AHA 2019 | Sapien vs Evolut: A Head-to-Head Study Seems Mandatory

Two French registries have carried out a propensity matched comparison which suggest differences between balloon-expandable valves (BEV) and self-expandable valves (SEV) in hard end points such as mortality. 

The only FDA approved commercially available transcatheter heart valves in the US are the BE Sapien 3 (Edwards Lifesciences) and the SE CoreValve Evolut PRO (Medtronic). Both devices (and their prior versions) had been shown superior to surgical valve replacement in a great number of clinical scenarios, but had never been compared head to head in a large randomized study. 

Operators usually choose devices based on personal experience, their institution’s commercial convenience, or a few anatomical or hemodynamic subtleties. 

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Dr. Eric Van Belle presented the FRANCE-TAVI registry analysis in the AHA 2019 scientific sessions, and it was simultaneously published in Circulation. The other registry was also published in Circulation, but it was not presented at the congress.

Dr. Van Belle’s conclusions suggest there are significant differences between these devices and therefore, we might be wrong to assume a class effect in TAVR.

The French registry included 12141 patients with severe aortic stenosis receiving TAVR with BEV (both XT and Sapien 3 n=8038) or the SEV (CoreValve n=4103) between 2013 and- 2015.

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They used propensity score to analyze 3910 pair of patients with similar baseline characteristics, and the CoreValve presented a higher primary end point rate (moderate to greater paravalvular regurgitation, and or inhospital mortality 19.8% vs 11.9% RR=1.68) as well as a higher rate of each separate component (paravalvular regurgitation ≥ moderate 15.5% vs 8.3%, RR 1.9 and inhospital mortality 5.6% vs 4.2%, RR 1.34).

2-year mortality also resulted higher for the CoreValve (29.8% vs 26.6%; HR 1.17; CI 95% 1.06-1.29). This difference was driven mainly by cardiovascular mortality (23.3% vs 20.9%; p=0.001). However, this divergence at 2 years was not continuous: curves parted between implantation day and month 3 (p=0.001) and stayed apart until year 2. 

Other points, such as pacemaker implantation rate (22.3% vs 11.0%; p<0.0001), infarction rate (0.4% vs 0.2%; p=0.02) and the need for a second valve (3.7% vs 1.0%; p<0.0001) were also against the CoreValve. The only point where the SEV was superior to the BEV was post-implantation mean gradient (7 mmHg vs 10 mmHg; p<0.001).

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These finding were consistent across all prespecified patient groups. 

At multivariable analysis, both paravalvular regurgitation severity and valve type were independent mortality predictors. 

The second study, published online and ahead of print in Circulation, was not presented at AHA 2019, but its outcomes will soon be analyzed here for us to be able to compare. 

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Título original: Balloon expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the France-TAVI registry.

Referencia: Van Belle E et al. Circulation. 2019; Epub ahead of print.

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