SOLACI | Latin American Society of Interventional Cardiology

TCT has presented the 5-year clinical and echocardiographic outcomes of low-risk patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using balloon-expandable Sapien valves vs. surgical aortic valve replacement (SAVR).

The first primary end point was a non-hierarchical composite of all-cause mortality stroke or rehospitalization. The second was a hierarchical composite including all-cause mortality, disabling and non-disabling stroke and rehospitalization.

When looking at the first primary end point vs SAVR patients, we observe a 21% reduction in events rate (HR at 5 years = 0.79 [CI 95% 0.61-1.02]; p=0.07). On the other hand, the second primary end point using the WinRatio showed a higher number of events in TAVR patients, with 1.17 (CI 95%, 0.90-1.51; p=0.25).

When looking at specific subgroups, we find smaller valves, such as # 26 and 23 (vs # 29), presented lower events rate, with 5-year HR 0.81 [CI 95% 0.51-1.29]; p=0.62. Also, valve area and valve failure rates were similar in both groups, with 5-year HR 0.86 [CI 95% 0.42-1.77]; p=0.69.

There were no significant differences between treatments when looking at quality of life, measured by KCCQ score >75 (71% vs. 71.9%), nor in valve durability, defined as the absence of failure (86.3% vs. 87.4%).

In sum, patients with severe aortic stenosis at low risk treated with Sapien-3 TAVR or SAVR showed similar rates and low numbers of clinical events. The differences in primary end point that initially had favored TAVR at one year, were attenuated after 5 years (from 7.1% to 4.3%). Both valve failure and valve deterioration saw low frequency with both treatments.