New bioprosthetic valve for TAVR fails to demonstrate non-inferiority

October 15, 2020

NEW YORK - October 15, 2020 - In a randomized clinical trial, SCOPE II, a new self-expanding bioprosthetic valve used in transcatheter aortic valve replacement (TAVR) failed to demonstrate non-inferiority compared to an existing self-expanding valve.

Findings were reported today at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The study was also published simultaneously in Circulation.

The SCOPE II trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves. A total of 796 patients aged 75 years or older with symptomatic severe aortic stenosis and an indication for transfemoral TAVR as agreed by the Heart Team were recruited at 23 tertiary heart valves centers in Denmark, France, Germany, Italy, Spain and the United Kingdom. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo (n=398) or the CoreValve Evolut devices (n=398).

The primary safety endpoint, powered for non-inferiority of the ACURATE neo valve using a noninferiority margin of 6%, was the composite of all-cause mortality or stroke at 12 months. The primary efficacy endpoint, powered for superiority, was new permanent pacemaker implantation at 30 days. Secondary endpoints included clinical efficacy and safety endpoints at 30 days and 12 months.

In the intention-to-treat analysis, death or stroke at one year was 15.8% in the ACURATE neo group compared to 13.9% in the CoreValve Evolut group, while in the per-protocol analysis it was 15.3% vs. 14.3%. Noninferiority of the ACURATE neo was not met for the primary endpoint in the intent-to-treat analysis, while it was met in the per-protocol analysis. Based on the prespecified statistical plan, due to these inconsistent results, non-inferiority was not established for the primary endpoint.

New pacemaker implantation at 30 days was 10.5% with ACURATE neo compared to 18.0% with CoreValve Evolut (Risk Difference -7.5%, 95% CI -12.4--2.60, P= 0.0027). Cardiac death at 30 days (2.8% vs 0.8%, p=0.03) and one year (8.4% vs 3.9%, p=0.01) was greater in the ACURATE neo group. The rate of moderate-severe aortic regurgitation was 9.6% vs 2.9% (P<0.0001) at 30 days and 4.0% vs. 3.3% (P<0.0001) at one year.

"TAVR with the ACURATE neo valve did not meet noninferiority compared with the CoreValve Evolut bioprosthesis with respect to a composite of death or stroke at one year," said Corrado Tamburino, MD, PhD, Division of Cardiology at C.A.S.T. (Centro Alte Specialità e Trapianti) Policlinico - University of Catania, Catania, Italy. "In a secondary analysis with limited statistical power, cardiac death was increased at one year in patients who received the ACURATE neo valve. The two valves also differed with respect to technical characteristics such as degree of aortic regurgitation and need for new permanent pacemaker implantation."
-end-
The SCOPE II trial was sponsored by the Center for European Research Initiatives in Cardiovascular Medicine (CERIC). Prof. Tamburino reported the following disclosures: speaker fees from Medtronic.

About CRF

The Cardiovascular Research Foundation (CRF) is one of the world's leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 32nd year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit http://www.crf.org and http://www.tctconference.com.

Cardiovascular Research Foundation

Related Acurate Neo Articles from Brightsurf:

Oncotarget: quantitative ultrasound radiomics in prediction of treatment response for breast cancer
The cover for Issue 42 of Oncotarget features Figure 4, ''Generation of parametric and texture maps from radiofrequency data,'' recently published in ''Quantitative ultrasound radiomics using texture derivatives in prediction of treatment response to neo-adjuvant chemotherapy for locally advanced breast cancer'' by Dasgupta, et al. which reported that to investigate quantitative ultrasound based higher-order texture derivatives in predicting the response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.

New bioprosthetic valve for TAVR fails to demonstrate non-inferiority
In a randomized clinical trial, SCOPE II, a new self-expanding bioprosthetic valve used in transcatheter aortic valve replacement (TAVR) failed to demonstrate non-inferiority compared to an existing self-expanding valve.

Being a selfish jerk doesn't get you ahead, research finds
Two studies provide empirical evidence to settle the question of whether being aggressively Machiavellian helps people get ahead.

Discovery of novel autoantibody that is a major risk factor for recurrent pregnancy loss
A Kobe University led study has revealed for the first time in the world the high frequency of a novel autoantibody in women suffering from recurrent pregnancy loss.

Large differences in personality traits between patients with social anxiety disorder
Individuals with social anxiety disorder have markedly different personality traits than others.

Male-killing bacteria linked to butterfly color changes
Like many poisonous animals, the African monarch butterfly's orange, white and black pattern warns predators that it is toxic.

Climate change influenced rise and fall of Northern Iraq's Neo-Assyrian Empire
Changes in climate may have contributed to both the rise and collapse of the Neo-Assyrian Empire in northern Iraq, which was considered the most powerful empire of its time, according to a new study.

Climate may have helped crumble one of the ancient world's most powerful civilizations
New research suggests it was climate-related drought that built the foundation for the collapse of the Assyrian Empire (whose heartland was based in today's northern Iraq)--one of the most powerful civilizations in the ancient world.

Scientists design protein that prods cancer-fighting T-cells
Scientists have created a new protein that mimics a key immune regulatory protein, interleukin 2 (IL-2).

Macrophage cells key to helping heart repair -- and potentially regenerate: New study
Macrophage cells have the ability to act in a neo-natal-like state, a time in life where they aid in the growth and development of organs, meaning they could be channeled to help repair the heart following a heart attack.

Read More: Acurate Neo News and Acurate Neo Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.