Separate Study Shows SAPIEN 3 Improves Outcomes For Major Endpoints at One Year Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) resulted in similar rates of death from disabling stroke or any cause in high-risk patients with aortic stenosis, according to results from the PARTNER 2A trial presented during ACC.16 in Chicago, and simultaneously published in the New England Journal of Medicine (NEJM). The trial, led by Martin B. Leon, MD, FACC, et al., looked at data from 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). Results showed that 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 primary endpoint of 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. Data also 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. According to a separate PARTNER 2 study also presented during ACC.16, intermediate-risk patients who received TAVR with SAPIEN 3 faired better than patients receiving traditional SAVR after one year. The trial involved more than 1,000 patients at 51 U.S. hospitals. TAVR patients were compared by a propensity score analysis to PARTNER 2A patients randomized to receive surgical intervention. In the study’s primary endpoint – a composite of death, stroke and moderate or severe aortic insufficiency – TAVR was found to be superior to surgery at one year, occurring 9. 2 percent less in the TAVR patients compared with surgery patients. TAVR was also superior to surgery for two out of three secondary outcomes, mortality and stroke. In unadjusted one-year outcomes, all-cause mortality was lower with TAVR, occurring in only 7.4 percent of TAVR patients as compared to 13 percent of patients receiving surgery. The rates of strokes overall and disabling strokes were both lower in TAVR patients, at 4.6 and 2.3 percent, respectively, as compared to 8.2 and 5.9 percent in surgery patients. “This study shows the lowest mortality rate ever of any transcatheter valve platform after one year, which is very exciting for the management of aortic stenosis,” said lead study author Vinod H. Thourani, MD, FACC, co-chair of ACC's Surgeons’ Section. “A previous analysis by our team showed that almost 20 percent of all patients undergoing surgical aortic valve replacement in the U.S. are in the intermediate-risk category, so I believe that this could have a major impact on the treatment options we have available for many of these patients.” Learn more about the Surgeons' Section at ACC.org/ Surgeons. Visit the Cardiac Surgery Clinical Topic Collection on ACC.org for the latest clinical news, patient case quizzes and more.
Published by American College of Cardiology. View All Articles.