TCT

TCT

Source:

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).

Disclosures: Tamburino reports he receives speaker fees from Medtronic. Reardon reports he receives consultant fees, honoraria and/or serves on the speaker’s bureau for Abbott Vascular, Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.
October 15, 2020
4 min read
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Acurate neo fails to meet noninferiority in head-to-head trial of TAVR valves

Source:

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).

Disclosures: Tamburino reports he receives speaker fees from Medtronic. Reardon reports he receives consultant fees, honoraria and/or serves on the speaker’s bureau for Abbott Vascular, Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.
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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).

Heart
Source: Adobe Stock.

“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.

Michael J. Reardon

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.”

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