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PARTNER 1: TAVR equivalent to surgery in high-risk patients, better than standard care in inoperable patients
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SAN DIEGO — At 5 years, a balloon-expandable transcatheter aortic valve replacement system and surgical aortic valve replacement were associated with similar outcomes in high-risk patients and with better outcomes than standard care in inoperable patients with severe aortic stenosis, according to the final results of the PARTNER 1 trial.
The results for both groups were published in The Lancet and the results for the high-risk cohort were presented at the American College of Cardiology Scientific Sessions.
High-risk patients
Michael J. Mack, MD, chairman of cardiovascular medicine and surgery at the Baylor Scott and White Health Care System, Dallas, and colleagues enrolled 699 patients with severe aortic stenosis at high risk for surgery in the PARTNER 1 trial. They randomly assigned 348 patients to TAVR with a balloon-expandable bovine pericardial tissue valve (Sapien, Edwards Lifesciences) by a transfemoral or transapical approach, and 351 to surgical AVR. Mean Society of Thoracic Surgeons Predicted Risk of Mortality Score was 11.7%.
Michael J. Mack
At 5 years, risk for death was 67.8% in the TAVR group vs. 62.4% in the surgical AVR group (HR = 1.04; 95% CI, 0.86-1.24), Mack, a member of the Cardiology Today’s Intervention Editorial Board, and colleagues found.
The researchers observed no structural valve deterioration requiring surgical valve replacement in either group.
At 5 years, TAVR and surgical AVR were similar in risk for stroke (HR = 1.14; 95% CI, 0.68-1.93) and all-cause mortality or stroke (HR = 1.09; 95% CI, 0.9-1.31).
“There was an increase in stroke rate initially associated with TAVR compared to surgical aortic valve replacement,” Mack said during a press conference. “By the time we got out to 2 years, those lines converged, and there was no difference in [the] 5-year stroke rate between the two approaches.”
In other 5-year results, moderate or severe aortic regurgitation occurred in 14% of the TAVR group vs. 1% of the surgical AVR group (P < .0001). Moderate or severe aortic regurgitation was associated with increased 5-year risk for mortality in the TAVR group (moderate or severe aortic regurgitation, 72.4%; mild aortic regurgitation or less, 56.6%; P = .003).
“The 5-year follow-up to this trial supports that TAVR is alternative to surgery in high-risk patients, with similar mortality and other clinical outcomes,” Mack said. “Functional outcomes were also similar, with improvements in both valve function maintained in both groups with no evidence of structural valve deterioration.”
Inoperable patients
The researchers enrolled 358 patients with severe symptomatic inoperable aortic stenosis (mean age, 83 years; 54% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality Score, 11.7%). They assigned 179 patients to TAVR with the balloon-expandable valve and 179 to standard treatment, often including balloon aortic valvuloplasty.
Risk for all-cause mortality at 5 years was 71.8% in the TAVR group vs. 93.6% in the standard treatment group (HR = 0.5; 95% CI, 0.39-0.65), according to the researchers. At 5 years, only six patients in the standard treatment group did not die, cross over to TAVR or withdraw from the study; five had aortic valve replacement treatment outside the study.
Also at 5 years, 86% of survivors in the TAVR group had NYHA class I or II HF symptoms vs. 60% of survivors in the standard-treatment group, according to the researchers.
Those in the TAVR group alive at 5 years showed durable hemodynamic benefit (aortic valve area, 1.52 cm2; mean gradient, 10.6 mm Hg) with no evidence of structural valve deterioration.
The Sapien valve is approved in the United States for inoperable and high-risk operable patients. Patients in the TAVR group of the PARTNER trial will be followed annually for life in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies registry. – by Erik Swain
References:
Kapadia SR, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)60290-2.
Mack MJ, et al. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Sessions: March 14-16, 2015; San Diego.
Mack MJ, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)60308-7.
Disclosure: The study was funded by Edwards Lifesciences. Mack reports receiving travel reimbursement from Edwards Lifesciences relating to his position as an unpaid member of the PARTNER trial executive committee.
Perspective
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Kenneth Rosenfield, MD, MHCDS, FACC, FSCAI
What is remarkable is how identical the curves look over time. It’s striking that the outcome in this very high-risk group of patients who either went to surgery or had TAVR were essentially the same. There are very slight differences, but the important thing about this trial is that it shows the percutaneously implanted valves are durable and that the outcome at 5 years is no different than it is at 1 year. A concern at the outset was whether this valve would be durable. This shows definitively that it is. What it means for the high-risk patients is that this is an excellent alternative and clearly may be preferred by patients.
The presence of paravalvular leak was associated with a slightly poorer outcome. Conversely, the subset who did not have paravalvular leak demonstrated slightly better outcomes than the surgically implanted valves. Paravalvular leak clearly impairs results. The good news, however, is that these were first-generation devices. In all of the newer generations — and there are now approximately 30 valve companies working on iterations — they are lower profile with a better seal around the outskirts of the valve so that there is less chance of paravalvular leak. In the device and interventional world, it is notable to have a first-generation device such as this initial Sapien valve to demonstrate equal results compared to an existing therapy that has a much longer track record, but is significantly more invasive. The 5-year results from the PARTNER trial confirm the fact that this is a game-changing therapy. Valve replacement will continue to trend toward minimally invasive techniques. I think we will never look back.
I appreciated that Michael Mack gave a nod to two very important people in the field who are no longer with us: Donald S. Baim, MD, and Michael J. Davidson, MD. The premature loss of both of them, Don from cancer and Michael from a gunshot wound, represents a loss for their families and friends, but also for the entire field of CVD. They will be remembered.
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