Table 1.
Results of major prospective randomized trials on TAVI vs. SAVR in high and intermediate to low risk patients.
| PARTNER 1A (6) | CoreValve HR (7) | PARTNER 2A (10) | NOTION (9) | SURTAVI (8) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time of recruitment | May 2007–August 2009 | February 2011–December 2012 | December 2011 –November 2013 | December 2009–April 2013 | June 2012 –June 2016 | ||||||||||
| THV | SAPIEN | CoreValve | SAPIEN XT | CoreValve | CoreValve | ||||||||||
| Primary endpoint | All-cause death at 1 year | All-cause death at 1 year | All-cause death or diasbling stroke at 2 years | All-cause death, disabling stroke or myocardial infarction at 1 year | All-cause death or disabling stroke at 2 years | ||||||||||
| TAVI | SAVR | p | TAVI | SAVR | p | TAVI | SAVR | p | TAVI | SAVR | p | TAVI | SAVR | 95% CI | |
| Number of randomized pts. | 348 | 351 | n/a | 394 | 401 | n/a | 1,011 | 1,021 | n/a | 145 | 135 | n/a | 864 | 796 | n/a |
| Age | 83.6 ± 6.8 | 84.5 ± 6.4 | 0.07 | 83.2 ± 7.1 | 83.5 ± 6.3 | n/a | 81.5 ± 6.7 | 81.7 ± 6.7 | n/a | 79.2 ± 4.9 | 79.0 ± 4.7 | n/a | 79.9 ± 6.2 | 79.7 ± 6.1 | n/a |
| Male gender | 57.8% | 56.7% | 0.82 | 53.6% | 52.9% | n/a | 54.2% | 54.8% | n/a | 53.8% | 52.6% | n/a | 57.6% | 55.0% | n/a |
| STS-PROM (%) | 11.8 ± 3.3 | 11.7 ± 3.5 | 0.61 | 7.3 ± 3.0 | 7.5 ± 3.2 | n/a | 5.8 ± 2.1 | 5.8 ± 1.9 | n/a | 2.9 ± 1.6 | 3.1 ± 1.7 | n/a | 4.4 ± 1.5 | 4.5 ± 1.6 | n/a |
| Log. EuroSCORE (%) | 29.3 ± 16.5 | 29.2 ± 15.6 | 0.93 | 17.6 ± 13.0 | 18.4 ± 12.8 | n/a | n/a | n/a | n/a | 8.4 ± 4 | 8.9 ± 5.5 | n/a | 11.9 ± 7.6 | 11.6.8.0 | n/a |
| Transfemoral access | 70.1% | – | – | n/a | – | – | 76.3% | – | – | 96.5% | – | – | 93.6% | – | – |
| Primary endpoint | 24.2% | 26.8% | 0.44 | 14.2% | 19.1% | 0.04 | 19.3% | 21.1% | 0.25 | 13.1% | 16.3% | 0.43 | 12.6% | 14.0% | −5.2 to 2.3 |
| All-cause mortality (30 days) | 3.4% | 6.5% | 0.07 | 3.3% | 4.5% | n/a | 3.9% | 4.1% | 0.78 | 2.1% | 3.7% | 0.43 | 2.2% | 1.7% | −0.9 to 1.8 |
| All-cause mortality (1 year) | 24.2% | 26.8% | 0.44 | 14.2% | 19.1% | 0.004 | 12.3% | 12.9% | 0.69 | 4.9% | 7.5% | 0.38 | 6.7% | 6.8% | −2.7 to 2.4 |
| All-cause mortality (2 years) | 33.9% | 35.0% | 0.78 | 22.2% | 28.6% | 0.04 | 16.7% | 18.0% | 0.45 | 8.0% | 9.8% | 0.54 | 11.4% | 11.6% | −3.8 to 3.3 |
| Stroke (30 days) | 3.8% | 2.1% | 0.2 | 4.9% | 6.2% | 0.46 | 5.5% | 6.1% | 0.57 | 1.4% | 3.0% | 0.37 | 3.4% | 5.6% | −4.2 to−0.2 |
| Myocardial infarction (30 days) | 0 | 0.6% | 0.16 | 0.8% | 0.8% | 0.92 | 1.2% | 1.9% | 0.22 | 2.8% | 6.0% | 0.2 | 0.9% | 1.0% | −1.0 to 0.9 |
| Major vascular complications (30 days) | 11.0% | 3.2% | <0.001 | 5.9% | 1.7% | 0.003 | 7.9% | 5.0% | 0.008 | 5.6% | 1.5% | 0.1 | 6.0% | 1.0% | 3.2 to 6.7 |
| Major or life-threatening bleeding (30 days) | 9.3% | 3.2% | <0.001 | 13.6% | 35.0% | <0.001 | 10.4% | 43.4% | <0.001 | 11.3% | 20.9% | 0.03 | 12.2% | 9.3% | −0.1 to 5.9 |
| New permanent pacemaker (30 days) | 3.8% | 3.6% | 0.89 | 19.8% | 7.1% | <0.001 | 8.5% | 6.9% | 0.17 | 34.1% | 1.6% | <0.001 | 25.9% | 6.6% | 15.9–22.7 |
| New-onset atrial fibrillation (30 days) | 8.6% | 16.0% | 0.006 | 11.7% | 30.5% | <0.001 | 9.1% | 26.4% | <0.001 | 16.9% | 57.8% | 0.001 | 12.9% | 43.3% | −34.7 to −26.4 |
| Acute kidney injury (30 days) | 1.2% | 1.2% | 0.95 | 6.0% | 15.1% | <0.001 | 1.3% | 3.1% | 0.006 | 0.7% | 6.7% | 0.01 | 1.7% | 4.4% | −4.4 to −1.0 |
| Moderate or severe PVL (1 year) | 6.8% | 1.9% | <0.001 | 6.1% | 0.5% | <0.001 | 3.4% | 0.4% | <0.001 | 15.7% | 0.9% | 0.001 | 5.3% | 0.6% | n/a |
| Rehospitalization (2 years) | 24.7% | 21.7% | 0.41 | n/a | n/a | – | 19.6% | 17.3% | 0.22 | n/a | n/a | – | 13.2% | 9.7% | 0.1–7.0 |
| Endocarditis (2 years) | 1.5% | 1.0% | 0.61 | 0.9% | 1.7% | 0.35 | 1.2% | 0.7% | 0.22 | n/a | n/a | – | n/a | n/a | – |
| AV reintervention (2 years) | n/a | n/a | – | 2.5% | 0.4% | 0.02 | 1.4% | 0.6% | 0.09 | n/a | n/a | – | 2.7% | 0.7% | 0.6–3.4 |
AV, aortic valve; CI, confidence interval; LogES, logistic EuroSCORE; PVL, paravalvular leakage; SAVR, surgical aortic valve replacement; STS-PROM, Society of Thoracic Surgeons predicted risk of operative mortality; TAVI, transcatheter aortic valve intervention; THV, transcatheter heart valve. Values are given as mean ± standard deviation or frequencies and percentages.