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PARTNER: TAVR remains comparable to surgery at 3 years
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SAN FRANCISCO — Three-year follow-up data from the PARTNER cohort A trial indicate that all-cause and CV mortality are nearly identical between transcatheter aortic valve replacement and surgical aortic valve replacement in patients at high risk for surgery, with no increased stroke risk with the transcatheter procedure after 30 days.
Among patients treated with TAVR (Sapien, Edwards Lifesciences; n= 348), 3-year all cause mortality was 44.2% vs. 44.8% for standard surgical AVR (HR=0.93; 95% CI, 0.74-1.15). Starting at 1 year, all-cause mortality was 26.3% in the TAVR arm vs. 24.5% in the AVR arm (HR=1.02; 95% CI, 0.74-1.40).
Vinod H. Thourani
Multivariable baseline predictors of mortality in the TAVR arm included BMI (P=.0003), AF (P=.0056), mean gradient at baseline (P=.0033), and liver (P=.025) and renal disease (CR ≥2; P=.013).
CV mortality was also nearly identical between both groups (TAVR, 30.1% vs. surgical AVR, 30.2%).
Although STS scores greater than 11 did not have a significant influence on mortality in the AVR group, higher scores had an influence in the TAVR group (STS >11, 49.1% vs. STS 0-11, 39.6%; P=.039).
Also of note in PARTNER, stroke, a primary concern for the TAVR approach due to the much higher rate observed at 30 days, no longer favored the AVR arm at 3 years (TAVR, 8.2% vs. AVR, 9.3%; HR=1.09; 95% CI, 0.62-1.91).
“TAVR should be considered an alternative to surgery with similar mortality and other major clinical outcomes,” Vinod H. Thourani, MD, PARTNER investigator with the Emory University School of Medicine, said at a presentation here at the American College of Cardiology Scientific Sessions. “Future efforts should be directed towards reducing TAVR procedure-related complications, including strokes, vascular events and paravalvular regurgitation.”
As previously reported by Cardiology Today, the multicenter, phase 3 PARTNER cohort A study assigned 699 high-risk patients with severe aortic stenosis to standard surgical AVR (n=351) or TAVR (n=348). Patients had a mean age of 84 years, nearly half had prior CABG (43%) and their STS score was roughly 12 in both patient groups, Thourani said.
The PARTNER study will continue to follow patients for 5 years to assess durability and longer-term outcomes of TAVR. – by Brian Ellis
For more information:
Thourani V. Late-breaking clinical trials III: General cardiology. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Disclosure: Thourani serves on the steering and publications committees for the PARTNER trial. Edwards Lifesciences funded the trial and provides funding to Emory University for the research.