Abstract 9001: Transcatheter Aortic Valve Implantation Reduces Neither 30-day nor Midterm Mortality Over Aortic Valve Replacement in High-risk Patients: A meta-analysis of Randomized and Adjusted Observational Studies
Background: Our preliminary meta-analysis suggests that transcatheter aortic valve implantation (TAVI) may not reduce 30-day mortality rate over surgical aortic valve replacement (AVR) in high-risk patients with severe aortic stenosis (AS). We performed an updated formal meta-analysis of TAVI versus AVR for reduction of not only early but also late all-cause mortality in AS.
Methods: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials weresearched through February 2012. Eligible studies were randomized controlled trials or adjusted observational comparative studies of TAVI versus AVR enrolling individuals with AS and reporting 30-day and/or ≥6-month all-cause mortality as an outcome. Odds ratios (ORs) and/or hazard ratios (HRs) with 95% confidence intervals (CIs) (adjusted ORs and/or adjusted HRs in case of observational studies) were abstracted from each individual study.
Results: Only one randomized controlled trial and 11 adjusted observational comparative studies enrolling 4134 patients with severe AS were identified. Pooled analysis suggested no significant difference in both 30-day (OR, 0.85; 95% CI, 0.64 to 1.13; P=0.26) and midterm total mortality (HR, 0.99; 95% CI, 0.83 to 1.20; P=0.96; Figure) among patients assigned to TAVI versus AVR. Exclusion of any single study from the analysis did not substantively alter the overall result of our analysis. There was no evidence of significant publication bias.
Conclusions: We found that, based on a meta-analysis of data on >4000 patients from 12 studies, TAVI is likely ineffective in reduction of both 30-day and midterm all-cause mortality in high-risk patients with AS.
- © 2012 by American Heart Association, Inc.