Real-world evidence vs. clinical trials: outcome disparities in valve interventions

Abstract Clinical trials serve as the gold standard for evaluating the safety and efficacy of valve therapies, including transcatheter and surgical procedures, which have undergone remarkable advancements in recent years. However, discrepancies between findings from randomized controlled trials (RCTs) and real-world evidence (RWE) derived from population-based studies, electronic health records, and registries present significant challenges in translating trial outcomes into routine clinical practice. This review explores these disparities by analyzing key differences in research design, patient selection, procedural outcomes, and generalizability between RCTs and RWE in valve therapies. A systematic search of peer-reviewed literature was conducted using the terms “valve interventions,” “RWE,” “clinical trials,” “TAVR,” “SAVR,” and “outcome disparities” across PubMed, Scopus, and Cochrane databases. Studies published between 2010 and 2025 that compared RWE and RCT findings in transcatheter and surgical valve procedures were included. By synthesizing data from multiple sources, this paper highlights the implications of these discrepancies for clinical practice, policy-making, and future research in valve therapies.