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SAPIEN 3 TAVR vs. SAVR in Intermediate-Risk Patients
Quick Takes
- In a large, propensity-matched analysis of intermediate-risk patients with severe, symptomatic aortic stenosis, the 5-year rate of death or disabling stroke was not statistically different following SAPIEN 3 (S3) TAVR and SAVR.
- The rates of structural valve deterioration-related hemodynamic valve deterioration or bioprosthetic valve failure also were not statistically different after S3 TAVR and SAVR, but ≥ mild paravalvular regurgitation and new permanent pacemaker were more common after S3 TAVR.
Study Questions:
What are the comparative 5-year outcomes for patients at intermediate surgical risk for transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 (S3) bioprosthesis and for surgical aortic valve replacement (SAVR)?
Methods:
Patients with severe, symptomatic aortic stenosis (AS) at intermediate surgical risk who underwent S3 TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 2 S3 intermediate-risk (P2S3i) single-arm study were compared with patients at intermediate surgical risk who underwent SAVR in the surgical arm of the PARTNER 2A (P2A) randomized clinical trial. Both trials had exclusion criteria that included congenitally bicuspid aortic valve, severe aortic regurgitation, left ventricular ejection fraction <20%, severe untreated coronary artery disease, and estimated life expectancy <2 years. Propensity-score matching was performed to account for baseline differences. The primary endpoint was the composite of all-cause death and disabling stroke at 5 years. Secondary endpoints included the incidence of the individual components of the primary composite endpoint, the echocardiographic assessment of paravalvular leak (PVL), and VARC-3 (Valve Academic Research Consortium) defined echocardiographic evidence of hemodynamic valve deterioration (HVD) or bioprosthetic valve failure (BVF) due to structural valve deterioration (SVD).
Results:
A total of 1,078 patients underwent S3 TAVR in the P2S3i study and 1,021 underwent SAVR in the P2A trial. Of these, 1,566 patients (783 matched pairs) with intermediate-risk severe AS were studied. The median follow-up was 4.70 years (interquartile range, 2.56-5.06 years); 5-year data were available for 641 (81.9%) S3 TAVR patients and 680 (86.8%) SAVR patients. There were no differences in the primary endpoint of composite all-cause death or disabling stroke between S3 TAVR and SAVR at 5 years (40.2% vs. 42.7%, hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.74-1.03; p = 0.10). The 5-year rates of all-cause death were not different between groups (39.2% vs. 41.4%, HR, 0.90; 95% CI, 0.76-1.06; p = 0.21), but disabling stroke occurred less frequently after S3 TAVR (5.8% vs. 7.9%, HR, 0.66; 95% CI, 0.43-1.00; p = 0.0046) and new permanent pacemaker occurred more frequently after S3 TAVR compared to SAVR (16.2% vs. 11.7%, OR, 1.38; 95% CI, 1.08-1.77; p = 0.01). The incidence of ≥ mild PVL was more common after S3 TAVR but without a significant difference between groups in moderate-to-severe PVL. There were no differences in the incidence of SVD-related stage 2 and 3 HVD (0.63% vs. 0.60%, p = 0.86) or BVF (0.63% vs. 0.37%, p = 0.22).
Conclusions:
In a propensity-matched analysis of intermediate-risk patients, 5-year rates of death or disabling stroke were similar between S3 TAVR and SAVR. Rates of SVD-related HVD were similar, but paravalvular regurgitation and new permanent pacemaker were more common after S3 TAVR. The authors conclude that longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability.
Perspective:
Increased operator experience, the evolution of procedural technique, and advances in transcatheter heart valve design all have contributed to improved clinical outcomes associated with TAVR. This large propensity-matched study that drew on patients from two prior studies (S3 TAVR patients from the P2S3i single-arm study and SAVR patients from the surgical arm of the P2A randomized clinical trial) found no significant differences in 5-year outcomes for the composite endpoint of all-cause mortality or disabling stroke among intermediate-risk patients following S3 TAVR or SAVR, or for the rates of SVD-related HVD or BVF; but higher rates of new permanent pacemaker and ≥ mild paravalvular regurgitation after S3 TAVR. The primary composite outcome finding in this study is similar to that found after self-expanding TAVR vs. SAVR in the SURTAVI trial (composite all-cause mortality or disabling stroke 31.3% vs. 30.8%, HR, 1.02; 95% CI, 0.85-1.22; p = 0.85; Van Mieghem NM, et al., JAMA Cardiol 2022;7:1000-8). Results from both studies help justify the expanding role of TAVR for the treatment of patients with severe, symptomatic AS. As the authors note, truly long-term data still are needed to evaluate bioprosthesis durability and longer-term adverse events.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Coronary Artery Disease, Echocardiography, Heart Valve Diseases, Pacemaker, Artificial, Risk Assessment, Stroke, Stroke Volume, Transcatheter Aortic Valve Replacement, Ventricular Function, Left
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