Key result
TAVR using CoreValve Evolut R resulted in a comparable 30-day combined safety endpoint compared to ACURATE neo (84.2% vs 85.5%; p=0.848).
Why the study?
Self-expandable prostheses are frequently used in highly calcified aortic annuli, prompting a comparative analysis of clinical and 30-day outcomes after TAVR using the CoreValve Evolut R versus ACURATE neo prosthesis.
Does TAVR with CoreValve Evolut R compared to ACURATE neo improve 30-day clinical and safety outcomes in patients with severe aortic stenosis?
Cohort (n=152)
Does TAVR with CoreValve Evolut R compared to ACURATE neo improve 30-day clinical and safety outcomes in patients with severe aortic stenosis?
Absolute Event Rate: 84.2% vs 85.5%
p-value: p=0.848
Both CoreValve Evolut R and ACURATE neo self-expanding prostheses demonstrate comparable and excellent 30-day safety and clinical outcomes for TAVR.
Comparable safety supports device flexibility in TAVR; leaves open randomized trials to guide selection in severe aortic stenosis.
Background: Transcatheter aortic valve replacement (TAVR) is associated with excellent results in patients with severe aortic stenosis. In highly calcified aortic anuli with increased risk of annulus rupture and in favor of the supra-annular design, self-expandable prostheses are frequently used. In this regard, we aimed to perform a comparative analysis of clinical and 30-day outcomes after TAVR using the self-expanding CoreValve ® Evolut R or ACURATE neo™ prosthesis. Methods: Out of 343 consecutive patients treated with either CoreValve ® Evolut R or ACURATE neo™ from January 2014 to December 2017, 76 patients were assigned each per group after 1:1 propensity score matching in regard of preoperative characteristics. Pre- and periprocedural outcomes were retrospectively collected and assessed. Outcomes at 30 days are reported according to the established Valve Academic Research Consortium (VARC-2) criteria. Results: Device success and 30-day survival accounted for 93.4% ( n = 71), respectively 97.4% ( n = 74) in both groups (p = 1.00). No statistically significant differences regarding clinical parameters were observed. The combined safety endpoint at 30 days was comparable (84.2% ( n = 64) CoreValve ® vs 85.5% ( n = 65) ACURATE neo™; p = 0.848). Except a trend toward higher stroke (p = 0.08) and pacemaker (p = 0.07) rate in the CoreValve ® group, major vascular complications, incidence of life-threatening or disabling bleeding, and incidence of postoperative acute kidney injury were comparable. Postoperative hemodynamic parameters showed no significant differences between the implanted valves. Conclusion: Both self-expandable prostheses showed good postoperative hemodynamic performance with a low incidence of severe paravalvular leakage, all- cause mortality, and comparable clinical outcomes.
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Ivanov et al. (2021) conducted a cohort in severe aortic stenosis (n=152). CoreValve Evolut R vs. ACURATE neo was evaluated on Combined safety endpoint at 30 days (p=0.848). TAVR using CoreValve Evolut R resulted in a comparable 30-day combined safety endpoint compared to ACURATE neo (84.2% vs 85.5%; p=0.848).
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