Mixed Results for Acurate Neo in Head-to-Head TAVR Trials

Speciality News

Head-to-head comparisons of transcatheter aortic valve replacement (TAVR) devices put the Acurate neo bioprosthesis somewhere in the middle of the pack.

The self-expanding device did not meet non-inferiority against the CoreValve Evolut, but was comparable to the Sapien 3 at 1 year, according to presentations at the virtual TCT Connect conference.

The good news is that TAVR development has entered the phase of direct device-versus-device studies, said Ori Ben-Yehuda, MD, of the CRF Clinical Trials Center, during a TCT press conference. “It really shows the maturity of the field.”

SCOPE II

Acurate neo was no match for CoreValve Evolut, according to the randomized SCOPE II trial.

Rates of all-cause death or stroke at 1 year on intention-to-treat (ITT) analysis reached 15.8% of Acurate neo patients versus 13.9% of peers who had CoreValve TAVR. Per-protocol analysis yielded corresponding rates of 15.3% versus 14.3% after accounting for people who had protocol violations.

The difference, driven mainly by excess cardiac deaths in Acurate neo group (8% vs 4%, P=0.01), was large enough that the device did not reach non-inferiority compared with the CoreValve Evolut, according to Corrado Tamburino, MD, PhD, of University of Catania in Italy. The study was simultaneously published in Circulation.

On core lab assessment, aortic regurgitation significantly favored the CoreValve Evolut group at both 30 days and 1 year.

In contrast, rates of new permanent pacemaker (PPM) implantation at 30 days significant favored Acurate neo (10.5% vs 18.0% on ITT analysis, P=0.0027). This was the only individual endpoint powered to show a difference between arms, Tamburino noted.

The cardiac death issue with Acurate neo should be teased out given that this endpoint lumps together several types of death, commented Dee Dee Wang, MD, of Henry Ford Health System in Detroit, during a press conference.

Tamburino said that the cardiac deaths were primarily attributed to heart failure or sudden death. He said his group’s theory is that aortic regurgitation, even mild aortic regurgitation, may have an impact on the survival of TAVR patients, he said.

SCOPE II participants were 796 patients randomized 1:1 to either TAVR device. Eligible patients had symptomatic, severe aortic stenosis, and were recommended TAVR by the heart team. Average age was 83, and more than two-thirds of the group were women. Mean STS-PROM score was 4.5%.

Acurate neo and CoreValve Evolut share similar frame and leaflet compositions. Differences between the devices include recapturability (Acurate neo not being recapturable whereas CoreValve Evolut is) and size availability (Accurate neo comes in smaller sizes).

TAVR procedures performed in the trial were largely similar between groups, though Acurate neo recipients were more likely to receive pre-dilation (79% vs 41%, P<0.0001) and post-dilatation (46% vs 36%, P=0.005).

Tamburino noted that procedural complication rates were no different between arms.

Limitations of SCOPE II include the limited duration of follow-up and the fact that not all patients underwent follow-up echocardiography.

SCOPE I

Acurate neo fared clinically no worse than the Sapien 3 TAVR system and left patients with better echocardiography findings at 1 year, according to SCOPE I investigators.

The composite endpoint of all-cause death or disabling stroke at 1 year reached 12.0% of the Acurate neo group versus 9.4% of those randomized to Sapien 3 instead (HR 1.28, 95% CI 0.81-2.0), reported Jonas Lanz, MD, MSc, of University Hospital Bern in Switzerland.

Neither group held an advantage in individual clinical outcomes of all-cause mortality, stroke, hospitalization for valve-related dysfunction or congestive heart failure, valve-related dysfunction requiring repeat procedure, endocarditis, valve thrombosis, PPM implantation, or new-onset atrial fibrillation or flutter.

In terms of valve performance, the proportion of patients left with no aortic regurgitation favored Sapien 3 at both 30 days and 1 year. However, the Acurate neo group maintained lower aortic valve mean gradients (7.20 vs 11.45 mmHg, P<0.001) and greater average effective orifice areas (1.76 vs 1.50 cm2, P<0.001) on echocardiography.

“Extended follow up data will be crucial to determine the impact of the differential valve performance on long-term outcomes,” Lanz said.

Acurate neo and Sapien 3 differ markedly in device characteristics, the former being self-expanding and the latter balloon-expandable. There are also major differences in the stent frame.

SCOPE I randomized 739 patients 1:1 to either device for transfemoral TAVR. Mean age was 83, and nearly 60% were women. The median STS-PROM score was 3.5% at baseline.

Acurate neo procedures required less time and contrast volume compared with Sapien 3 one. Operators also used significantly more predilation (88.0% vs 23.0%, P<0.0001) and postdilatation (52.0% vs 13.0%, P<0.0001).

As in SCOPE II, procedural complication rates were no different between arms.

Previously, study authors reported that the Acurate neo valve failed to meet non-inferiority against the Sapien 3 in terms of the combined early safety and clinical efficacy endpoint at 30 days (23.7% vs 16.5%). This had been primarily due to higher rates of paravalvular regurgitation and acute kidney injury among Acurate neo recipients, according to Lanz.

Rates of new PPM had reached 11.5% and 10.3% of Acurate neo and Sapien 3 arms, respectively (P=0.68).

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    Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

SCOPE II was supported by the Center for European Research Initiatives in Cardiovascular Medicine/Symetis. SCOPE I was supported by the University Hospital Bern/Boston Scientific.

Tamburino disclosed relevant relationships with Medtronic.

Lanz disclosed no relevant relationships with industry.

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