Transcatheter aortic valve implantation versus surgical aortic valve replacement for treatment of severe aortic stenosis: comparison of results from randomized controlled trials and real-world data

Abstract Objective: Results from randomized controlled trials (RCTs) and real-world study (RWS) appear to be discordant. We aimed to investigate whether data derived from RCTs and RWS evaluating long-term all-cause mortality of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) were in agreement. Methods: RCTs or RWS comparing TAVI and SAVR, reporting longterm (≥2-year follow-up) all-cause mortality, were identified. We also carried out subgroup analyses to access the effect in different subgroups. A pre-designated data extraction form including 5 domains and 26 items was used to explore the relationship between RCTs and RWS. Mortality and effect in different subgroups were evaluated using random-effects meta-analyses. Results: Five RCTs (5421 participants, TAVI: 2759, SAVR: 2662) and 33 RWS (20839 participants; TAVI: 6585, SAVR: 14254) were identified. Pooled RCT analysis showed no difference in all-cause mortality between TAVI and SAVR (HR=0.97, 95% CI: 0.88-1.07; P=0.55). In RWS, TAVI was associated with an increased risk of allcause mortality (HR=1.46, 95% CI: 1.26-1.69; P<0.001) compared to SAVR. Conclusion: These results highlight the inconsistencies between RCTs and RWS in assessing long-term all-cause mortality in the treatment of AS using TAVI or SAVR, which may be caused by interactions of clinical characteristics or study design. RCTs as well as RWS are both developing and improving; the advantages of one kind of design, measurement and evaluation can and should be thoughtfully referred to the other.

Validity and Reproducibility of a Revised Semiquantitative Food Frequency Questionnaire (SQFFQ) for Women of Age-group 12-44 Years in Chengdu.

To find a credible nutritional screening tool for evaluating relationship between nutritional status and diseases in Chengdu female residents, the reliability and validity of a revised semi-quantitative food frequency questionnaire (SQFFQ) were tested. The validity was assessed by comparing the SQFFQ with the ‘standard’ method of 3 days’ dietary recall, and the reliability was assessed by comparing the first SQFFQ with the second SQFFQ at 4 weeks interval. Correlation analysis showed that, for reliability, the average correlation coefficient (CC) of 22 kinds of nutrients was 0.66 and reduced to 0.60 after adjusting for energy; the average of intra-class correlation coefficients (ICC) was 0.65. For validity, the average CC was 0.35 and remained stable after adjusting for CC of energy or nutrients. Validity of 17 nutrients in SQFFQ survey had correlation with result of 3 days’ dietary recall. The results showed that the revised SQFFQ can be used for investigating the role of nutrients in development of disease in Chengdu female residents.