CoreValve still better than surgery at three years in high-risk patients

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Data simultaneously published in the Journal of the American College of Cardiology and presented at the American College of Cardiology (ACC; 2–4 April, Chicago, USA) shows that transcatheter aortic valve implantation (TAVI) with CoreValve (Medtronic) continues to be associated with significantly better outcomes than surgery at three years in high-risk patients. Previously published data for the device have indicated that it has better outcomes at one and two years after the index procedure.

 

Three-year data were available for 407 patients from the CoreValve High Risk study—of whom, 228 had been randomised to undergo TAVI with the CoreValve device and 179 had been randomised to undergo surgical aortic valve replacement. These show that CoreValve is associated with a significantly lower rate of the combined endpoint of all-cause mortality or stroke—37.3% vs. 46.7% for surgery; p=0.006. The individual rate of all stroke was also significantly lower with CoreValve (12.6% vs. 19%, respectively; p=0.03), but there were no significant differences in the rate of all-cause mortality between groups (although numerically lower with CoreValve—32.9% vs. 39.1%; p=0.07).


The three-year results also showed that the CoreValve system had significantly better valve performance that the surgical valve used in the study (p<0.001). Additionally, it was associated with significantly lower rates of major adverse cardiovascular and cerebrovascular events (MACCE): 40.2% vs. 47.9% for surgery; p=0.03.


G Michael Deeb (University of Michigan Frankel Cardiovascular Center, Ann Arbor, USA), who presented the data at the ACC, says: “It is reassuring to see that the CoreValve High Risk Study continues to show that TAVI is superior to surgery at three years for the combined endpoint of mortality and stroke, which has the most important impact on patients. Most importantly, the new data supports the viability of TAVR out to three years with no signal of a significant increase in mean gradient or aortic regurgitation.