News | Heart Valve Technology | November 08, 2017

New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients

Presented at TCT, Evolut TAVR platform showcases positive clinical outcomes in patients wanting to return to more active lives

New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients

November 8, 2017 —  Medtronic plc recently presented new clinical research to support the positive clinical performance of the Evolut Transcatheter Aortic Valve Replacement (TAVR) Platform in intermediate-risk, severe, symptomatic, aortic stenosis patients. Outcomes from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial and the Evolut R FORWARD “real-world” study were presented at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting, Oct. 29-Nov. 2, in Denver, reinforcing the valve’s strong performance in healthier, more active patients.

Complete one-year outcomes from the SURTAVI trial based on Kaplan-Meier analyses confirmed the strong performance of the CoreValve and Evolut R TAVR systems versus the gold standard of open-heart surgery in an intermediate-risk severe symptomatic aortic stenosis patient population. The results indicate the platform continued to provide comparable results to surgery with regard to the primary combined endpoint of all-cause mortality or disabling stroke (7.8 percent for TAVR vs. 8.5 percent for surgery; p=0.55) at one year. A subgroup analysis of the SURTAVI Continued Access Study (CAS) showed consistently positive safety data for the Evolut R System in intermediate-risk patients with high rates of survival (100 percent) and low rates of all stroke (1.5 percent) or disabling stroke (0.4 percent) at 30-days.

“With its supra-annular and self-expanding design, the Evolut TAVR platform is well-suited to deliver excellent valve performance for intermediate-risk patients who are often considered to be more active than high- or extreme-risk patients,” said Nicolas M. Van Mieghem, M.D., director of interventional cardiology at Erasmus Medical Center in Rotterdam, the Netherlands, and presenter of the SURTAVI one-year data at the meeting. “As new clinical data are gathered for this patient population, we continue to see the exceptional clinical benefits this self-expanding valve provides as a minimally-invasive treatment alternative to surgery.”

Additionally, a sub-analysis from the SURTAVI trial where patients were stratified based on their STS Predicted Risk of Mortality (PROM) showed that TAVR patients demonstrated a significantly lower rate of all-cause mortality or disabling stroke at one year (1.5 percent vs. 6.5 percent; p=0.04) in the category of patients with STS-PROM < 3 percent. Patients treated with TAVR also showed mortality improvements across risk categories at one year, whereas surgical mortality rates were similar across all STS score categories.

Similarly, results from a subset of 257 “real-world” patients enrolled in the Evolut R FORWARD Study with an STS PROM < 3 percent demonstrated excellent clinical outcomes, with a low rate of all-cause mortality (2 percent) and disabling stroke (1.2 percent) at 30-days post implant.

The CoreValve Evolut TAVR platform consists of the CoreValve, CoreValve Evolut R and the Evolut PRO systems, which are available for use in the United States and Europe for severe aortic stenosis patients at an intermediate surgical risk or greater.

Watch the VIDEO "TAVR Stands Equal to Surgical Valve Replacement" — an interview with Michael Reardon, M.D.

 

 

Related Content

TCT 2017 Late-breaking Clinical Trial Presentations

 

References:

1. Michael J. Reardon, M.D., Nicolas M. Van Mieghem, M.D., Ph.D., Jeffrey J. Popma, et al. “Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.” N Engl J Med 2017; 376:1321-1331April 6, 2017DOI: 10.1056/NEJMoa1700456. 

2. Eberhard Grube, Nicolas M. Van Mieghem, Sabine Bleiziffer, et al. “Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study.” JACC. Volume 70, Issue 7, August 2017. DOI: 10.1016/j.jacc.2017.06.045

 

Related Content

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...