CoreValve Versus Sapien Valve

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CoreValve Versus Sapien Valve
CHOICE Randomised Clinical Trial
The CHOICE study is the only randomised controlled trial (RCT) comparing a self-expandable valve (MCV) to a balloon-expandable valve (ESV). In this trial the primary endpoint was device success as measured by: successful vascular access; and deployment and retrieval without the need for a second valve; and less than mild AR post-procedure. Secondary endpoints included the need for a permanent pacemaker system, cardiovascular and all-cause mortality at 30 days.

Results from this trial showed that although cardiovascular mortality, bleeding and vascular complications were similar for both valves, there was a higher risk of pacemaker insertion following MCV implantation, a lower rate of more than mild AR following ESV implantation and better device success with the ESV valve (95.5 % versus 77.5 % p<0.001).²³

PRAGMATIC Study
The aim of the PRAGMATIC study was to compare outcomes from transfemoral TAVI between the Medtronic CoreValve and Edwards Sapien/XT valves for patients with severe aortic stenosis. This non-randomised, retrospective study analysed pooled data from four experienced European centres, which underwent propensity score matching in view of differences in baseline characteristics. Of a total of 793 possible patients, 204 in each group were identified. There was no difference in 30-day all-cause mortality (MCV 8.8 % versus ESV 6.4 %, p=0.3520), major vascular complications (MCV 9.3 % versus ESV 12.3 %, p=0.340), or one-year all-cause or cardiovascular mortality between the two valves. There was a higher incidence of permanent pacemakers in the MCV group at 22.5 % versus 5.0 % in the ESV group (p≤0.001), which is likely a result of valve design. In addition, this study found that although there was no difference observed in the incidence of AR of any grade between the two valves types, residual moderate to severe AR was associated with an increased one-year mortality.²⁴

UK Registry
Data from the UK TAVI registry evaluated outcomes according to valve type and method of delivery. In essence, there was no significant difference in mortality between the ESV and MCV groups at any timepoints, and no difference in mortality between the two valves types for transfemoral delivery. There was a higher incidence of permanent pacemaker implantation as well as paravalvular regurgitation with the MCV prosthesis. Transapical delivery of the ESV valve was associated with higher mortality at 30 days as well as one-year when compared with transfemoral delivery of the same valve type. Trans-subclavian delivery of the MCV was associated with higher mortality, although this did not reach statistical significance. Cumulative survival for transapically implanted ESV was found to be associated with a lower survival than with transfemoral delivery. Survival rates for subclavian delivery of the MCV cohort initially tracked that of both valves when delivered via the transfemoral route, but at six months this fell dramatically, meeting the poorer survival rates for transapically delivered ESV.²

FRANCE 2 Registry
This study was a prospective multicentre study of the French national TAVI registry. The primary endpoint was death from any cause. A total of 3,195 patients were included, having undergone TAVI using the ESV and the MCV between January 2010 and October 2011, at 34 centres. Results from this study were comparable with the PARTNER trial in terms of mortality at 30 days (9.7 %) and one-year (24 %). MCV use as associated with a higher rate of permanent pacemaker (PPM) as well as periprosthetic regurgitation. Multivariate analysis indicated that a higher logistic EuroSCORE and transapical approach as well as residual paravalvular regurgitation was associated with an increased mortality.²⁵

Meta-analysis of Impact, Incidence and Predictors of Aortic Regurgitation after Transcatheter Aortic Valve Implantation.This meta-analysis of 45 studies included a total of 12,926 patients. Results indicated that AR was common post-TAVI and was an adverse prognostic indicator of short and long-term survival. AR was also more prevalent in the MCV group at 16.1 % versus 9.1 % in the ESV group (p=0.005).²⁶