Results of the PARTNER Trial Cohort B 2-year follow up presented at TCT 2011

November 10, 2011

A two-year study of patients in the landmark PARTNER trial, which compared transcatheter aortic valve replacement (TAVR) in patients who have severe aortic stenosis and are not candidates for open heart surgery, confirm the one-year findings and support the role of TAVR as the standard of care.

Trial results were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Cohort B of the PARTNER trial – those patients with severe aortic stenosis who were not candidates for surgery - randomized 358 patients to transfemoral TAVR with an early generation balloon-expandable bovine pericardial valve or standard therapy (ST, including balloon valvuloplasty) at 21 centers, emphasizing a multi-disciplinary heart team approach.

The primary end point was death from any cause at one year and secondary endpoints included symptom status, serial echo assessments (core lab) and early/late adverse events (e.g. strokes).

After two years, the rate of all cause mortality was 18.2% in the TAVR group and 35.1% in the standard therapy group. The rate of cardiovascular mortality was 13.2% in the TAVR group and 32.1% in the standard therapy group.

The rate of repeat hospitalization was 35.0% in the TAVR group and 72.5% in the standard therapy group.

The rate of stroke at two years was higher – 13.8% in the TAVR group and 5.5% in the standard therapy group.

"At two years, in patients with symptomatic who are not suitable candidates for surgery, TAVR remained superior to standard therapy with incremental benefit from one to two years markedly reducing the rates of all cause mortality, cardiovascular mortality and repeat hospitalization," said Raj R. Makkar, MD, the principal site investigator for the PARTNER trial. Dr. Makkar is Director of Interventional Cardiology and the Cardiac Catheterization Laboratory at Cedars-Sinai Medical Center and Associate Director of the Cedars- Sinai Heart Institute

"There were more neurologic events in TAVR patients compared to standard therapy (16.2% vs. 5.5%; p = 0.003) with five new events (three strokes and two TIAs) between 1-2 years in TAVR patients. After 30 days, differences in stroke frequency were largely due to increased hemorrhagic strokes in TAVR patients." Dr. Makkar said.

"Two year data continues to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates," said Dr. Makkar.

"The ultimate value of TAVR in 'inoperable' patients will depend on careful selection of patients who are not surgical candidates, and yet do not have extreme co-morbidities that overwhelm the benefits of TAVR."

Explore further: Heart valve replacement without opening the chest gives new option for non-operable patients

Related Stories

Heart valve replacement without opening the chest gives new option for non-operable patients

June 24, 2011
An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered at Rush University Medical Center to patients with severe aortic stenosis who are at high-risk or not suitable candidates ...

New option for patients with untreatable, non-perative heart condition

June 28, 2011
(Medical Xpress) -- An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered at Rush University Medical Center to patients with severe aortic stenosis who are at high-risk ...

Recommended for you

Could aggressive blood pressure treatments lead to kidney damage?

July 18, 2017
Aggressive combination treatments for high blood pressure that are intended to protect the kidneys may actually be damaging the organs, new research from the University of Virginia School of Medicine suggests.

Quantifying effectiveness of treatment for irregular heartbeat

July 17, 2017
In a small proof-of-concept study, researchers at Johns Hopkins report a complex mathematical method to measure electrical communications within the heart can successfully predict the effectiveness of catheter ablation, the ...

Concerns over side effects of statins stopping stroke survivors taking medication

July 17, 2017
Negative media coverage of the side effects associated with taking statins, and patients' own experiences of taking the drugs, are among the reasons cited by stroke survivors and their carers for stopping taking potentially ...

Study discovers anticoagulant drugs are being prescribed against safety advice

July 17, 2017
A study by researchers at the University of Birmingham has shown that GPs are prescribing anticoagulants to patients with an irregular heartbeat against official safety advice.

Protein may protect against heart attack

July 14, 2017
DDK3 could be used as a new therapy to stop the build-up of fatty material inside the arteries

Heart study finds faulty link between biomarkers and clinical outcomes

July 14, 2017
Surrogate endpoints (biomarkers), which are routinely used in clinical research to test new drugs, should not be trusted as the ultimate measure to approve new health interventions in cardiovascular medicine, according to ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.