The challenges of a randomised placebo-controlled trial of CTO PCI vs. placebo with optimal medical therapy: The ORBITA-CTO pilot study design and protocol

Frontiers in Cardiovascular Medicine

Cardiovascular Medicine

Kare Tang¹  Paul Kelly¹  Shah Mohdnazri¹  John R. Davies²  Christopher M. Cook²  Samer Fawaz²  Craig Robertson²  Rupert Simpson²  Thomas R. Keeble²  Sarosh Khan²  Peter O’Kane³  James Spratt⁴  Sean Gallagher⁵  Emmanouil S. Brilakis⁶  Rasha Al-Lamee⁷  Grigoris V. Karamasis⁸ 

[1] Department of Interventional Cardiology, Essex Cardiothoracic Centre, Basildon, United Kingdom;Department of Interventional Cardiology, Essex Cardiothoracic Centre, Basildon, United Kingdom;Department of Interventional Cardiology, Anglia Ruskin University, Chelmsford, United Kingdom;Department of Interventional Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom;Department of Interventional Cardiology, St. George's Hospital, London, United Kingdom;Department of Interventional Cardiology, University Hospital of Wales, Cardiff, United Kingdom;Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, United States;National Heart and Lung Institute, Imperial College London, London, United Kingdom;School of Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece;

关键词: chronic total occlusion (CTO);    percutaneous coronary intervention (CTO);    chronic coronary artery disease;    chronic coronary syndrome (CCS);    stable angina;   

DOI  :  10.3389/fcvm.2023.1172763

 received in 2023-02-23, accepted in 2023-03-13,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundPercutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) has been performed for the improvement of symptoms and quality of life in patients with stable angina. The ORBITA study demonstrated the role of the placebo effect in contemporary PCI in non-CTO chronic coronary syndromes. However, the benefit of CTO PCI beyond that of a placebo has not been demonstrated.AimsThe ORBITA-CTO pilot study will be a double-blind, placebo-controlled study of CTO PCI randomising patients who have: (1) been accepted by a CTO operator for PCI; (2) experienced symptoms due to a CTO; (3) evidence of ischaemia; (4) evidence of viability within the CTO territory; and (5) a J-CTO score ≤3.MethodsPatients will undergo medication optimisation that will ensure they are on at least a minimum amount of anti-anginals and complete questionnaires. Patients will record their symptoms on an app daily throughout the study. Patients will undergo randomisation procedures, including an overnight stay, and be discharged the following day. All anti-anginals will be stopped after randomisation and re-initiated on a patient-led basis during the 6-month follow-up period. At follow-up, patients will undergo repeat questionnaires and unblinding, with a further 2-week unblinded follow-up.ResultsThe co-primary outcomes are feasibility (blinding) in this cohort and angina symptom score using an ordinal clinical outcome scale for angina. Secondary outcomes include changes in quality-of-life measures, Seattle Angina Questionnaire (SAQ), peak VO2, and anaerobic threshold on the cardiopulmonary exercise test.ConclusionThe feasibility of a placebo-controlled CTO PCI study will lead to future studies assessing efficacy. The impact of CTO PCI on angina measured using a novel daily symptom app may provide improved fidelity in assessing symptoms in patients with CTO's.

【 授权许可】

Unknown   
© 2023 Khan, Fawaz, Simpson, Robertson, Kelly, Mohdnazri, Tang, Cook, Gallagher, O'Kane, Spratt, Brilakis, Karamasis, Al-Lamee, Keeble and Davies.