What is the clinical evidence from this study?

Study design: Observational. Population: Severe aortic stenosis (n=629). Intervention: Evolut PRO transcatheter aortic valve vs. Pre-specified performance goal. Primary outcome: All-cause mortality at 30 days (95% CI upper limit 4.6, p=0.004).

November 1, 2020Open Access

Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study

Key Result

The Evolut PRO transcatheter aortic valve resulted in a 30-day all-cause mortality rate of 3.2%, which was significantly lower than the pre-specified performance goal of 5.5%.

Study Design

Type

Observational (n=629)

Multicenter

Yes

Structured PICO

Does transcatheter aortic valve implantation with the Evolut PRO valve achieve acceptable 30-day all-cause mortality compared to a pre-specified performance goal in patients requiring TAVI?

Population

629 non-consecutive patients undergoing transcatheter aortic valve implantation, mean age 81.7 years, 61.8% female, multinational (39 centres). Key risk profile: STS score 4.7%, 33.6% frail.

Intervention

Transcatheter aortic valve implantation (TAVI) with the Evolut PRO self-expanding valve (23, 26, or 29 mm) featuring an external pericardial wrap.

Comparator

Pre-specified performance goal (5.5% all-cause mortality at 30 days)

Outcome

Rate of all-cause mortality at 30 dayshard clinical

The Evolut PRO transcatheter aortic valve demonstrated a low 30-day all-cause mortality rate of 3.2% and low rates of paravalvular leak in standard clinical practice.

Main Result

Absolute Event Rate: 3.2% vs 5.5%

p-value: p=0.004

Limitations

Patient selection bias could have been introduced as selection was based on local Heart Team evaluation
Single-arm observational study design without a concurrent control group

Abstract

AIMS: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice. METHODS AND RESULTS: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge. CONCLUSIONS: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011

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