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PARTNER: 2-year data support TAVR use
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CHICAGO — New results from the PARTNER trial show comparable mortality and durability after transcatheter and surgical aortic valve replacement at 2 years in high-risk surgical candidates with severe aortic stenosis. These data build on previously reported 1-year data indicating comparable mortality rates and treatment benefit between the two procedures.
“Two-year mortality data are statistically indistinguishable – no suggestions of mortality benefit of one procedure or another. We’re encouraged to think we have a less-invasive alternative that can treat many more of these patients who aren’t getting treatment now,” Susheel K. Kodali, MD, stated in a press release.
All-cause mortality at 2 years was 35% in the surgical aortic valve replacement (AVR) group and 33.9% in the transcatheter aortic valve replacement (Sapien, Edwards Lifesciences) group (P=.78). CV mortality was 20.5% and 21.4%, respectively (P=.8).
Although nearly twice as many strokes occurred in the TAVR group compared with the surgical AVR group at 30 days, the frequency of strokes was similar at 2 years, suggesting that TAVR did not increase late stroke risk (HR=1.22; 95% CI, 0.67-2.23).
Frequency of aortic or paravalvular regurgitation at 2 years was higher after TAVR (P<.001), but Kodali noted that these PARTNER data do not differ significantly from those reported in other studies. Even mild paravalvular regurgitation was associated with increased late mortality, however (P<.001).
“[Regurgitation] is an important target for us to address. Longer term, if we can reduce these events and complications, we may have better outcomes than we have right now,” Kodali said. “This is an early-stage trial and we want to look at improvements associated with TAVR in the long term.”
Improvement in valve areas was similar with TAVR and surgical AVR and was maintained for 2 years. The researchers found no evidence of late valve failure, valve deterioration, endocarditis or infection after TAVR.
“We’re most concerned about valve durability, which you have to look at over 5 to 10 years, but any longer-term information is useful because trends tend to hold true over time,” Kodali said in a press release. “We have no evidence that the initial good results in improved valve performance have deteriorated during the follow-up to this time point. TAVR appears to be as durable as [surgical] aortic valve replacement.”
The PARTNER trial included 699 high-risk patients with severe aortic stenosis (mean age <85 years) who were assigned to TAVR or surgical AVR. Participants were followed for at least 2 years.
For more information:
- Kodali SK. Late-breaking clinical trials III. Presented at: the American College of Cardiology 61st Scientific Sessions & Expo; March 24-27, 2012; Chicago.
- Kodali SK. N Engl J Med. 2012;doi:10.1056/NEJMoa1200384.
Disclosure: The PARTNER trial is supported by Edwards Lifesciences. Dr. Kodali is a principal site investigator for the PARTNER II Trial (US) for Edwards Lifesciences and is a case proctor. He has received consulting fees from Medtronic and St. Jude Medical as well as equity from Thubrikar AorticValve.
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At 1 year, we learned that outcomes between TAVR and surgery were more or less comparable and at 2 years we are seeing the same thing. I don’t think this is huge news, but it is good news. Each year we will continue to looking at [the data] because the biggest question is what is the duration or longevity of the equivalent benefit for the percutaneous valve. The big news will probably come 4 or 5 years later. The trouble is that we are dealing with a very high-risk group, and will not likely get a 10-year perspective on this. The point that there is more aortic insufficiency with TAVR is valid. Whether that is important at 2 years is the question. The fact that risk for stroke was not significantly different at 2 years is still not completely reassuring because it did look like more strokes occurred with TAVR than with the surgical AVR [eight vs. 12 strokes]. We are still in the adolescence of percutaneous valves, and these results are good enough to make me believe that we will have good news 5 to 10 years from now.
— Spencer King III, MD
Cardiology Today Editorial Board member
Disclosure: Dr. King reports no relevant financial disclosures.