In September 2014, the Transcatheter Cardiovascular Therapeutics Conference was held in Washington, D.C., USA. Dr. Samir Kapadia, Cleveland Clinic, USA, presented the 5-year results of the PARTNER study on behalf of the participating study experts. The short conclusion is that TAVI can prolong life and reduce the frequency of hospitalizations.
(ee) The PARTNER (Placement of AoRtic TraNscathetER Valves) trial has been investigating for five years the effect of transcatheter aortic valve implantation (TAVI) on patients with severe, symptomatic aortic stenosis in whom surgical valve replacement is not an option because of the high surgical risk. Previously, TAVI had been recommended for severe aortic stenosis and inoperability, but there were no data on the long-term benefit to patients or on the long-term performance of the valves implanted.
358 patients participated in the study. The mean age was 83 years, and approximately 92% had NYHA grade III or IV heart disease. Study participants were randomized into two groups: One (n=179) received standard drug therapy, and the other (n=179) was treated with TAVI (Sapien valve system). The primary endpoint of the study was all-cause mortality.
Longer life for patients with TAVI
Patients in the TAVI group lived a median of 29.7 months after the procedure, compared with only 11.1 months for patients receiving standard therapy. Among patients who were alive two years after the start of the study, the TAVI group showed a continued reduction in mortality: over the next three years, mortality was significantly lower in TAVI patients (38.9%) than in patients receiving standard therapy (66.7%). And even five years after the start of the study, the survival benefit for patients with TAVI was evident. Fifty-one people (out of 179 originally) were still alive in their group, and six people (out of 179) were still alive in the standard therapy group. The mortality rate at this time point was 71.8% in the TAVI group and 93.6% in the standard therapy group.
Subgroup analyses showed that all patients in the TAVI group benefited from reduced mortality, regardless of patient characteristics such as sex, age, BMI, ejection fraction, pulmonary hypertension, or previous cardiovascular surgery. Only in patients receiving oxygen therapy for COPD was no significant decrease in mortality observed. Patients who died in the first five years after study entry showed different rates of cardiovascular mortality: this was significantly higher in the standard therapy group than in the TAVI group (85.9 vs. 57.3%).
Fewer hospitalizations in the TAVI group
An important factor that negatively affects quality of life is hospitalizations. During the first five years of the study, significantly fewer patients were readmitted to the hospital for cardiovascular reasons in the TAVI group than in the control group (48 vs. 87%). Previous analyses had shown that patients undergoing TAVI were at increased risk for parainterventional stroke. However, in the years after the procedure, there was no greater risk of stroke than in the group receiving standard therapy.
At the beginning of the study, there was also the question of how long the artificial valves would “last”. Therefore, the function of the prosthetic valves was monitored by echocardiography once a year in all study participants. It was found that function did not deteriorate within the first five years. The good durability of the implanted valves is also supported by the fact that neither a relevant increase of the transvalvular pressure gradient nor a shrinkage of the valve area occurred in five years.
Source: Kapadia S, et al.: PARTNER I: Five-Years Results from a Prospective Randomized Trial of Transcatheter Aortic Valve Replacement with a Balloon-expanding Device versus Conservative Care in Extremely High-Risk Patients with Aortic Stenosis. Transcatheter Cardiovascular Therapeutics Conference 2014, Plenary Session V: Late-Breaking Clinical Trials 1.
HAUSARZT PRAXIS 2015; 10(1): 27-28
CARDIOVASC 2015; 14(1): 31-31
