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March 29, 2020
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UK TAVI: In real-world population, TAVR noninferior to surgery at 1 year

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William D. Toff

In the UK TAVI randomized pragmatic trial of older real-world patients with severe symptomatic aortic stenosis, those who underwent transcatheter aortic valve replacement had similar rates of all-cause mortality and stroke at 1 year compared with patients who underwent surgical AVR.

Patients who underwent TAVR had higher rates of vascular complications and were more likely to have a pacemaker implanted, but had a shorter average hospital stay and less major bleeding compared with patients who had open surgery.

According to research presented at the virtual American College of Cardiology Scientific Session, at 1 year, among patients with severe symptomatic aortic stenosis referred for intervention, compared with those who underwent surgical AVR, those who underwent TAVR experienced:

  • Similar all-cause mortality (TAVR, 4.6%; surgery, 6.6%; HR = 0.69; 95% CI, 0.38-1.26);
  • Similar stroke (TAVR, 5%; surgery, 2.9%; HR = 1.75; 95% CI, 0.84-3.61);
  • Similar all-cause mortality or stroke (TAVR, 8.5%; surgery, 9%; HR = 0.94; 95% CI, 0.56-1.56);
  • Less major bleeding (6.3% vs. 17.1%; HR = 0.34; 95% CI, 0.25-0.46);
  • More pacemaker implantation (12.2% vs. 6.6%; HR = 1.92; 95% CI, 1.33-2.76);
  • More vascular complications (4.8% vs. 1.3%; HR = 3.69; 95% CI, 1.79-7.6);
  • Higher prevalence of moderate aortic regurgitation (2.3% vs. 0.6%); and
  • A shorter median hospital stay (3 days vs. 8 days).

Both groups improved in NYHA class, with no difference in degree of improvement at 1 year (P = .53), but the TAVR group had greater improvement at 6 weeks (P < .001), according to the researchers.

Compared with the surgery group, the TAVR group had greater improvement in quality of life at 1 year as assessed by the EuroQol EQ-5D-5L utility score (P < .001), but Minnesota Living with Heart Failure scores were similar (P = .23).

“In patients aged 70 years or older with severe symptomatic aortic stenosis, at increased operative risk due to age or comorbidity, TAVR is not inferior to conventional surgery in respect of death from any cause at 1 year,” William D. Toff, MD, FACC, professor of cardiology at University of Leicester, U.K., said in his presentation. “TAVR is associated with less major bleeding than surgery but an increased rate of vascular complications, pacemaker implantation and mild or moderate aortic regurgitation. TAVR is associated with a shorter hospital stay and more rapid improvements in functional capacity and quality of life.”

For this randomized controlled trial, participants from 34 U.K. centers were randomly assigned to undergo either TAVR or surgical AVR with the goal of determining differences in 1-year outcomes, with the primary endpoint of all-cause mortality. Patients were included if aged at least 80 years or if aged at least 70 years with increased operative risk from surgical AVR.

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“We do however require longer follow up, and this is ongoing to confirm sustained clinical benefit and to inform future clinical practice,” Toff said during his presentation. “This will be particularly important in younger patients.”

Compared with past trials

In a follow-up discussion, Rick A. Nishimura, MD, chair of the division of structural heart disease and consultant in the division of structural heart disease at Mayo Clinic, Rochester, Minnesota, said he was interested in “what incremental value a clinician would gain from this kind of clinical pragmatic approach versus the prior randomized trials.”

“Our results are concordant with the results of the intermediate and low risk trials,” Toff said in the discussion. “What [our results] add is that they show that those results which were generated in trials that were perhaps performed in some of the best centers that had many exclusion criteria [selecting patients] who might be most likely to benefit from TAVR we've replicated those results in a population which is more representative of the real world and similarly representative of every center in a country that performs TAVR rather than just in the best centers.”

Considerations for further investigation

“As Dr. Toff said, it's important to mention the shorter hospital stay with TAVR, the rapid improvement in functional capacity and statistically important difference to major bleeding and vascular complications,” Julia Grapsa, MD, PhD, FACC, consultant cardiologist at Barts Health NHS Trust/St. Bartholomew's Hospital, head of the echocardiography department at The Royal London Hospital and editor-in-chief of JACC: Case Reports, said during a press conference. “Something that was very striking to me and maybe something the authors will investigate further in the future was the moderate aortic regurgitation observed at 2.3% of the TAVR at 52 weeks when compared to 0.6% of the surgical arm. Of course, they will keep following up these patients up to 5 years. It will be interesting to have the substudies on the different types of valves implanted.” – by Scott Buzby

Reference:

Toff W, et al. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).

Disclosures: Toff, Nishimura and Grapsa report no relevant financial disclosures.