SURTAVI: TAVR remains noninferior to surgery in intermediate-risk patients at 5 years
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Transcatheter aortic valve replacement with a self-expanding valve was noninferior to surgical AVR in intermediate-risk patients at 5 years, according to new data from the SURTAVI trial.
As Healio previously reported, at 2 years, in patients with severe aortic stenosis at intermediate surgical risk, there was no difference in all-cause death or disabling stroke between those assigned TAVR with a self-expanding valve (CoreValve or Evolut R, Medtronic) and those assigned surgical AVR.
At TCT 2021, Nicolas M. Van Mieghem, MD, PhD, FESC, FACC, medical director of interventional cardiology at Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands, presented 5-year results from 864 patients assigned TAVR and 796 patients assigned surgery.
At 5 years, the rate of the primary outcome of all-cause death or disabling stroke was 31.3% in the TAVR group compared with 30.8% in the surgery group (HR = 1.02; 95% CI, 0.85-1.22; P = .85), Van Mieghem said during a press conference.
“Throughout the 5 years, the endpoints are almost completely superimposed,” he said.
In a landmark analysis, there was no difference between the groups in the primary outcome from baseline to 2 years (12.7% in both groups; log-rank P = .96) or from 2 to 5 years (TAVR, 21.3%; surgery, 20.7%; log-rank P = .77), he said.
Forward-flow hemodynamics, including effective orifice area and mean gradient, favored the TAVR group at 5 years (P for all < .001), Van Mieghem said.
The proportion of patients with mild paravalvular leak was higher in the TAVR group than in the surgery group at 5 years (27.1% vs. 2.7%; P < .001), according to the researchers.
Pacemaker implantation was more frequent in the TAVR group at 5 years (35.8% vs. 14.6%; P < .001), but that was driven by results from the first 2 years (30.9% vs. 9.8%; P < .001) and not from between 2 and 5 years (TAVR, 12.7%; surgery, 12.5%; P = .89), Van Mieghem said.
Similarly, he said, reintervention rates were higher in the TAVR group at 5 years (3.5% vs. 1.9%; P = .02) due to the first 2 years (2.5% vs. 0.2%; P = .002) but not afterward (TAVR, 1%; surgery, 1.3%; P = .6).
“Of note, there were low rates of thrombosis and endocarditis for both treatment strategies,” Van Mieghem said.
He noted that the TAVR valves used in the trial are no longer in regular use in clinical practice, and that the current version, Evolut Pro Plus, “has additional features to optimize a TAVR procedure.”
Perspective
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Gilbert H. Tang, MD
There are no major surprises here. TAVR with a supraannular self-expanding valve has durable performance at 5 years in intermediate-risk patients compared with surgery, given similar death and stroke, but better hemodynamics, at the expense of higher pacemaker rates and early valve reintervention.
TAVR in intermediate-risk patients appears to be a durable therapy up to 5 years with the supraannular self-expanding valve. The reasons for aortic valve reintervention and increasing pacemaker rates need to be investigated.
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Van Mieghem NM, et al. Late-Breaking Clinical Trials Session II, in Collaboration with JAMA. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando (hybrid meeting).
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