Key result
Evolut PRO linked to ~34% lower risk of moderate-to-severe PVL vs. Evolut R.
Why the study?
New transcatheter valve designs are becoming available to address the shortcomings of previous devices and improve clinical outcomes in patients with aortic stenosis.
Does the Evolut PRO valve reduce procedural complications and improve clinical outcomes compared to the Evolut R valve in patients undergoing TAVI for aortic stenosis?
Meta-Analysis (n=12,363)
Does the Evolut PRO valve reduce procedural complications and improve clinical outcomes compared to the Evolut R valve in patients undergoing TAVI for aortic stenosis?
Effect estimate: RR 0.66 (95% CI 0.52-0.86)
p-value: p=0.002
The Evolut PRO valve offers similar short-term clinical outcomes to the Evolut R but significantly reduces the risk of moderate-to-severe paravalvular leak and serious bleeding.
Supports Evolut PRO to reduce paravalvular leak in TAVI; leaves open randomized confirmation of net clinical benefit.
Background: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. Methods: A systematic review and meta-analysis was carried out to compare Medtronic’s Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed. Results: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p < 0.001), sex (p < 0.001) and STS–PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications. Conclusions: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.
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Gozdek et al. (2023) conducted a meta-analysis in Aortic stenosis (AS) (n=12,363). Medtronic's Evolut PRO vs. Evolut R was evaluated on Moderate-to-severe paravalvular leak (PVL) (RR 0.66, 95% CI 0.52-0.86, p=0.002). Medtronic's Evolut PRO was associated with a lower risk of moderate-to-severe paravalvular leak compared to the Evolut R (RR 0.66; 95% CI 0.52-0.86; p=0.002).
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