Outcomes 2 Years After TAVR in Patients at Low Surgical Risk
- The overall composite primary endpoint continued to favor TAVR at 2 years, largely due to a continued higher rate of cardiovascular re-hospitalization events after surgery.
- However, death and stroke were more frequent with TAVR between 1 and 2 years, although cumulative rates remained lower with TAVR.
- Echocardiography findings through 2 years indicated stable valve hemodynamics and no differences in valve durability parameters between TAVR and SAVR.
What are the clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial?
The investigators randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score, 1.9%; mean age, 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. A categorical analysis combining survival and changes in health status was evaluated through 2 years. Time-to-event analyses used Kaplan-Meier estimates and log-rank tests and were presented as hazard ratios (HRs) with 95% confidence intervals (CIs).
Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; HR, 0.63; 95% CI, 0.45-0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; three events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.
The authors concluded that at 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis.
This study reports that the overall composite primary endpoint continued to favor TAVR at 2 years, largely due to a continued higher rate of cardiovascular re-hospitalization events after surgery, which usually occurred within 6 months of the procedure. However, death and stroke and valve thrombosis were more frequent with TAVR between 1 and 2 years. Furthermore, echo findings through 2 years indicated stable valve hemodynamics and no differences in valve durability parameters. Additional longer-term follow-up is needed to determine the usefulness and durability of TAVR as an alternative to surgery in patients with aortic stenosis.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Valve Diseases, Hemodynamics, Quality of Life, Secondary Prevention, Stroke, Thrombosis, Transcatheter Aortic Valve Replacement
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