TAVR noninferior to surgery in real-world lower-risk patient population
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Key takeaways:
- Transcatheter aortic valve replacement was noninferior to surgery for death and stroke at 1 year in a real-world patient population with severe aortic stenosis.
- The TAVR group had a 57% reduced risk for death at 1 year.
ATLANTA — In a real-world population of patients with severe aortic stenosis at low or intermediate surgical risk, transcatheter aortic valve replacement was noninferior to surgery for death and stroke at 1 year, researchers reported.
For the DEDICATE-DZHK6 noninferiority trial presented at the American College of Cardiology Scientific Session and simultaneously published in The New England Journal of Medicine, the researchers randomly assigned 1,414 patients from 38 sites in Germany with severe aortic stenosis at low or intermediate surgical risk (mean age, 74 years; 57% men; median Society of Thoracic Surgeons Predicted Risk of Mortality, 1.8%) to undergo TAVR with any contemporary device (balloon-expandable valve, 61.4%; self-expanding valve, 35.1%) or surgical AVR.
“TAVI has become the preferred treatment option for most patients with symptomatic severe aortic stenosis. Current evidence for younger low-risk patients, however, remains restricted to the device-specific and industry-sponsored trials, thus potentially limiting the applicability to routine practice,” Moritz Seiffert, MD, from the department of cardiology and the Center for Population Health Innovation, University Heart and Vascular Center Hamburg, University Medical Center Hamburg–Eppendor, and German Center for Cardiovascular Research (Deutsches Zentrum für Herz-Kreislauf-Forschung [DZHK]) partner site Hamburg–Kiel–Lübeck, said during a presentation. “Hence, in low-risk patients eligible for both [TAVR or surgical AVR] with unrestricted access to contemporary transcatheter heart valve devices, the optimal treatment strategy still remains unknown. That’s the reason why we designed the DEDICATE trial.”
The primary outcome of all-cause death or fatal or nonfatal stroke at 1 year occurred in 5.4% of the TAVR group and 10% of the surgery group (HR = 0.53; 95% CI, 0.35-0.79; P for noninferiority < .001), Seiffert said.
The rates of all-cause death were 2.6% in the TAVR group and 6.2% in the surgery group (HR = 0.43; 95% CI, 0.24-0.73), and the rates of fatal or nonfatal stroke were 2.9% in the TAVR group and 4.7% in the surgery group (HR = 0.61; 95% CI, 0.35-1.06) at 1 year, he said.
Procedural complications occurred in 1.5% of the TAVR group and 1% of the surgery group, according to the researchers.
The following secondary endpoints favored TAVR at 1 year: disabling stroke (TAVR, 1.3%; surgery, 3.1%; HR = 0.42; 95% CI, 0.19-0.88), CV death (TAVR, 2%; surgery, 4.4%; HR = 0.47; 95% CI, 0.24-0.86), major or life-threatening/disabling bleeding (TAVR, 4.3%; surgery, 17.2%; HR = 0.24; 95% CI, 0.16-0.35) and new-onset atrial fibrillation (TAVR, 12.4%; surgery, 30.8%; HR = 0.36; 95% CI, 0.28-0.46), Seiffert and colleagues found.
Conversely, the following secondary endpoints favored surgery at 1 year: minor or major vascular access-site complications (TAVR, 7.9%; surgery, 0.7%; HR = 10.64; 95% CI, 4.84-28.94), new-onset left bundle branch block (TAVR, 32%; surgery, 17.5%; HR = 2.03; 95% CI, 1.63-2.54) and new permanent pacemaker implantation (TAVR, 11.8%; surgery, 6.7%; HR = 1.81; 95% CI, 1.27-2.61), they found.
There were no differences in acute kidney injury, MI, prosthetic valve dysfunction, prosthetic valve endocarditis, prosthetic valve thrombosis, aortic valve reintervention or CV rehospitalization.
The results in the as-treated population were similar to those in the intention-to-treat population, Seiffert said.
At 1 year, aortic valve mean gradient and aortic valve area were similar between the groups, and there was no or trace aortic regurgitation in 73.8% of the TAVR group and 88.4% of the surgery group, he said, noting both groups had similar improvement in NYHA class.
“In the DEDICATE trial, an investigator-initiated, independent trial, designed to evaluate patients with aortic stenosis at low or intermediate surgical risk that mirror our daily clinical routine, TAVI with a prosthesis selection based on operator discretion was noninferior to [surgical] AVR with respect to death from any cause or stroke at 1 year,” Seiffert said during the presentation.
The cohort will be revisited at 5 years, and those results will be powered for superiority, Seiffert said.
Reference:
Perspective
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Kimberly Guibone, DNP, ACNP-BC, FACC
This is further generation of evidence that may encourage more likelihood of the low-to-intermediate-risk patients selecting TAVR with a good understanding, and with a likelihood of good outcomes and, hopefully, durability, which we hope to see. This generation of evidence is very helpful for shared decision-making, particularly now where the less-invasive nature of TAVR makes it more appealing, but not necessarily quite the right decision for everyone.
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Seiffert M, et al. Late-breaking clinical trials V. Presented at: American College of Cardiology Scientific Session; April 6-8, 2024; Atlanta.
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