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SURTAVI: TAVR noninferior to surgery in intermediate-risk patients
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WASHINGTON — The SURTAVI trial met its primary endpoint demonstrating that transcatheter aortic valve replacement with a self-expanding bioprosthesis was comparable to surgery for all-cause mortality or disabling stroke at 24 months, Michael J. Reardon, MD, reported.
“We know that in patients who are at high surgical risk and [have] symptomatic, severe aortic stenosis, TAVR with the self-expanding valve is superior to surgery,” Reardon, professor of cardiothoracic surgery and the Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital, said during a presentation of the first results from the SURTAVI trial. “What we don’t know yet is the comparative efficacy as we move down the risk scale to lower surgical risk.”
Reardon and colleagues sought to assess the safety and efficacy of TAVR with the self-expanding valve (CoreValve Evolut R, Medtronic) vs. surgery in patients with severe aortic stenosis who are at intermediate surgical risk.
The researchers randomly assigned 1,746 patients (mean age, 80 years) at 87 centers in the United States, Europe and Canada to undergo TAVR or surgical AVR. All were considered at intermediate surgical risk, with an estimated risk for 30-day surgical death of 3% to 15% based on a combination of the Society for Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) criteria, as well as a series of frailty, disability and other measures. Patients were seen by a neurologist or trained stroke specialist at baseline, and follow-up assessments were conducted at discharge, 30 days, 6, 12, 18 and 24 months.
The primary endpoint was a composite of all-cause mortality or disabling stroke at 24 months. Bayesian analytical models were used in the researchers’ analysis, with a margin for noninferiority of 0.07, and primary and secondary endpoints were evaluated in a modified intention-to-treat population (TAVR, n = 879; surgery, n = 867).
Eighty-four percent of the TAVR group received the CoreValve and 16% received the newer-generation Evolut R bioprosthesis.
At 24 months, the estimated incidence of the primary endpoint was 12.6% (95% credible interval, 10.2-15.3) in the TAVR group vs. 14% (95% credible interval, 11.4-17) in the surgery group, translating to a difference of –1.4% (95% credible interval, –5.2 to 2.3) and a posterior probability of noninferiority > 0.999.
All-cause mortality was similar between the TAVR and surgery groups at 30 days (2.2% vs. 1.7%), 1 year (6.7% vs. 6.8%) and 2 years (11.4% vs. 11.6%; 95% credible interval for difference, –3.8 to 3.3), according to the data. Additionally, the difference in rates of disabling stroke between the TAVR and surgery groups were not significant at 2 years (2.6% vs. 4.5%; 95% credible interval for difference, –4 to 0.1). However, rate of any stroke at 30 days favored TAVR, as compared with surgery (3.4% vs. 5.6%; 95% credible interval for difference, –4.2 to –0.2).
Acute kidney injury, atrial fibrillation, cardiogenic shock and transfusion requirements were lower, and quality of life and hemodynamics were better with TAVR vs. surgery. However, TAVR was linked to more moderate to severe paravalvular leakage and greater need for pacemaker implantation.
TAVR was also associated with improved quality of life at 30 days and better hemodynamics at all time points, as compared with surgery, Reardon noted.
“We saw the best surgical outcomes we’ve seen yet and TAVR did just as well,” he said in a press release. “This is now the second randomized trial that has met its noninferiority endpoint and should lead to changes in clinical guidelines that will move the field forward and also benefit our patients.” – by Melissa Foster
Reference:
Reardon MJ, et al. Joint ACC/JACC Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Reardon MJ, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa170045.
Disclosure : The study was funded by Medtronic. Reardon reports receiving research grants from Medtronic.
Perspective
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Roxana Mehran, MD
This trial is very exciting and offers more excellent data with consistent evidence for TAVR noninferiority compared with surgical AVR for patients with aortic stenosis and intermediate risk, now with a different valve. The proven noninferiority with TAVR gives me as a clinician a sense of superiority of TAVR, because there is less hospitalization, better quality of life and less stroke. Those are the superiority aspects — the types of things we may overlook. Having a second valve available in intermediate-risk patients in the United States is going to be incredibly important.
Perspective
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Samir Kapadia, MD
The most important message from SURTAVI is that we confirmed that TAVR and surgical AVR have similar outcomes in intermediate-risk patients. This is an incredibly important landmark for TAVR because it confirms what was found in the PARTNER 2A trial, which now becomes science. It will impact decision-making about who should get TAVR. With two randomized trials showing benefit in this population, the guidelines may be revised to give TAVR the highest indication for use in intermediate-risk patients. It should lead to more confidence in recommending TAVR for intermediate-risk patients, both from the patient perspective and the physician perspective.
The beauty of the results is that the only two complications that were higher in TAVR — paravalvular leak and pacemaker implantation — have been shown to be lower with the newer generation of the device, the CoreValve Evolut R (Medtronic), which is more positionable and has a better seal. A lot of effort has gone in to overcome the limitations of the devices, and the newer versions are already addressing those issues. We also expected to see a lower rate of complications for TAVR in acute kidney injury, AF and bleeding. In its current form, TAVR has improved considerably from the system used in SURTAVI, while surgery, which is an outstanding option, has not changed much.
Patients and physicians should feel more comfortable with TAVR as an alternative to surgery. This is a tremendous outcome.
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