NOTION: 2-Year Data Show Positive Outlook for TAVR in Lower-Risk Patients
PARIS, France—In the first trial to randomize lower-risk patients with aortic stenosis to TAVR or surgery, the 2 procedures proved comparable in terms of the composite risk of all-cause death, MI, or stroke at 2 years, according to results presented May 19, 2015, at EuroPCR.
For NOTION, Lars Søndergaard, MD, of Rigshospitalet-Copenhagen University Hospital (Copenhagen, Denmark), and colleagues randomized 280 lower-risk patients (average age 79 years; 53% male) with aortic stenosis and a life expectancy of at least 1 year to undergo TAVR with the CoreValve device (Medtronic) or surgery at 3 European centers between December 2009 and April 2013. Average STS score was about 3.0 and more than 80% had a score of less than 4.
One-year results, presented at ACC 2015 in March, showed equivalence between the 2 procedures for the primary composite endpoint (all-cause death, stroke, or MI), but failed to show superiority of TAVR.
Two-year results were consistent with what was shown at 1 year. Additionally, those assigned to TAVR were more likely to need a pacemaker, and those assigned to surgery were more apt to report A-fib (table 1).
Valve performance was better after TAVR, with a higher effective orifice area and lower mean gradient at 2 years compared with surgery (P < .001 for both). Mild/severe aortic regurgitation was more common in the TAVR arm through 2 years (54.4% vs 16.1%; P < .001). Also, at 1 year, more surgery than TAVR patients were in NYHA class I, but this difference disappeared at 2 years (P = .44).
Continuous Follow-Up Is Necessary
“These 2-year data support the safety and efficacy of [TAVR] in lower-risk patients,” Dr. Søndergaard said. “However, we believe longer-term data on prosthesis durability for the [TAVR] group and more randomized trials are needed before moving [TAVR] routinely to lower-risk patients.”
Panelist Neil E. Moat, MBBS, MS, of the Royal Brompton and Harefield National Health Service Foundation Trust (London, England), called NOTION “very important” as the first trial to look at TAVR in intermediate-risk patients. “It’s further encouraging data,” he said, noting, however, a discrepancy between this study and the CoreValve US Pivotal trial with regard to the difference between surgery and TAVR.
“This is a completely different patient cohort,” Dr. Søndergaard responded. “These patients are not as sick as the patients who went into the high-risk trials in the US. Most of those patients who went into the high-risk group were actually kept alive in hospital and at home with less care and quite a few of these patients died from their comorbidities.”
Moreover, “these patients don’t have the same kind of comorbidities, so if they survive the procedure itself, they have a very good prognosis,” he added.
As for follow-up, Dr. Søndergaard said his team has permission to track patients for 10 years, “but quite a few will live longer than that,” he said. “It's one thing to show durability in a patient who’s 85 years [old], but what about the patient who is 70 years?”
Dr. Moat agreed. “It’s so important that these studies don’t end in years,” he said.
Søndergaard L. 2-year results from an all-comers randomized clinical trial comparing transcatheter with surgical aortic valve replacement in patients with aortic valve stenosis. Presented at: EuroPCR; May 19, 2015; Paris, France.
- NOTION was funded by the Danish Heart Foundation.
- Dr. Søndergaard reports no relevant conflicts of interest.