Acurate neo fails to meet noninferiority in head-to-head trial of TAVR valves
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In the SCOPE 2 trial, transfemoral TAVR with the self-expanding Acurate neo valve failed to establish noninferiority compared with the self-expanding CoreValve Evolut valve for safety at 1 year.
The primary endpoint of all-cause death or stroke at 1 year occurred in 15.8% of patients with symptomatic severe aortic stenosis who underwent transfemoral TAVR with the Acurate neo valve (Boston Scientific) compared with 13.9% of those who received the CoreValve Evolut (Medtronic) in the intention-to-treat population (one-sided upper 95% CI limit, 6.1%; P for noninferiority = .0549). However, in the per-protocol population, all-cause death or stroke occurred in 15.3% of the Acurate neo group compared with 14.3% of the CoreValve Evolut group at 1 year (absolute risk difference, 1%; one-sided upper 95% CI limit, 5.4%; P = .0314 for noninferiority).
“Because the results of the intention-to-treat and per-protocol analyses were inconsistent, noninferiority of the Acurate neo was not established for the primary endpoint,” Corrado Tamburino, MD, PhD, with the division of cardiology at University of Catania, Italy, said during a late-breaking clinical trial session at the virtual TCT Connect.
The group that received the Acurate neo valve had a lower incidence of the primary efficacy endpoint of new permanent pacemaker implantation at 30 days (10.5% vs. 18%; absolute risk difference, –7.5%; 95% CI, –12.4 to –2.6; P = .0027).
The randomized SCOPE 2 trial compared clinical outcomes after implantation of the Acurate neo or CoreValve Evolut supra-annular, self-expanding TAVR devices. Acurate neo is not currently available for use in the United States, but was approved for use in Europe in 2014.
Researchers enrolled patients aged 75 years and older at 23 sites in six countries from April 2017 to April 2019. All had an indication for transfemoral TAVR as agreed by the heart team and were randomly assigned to receive the Acurate neo (n = 398) or CoreValve Evolut (n = 398) bioprostheses. The mean age was 83 years, 68% were women and mean STS-PROM score was 4.6%.
In other results presented at TCT Connect, cardiac death at 30 days (2.8% vs. 0.8%; P = .03) and 1 year (8.4% vs. 3.9%; P = .01) was greater in the Acurate neo group. The rate of moderate to severe regurgitation at 30 days (9.6% vs. 2.9%; P < .0001) and at 1 year (4% vs. 3.3%; P < .0001) was also increased in the Acurate neo group.
“The two bioprostheses differed with respect to technical characteristics such as degree of aortic regurgitation and need for new permanent pacemaker implantation,” Tamburino said during the presentation.
These data come on the heels of SCOPE 1, presented at TCT 2019, in which transfemoral TAVR with the Acute neo device did not meet noninferiority compared with the balloon-expandable Sapien 3 device (Edwards Lifesciences) for the combination of Valve Academic Research Consortium (VARC-2)-derived early safety and clinical efficacy at 30 days.
During a panel discussion following presentation of the SCOPE 2 data, Michael J. Reardon, MD, the Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiovascular surgery at Houston Methodist DeBakey Heart and Vascular Center, highlighted the importance of new-generation TAVR valves like the Acurate neo compared with established valves, but noted that the findings “need to be taken with a grain of salt.”
“People are learning in these trials and these valves are being iterated,” Reardon said.
He noted that the increased cardiac death in the Acurate neo group “clearly worries us,” but rates of stroke, bleeding, coronary obstruction and other secondary endpoints were similar between the groups, while pacemaker implantation and new left bundle branch block were better in patients who received the Acurate neo.
Outcomes with the next-generation Acurate neo2 “will hopefully be better,” Reardon said. “These are all iterations. To cut anybody off early would be a disservice to our field.”
Reference:
Perspective
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Anita W. Asgar, MD, MSc, FRCPC, FACC
In my opinion, the most important take-home messages are:
No. 1, direct randomized TAVR device comparisons are important to understand the performance of newer valves against those that have an established evidence base and have been well-studied.
No. 2, overall, the study missed the noninferiority endpoint just slightly for the primary endpoint of all-cause death or stroke. However, this is the second trial in which this iteration of the device fails to compare favorably with the two most-studied devices: Sapien 3 (Edwards Lifesciences) and CoreValve Evolut.
No. 3, very concerning, however, was the statistically significant increase in cardiac deaths in the Acurate neo group compared with Evolut, mostly due to HF. This occurred in the setting of increased moderate-to-severe aortic insufficiency (mainly paravalvular) at 30 days which is likely a contributing factor.
No. 4, permanent pacemaker implantation and new left bundle branch block were lower in the Acurate neo group compared to the Evolut group.
Given the literature and evidence from SCOPE 1 and now SCOPE 2, it would appear that this iteration of the device is not noninferior to the Sapien 3 or Evolut devices, therefore changes need to be made. Device changes addressing sizing, in particular larger available sizes, and strategies to mitigate paravalvular leak will be essential in the next generation to remain competitive with the industry standards.
For this particular version of the device, no further data are needed. In order for the device to have a future, newer iterations will have to show improvements and be compared once more to establish that there are safe alternatives to current available devices.
It is reassuring to see this kind of research study published because it highlights that the results of TAVR are not a class effect and new devices in the field need to demonstrate their noninferiority or superiority to industry standards prior to widespread adoption. Not all devices are created equal.
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Tamburino C, et al. Late-breaking clinical science session II, co-sponsored by JAMA: Valvular heart disease therapies. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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