PARTNER Quality-of-Life Analysis: Large and Sustained Benefits in TAVI Group

Shelley Wood

November 15, 2010

November 15, 2010 (Chicago, Illinois) — Inoperable patients with severe aortic stenosis treated by transcatheter aortic-valve implantation (TAVI) experience significant and sustained improvements in quality of life (QoL) and "health status" as compared with patients treated with best standard care, an analysis of the PARTNER cohort B shows.

Dr David Cohen

The results, while not surprising, may to the patients themselves mean even more than the survival benefit seen in the TAVI group, trial presenter Dr David Cohen (Saint Luke's Mid America Heart Institute, Kansas City, MO) told heartwire here at the American Heart Association 2010 Scientific Sessions.

"The mean age of the patients in PARTNER was 83 years, 70% of them were over 80, and most of them are far more concerned about living well than about how long they live. Obviously duration of life is important also, but prolonging life without improving quality of life in these patients would not, frankly, have been acceptable."

Cohen presented the QoL analysis during a Clinical Science: Special Reports session here on Monday.

The QoL results provide the missing piece for a trial result that has already been hailed as one of the most dramatic interventions in recent memory, with an absolute mortality difference of 20% seen in TAVI-treated, cohort B patients in the overall trial, as reported by heartwire .

"If people were wowed by the fact that the number needed to treat to prevent one death in the main PARTNER trial was five, the number needed to treat to improve quality of life by a major amount was just three," Cohen emphasized to heartwire .

"This speaks to the fact that this is unequivocally a unique intervention, improving quality of life and increasing duration of life. The only other thing you could ask for would be to save money, and we don't know the answer to that yet, but we're in the process of trying to study that."

PARTNER COHORT B

As previously reported by heartwire , PARTNER cohort B randomized 358 patients at one of 21 centers to either TAVI or standard care, including balloon valvuloplasty. Within the first 30 days, strokes and major vascular complications were higher in the TAVI group, a difference that reached statistical significance for vascular complications. At one year, however, the rate of all-cause death was 30.7% in the TAVI group compared with 50.7% in the standard-therapy group. The co–primary composite end point of death or repeat hospitalization was also dramatically lower in the TAVI group. For those who survived 12 months, rates of NYHA class 3 or 4 heart failure were higher among patients in the standard-therapy group.

All Quality-of-Life Instruments Favored TAVI

Quality of life was measured in surviving PARTNER participants at baseline, one, six, and 12 months, using three self-administered questionnaires: the Kansas City Cardiomyopathy Questionnaire (KCCQ) was used as the primary end point, while the SF-12 physical and mental and the EQ-5D were secondary end points. For all three measures, higher scores indicate better quality of life.

For KCCQ scores overall, TAVI-treated patients had an almost 21-point improvement in scores by six months, reaching 24.5 points by 12 months, a statistically significant difference. More than 77% of patients in the TAVI group, as compared with 34% in the standard-therapy group, made gains from baseline of 10 points or greater at 12 months, and 62% vs 23% improved by 20 points or more, respectively.

Similarly significant and sustained improvements were seen for KCCQ symptoms, physical limitations, social limitations, and quality of life--this last reaching a 30-point difference by 12 months.

12-Month Differences in Change From Baseline on KCCQ Scores, TAVI Group vs Controls

KCCQ score Intergroup differences in change (points) p
Overall summary 24.5 <0.001
Symptom score 18.0 <0.001
Physical limitations 18.0 <0.001
QoL 29.9 <0.001
Social limitations 27.5 <0.001

Improvements in KCCQ summary scores were seen among all analyzed subgroups, based on age, gender, baseline risk, AV gradient, and chronic obstructive pulmonary disease (COPD) status. "Everybody benefited," Cohen told heartwire . "We couldn't find any groups that got less or more benefit--the effect really was across the board."

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical [aortic-valve replacement]," Cohen concluded in his presentation.

Dr Timothy Gardner (Christiana Care's Center for Heart & Vascular Health, Wilmington, DE) commenting on the QoL results for heartwire , said he's frequently seen patients in their 80s "who really needed their aortic valves fixed but were sufficiently frail and elderly that I really was reluctant to put them through conventional sternotomy surgery. And that is the group for whom the TAVI is so helpful. So I'm not at all surprised that QoL for those patients is turning out to be favorable--I think these data are extremely important."

A Very Sick Population

To heartwire , Cohen emphasized just how sick the patients were at baseline. The physical limitations score on the SF-12 questionnaire was just 28 in both groups. "The mean score in the US population is 50, and 10 points is a standard deviation," said Cohen, "So these people were a full two standard deviations below the average US patient, which is enormous."

As well, the baseline utility measure in the EQ-5D questionnaire ranged from 0.57 to 0.59 (out of a maximum score of one). "That's about the level of someone who's had a major stroke, so these patients were severely impaired."

Improvements in both of these represent substantial gains, he stressed to heartwire : "Survival is important, but if you asked these patients what they would prefer, 10 years as they are now or two years of feeling better, [they'd want the latter]. This really just shows that this is a treatment we need to be able to offer these patients."

The Sapien valve (Edwards Lifesciences) used in the PARTNER trial is available in Europe but is still investigational in the US and other parts of the world.

Edwards sponsored the PARTNER trial.

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