Courtesy of Dr. Carlos Fava.
TAVR has largely been shown superior or non-inferior in high or intermediate risk patients. Indeed, the development of new technologies, the more simplified procedure and the increased experience of operators and team have allowed these groups to benefit from this strategy.
However, there is little evidence available on low risk patients, and it is based on first generation valves, such as the NOTION trial outcomes (though these were promising).
The PARTNER 3 trial was a randomized 1:1 multicentered trial, and which compared TAVR with a third-generation valve (Edwards SAPIEN 3) via transfemoral approach vs. surgery in low-risk patients (STS <4).
Read also: ACC 2019 | TAVR in Low-Risk Patients Is Noninferior.
Primary end point was all cause death, stroke or rehospitalization at one year.
It included 496 patients undergoing TAVR and 454 undergoing surgery.
Characteristics were similar: mean age was 73, they were mostly men, 30% were diabetic, STS was 1.9, EuroSCORE II 1.5, infarction rate was 5.7%, and stroke rate 4%. There were no frail patients, and the group undergoing TAVR had more cardiac failure FC III-IV.
Read also: TAVR in Low-Risk Patients with “Zero” Mortality and “Zero” Stroke.
The procedure was done under conscious sedation in 65.1% of cases in the TAVR group and 24.3% in the minimally invasive surgery group. Concomitant heart revascularization was 6.5% and 12.8% respectively.
At 30 days, the TAVR group presented lower stroke rate (0.6% vs. 24%, p=0.02), lower death or stroke rate (1% vs. 3.3% p=0.01), lower atrial fibrillation (5% vs. 39.5% P<0.001), shorter hospitalization (3 vs. 7 P<0.001) and lower risk of poor evolution (death and worse quality of life KCCQ), with no differences in vascular complication, need of pacemaker implantation or moderate to severe paravalvular leak.
At one-year follow, outcomes favored TAVR (8.5% vs. 15.1%; absolute difference, −6.6 percentage points; 95% confidence interval [CI], −10.8 to −2.5; p<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; p=0.001 for superiority). The presence of mild leaks was higher in TAVR, with no difference in moderate to severe leaks.
Conclusion
In patients with severe aortic stenosis presenting low risk of surgery, the composite of death, stroke or rehospitalization at one year was significantly lower with TAVR, compared against surgery.
Courtesy of Dr. Carlos Fava.
Original title: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.
Reference: M.J. Mack, et al. N Engl J Med DOI: 10.1056/NEJMoa1814052.
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