Presented as a late-breaking clinical trial at EuroPCR (19–22 May, Paris, France), new two year results from the NOTION trial showed that transcatheter aortic valve implantation (TAVI) with CoreValve is as safe and effective as surgery in patients that are at a low- or intermediate-risk for surgery.
NOTION is the first trial to evaluate TAVI vs. surgical aortic valve replacement (SAVR) in a lower risk patient population with 81.8% of patients considered low-risk (STS <4%). Key results from the trial out to two years include:
The composite primary endpoint of death from any cause, stroke or myocardial infarction was similar and low in both the TAVI and SAVR groups (15.8% vs. 18.8%, p=0.43).
- Rates of mortality from any cause numerically favoured TAVI over SAVR (8.0% vs. 9.8%; p=0.54)
- Rates of stroke also numerically favored the TAVI-treated patients vs. the SAVR-treated group (3.6% vs. 5.4%; p=0.46).
With low rates of mortality and stroke, the two year outcomes from NOTION show promise that the CoreValve system may be a viable treatment option for a broader patient population. Results from the large SURTAVI trial, which also looks at treating intermediate risk patients with the CoreValve system, will help validate the NOTION findings.