Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial
| Autor: | Emilie P. Belley-Côté, Michael W.A. Chu, Filip Rega, Alexander Bogachev-Prokophiev, Katheryn Brady, Peter Verbrugghe, Graham R. McClure, John W. Eikelboom, Serban Stoica, P. J. Devereaux, Richard P. Whitlock, Ravil Sharifulin, Shrikant I. Bangdiwala, Hanna Hronyecz |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty medicine.medical_treatment Pilot Projects law.invention Medicine General & Internal LONG-TERM OUTCOMES Aortic valve replacement Valve replacement Randomized controlled trial law General & Internal Medicine adult cardiology medicine Humans METAANALYSIS Bioprosthesis Heart Valve Prosthesis Implantation AORTIC-VALVE Science & Technology business.industry Ross procedure valvular heart disease General Medicine Perioperative Middle Aged medicine.disease Cardiac surgery Log-rank test Treatment Outcome Aortic Valve Heart Valve Prosthesis Physical therapy Medicine OPERATION Surgery business Life Sciences & Biomedicine cardiac surgery |
| Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 9 (2021) |
| ISSN: | 2044-6055 |
| Popis: | IntroductionIn 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 analysisRoss 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 disseminationREVIVAL 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 numberClinicalTrials.gov Identifier: NCT03798782Protocol versionJanuary 29, 2019 (Final Version 1.0) |
| Databáze: | OpenAIRE |
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