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Open Access Study protocol

The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial

Muhammed Zeeshan Khawaja12*, Duolao Wang3, Stuart Pocock4, Simon Robert Redwood12 and Martyn Rhys Thomas2

Author Affiliations

1 The Rayne Institute, Cardiovascular Division, King’s College London, BHF Centre of Excellence, St Thomas’ Hospital, Westminster Bridge Road, London SE1 7EH, UK

2 Department of Cardiology, Guy’s & St Thomas’ NHS Foundation Trust, Westminster Bridge Road, London SE1 7EH, UK

3 Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Pl, Liverpool, Merseyside L3 5QA, UK

4 Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK

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Trials 2014, 15:300  doi:10.1186/1745-6215-15-300

Published: 24 July 2014

Abstract

Background

Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation (TAVI).

Methods/Design

The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial is a randomized, controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention (PCI - test arm) or no PCI (control arm). Significant coronary disease is defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion. The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI, with a composite primary outcome of 12-month mortality and rehospitalization. Secondary outcomes include efficacy end-points such as 30-day mortality, safety endpoints including bleeding, burden of symptoms, and quality of life (assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire).

In conclusion, we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50% severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique.

Trial registration

ISRCTN75836930, http://www.controlled-trials.com/ISRCTN75836930 (registered 19 November 2011).

Keywords:
Transcatheter aortic valve implantation; Percutaneous coronary intervention; Aortic stenosis; Coronary