乌鸦传媒

In lower-risk patients, the CoreValve transcatheter aortic valve replacement (TAVR) device beat surgery when it came to patient survival, found a subanalysis of the pivotal trial that led to approval for high-risk patients.

All-cause among lower-risk recipients of the self-expanding device at 2 years versus 26.3% for surgical aortic valve replacement (log-rank P=0.01), , of Houston Methodist DeBakey Heart and Vascular Center, and colleagues reported online in JAMA Cardiology.

Both procedures were associated with comparable improvements in self-reported quality of life (score of 20.0 for TAVR versus 18.6 for surgery, P=0.71, both P<0.001 compared with baseline). And similar proportions of either group survived to 2 years with good quality of life (51.0% versus 44.4%, P=0.28).

Nevertheless, "it is important to note that the patients in this analysis were deemed to be at high surgical risk based on screening committee assessment despite their [Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM)] scores," Reardon's group cautioned.

Their multicenter, randomized CoreValve US Pivotal High Risk Trial included 705 individuals who underwent TAVR or surgery. The current study was a retrospective subanalysis focusing only on participants with STS PROM scores of 7% and below who were enrolled in the TVT Registry. The median STS PROM score was 5.3% in both TAVR and surgery groups.

"Although the STS PROM has decreased in U.S. trials and the TVT Registry, the benefit of TAVR in this patient population appears to be preserved," the authors concluded.

CoreValve was recently approved for intermediate-risk TAVR patients in Europe, and many expect a similar decision by the FDA soon.

The balloon-expandable Sapien XT TAVR device demonstrated non-inferiority to surgery for the combined endpoint of death or disabling stroke in an intermediate-risk group with a mean STS score of 5.8%. It showed no overall mortality advantage over surgery in the PARTNER 2 trial.

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