Low-Risk TAVR Clinical Trial Results Released

By Adam Pick on March 17, 2019

Finally!  We have results for one of the most talked about heart valve clinical trials at HeartValveSurgery.com!

On Friday, at the American College of Cardiology (ACC) conference in New Orleans, the results for the low-risk, transcatheter aortic valve replacement (TAVR) were released.

As for the results… Drum roll please…

 

 

The results of this clinical trial, known as the PARTNER 3 research study, were quickly applauded, cheered and celebrated!

In fact, words like “game changer” have been used to describe the success of the clinical trial which investigated the use of the SAPIEN 3 device, a non-invasive treatment of aortic stenosis, in low-risk patients.  Aortic stenosis is an often mis-diagnosed and under-treated form of heart disease that can be fatal.

 

Data Compares Low-Risk TAVR to Surgical Aortic Valve Replacement

Similar to other clinical trials, the PARTNER 3 research study evaluated the outcomes of the current standard of care – surgical aortic valve replacement (SAVR) – to TAVR.  As you may know, TAVR is a percutaneous and minimally-invasive method for replacing a stenotic aortic valve (i) without an incision the patient’s chest or ribs and (ii) without the use of the heart-lung machine.  You can learn more about TAVR here.

Although TAVR was previously approved by the Food & Drug Administration (FDA) in the United States for inoperable, high-risk and intermediate risk patients, the use of TAVR for low-risk patients was the sole focus of the PARTNER 3 study sponsored by Edwards Lifesciences.

When comparing TAVR to SAVR in this low risk trial, here select data that Dr. Marty Leon and Dr. Michael Mack, the national principal investigators of PARTNER 3, revealed at the ACC for the 1,000 patient study:

  • All cause death was 1% for TAVR and 2.5% for SAVR
  • Stroke was 1.2% for TAVR and 3.1% for SAVR
  • Re-hospitalizations were 7.3% TAVR and 11% for SAVR
  • Atrial fibrillation incidence was 5% for TAVR and 39.5% for SAVR

At the same time…  There was similar data to the previous TAVR clinical trials in which SAVR outperformed TAVR specific to select complications including:

  • Vascular complications was 1.5% for SAVR and 2.2% for TAVR
  • Permanent pacemaker implants was 4.1% for SAVR and 6.6% for TAVR
  • Paravalvular leak was 0% for SAVR and 0.8% for TAVR
  • Coronary artery obstruction was 0.2% for SAVR and 0.7% for TAVR

 

Will TAVR Get FDA Approval for Low-Risk Patients?

Given the impressive results and data for the PARTNER 3 study, I’m guessing you might be wondering, “Will the FDA approve TAVR for low-risk patients?”

Reflecting on that question, there are two important and integrated considerations.  First, the data for PARTNER 3 is limited to a single year of patient outcomes and research.  Second, the results do not address the potential long-term durability of the SAPIEN 3 aortic valve in low-risk patients.

That said… The flood gates supporting FDA-approval of TAVR in low-risk patients have sprung wide open…

  • According to a New York Times report, “The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 intermediate- and high-risk patients who get the operation now.”
  • Dr. Howard Herrman, a cardiologist at the University of Pennsylvania’s Heart & Vascular Center stated, “[This] trial will result in approval of TAVR for low-risk patients.”
  • Dr. Mack stated, “This is a clear win for TAVR.”

 

Congratulations to the Research Teams & Edwards Lifesciences!

On behalf of the patient community at HeartValveSurgery.com, I need to extend an extraordinary and mighty “THANK YOU” to the 50+ research teams who participated in the PARTNER 3 low-risk TAVR research study.   Without your curiosity, without your patient support, without your patient care, and without your willingness to try something new, I would not be able to write the encouraging words above.  Your dedication to this trial was amazing.

To the Edwards Lifesciences team that sponsored this massive clinical trial,  I can not thank you enough for developing the SAPIEN 3 and all of its previous, evolutionary iterations.  Your research, your development, your investment, your patient-centric approach, and your innovative spirit continues to transform valvular science, next-generation therapies and, most importantly, the lives of patients, their family members and friends.

Great job to everybody who participated on this Low-Risk TAVR Clinical Trial!

Keep learning about TAVR and aortic stenosis:

Keep on tickin!
Adam


Written by Adam Pick
- Patient & Website Founder

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

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