Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial

Abstract

Introduction: In non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.

Methods and analysis: Ross for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18-60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented.

Ethics and dissemination: REVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre.

Trial registration number: ClinicalTrials.gov Identifier: NCT03798782 PROTOCOL VERSION: January 29, 2019 (Final Version 1.0).

Keywords: adult cardiology; cardiac surgery; valvular heart disease.

Conflict of interest statement

Competing interests: RW reports grants from Bayer, Roche and Boeringer-Ingelheim outside the submitted work. He also reports speaker honorarium from Boeringer-Ingelheim outside the submitted work and consultancy for AtriCure and PhaseBio outside the submitted work. EB-C reports grants from Bayer and Roche outside the submitted work. MC reports speaker honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, Boston Scientific, and Abbott Vascular. JE reports consulting/honoraria support fom Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myer-Squibb, Daiichi-Sankyo, Eli-Lilly, Glaxo-Smith-Kline, Pfizer, Janssen, Sanofi-Aventis and Servier. He reports grants and/or in-kind support from Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myer-Squibb, Glaxo-Smith-Kline, Pfizer, Janssen, Sanofi-Aventis. PJD reports grants from Abbott Diagnostics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Coviden, Octapharma, Philips Healthcare, Roche Diagnostics, Siemens and Stryker. PJD has participated in advisory board meetings for GlaxoSmithKline, Boehringer Ingelheim and Bayer. He also attended an expert panel meeting with AstraZeneca and Boehringer Ingelheim. FR reports a grant from Medtronic, and consultancy fees from Atricure & LivaNova.

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