Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 transcatheter valve (Edwards Lifesciences; Irvine, CA) was both noninferior and superior to surgery in the rate of the composite primary end point, according to a propensity score analysis from the PARTNER 2 trial.

“With the propensity score, not only were we noninferior, but we were superior [with TAVR] in the entire primary end point, but also for mortality and stroke; surgery did have superiority toward aortic insufficiency,” study investigator Vinod H. Thourani, MD, of the Emory University School of Medicine in Atlanta, said at a press conference.

Dr Thourani presented the results, which were simultaneously published in Lancet, at the 2016 American College of Cardiology Scientific Sessions & Expo during a late-breaking trial session.


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In the analysis, Dr Thourani and colleagues compared the surgery-treated patients from the PARTNER 2 cohort A study with the SAPIEN 3 cohort from the PARTNER 2 study. 

The primary end point was a composite of all-cause mortality, all stroke, or moderate or severe aortic regurgitation at 1 year, which was analyzed in a non-inferiority propensity score analysis.

In the propensity score analysis, each of the 5 patient groups in the quintile favored TAVR with regard to the primary end point. In fact, according to Dr Thourani, researchers made a conservative analysis against TAVR by giving the highest weight (0.25) to the worst TAVR outcome, and they still showed a –9.2% difference (P<.001 for both noninferiority and superiority) in favor of TAVR.

Further analysis of the primary end point components indicated that mortality (superiority P<.001) and stroke (superiority P=.004) favored TAVR, whereas surgery performed better in reducing aortic insufficiency (superiority P=.0149).

An unadjusted time-to-event analysis found that all-cause mortality and all stroke were reduced with TAVR (10.8% vs 18.8%).

“We believe that … intermediate risk really should … head to the pathway for transcatheter valve therapies,” Dr Thourani concluded.

References

  1. Thourani VH, Kodali S, Makkar R, et al. Late-Breaking Clinical Trials III. SAPIEN 3 transcatheter aortic valve replacement compared with surgery in intermediate-risk patients: a propensity score analysis. Presented at the 65th Annual Scientific Session and Expo of the American College of Cardiology. April 2-4, 2016; Chicago, IL.
  2. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement vs surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016. doi: 10.1016/S0140-6736(16)30073-3.