Aortic Valve Replacement for Severe Asymptomatic Aortic Stenosis-A Systemic Review and Bayesian Meta-analysis

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Clinical Trials

Background:

• Previous meta-analyses suggested early aortic valve replacement (AVR) reduces cardiovascular events in severe asymptomatic aortic stenosis (AS).
• These analyses did not utilize individual patient data (IPD) and may have overlooked biases.
• The current study addresses these limitations by re-evaluating existing randomized clinical trials (RCTs).

Purpose of the Study:

• To determine the long-term efficacy of early AVR versus clinical surveillance (CS) in severe asymptomatic AS using IPD.
• To investigate potential biases, such as early unblinding, influencing previous findings.
• To provide evidence-based recommendations for the standard of care in asymptomatic AS.

Main Methods:

• Systematic review of RCTs focusing on mortality and cardiac hospitalization outcomes.
• Reconstruction of IPD to calculate time-varying risks.
• Bayesian meta-analysis of reconstructed IPD with vague priors.

Main Results:

• Pooled analysis indicated a long-term hazard ratio (HR) of 0.52 (95% credible interval (CrI) 0.25 - 0.93) for early AVR.
• The EARLY_TAVR trial showed a significant one-year benefit (HR 0.33), potentially due to increased crossover rates.
• A one-year landmark analysis revealed no significant long-term AVR benefit across studies (pooled RR 0.59).

Conclusions:

• One-year landmark analysis indicates no definitive longer-term benefit for early AVR in asymptomatic AS.
• The observed early benefit may be attributed to performance bias.
• Further research is needed before early AVR can be established as the standard of care for asymptomatic AS.