0% vs. 0% vs. 2.1% (P < 0.01) |
2.1% vs. 8.3% vs. 16.7% (P = 0.046) |
1.0% vs. 2.2% vs. 2.7% (P = 0.659) |
0% vs. 0% vs. 0% (P = NA) |
PS propensity score, PVL paravalvular leak, ES II Euroscore II, LES logistic Euroscore, STS Society of Thoracic Surgeons predicted risk of mortality, NA not available/assessed
+ Independent event adjudication and echocardiographic core laboratory assessment were applied (no other studies comprised independent event adjudication or core laboratory echocardiographic assessment)
*1Selective cohort with an aortic annulus area < 400 mm2
*2Selective cohort with pre-existent right bundle branch block and no pacemaker at baseline