UK TAVI: Real-world TAVR and SAVR Have Similar 1-Year Mortality
The novel RCT included all centers across the UK that perform TAVR, allowing for the use of any valve or access route.
Patients with severe aortic stenosis and increased operative risk who are treated at community-based hospitals have similar rates of death from any cause at 1 year whether they undergo TAVR or surgery, data from the UK TAVI trial suggest.
During a presentation today at the “virtual” American College of Cardiology 2020 Scientific Session, William D. Toff, MD (University of Leicester, England), stressed that patients will be followed up to a minimum of 5 years to ensure that the clinical benefits are sustained and that no differences emerge over time.
“In terms of how this will influence practice going forward, our feeling is that treatment recommendations should continue to be determined by a multidisciplinary heart team, and patients should be made aware of the alternative treatment options and their pros and cons. Treatment decisions clearly need to be individualized, taking into account patient clinical factors and also patient preference,” Toff said.
Rates of death from any cause in the TAVR and SAVR groups were 4.6% and 6.6%, respectively, at 1 year (P = 0.23), meeting the trial’s prespecified threshold for noninferiority of TAVR.
The results are reassuring and confirm that TAVR is noninferior to SAVR in all-comer patients with age > 70 years old treated in a real-life clinical context. Philippe Pibarot
Commenting for TCTMD via email, Philippe Pibarot, DVM, PhD (Université Laval, Québec City, Canada), noted that the UK TAVI trial used a pragmatic approach in which every medical center in the United Kingdom that performs TAVR was included. Overall, 913 patients from 34 sites were randomized to TAVR or SAVR between 2014 and 2018. Enrollment criteria allowed for any CE-Marked valve and any access route, with treatment taking place within 6 weeks of randomization.
“As opposed to previous RCTs comparing TAVR versus SAVR which were conducted in some selected sites and had several inclusion/exclusion criteria, the UK TAVI trial is more a real-life trial,” Pibarot observed. “The results are reassuring and confirm that TAVR is noninferior to SAVR in all-comer patients with age > 70 years old treated in a real-life clinical context.”
More than eight different types of TAVI valves were included, although 57% received some type of Sapien valve (Edwards Lifesciences), Toff noted.
Responding to a question from panelist Rick A. Nishimura, MD (Mayo Clinic, Rochester, MN), about the incremental value to clinicians of this pragmatic approach to trial design compared with standard randomized trials, Toff said the findings support those of earlier TAVR trials while being “more reflective of the real world.”
Questions About Long-term AR and Age
The absolute difference in mortality at 1 year between TAVR and surgery was 2% in favor of TAVR (4.6% vs 6.6%; HR 0.69; 95% CI 0.38-1.26). In subgroup analyses accounting for age, gender, STS score, frailty, and CAD requiring revascularization, “the treatment effect was similar throughout,” Toff said.
Compared with surgery, TAVR patients had shorter ICU stays, had shorter postprocedural hospital stays, and were more likely to be discharged home.
At 1 year, major bleeding complications occurred in 6.3% of TAVR patients compared with 17.1% of SAVR patients (P < 0.001). Functional capacity and quality of life, while better in the TAVR group at 6 months, were similar between the two groups at 1 year. In terms of echocardiographic outcomes, reduction in valve gradient and improvement in effective orifice area were similar at 6 months and 1 year in both treatment groups.
More TAVR patients than surgical patients had a vascular complication (4.8% vs 1.3%; P < 0.001), and they were also more likely to have a pacemaker implanted. Additionally, TAVR patients had more mild aortic regurgitation at 6 weeks than surgical patients (43.7% vs 12.3%), but Julia Grapsa, MD, PhD (Barts Health NHS Trust, London, England), speaking in a press conference, said she said she found it “very striking” that they also had higher rates of moderate aortic regurgitation at 52 weeks (2.3% vs 0.6%). According to Grapsa, this is one more area where the planned long-term follow-up will be important.
To TCTMD, Pibarot said another issue is that since the main inclusion criteria for UK TAVI was age (≥ 80 years or ≥ 70 years with intermediate or high operative risk for surgery), the results cannot be extrapolate to patients younger than age 70. He also noted that the baseline characteristics of the study population suggest that most patients in the trial were intermediate surgical risk. The median STS risk score was 2.6%, and the mean age was 81.1 years.
Similarly, David Adams, MD (Icahn School of Medicine at Mount Sinai, New York, NY), questioned the use of older age alone to qualify patients independent of risk.
“Your data and all these trials are showing surgery and TAVR are very safe procedures,” he said. “That means as we're continuing to understand durability of TAVR, should we start qualifying patients based more on their life expectancy and whether we think durability can be an issue, as opposed to specific risk of the procedure?”
Toff responded that it’s possible that if they were to do the trial over again, they might consider all comers over age 70, regardless of risk.
Toff WD. The United Kingdom Transcatheter Valve Implantation (UK TAVI) trial. Presented on: March 29, 2020. ACC 2020.
- Toff reports no relevant conflicts of interest.
- Pibarot reports research support and/or consulting fees from Edwards Lifesciences, Medtronic, Cardiac Phoenix, and V-Wave.