Rates of Death Similar for High-Risk Patients Undergoing TAVR or Surgical Aortic Valve Replacement
Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement resulted in similar rates of death from disabling stroke or any cause in high-risk patients with aortic stenosis, according to a study presented on April 2 at ACC.16 in Chicago and simultaneously published in the New England Journal of Medicine.
The study, led by Martin B. Leon, MD, FACC, et al, looked at data from Placement of Aortic Transcatheter Valves (PARTNER) 2A, a randomized trial of 2,032 intermediate-risk patients at 57 sites across the U.S. and Canada.
In the previous PARTNER 1 trial, TAVR was shown to be superior to standard therapy in patients with symptomatic severe aortic stenosis who were not candidates for surgery. This result was equivalent to that of surgery in high-risk patients. However, experiences with first-generation TAVR systems resulted in recurrent peri-procedural complications. For PARTNER 2A, the authors set out to compare the safety and effectiveness of the second-generation SAPIEN XT TAVR system.
The patients in the PARTNER 2A trial were placed into two cohorts: 76.3 percent were entered into the transfemoral-access cohort and 23.7 percent were entered into the transthoracic-access cohort. The patients were randomly assigned to undergo either TAVR with a second-generation valve system (1,011 patients) or surgical replacement (1,021 patients). The study's authors hypothesized that TAVR would not be inferior to surgical replacement. The primary endpoint was mortality from any cause or disabling stroke at two years.
The rate of death from the primary endpoint was similar in the TAVR group and the surgery group. In the transfemoral-access cohort, TAVR resulted in a lower risk of death or disabling stroke than surgery. In the transthoracic-access cohort, the outcomes were similar in both groups. At two years, the rate of death from any cause was 16.7 percent after TAVR and 18 percent after surgery. The rate of disabling stroke was 6.2 percent after TAVR and 6.4 percent after surgery.
The trial data showed that major vascular complications were more frequent in the TAVR group than in the surgery group at 30 days. But complications such as life-threatening bleeding, acute kidney injury, and new-onset atrial fibrillation were less frequent in the TAVR group.
Although long-term durability assessments of transcatheter bioprosthetic valves need further clinical investigation, the authors of PARTNER 2A affirm that the results of the study support the use of TAVR as an alternative to surgery in intermediate risk patients.
In an accompanying editorial, Neil E. Moat, MB, BS, noted the importance of the decreased rates of acute kidney injury and atrial fibrillation, along with shorter hospital stays reported in the TAVR group. "These are very important findings and reinforce the fact that TAVR is less invasive than conventional surgery." In addition, Moat stated that "the results published in the Journal seem to confirm that TAVR is the treatment of choice in most patients with aortic stenosis who are at high risk for early death and major complications from conventional surgery."
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