Author + information
- Guillaume Marquis Gravel, MD, MSc and
- Philippe Généreux, MD∗ ()
- ↵∗Hôpital du Sacré-Coeur de Montréal, Université de Montréal, 5400 Boul. Gouin Ouest, Montréal, Québec, H4J 1C5, Canada
The investigators of the NOTION (Nordic Aortic Valve Intervention) trial showed that in an all-comers population of patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) using the CoreValve self-expanding bioprosthesis (Medtronic Inc., Minneapolis, Minnesota) yielded similar rates of the composite endpoint of all-cause death, stroke, or myocardial infarction at 1 year compared with surgical bioprosthetic aortic valve replacement (1). Their study is the first to assess in a randomized trial the results of TAVR in a population including a high proportion of patients with low surgical risk (81.8% of patients). The scope of their findings paves the way toward the expanded use of TAVR, from extreme- to high-risk patients (2–5) to patients bearing lower surgical risks. However, the results of the primary analysis do not allow comment on the effects of TAVR among low-risk population. As the CoreValve trial taught (5), high-risk patients undergoing a self-expandable TAVR yield better outcomes (lower mortality) than with surgical bioprosthetic aortic valve replacement. It is likely that, among both groups of the NOTION trial, adverse events were concentrated in the minority of moderate- to high-risk patients, mirroring the results of the high-risk CoreValve trial. Consequently, clinical equipoise, with low event rates in both groups, is more than likely among their low-risk patient population. Although Thyregod et al. have to be commended for their pioneer work, this information is currently not available in their report. Obviously, with only 280 enrolled patients, the current trial lacks power to identify significant differences among important subgroups; however, to provide the rates of adverse events between TAVR and surgical bioprosthetic aortic valve replacement among their low-risk population would be highly informative, potentially disruptive, and could help to foster future investigations. Although ongoing trials (PARTNER IIA [Placement of AoRTIc TraNscathetER Valves][NCT01314313], SURTAVI [Safety and Efficacy Study of the Medtronic Corevalve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement] [NCT01586910]) will bring more definitive answers related to the place of TAVR in the treatment of lower-risk patients, the authors are encouraged to provide additional analysis of the primary outcome in patients according to their surgical risks.
Please note: Dr. Généreux has received speaker fees from Abbott Vascular; consultant and research grants from Cardiovascular Systems Inc.; and speaker fees from Edwards Lifesciences. Dr. Marquis Gravel has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
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