PARTNER: “fundamental breakthrough” for transcatheter aortic-valve implantation 1

Patients with aortic stenosis who are not candidates for aortic valve replacement surgery can benefit from transcatheter aortic-valve implantation (TAVI), according to results of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial published in the New England Journal of Medicine. (The trial will also be presented at the TCT conference on Thursday.) Martin Leon and colleagues randomized 358 patients with aortic stenosis who were judged ineligible for aortic replacement by a surgeon to receive TAVI or standard medical therapy.

At one year the mortality rate (the primary endpoint of the study) was 30.7% in the TAVI group versus 50.7% in the control group, a highly significant difference (HR 0.55, CI 0.40-0.74, p<0.001). The coprimary endpoint, a composite of death from any cause or repeat hospitalization, occurred in 42.5% of the TAVI group versus 71.6% of the control group (HR 0.46, CI 0.35-0.59, p<0.0001). Stroke or TIA, however, occurred in 10.6% of the TAVI group versus 4.5% of controls (p=0.04). Major vascular complications occurred in 16.8% of the TAVI group versus 2.2% of controls (p<0.001).

As expected, TAVI was associated with more early hazards: at 30 days there were more deaths and strokes in the TAVI group, although these differences did not reach statistical significance. The increases in bleeding and vascular complications, however, were highly significant both at 30 days and at one year. Balloon aortic valvuloplasty was performed in nearly two-thirds of patients in the control group in the first 30 days and in an additional 20% of controls after 30 days.

The authors concluded:

On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery (like the patients enrolled in this study). These results cannot be extrapolated to other patients with aortic stenosis.

This first installment of the PARTNER trial is called Cohort B. The second installment, Cohort A, which is comparing TAVI to surgical valve replacement in high risk patients, is expected to report its findings next year.

This post is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site.

David Kandzari provided the following comment to CardioBrief on the trial:

The results of this cohort from the PARTNER trial represent a fundamental breakthrough for the patients and the medical community in the United States against the background of prior experiences in Canada and Europe. Aside from the study result alone, the outcome represents a paradigm shift in management of patients otherwise often not considered for definitive treatment. There will be questions regarding the procedural risk, imbalances in risk between cohorts, and underestimation of mortality in both cohorts, yet the fundamental balance is a 20% absolute reduction in mortality and symptom improvement compared with an approximate 4% increased risk of stroke—an estimate most patients would be willing to accept. Any investigational site will share with you the resources, education and practical experience required to develop a transcatheter aortic program. It has oftentimes not been an easy path, and yet the trial results validate the successes following a steep learning curve that has not been common in recent years for the interventional community

Here is the Edwards press release:

The New England Journal of Medicine Publishes Transcatheter Heart Valve Trial Results

PARTNER Trial Successfully Meets Primary Endpoints

IRVINE, CA, September 22, 2010 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, reported that The New England Journal of Medicine today published results from Cohort B of The PARTNER Trial, which studied the Edwards SAPIEN transcatheter heart valve for the treatment of severe aortic stenosis. The results of the trial successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization.

The study authors concluded, “in patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI [transcatheter aortic valve implantation], as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events.” The article further states, “on the basis of a rate of death from any cause at one year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.”

According to the study authors, “aortic stenosis is an insidious disease with a long latency period followed by rapid progression after the appearance of symptoms, resulting in a high rate of death” and concluded that “standard medical therapy… did not alter the natural history of severe aortic stenosis.”

“The commitment and partnership demonstrated by the interventional cardiologists, surgeons and their heart teams during this very rigorous trial was inspiring as they diligently seek new treatment options for their patients,” said Michael A. Mussallem, Edwards’ chairman and CEO.

This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy.

The Edwards SAPIEN transcatheter valve is an investigational device in the U.S. and not yet available commercially in this country.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at http://www.edwards.com.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1362467

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1362474

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1362470

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1362479

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1362485

Video-Link Available: http://www2.marketwire.com/mw/frame_mw?attachid=1369685

Video-Link Available: http://www2.marketwire.com/mw/frame_mw?attachid=1369687

Video-Link Available: http://www2.marketwire.com/mw/frame_mw?attachid=1369689

# # #

One comment

  1. Pingback: FDA Releases Briefing Documents for Advisory Panel on the Edwards Sapien Transcatheter Aortic Valve Implant « CardioBrief

What do you think?

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s