This article is more than 5 years old. Information may no longer be current.

PARTNER B: TAVR bested standard therapy at 2 years

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

TCT 2011

SAN FRANCISCO — Two-year data support the role of transcatheter aortic valve replacement as the standard of care for symptomatic patients with aortic stenosis who are not surgical candidates.

The PARTNER investigators said these data confirm the 1-year findings and support the role of transcatheter aortic valve replacement (TAVR) as standard of care.

After 2 years, the rate of all-cause mortality was 18.2% in patients who underwent TAVR (Sapien, Edwards Lifesciences) and 35.1% for patients who received standard therapy (HR=0.58; 95% CI, 0.37-0.92). The rate of CV mortality was 13.2% 2 years after TAVR and 32.1% after standard therapy (HR=0.48; 95% CI, 0.29-0.81).

Results also showed that TAVR was associated with a 35% rate of repeat hospitalization and standard therapy with a rate of 72.5% (HR=0.41; 95% CI, 0.30-0.58).

The stroke rate at 2 years, however, was higher with TAVR: 13.8% vs. 5.5% (HR=2.79; 95% CI, 1.25-6.22). After 30 days, differences in stroke frequency were largely due to increased hemorrhagic strokes in TAVR patients. There were also more neurologic events in TAVR patients compared with standard therapy (16.2% vs. 5.5%; P=.003).

According to other results, TAVR improved NYHA functional status and decreased NYHA Class III/IV symptoms compared with standard therapy.

TAVR hemodynamics by echo showed durable improvements in aortic valve area and mean gradients up to 3 years after implantation. Moderate or severe paravalvular aortic regurgitation in the TAVR patients did not influence 2-year survival, and there was a trend toward reduced paravalvular aortic regurgitation between 1 and 2 years.

A subgroup analysis according to surgical risk score suggests that the most pronounced benefit of TAVR is in patients without extreme clinical comorbidities.

“The ultimate value of TAVR in inoperable patients will depend on careful selection of patients who are not surgical candidates and do not have extreme comorbidities that overwhelm the benefits of TAVR and render the intervention futile,” said Raj J. Makkar, MD, director of interventional cardiology and the Cardiac Catheterization Laboratory at Cedars-Sinai Medical Center. Makkar presented the 2-year follow-up results of the PARTNER Trial Cohort B here at 2011 Transcatheter Cardiovascular Therapeutics scientific symposium.

The trial was designed to compare TAVR vs. best standard therapy in patients with severe aortic stenosis who are not candidates for CABG. Researchers randomly assigned 358 patients to transfemoral TAVR with an early-generation balloon-expandable bovine pericardial valve or standard therapy, including balloon valvuloplasty.

Disclosure: The PARTNER trial was funded by Edwards Lifesciences. Dr. Makkar reports receiving consulting fees, grant support and lecture fees from Medtronic, equity from Entourage Medical Technologies and grant support from St. Jude Medical.

For more information:

• Makkar RJ. Plenary session XIII. Late-breaking clinical trials and first report investigations II. Presented at: the 2011 Transcatheter Cardiovascular Therapeutics Scientific Symposium; Nov. 7-11; San Francisco.

Follow CardiologyToday.com on Twitter.