March 15th, 2015
Encouraging 5-Year Results for TAVR
The publication five years ago of the two-part PARTNER trial brought a major change to the treatment of aortic valve replacement. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who were not surgical candidates and then for patients who were at high risk for surgery. One important lingering concern about TAVR was whether its results would prove to be sufficiently durable. Now the final five-year findings from the trial, published in two papers in the Lancet, provide strong reassurance regarding the durability of TAVR.
The first report was also presented at the American College of Cardiology meeting in San Diego. At five years TAVR maintained its superiority to standard treatment in patients with inoperable aortic stenosis with impressive improvements in mortality and heart function. At five years the all-cause mortality rate was 71.8% in the TAVR group versus 93.6% in the standard treatment group (HR 0.50, CI 0.39–0.65, p<0.0001). Eighty-six percent of TAVR patients (42 of 49) had NYHA class 1 or 2 symptoms compared with 60% (3 out of the remaining 5 patients) in the control arm.
The investigators concluded that “TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximize the benefit of TAVR and reduce mortality from severe comorbidities.”
In the second report, at five years TAVR was still a reasonable alternative to surgery in the group of patients at high surgical risk. The five-year mortality rate was 67.8% in the TAVR group versus 62.4% in the surgery group (HR 1.04, CI 0.86–1.24, p=0·76). The investigators said that both the TAVR and surgical devices remained intact over five years and did not require surgical replacement. The rate of moderate or severe aortic regurgitation was 14% in the TAVR group versus 1% in the surgical group.
In an accompanying comment, Arie Kappetein writes that for patients not suitable for surgery TAVR is clearly superior to standard treatment but strongly recommends “a preoperative discussion between the heart team, patient, and other decision makers” to determine if TAVR is suitable for the individual patient. For patients at high surgical risk, “most patients will not consider the likelihood of a long-term benefit but instead choose the less invasive option.”
To view all of our coverage from the ACC meeting, go to our ACC.15 Headquarters page.