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PARTNER II Trial Finds Minimally Invasive Heart Valve Replacement Method A Safe Alternative To Traditional Surgery For Many Patients (NewYork-Presbyterian)
Transcatheter aortic valve replacement (TAVR) is a viable alternative to traditional open heart surgery for patients with severe aortic stenosis at intermediate risk for surgery, according to results from the Placement of AoRTic TraNscathetER Valves (PARTNER) II Trial.
Researchers from NewYork-Presbyterian/Columbia University Medical Center will present the study’s results as part of the late-breaking clinical trials at the American College of Cardiology (ACC) conference this weekend in Chicago. The study has also been published online in the New England Journal of Medicine.
“The PARTNER II trial is unique in its size, distinctive in rigor of execution and exceptional in patient outcomes, making it one of the most important trials in the history of our field,” said Dr. Craig Smith, surgeon-in-chief at NewYork-Presbyterian/Columbia University Medical Center, chair of the Department of Surgery at Columbia University Medical Center, senior author and co-principal investigator of the PARTNER II Trial.
The trial examined outcomes for 2,032 patients with severe aortic stenosis and cardiac symptoms at intermediate risk for traditional surgery at 57 centers across the United States and Canada between December 2011 and November 2013. Patients were stratified in cohorts according to access route (transfemoral or transthoracic) and were then randomly assigned to receive either TAVR with the SAPIEN XT valve or surgical aortic valve replacement. All patients were followed for at least two years, undergoing clinical assessments by physicians across various disciplines.
The combined primary endpoint of the trial was all-cause mortality or disabling stroke at two years — the rate for patients who received TAVR was 19.3 percent for TAVR with the SAPIEN XT valve, compared with 21 percent for surgery. For the 76 percent of SAPIEN XT patients treated via the transfemoral approach, the event rate was 16.8 percent, significantly less than the rate for traditional surgery.
“We are confident the PARTNER IIA Trial will contribute to changing the guidelines for aortic valve replacement procedures,” said Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, professor of medicine at Columbia University Medical Center and a co-author of the trial. “Because TAVR is a less invasive procedure, it is desirable to patients. We believe that the PARTNER IIA data will support the use of TAVR as an alternative or preferred choice in many patients with intermediate risk.” Dr. Leon will be attending the ACC and will be available to speak on behalf of the outcomes.
This study comes after the previous PARTNER Trial in 2011 – the world’s first randomized clinical trial of a transcatheter aortic heart valve – which yielded successful results after one-year survival in high-risk patients.
The aortic valve replacement devices used in the study are manufactured by Edwards Lifesciences of Irvine, CA, which also funded the study.