Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis.
For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking.
At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population.
A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement.
Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).
Généreux P
，Schwartz A
，Oldemeyer JB
，Pibarot P
，Cohen DJ
，Blanke P
，Lindman BR
，Babaliaros V
，Fearon WF
，Daniels DV
，Chhatriwalla AK
，Kavinsky C
，Gada H
，Shah P
，Szerlip M
，Dahle T
，Goel K
，O'Neill W
，Sheth T
，Davidson CJ
，Makkar RR
，Prince H
，Zhao Y
，Hahn RT
，Leipsic J
，Redfors B
，Pocock SJ
，Mack M
，Leon MB
，EARLY TAVR Trial Investigators
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Meta-analysis of longitudinal comparison of transcatheter versus surgical aortic valve replacement in patients at low to intermediate surgical risk.
Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding.
A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs.
A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups.
TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.
Ahmed M
，Ahsan A
，Shafiq A
，Nadeem ZA
，Arif F
，Zulfiqar E
，Kazmi MH
，Yadav R
，Jain H
，Ahmed R
，Alam M
，Shahid F
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