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TAVI vs. Surgery and All-Cause Mortality in Aortic Stenosis
Quick Takes
- Among patients aged ≥70 years with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year.
- Additional longer-term follow-up is required to monitor clinical outcomes and the need for reintervention given some concerns about the long-term durability of TAVI valves.
- Pending long-term follow-up, treatment selection should be individualized and take into account durability concerns, particularly in younger patients with long life expectancies.
Study Questions:
What are outcomes with transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (surgery) in patients with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity?
Methods:
The UK TAVI Trial investigators conducted a randomized clinical trial at 34 UK centers. A total of 913 patients aged ≥70 years with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014–April 2018 and followed up through April 2019. TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgery (n = 455) was compared. The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the one-sided 97.5% confidence interval (CI) for the absolute between-group difference in mortality. There were 36 secondary outcomes, including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation.
Results:
Among 913 patients randomized (median age, 81 years [IQR, 78-84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0-3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (one-sided 97.5% CI, −∞ to 1.2%; p < 0.001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2-5 days] vs. 8 days [IQR, 6-13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs. 20.2%, respectively; adjusted hazard ratio [HR], 0.33; 95% CI, 0.24-0.45) but significantly more vascular complications (10.3% vs. 2.4%; adjusted HR, 4.42 [95% CI, 2.54-7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs. 7.3%; adjusted HR, 2.05 [95% CI, 1.43-2.94]), and mild (38.3% vs. 11.7%) or moderate (2.3% vs. 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs. none, 4.89 [95% CI, 3.08-7.75]).
Conclusions:
The authors concluded that among patients aged ≥70 years with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year.
Perspective:
This randomized trial that enrolled patients aged ≥70 years with severe, symptomatic aortic stenosis and moderately increased operative risk reports that TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Of note, these findings are concordant with those from other studies in aortic stenosis patients with intermediate risk or low risk. A limitation of the current analysis is only short-term (i.e., 1-year) outcomes. Additional longer-term follow-up is required to monitor clinical outcomes and the need for reintervention given some concerns about the long-term durability of TAVI valves. Pending long-term follow-up, treatment selection should be individualized and take into account durability concerns, particularly in younger patients with longer life expectancies.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Comorbidity, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Hemorrhage, Length of Stay, Pacemaker, Artificial, Risk Factors, Transcatheter Aortic Valve Replacement, Vascular Diseases
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