PARTNER A: Mortality comparable between TAVR and AVR procedures

Issue: May 2011

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – New results from the PARTNER A cohort have indicated that despite a higher rate of stroke among patients treated with transcatheter aortic valve replacement compared with aortic valve replacement, rates of mortality were similar between both procedures at 1 year.

The trial included 699 high-risk older patients (median age, 84.1 years) with severe aortic stenosis who were randomly assigned to receive either transcatheter aortic valve replacement (TAVR; Sapien, Edwards Lifesciences; n=348) or aortic valve replacement (AVR; n=348). The primary endpoint was all-cause mortality at one year, with stroke and major vascular and bleeding events serving as additional endpoints.

Despite a more favorable outcome for TAVR in mortality (3.4% vs. 6.5%) and symptoms at one month, by one year both rates were similar between the two procedures. Important differences, however, were reported in rates of stroke at one year (TAVR, 5.1% vs. AVR, 2.4%), vascular complications at one month (TAVR, 11% vs. AVR, 3.2%), major bleeding (TAVR, 9.3% vs. AVR, 19.5%) and new-onset irregular heart rhythms of atrial fibrillation (TAVR, 8.6% vs. AVR, 16%).

“This opens up a new set of patients who may very well benefit as much by TAVR as by conventional the gold standard surgery,” said Craig R. Smith, MD, chief, division of cardiothoracic surgery, New York-Presbyterian Hospital, Columbia University Medical Center, New York, and the study’s co-principal investigator, in a press conference. “As everyone knows no one wants surgery — no one should want surgery — and an equivalent therapy is always a good thing.”

Upcoming for the PARTNER trial is the recently approved PARTNER II trial which will pair the next generation of TAVR and a different catheter-based delivery system against the valve and delivery method used in the first trial. – by Brian Ellis

Disclosures: Drs. Smith, Moliterno and Tuzcu report no relevant financial disclosures.

For more information:

Smith C. LBCT I, Session 3010. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

You are all witnessing history in the making. Those of you who saw Dr. Smith’s presentation really did see history unfolding. I think it probably will be seen as one of the biggest steps in CV medicine as far as intervention is concerned potentially in our lifetime. If we look back to balloon angioplasty, the advent of stents, and then drug-eluting stents, probably on the life-scale of the calendar [percutaneous valve intervention ] will be seen as the next major turning point.

– David Moliterno, MD
Chief, Division of Cardiovascular Medicine,
University of Kentucky, Lexington, KY

These extraordinary results are accomplished because of an unprecedented team work between a cardiologist, cardiac surgeon and the associate care givers. I just want to emphasize that if we fail to not pay equal attention to what we have done in this trial after this device is approved, I don’t think we will be able to replicate these results. The cardiac surgeon profession and the cardiology profession, particularly interventional cardiologists, had a sometimes not easy relationship over the past 50 years, but now over the past 5 years as evidenced by this trial on how we interact with each other, how we perform as a single team, are really diametrically opposite … So I think it is critical to emphasize that.

–E. Murat Tuzcu, MD
Vice Chair, Clinical Operations,
Department of Cardiovascular Medicine,
Cleveland Clinic, Cleveland OH

Follow CardiologyToday.com on Twitter.