This article is more than 5 years old. Information may no longer be current.
NOTION: TAVR not superior to surgical AVR in low-risk patients
SAN DIEGO — At 1 year, low-risk patients assigned transcatheter aortic valve replacement or surgical aortic valve replacement had similar composite rates of all-cause death, stroke or MI.
“NOTION was the first all-comers trial to randomize low-risk patients to TAVR vs. surgery. TAVR was safe and effective, but not superior to surgical AVR regarding the composite [primary outcome],” Hans Gustav Hoersted Thyregod, MD, from the department of cardiothoracic surgery at the Heart Centre Rigshospitalet, Copenhagen University Hospital, Denmark, said at the American College of Cardiology Scientific Sessions.
Thyregod reported data on 280 patients aged at least 70 years with severe aortic valve stenosis and no significant CAD. Eighty-one percent were considered low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality Score < 4). Half of the patients were randomly assigned to undergo TAVR (CoreValve, Medtronic; n = 145) and the other half to surgical AVR (n = 135).
A composite rate of all-cause death, stroke or MI at 1 year served as the primary endpoint. In the intention-to-treat population, the primary endpoint occurred in 13.1% of the TAVR group vs. 16.3% of the surgical AVR group (–3.2% absolute difference; P = .43 for superiority). In the as-treated population (TAVR, n = 142; surgical AVR, n = 134), the primary endpoint occurred in 11.3% of the TAVR group vs. 15.7% of the surgical AVR group (–4.4% absolute difference; P = .3).
Examined individually, all-cause death occurred in 4.9% of the TAVR group vs. 7.5% of the surgical AVR group (P = .38).
At 30 days, patients assigned surgical AVR had increased rates of life-threatening bleeding (20.9% vs. 11.3%; P = .03), cardiogenic shock (10.4% vs. 4.2%; P = .05), acute kidney injury (6.7% vs. 0.7%; P = .01) and new-onset or worsening atrial fibrillation (57.8% vs. 16.9%; P < .001), but a lower rate of pacemaker implantation (1.6% vs. 34.1%; P < .001).
At 1 year, patients assigned TAVR had more conduction abnormalities requiring pacemaker implantation (38% vs. 2.4%; P < .001), but less new-onset or worsening AF (21.2% vs. 59.4%; P < .001).
Patients assigned to TAVR or surgical AVR had significant improvements in dyspnea through 1 year, but more mild dyspnea was present in the TAVR group at 1 year (29.5% vs. 15%; P = .01).
TAVR was associated with greater improvement in effective orifice area from baseline to 1 year (mean change, 1 cm2 vs. 0.6 cm2; P < .001). The decrease in mean pressure gradient was similar in both groups at 1 year (mean change, –34.8 mm Hg vs. –32 mm Hg; P = .23). Moderate to severe total aortic valve regurgitation was higher at 1 year in the TAVR group (15.7% vs. 0.9%; P < .001).
The researchers noted in the Journal of the American College of Cardiology that “the NOTION trial was initiated only 2 years after TAVR was introduced and experience with the procedure was limited. Furthermore, since the trial was designed in 2009, a number of improvements in relation to the TAVR procedure have been introduced.
“At present, we are not able to recommend or refute one procedure over the other in lower-risk patients. More randomized clinical trials in this patient population are needed,” the researchers concluded. – by Rob Volansky
References:
Thyregod HG, et al. Featured Clinical Research I. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Thyregod HG, et al. J Am Coll Cardiol. 2015;doi:10.1016/j.jacc.2015.03.014.
Disclosure: Thyregod reports no relevant financial disclosures.
Perspective
Back to Top
This was an all-comers trial; anybody aged 70 years or older with severe aortic stenosis could get in. Most were low risk or intermediate risk. [The trial recruited patients] over a very long period of time, so we must remember that the early TAVR procedures were not done the same way that we do them now. It is not a huge trial, but it is thought-provoking. It was set up as a superiority trial with a combined endpoint of mortality, stroke and MI.
The investigators thought that with this combined endpoint, they might see superiority with TAVR over surgical AVR. What they found was that the combined endpoint was numerically less for TAVR over surgical AVR, but didn’t reach statistical significance. That’s not a real big surprise because they had very small numbers. If you break it out into each component, mortality, MI and stroke, each one of those was numerically less in TAVR than in surgery, but none of them reached statistical significance. When the TAVR curves are better in all of them, even if it doesn’t reach statistical significance, I think that’s a thought-provoking outcome that basically says anybody [aged] 70 or older could do just as well with TAVR as with surgical AVR; forget the risk if you’re [aged] 70 or older, let’s just get your procedure done.
More data have indicated that intermediate-risk [patients could also be] a very reasonable population for TAVR. The next most definitive answer to this question is going to come from the PARTNER IIA and SURTAVI intermediate-risk studies. We eagerly await the outcomes of those trials. PARTNER IIA is finished and has passed its 1-year landmark, but has a 2-year endpoint so it will probably be reported next year. We are still recruiting for SURTAVI, but are up to almost 1,200 people.