What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Severe aortic stenosis (n=1460). Intervention: Evolut R vs. Sapien 3. Primary outcome: Overall device success (OR 1.12, 95% CI 0.66-1.89, p=0.68).

September 12, 2019Open Access

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

CHChenglin HeHunan University XLXiao LangFirst People's Hospital of Chongqing JLJun‐Li LiuLiaoning University

Key Result

Evolut R and Sapien 3 valves demonstrated comparable overall device success rates (95.7% vs 94.2%; OR 1.12) and short-term safety profiles for transcatheter aortic valve implantation.

Study Design

Type

Meta-Analysis (n=1,460)

Structured PICO

Does the self-expandable Evolut R valve improve clinical efficacy and safety compared to the balloon-expandable Sapien 3 valve in patients undergoing TAVI?

Population

1,460 patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with either Evolut R or Sapien 3 valves across 5 observational studies.

Intervention

Self-expandable Evolut R valve

Comparator

Balloon-expandable Sapien 3 valve

Outcome

Device successcomposite

The Evolut R and Sapien 3 valves demonstrate comparable device success and short-term clinical outcomes, although Evolut R yields lower post-procedural aortic valve gradients.

Main Result

Odds Ratio: 1.12 (95% CI 0.66–1.89)

Absolute Event Rate: 95.7% vs 94.2%

p-value: p=0.68

Limitations

Meta-analysis of retrospective observational studies with inherent probability of bias
Study-level rather than patient-level meta-analysis
Participants in the two groups were not matched for all baseline characteristics
Only short-term outcomes were compared as long-term data was not available
Not all studies utilized the transfemoral route in all patients

Abstract

The aim of this study was to systematically search literature and conduct a meta‑analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66‑1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83‑3.54; P=0.14; I2=0%). Both mean random; mean difference (MD) = ‑3.96; 95% CI, ‑4.61 to ‑3.31; P<0.00001, I2=0% and peak (random; MD = ‑6.85; 95% CI, ‑8.22 to ‑5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30‑day mortality (OR, 1.32; 95% CI, 0.45‑3.87; P=0.62; I2=0%) or 30‑day stroke outcomes (OR, 0.76; 95% CI, 0.32‑1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short‑term complications. The differences between the 2 devices for post‑operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi‑center randomized controlled trial to provide stronger evidence on this subject.

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