The following is a summary of “Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years,” published in the October 2023 issue of Cardiology by Mack et al.
Transcatheter Aortic Valve Replacement (TAVR) reduced 1-year mortality, stroke, and rehospitalization in low-risk aortic stenosis patients. Researchers performed a retrospective study to evaluate long-term outcomes of TAVR in low-risk aortic stenosis patients.
The study involved the random assignment of patients with low surgical risk and severe, symptomatic aortic stenosis to either undergo TAVR or traditional surgery. Two primary objectives guided this research. The first primary endpoint focused on a composite measure that included death, stroke, and rehospitalization related to valve complications, the procedure, or heart failure. The second primary endpoint was a hierarchical composite, considering death, disabling stroke, non-disabling stroke, and the number of rehospitalization days, analyzed using a win ratio approach. Over a 5-year monitoring period, diverse outcomes, including clinical, echocardiographic, and health-status parameters, were evaluated to inform the study’s conclusions.
The study included 1,000 patients, with 503 undergoing TAVR and 497 opting for surgery. In the TAVR group, 111 out of 496 patients experienced a component of the first primary endpoint. In contrast, in the surgery group, 117 out of 454 patients in the surgery group (Kaplan–Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, −4.3 percentage points; 95% CI, −9.9 to 1.3; P=0.07). The win ratio for the second primary endpoint was 1.17 (95% CI, 0.90 to 1.51; P=0.25). For the components of the first primary endpoint, the study revealed death rates of 10.0% for TAVR and 8.2% for surgery, stroke rates of 5.8% and 6.4%, and rehospitalization rates of 13.7% and 17.4%, respectively. The hemodynamic performance of the valve, as assessed by mean (±SD) valve gradient, was 12.8±6.5 mm Hg for TAVR and 11.7±5.6 mm Hg for surgery. Bioprosthetic-valve failure occurred in 3.3% of TAVR patients and 3.8% of surgery patients.
The study found TAVR and surgery have similar long-term outcomes in low-risk aortic stenosis patients.
Source: nejm.org/doi/full/10.1056/NEJMoa2307447?query=featured_cardiology