TAVR Deaths at Five Years in PARTNER: Sobering and Remarkable

Shelley Wood

September 13, 2014

WASHINGTON, DC — The vast majority of inoperable aortic-valve-disease patients treated in the PARTNER trial are no longer alive five years after their treatment with either the Sapien transcatheter valve or usual care, according to late-breaking results presented here at TCT 2014 .

But even at five years, investigators saw a significant survival difference between transcatheter aortic-valve replacement (TAVR) vs usual care and significant differences in repeat hospitalizations, suggesting that patients, who were 83 years of age on average at the start of the trial, are living both longer and better following transcatheter-valve implantation.

"If you look at median survival, if you have standard therapy you live less than a year, and if you do TAVR, you live two and a half years. This is a big difference," Dr Samir Kapadia (Cleveland Clinic, OH) told a morning press conference. "And these two and a half years are a functionally good two and a half years," not two and a half years as an invalid, he added.

Dr Samir Kapadia

Only six patients out of 179 patients randomized to standard therapy in PARTNER B were still alive at five years compared with 51 of 179 in the TAVR group, and all six of those standard-care patients had had some kind of aortic-valve procedure in the intervening years, Kapadia said—either balloon valvuloplasty, TAVR, or in two cases aortic-valve surgery (despite being deemed inoperable at the time of PARTNER enrollment).

At 60 months, 93.6% of patients in the standard-therapy group had died, compared with 71.8% in the TAVR group (log rank p<0.0001). Moreover, in a landmark analysis that looked at deaths between three and five years, survival still favored TAVR, with 39% of those patients still alive at three years dying by year five in the TAVR group, vs 67% of those in the standard-care group.

This is "extremely remarkable," said Kapadia, "when you consider that most of the patients were dead at three years."

Lower Cardiovascular Deaths with TAVR

Dr Ajay Kirtane

Importantly, the most common cause of death in the standard-care group was cardiovascular in nature, at 48%, while noncardiovascular deaths accounted for 17.5% (the remainder "unknown"). In TAVR-treated patients, by contrast, cause of death was evenly distributed across the three categories.

"So often when we see mortality rates this high and everybody is dying of other things, you see the curves start to converge, and in this case they are clearly separate, and that's very notable," press conference moderator Dr Ajay Kirtane (Columbia University Medical Center, New York, NY) observed.

In another key finding, a survival advantage for TAVR was seen across all three tertiles of STS score, including patients with baseline STS scores of >15, something that was not seen in earlier follow-up.

Dr Jeff Popma

This finding stood out for Dr Jeff Popma (Beth Israel Deaconess Medical Center, Boston, MA), who also attended the morning press conference." This is going to change my practice, because I was more hesitant in doing patients who I thought were 'cohort C' [ie, too sick to benefit] based on their STS risk score; I think I've learned from this that I should be looking longer term."

Five-year data also showed significant differences in repeat hospitalizations, which were 87% in the standard-care group and 48% in the TAVR-treated patients (log rank p<0.0001). Only 14.3% of TAVR patients were in NYHA class 3 or 4 heart failure by year five, compared with 40% of standard-care patients, although due to the low numbers, the difference was not statistically significant.

For Popma, that answers a question that has repeatedly been raised about offering an expensive therapy to a typically elderly, sick population. This tells physicians that "we're still doing the right thing by treating these patients: they get quality of life and they get improvement; these are overwhelming data."

Extending, Improving Life

Dr Matthew Reynolds

To heartwire , experts discussing the five-year results agreed that it's impossible to ignore the very high mortality in these patients, especially given limited healthcare costs. Dr Matthew Reynolds (Harvard Clinical Research Institute, Boston, MA) estimated that the incremental cost of TAVR is $60 000 in the first year, although he noted that patients who don't undergo procedures end up having very high healthcare costs down the road. "At a certain point, you're just paying to keep patients alive."

Kirtane acknowledged: "A lot of effort has been made and will continue to be made to select up front which patients are going to have potential worse outcomes and won't benefit. This is not something that is inexpensive."

Age Alone No Barrier

For Kapadia, however, the five-year data underscore the fact that age alone should not be a barrier. If the patient has high "mental" and "social" function, he says, "it is hard [on the basis of these data] to deny this therapy to patients who are otherwise functioning well."

Dr Axel Linke

Indeed, Dr Axel Linke (University of Leipzig, Germany), who also spoke at the press conference, noted that he had recently treated a 100-year-old patient and agreed that there is "no need to withhold therapy" in patients who are living independently, with no dementia, etc.

In Europe and South America, TAVR use is also expanding in the other direction—to younger and lower-risk patients. For these patients, there's also good news in the new PARTNER findings: no increase in transvalvular gradient or attrition of valve area, suggesting good durability at least to five years.

As such, the PARTNER results represent the "worst of the outcomes we can expect to see," Popma stressed following Kapadia's formal presentation of the data. And PARTNER set the benchmark, making it unethical to do another study in which the most vulnerable patients are randomized to standard care, where, as today's presentation showed, patients did very poorly over the long term. "Everything from here will be better than that," Popma said.

Linke disclosed grant/research support from Medtronic and Claret Medical and consulting fees/honoraria from Medtronic, St Jude Medical, Boston Scientific, Edwards Lifesciences, and Claret Medical. Reynolds disclosed grant/research support from Medtronic and Edwards Lifesciences and consulting fees/honoraria from Medtronic. Kirtane reported grant/research support from Abbott Vascular, Vascular Dynamics, Daiichi-Sankyo/Eli Lilly, St Jude Medical, Medtronic, and Boston Scientific. Popma reported grant/research support from Abbott Vascular Boston Scientific, Cook Medical, ev3, Medtronic, and Abiomed and consulting/speaker fees/honoraria from Abbott Vascular, ev3, and Boston Scientific. Kapadia had no conflicts of interest.

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