MedPath

ACURATE neo2 Aortic Valve System Shows Mixed Results in Aortic Stenosis Trial

• The ACURATE IDE trial assessed the ACURATE neo2 valve against standard valves for severe aortic stenosis, revealing a higher composite rate of mortality, stroke, or rehospitalization. • Post-hoc analysis identified that approximately 20% of ACURATE neo2 valves were under-expanded, impacting overall outcomes and suggesting the importance of procedural optimization. • Boston Scientific is working with the FDA on regulatory strategy for ACURATE valve platform approval in the U.S. and plans further studies on improved implantation techniques. • The study highlights the importance of procedural optimization in TAVR, with implications for other commercially available valves.

Boston Scientific's ACURATE neo2 Aortic Valve System, a second-generation transcatheter aortic valve replacement (TAVR) technology, demonstrated mixed outcomes in the ACURATE IDE clinical trial. The trial, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024, evaluated the system's efficacy in treating patients with severe, symptomatic aortic stenosis across various surgical risk levels.
The randomized trial compared the ACURATE neo2 valve against a control group receiving either the SAPIEN valve or the Evolut transcatheter aortic valve system, chosen at the physician's discretion. The primary endpoint, a composite of all-cause mortality, stroke, or rehospitalization at one year, occurred in 16.16% of patients in the ACURATE neo2 arm versus 9.53% in the control arm. This difference did not meet the pre-specified criterion for non-inferiority (posterior probability for non-inferiority was 77.9%, below the 97.5% threshold).

Procedural Optimization Insights

A post-hoc analysis of the ACURATE IDE trial identified that approximately 20% of implanted ACURATE neo2 valves were under-expanded. This assessment involved reviewing key procedural factors, including pre- and post-dilation techniques crucial for proper valve expansion. The data indicated that the rate of death, stroke, or rehospitalization at one year was similar between the expanded ACURATE neo2 group and the control group.
"This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and co-principal investigator of the ACURATE IDE trial. "These data add to the breadth of clinical knowledge of the ACURATE valve platform and provide compelling insights on the importance of procedural optimization that will be beneficial for TAVR moving forward."

Implications for TAVR

The findings suggest that optimizing valve expansion during TAVR procedures is critical for improving patient outcomes. Boston Scientific is actively collaborating with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for the ACURATE valve platform in the U.S. Further studies are planned to investigate improved implantation techniques to mitigate valve under-expansion.
"The data presented today give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "We believe the findings from the ACURATE IDE post-hoc analysis and implementation of steps to mitigate valve under-expansion may improve outcomes for the ACURATE valve and have important implications on other commercially available TAVR valves, and we look forward to studying these improved techniques in future trials of the device."
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

iTeos Therapeutics Presents Inupadenant Data at ESMO IO Congress, Prioritizes Other Programs

iTeos Therapeutics presented Phase 2 A2A-005 trial data of inupadenant plus chemotherapy in post-immunotherapy metastatic NSCLC at ESMO IO Congress.
The combination showed a 63.9% overall response rate and a median progression-free survival of 7.7 months across all evaluable patients.

Medtronic's Evolut TAVR System Shows Positive Outcomes in Aortic Stenosis Treatment

Medtronic's Optimize PRO study demonstrates positive outcomes using the cusp overlap technique (COT) with the Evolut TAVR system in treating severe aortic stenosis.
The study reported a low 30-day permanent pacemaker implantation rate of 6.4% with COT compliance and no moderate or severe aortic regurgitation at discharge.

Novel TAVR Valve Demonstrates 100% Procedural Success in Early Chinese Study

A new transcatheter aortic valve replacement (TAVR) valve has shown promising initial results in a study conducted in China.
The study reported a 100% procedural success rate with the novel TAVR valve.

Aortic Valve Replacement Improves Outcomes in Cardiogenic Shock Due to Aortic Stenosis

A Cleveland Clinic study reveals high mortality rates in patients with cardiogenic shock due to severe aortic stenosis (AS-CS), especially with medical management.
Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) demonstrate more lasting benefits compared to balloon aortic valvuloplasty (BAV).

Early Heart Valve Replacement Shows Superior Outcomes in Aortic Stenosis Patients

A new study suggests early heart valve replacement with minimally invasive procedures is more effective for patients with severe aortic stenosis.
Early surgery halved the risk of hospitalization for heart problems compared to the traditional watch-and-wait approach.

ACURATE neo2 TAVI Fails to Meet Primary Endpoint in ACURATE IDE Trial

The ACURATE IDE trial showed that the Acurate neo2 TAVI valve did not meet noninferiority criteria compared to commercially available valves for severe aortic stenosis.
At 1 year, the rate of all-cause mortality, stroke, or rehospitalization was significantly higher in patients treated with Acurate neo2.

Boston Scientific's Acurate neo2 TAVR Fails to Meet Primary Endpoint in IDE Trial

Boston Scientific's Acurate neo2 TAVR system did not meet its primary endpoint in a study evaluating its use in severe aortic stenosis patients.
The trial showed a higher rate of all-cause mortality, stroke, or rehospitalization at one year in the Acurate neo2 arm compared to the control arm.

Edwards Lifesciences' EVOQUE System Demonstrates Superior Outcomes in TRISCEND II Trial for Tricuspid Regurgitation

The TRISCEND II trial demonstrated a 95.4% successful implantation rate for Edwards' EVOQUE transcatheter tricuspid valve replacement system.
95.3% of patients treated with the EVOQUE system achieved near-complete elimination of tricuspid regurgitation at one year, compared to 2.3% with optimal medical therapy alone.

Early Aortic Valve Intervention Fails to Show Benefit in Asymptomatic Patients with Severe Aortic Stenosis and Myocardial Fibrosis

A randomized clinical trial involving 224 patients revealed that early aortic valve intervention did not significantly reduce the composite outcome of all-cause death or unplanned aortic stenosis-related hospitalization.
The study focused on asymptomatic patients with severe aortic stenosis who also exhibited myocardial fibrosis, a condition associated with adverse long-term prognosis.

AI Decision Support Tool Shows No Improvement in Cardiovascular Outcomes for Chest Pain Patients

The RAPIDxAI trial assessed an AI tool's impact on managing emergency department patients with elevated high-sensitivity cardiac troponin (hs-cTn).
The study found no significant difference in the composite of cardiovascular death, myocardial infarction, and unplanned CV readmission at 6 months between the AI and standard care groups.

Reference News

[1]
ACURATE neo2™ Aortic Valve System Data Presented at Late-Breaking Clinical Trial ...
prnewswire.com · Oct 31, 2024

Boston Scientific announced ACURATE neo2 Aortic Valve System results in ACURATE IDE trial, showing 16.16% composite rate...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy