EARLY transcatheter aortic-valve replacement (TAVR) was found to be more effective than routine clinical surveillance in reducing the incidence of death, stroke, or unplanned cardiovascular hospitalisations in patients with asymptomatic severe aortic stenosis and preserved left ventricular function, according to recent research.
Current guidelines for asymptomatic severe aortic stenosis with preserved left ventricular ejection fraction recommend regular clinical follow-up every six to twelve months, aiming to monitor progression and time intervention appropriately. However, there is limited evidence from randomised controlled trials to establish if early intervention could improve patient outcomes. This study aimed to assess the efficacy of early TAVR as a proactive treatment strategy compared to the current approach of clinical surveillance. Conducted across 75 centres in the US and Canada, the study involved 901 patients to evaluate whether early TAVR would lead to better clinical outcomes by reducing significant cardiovascular events.
Participants in this study were randomly assigned to receive either TAVR with a balloon-expandable valve or clinical surveillance, maintaining a 1:1 ratio. The primary endpoint included death, stroke, or unplanned hospitalisations for cardiovascular causes. In total, 455 patients received TAVR while 446 were assigned to surveillance. The cohort had a mean age of 75.8 years, and 83.6% were considered low-risk for surgery based on their Society of Thoracic Surgeons Predicted Risk of Mortality scores, which averaged at 1.8%. Over a median follow-up of 3.8 years, 26.8% of patients in the TAVR group reached the primary endpoint, compared to 45.3% in the surveillance group, representing a hazard ratio of 0.50 (95% confidence interval, 0.40 to 0.63; P<0.001). Among the TAVR group, death occurred in 8.4% of patients, stroke in 4.2%, and unplanned cardiovascular hospitalisations in 20.9%. Conversely, these rates were higher in the surveillance group, at 9.2%, 6.7%, and 41.7%, respectively. Notably, 87% of patients in the surveillance group eventually underwent aortic-valve replacement, with no significant increase in procedure-related adverse events compared to those who had received early TAVR.
This trial suggests that early TAVR may be clinically advantageous for patients with severe asymptomatic aortic stenosis, potentially reducing adverse events and unplanned hospitalisations. These findings underscore the need to reassess the current conservative approach, suggesting that early intervention may offer benefits for patients with low surgical risk. Future studies should further explore optimal timing for TAVR, balancing patient quality of life, healthcare resource allocation, and long-term outcomes.
Reference
Généreux P et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2024;DOI:10.1056/NEJMoa2405880.
