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PARTNER 3: TAVR improves quality of life compared with surgery
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SAN FRANCISCO — Compared with patients assigned surgery, those assigned transcatheter aortic valve replacement had a better Kansas City Cardiomyopathy Questionnaire-Overall Summary, or KCCQ-OS, score at 1 month, 6 months and 12 months, according to new data from the PARTNER 3 trial presented at TCT 2019.
As Healio previously reported, in the main results of PARTNER 3, TAVR with a balloon-expandable valve (Sapien 3, Edwards Lifesciences) was associated with lower risk for death, stroke or rehospitalization compared with surgical AVR (HR = 0.54; 95% CI, 0.37-0.79) at 12 months in patients at low surgical risk.
For the present analysis, researchers administered the KCCQ to assess health status. TAVR was associated with greater improvement in KCCQ-OS score compared with surgery at 1 month (mean difference, 16 points; P < .001), 6 months (mean difference, 2.6 points, P < .04) and 12 months (mean difference, 1.8 points, P < .04), Suzanne J. Baron, MD, MSc, cardiologist at Lahey Hospital and Medical Center in Burlington, Massachusetts, said during a press conference.
“Not surprisingly, patients who underwent TAVR experienced substantially improved health status at 1 month,” she said. “However, in contrast to prior studies, at 6 months and 12 months, the benefit of TAVR over surgery persisted, although the magnitude was smaller.”
The findings were simultaneously published in the Journal of the American College of Cardiology.
The percentage of patients with an excellent outcome, defined as being alive with a KCCQ score of at least 75 and no significant decline from baseline, was greater in the TAVR group compared with the surgery group at 6 months (90.3% vs. 85.3%; P = .03) and 12 months (87.3% vs. 82.8%; P = .07), Baron said.
A categorical analysis combining survival and KCCQ score favored the TAVR group at 1 month (P < .001), 6 months (P = .015) and 12 months (P = .03), she said.
The treatment effect of TAVR on KCCQ score at 12 months was more pronounced in those with NYHA class III or IV HF compared with those with NYHA class I or II HF (P for interaction = .02), according to the researchers.
The SF-36 physical score, SF-36 mental score and EQ-5D score all favored TAVR at 1 month (P < .001 for all), but did not differ between the groups at 6 and 12 months, the researchers found.
The difference in KCCQ score but not the others at 6 and 12 months “is likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive at detecting meaningful differences in this population,” Baron said during the press conference.
The cohort available for analysis included 494 patients assigned TAVR (mean age, 73 years; 67% men) and 449 patients assigned surgery (mean age, 74 years; 71% men). Both groups had a Society of Thoracic Surgeons Predicted Risk of Mortality Score of 1.9%. – by Erik Swain
References:
Baron SJ, et al. Late-Breaking Trials 4. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Baron SJ, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2019.09.007.
Disclosure: The study was funded by Edwards Lifesciences. Baron reports she received consultant fees from Edwards Lifesciences and received research grant support and serves on an advisory board for Boston Scientific.
Perspective
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Suzanne V. Arnold, MD, MHA
There were two things I found remarkable about the PARTNER 3 health status outcomes analysis of low-risk patients who underwent TAVR or surgical AVR. The first is that the patients were not particularly symptomatic going in to the trial, and yet the TAVR group still had a nearly 20-point improvement in KCCQ-OS score at 1 month. We expect a “ceiling effect” in which if you start with a good score, it may not get much better. Yet, there were large health status improvements regardless of baseline score. That is remarkable and may be specific to this cohort; these patients don’t have a lot of comorbidities that will impact their health status other than the aortic stenosis. If you fix the aortic stenosis, some of these patients will have a score of 100. Also of interest was the health status benefit was much smaller at 6 months and 12 months than it was at 1 month. That may reflect a small percentage of patients who seem to get a larger benefit. Are there complications that are driving this?
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