At two-year followup, primary end point continued to be significantly lower with Sapien 3 vs. conventional surgery, but the initial difference in death and stroke in favor of TAVR started to shrink. In addition, there was higher risk of valve thrombosis in TAVR patients.
The PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients with Aortic Stenosis) included patients with severe aortic stenosis and low surgical risk randomized to transcatheter aortic valve replacement with balloon expandable valve vs. surgical replacement. The study had shown the superiority of TAVR for the combined end point of death, stroke and rehospitalization at one year.
1000 patients were randomized 1:1 to transfemoral TAVR with Sapien 3 vs. surgery. Mean STS was 1.9% and mean age was 73. There was clinical followup and echocardiography at 30 days, one year and 2 years.
At 2 years, the combined end point resulted 11.5% for TAVR vs 17.4% for surgery, a significant difference (HR: 0.63; CI 95%: 0.45 to 0.88; p=0.007). However, looking separately at death (2.4% vs 3.2%; p=0.47) and stroke (2.4% vs 3.6%; p=0.28) these differences were no longer significant over time.
Valve thrombosis resulted higher in the TAVR group, with 2.6% vs only 0.7% of surgical valves (p=0.02).
Echocardiographic findings and deterioration signs were similar between the strategies.
The approaching of curves over time is not surprising when we compare two completely different procedures, considering invasiveness. We expect a higher rate of events at the beginning with surgery and curves to approach of over time.
After 2 years, the combined end point remained significantly lower with TAVR vs. surgery in low-risk patients with severe aortic stenosis, though the initial difference saw a reduction.
Original Title: Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk.
Reference: Martin B. Leon et al. J Am Coll Cardiol. 2021 Mar, 77 (9) 1149–1161. doi: 10.1016/j.jacc.2020.12.052.