TAVR significantly reduced the risk of all-cause death at 1 year compared to SAVR in low-risk patients with severe aortic stenosis (2.1% vs. 3.5%; RR 0.61; 95% CI 0.39-0.96; p=0.03).
Meta-Analysis (n=2,887)
Does transcatheter aortic valve replacement reduce all-cause death at 1 year compared to surgical aortic valve replacement in low-risk patients with severe aortic stenosis?
In low-risk patients with severe aortic stenosis, TAVR significantly reduces all-cause and cardiovascular death at 1 year compared to SAVR.
Relative Risk: 0.61 (95% CI 0.39–0.96)
Absolute Event Rate: 2.1% vs 3.5%
p-value: p=0.03
BACKGROUND Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice. OBJECTIVES This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients. METHODS Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality STS-PROM score <4%) were included. Primary outcome was all-cause death at 1 year. Random-effects models were used to calculate pooled risk ratio (RR) and corresponding 95% confidence interval (CI). RESULTS The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I2 = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II. CONCLUSIONS In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR.
“This is a historic moment, and all of us here should recognize it as such. We're going to remember it. We're going to tell our grandchildren and great grandchildren that we were there at the time these incredible advances in the care of patients with aortic stenosis were presented.”
Kolte et al. (Sun,) conducted a meta-analysis in severe aortic stenosis (n=2,887). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on all-cause death at 1 year (RR 0.61, 95% CI 0.39 to 0.96, p=0.03). TAVR significantly reduced the risk of all-cause death at 1 year compared to SAVR in low-risk patients with severe aortic stenosis (2.1% vs. 3.5%; RR 0.61; 95% CI 0.39-0.96; p=0.03).
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