PARTNER Shows Clear TAVR Benefit at 5 Years in Inoperable Patients

Five-year results from PARTNER I show a substantial long-term advantage of transcatheter aortic valve replacement (TAVR) compared with standard therapy in extremely high-risk patients with aortic stenosis who are not candidates for surgery, according to late-breaking trial data presented Saturday at TCT 2014.

Samir Kapadia, MD, of the Cleveland Clinic, presented findings of 358 inoperable patients who were randomized to TAVR with the Sapien valve (Edwards Lifesciences; n=179) or standard medical therapy (n=179).

At 5 years, TAVR offered an absolute reduction in mortality of 21.8% (see Figure). Of the six standard therapy patients who were alive after 5 years, five had undergone some sort of valve replacement (TAVR outside the United States, surgical AVR, or apical-aortic conduit) and one patient had three balloon aortic valvuloplasty procedures.

Moreover, median survival was nearly 2.5 years longer in TAVR patients compared with those receiving standard therapy (29.7 vs. 11.1 months; P<.0001). Cardiovascular mortality was much lower in the TAVR arm as well (57.3% vs. 85.9%; P<.0001). Landmark analysis showed all-cause mortality rates between 3 and 5 years of 38.9% in the TAVR group and 66.7% in the standard therapy group (HR 0.47; 95% CI 0.24-0.94).

Cause of death was more likely to be noncardiovascular among those treated with TAVR vs. medical therapy (34% vs. 18%). Additionally, when outcomes were stratified by STS score, TAVR significantly reduced all-cause and cardiovascular mortality even in the highest risk group (STS>15).

Importantly, 47.6% of TAVR patients were rehospitalized within 5 years compared with 87.3% of the standard therapy patients (P<.0001). In addition, only 14.3% of patients who received TAVR remained categorized as NYHA class III-IV compared with 40% of those who received standard therapy. There was no additional stroke risk or additional cases of severe or moderate paravalvular leak with TAVR at 4- or 5-year follow-up.

Lastly, valve durability was confirmed with serial echocardiograms — mean gradient and effective orifice area remained consistently low and high, respectively, over the study period.

Evidence-based medicine ‘at its finest’

During a panel discussion, Michael J. Mack, MD, of Baylor Scott & White Health in Dallas, Texas, commented that PARTNER has demonstrated improved quantity and quality of life with TAVR in operable patients. Because of this, he said, “this pivotal trial … has such a strong evidence base of benefit that nobody disputes, nobody doubts. The debate is over. This is evidence-based medicine done at its finest.”

Jeffrey J. Popma, MD, of Beth Israel Deaconess Hospital, Boston, said the trial is practice-changing. “I was more hesitant in [performing procedures on] patients who I thought were [extremely high risk] based on their STS risk scores,” he said at a press conference, adding that the long-term benefit shown in PARTNER demonstrates that there is more to evaluating patients than merely looking at STS scores.

Looking forward, said Ajay J. Kirtane, MD, SM, of Columbia University Medical Center, “When you see this type of durability data and long-term data in the highest-risk patients, it gives us more leeway and enthusiasm to move TAVR into lower-risk patient populations as well.”

Disclosures: 

• Kapadia reports use of off-label newer aortic valves and mitral devices.