Table 1. Summary of randomized controlled trials comparing transcatheter versus surgical aortic valve replacement in patients at intermediate to low surgical risk.
| Characteristics | PARTNER 2 cohort A22) | SURTAVI23) | NOTION24),25) | |
|---|---|---|---|---|
| Study period | Dec 2011–Nov 2013 | Jun 2012–Jun 2016 | Dec 2009–Apr 2013 | |
| Participants | 2,302 | 1,746 | 280 | |
| Transcatheter valves | Sapien XT | CoreValve and Evolut R | CoreValve | |
| Study criteria | Inclusion: STS-PROM ≥4% or other intermediate-risk profile with comorbidities determined by heart team | Inclusion: STS-PROM 3–15% and <15% | Patients ≥70 years old with severe aortic valve stenosis and no significant coronary artery disease regardless of surgical risk of death | |
| Exclusion: unicuspid, bicuspid, or non-calcified valves | Exclusion: bicuspid or unicuspid valve | |||
| Age and the STS-PROM score in TAVI arm | 82±7 years/5.8±2.1% | 80±6 years/4.4±1.5% | 79±5 years/2.9±1.6% | |
| Outcomes (TAVI vs. SAVR) | ||||
| Primary endpoint | Composite of all-cause death and disabling stroke at 2 years | Composite of all-cause death and disabling stroke at 2 years | Composite of all-cause death, stroke, and myocardial infarction at 1 year | |
| 19.3% vs. 21.1% (HR, 0.89; 95% CI, 0.73–1.09; p=0.001 for non-inferiority, p=0.25 for superiority) | 12.6% vs. 14.0% (95% credible interval −5.2 to 2.3%; posterior probability of non-inferiority >0.999) | 13.1% vs. 16.3%; p=0.43 | ||
| All-cause death | At 1 year: 12.3% vs. 12.9%; p=0.69 | At 1 year: 6.7% vs. 6.8%; 95% credible interval −2.7 to 2.4% | At 1 year: 4.9% vs. 7.5%; p=0.38 | |
| At 2 years: 16.7% vs. 18.0%; p=0.45 | At 2 years: 11.4% vs. 11.6%; 95% credible interval −3.8 to 3.3% | At 5 years: 27.7% vs. 27.7%; p=0.90 | ||
| Any stroke | At 30 days: 5.6% vs. 6.1%; p=0.63 | At 30 days: 3.4% vs. 5.6%; 95% credible interval −4.2 to −0.2% | At 30 days: 1.4% vs. 3.0%; p=0.37 | |
| At 2 years: 9.6% vs. 9.0%; p=0.66 | At 2 years: 6.2% vs. 8.4%; 95% credible interval −5.0 to 0.4% | At 5 years: 10.5% vs. 8.2%; p=0.67 | ||
| Moderate-to-severe paravalvular leakage at 1 year | 3.4% vs. 0.4%; p<0.001 | 5.3% vs. 0.6%; 95% credible interval 2.8 to 6.8% | 15.7% vs. 0.9%; p<0.001 | |
| New permanent pacemaker implantation at 30 days | 8.5% vs. 6.9%; p=0.17 | 25.9% vs. 6.6%; 95% credible interval 15.9 to 22.7% | 34.1% vs. 1.6%; p<0.001 | |
| Life-threatening or major bleeding | At 30 days: 10.4% vs. 43.4%; p<0.001* | At 30 days: 12.2% vs. 9.3%; 95% credible interval −0.1 to 5.9% | At index hospitalization: 11.3% vs. 20.9%; p=0.03 | |
CI = confidence interval; HR = hazard ratio; NOTION = Nordic Aortic Valve Intervention Trial; PARTNER = Placement of AoRTic TraNscathetER Valve; SAVR = surgical aortic valve replacement; STS-PROM = Society of Thoracic Surgeons Predicted Risk of Mortality; SURTAVI = Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients; TAVI = transcatheter aortic valve implantation.
*Incidence of life-threatening or disabling bleeding was reported in the PARTNER 2A trial.