Khan, S;
Fawaz, S;
Simpson, R;
Robertson, C;
Kelly, P;
Mohdnazri, S;
Tang, K;
Cook, CM;
Gallagher, S;
O'Kane, P;
et al.
Khan, S; Fawaz, S; Simpson, R; Robertson, C; Kelly, P; Mohdnazri, S; Tang, K; Cook, CM; Gallagher, S; O'Kane, P; Spratt, J; Brilakis, ES; Karamasis, GV; Al-Lamee, R; Keeble, TR; Davies, JR
(2023)
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.
Front Cardiovasc Med, 10.
p. 1172763.
ISSN 2297-055X
https://doi.org/10.3389/fcvm.2023.1172763
SGUL Authors: Spratt, James
Abstract
BACKGROUND: Percutaneous 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. AIMS: The 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. METHODS: Patients 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. RESULTS: The 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. CONCLUSION: The 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.
Item Type: |
Article
|
Additional Information: |
© 2023 Khan, Fawaz, Simpson, Robertson, Kelly, Mohdnazri, Tang, Cook, Gallagher, O'Kane, Spratt, Brilakis, Karamasis, Al-Lamee, Keeble and Davies. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
Keywords: |
chronic coronary artery disease, chronic coronary syndrome (CCS), chronic total occlusion (CTO), percutaneous coronary intervention (CTO), stable angina |
SGUL Research Institute / Research Centre: |
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) |
Journal or Publication Title: |
Front Cardiovasc Med |
ISSN: |
2297-055X |
Language: |
eng |
Dates: |
Date | Event |
---|
3 May 2023 | Published | 13 March 2023 | Accepted |
|
Publisher License: |
Creative Commons: Attribution 4.0 |
PubMed ID: |
37206100 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/115519 |
Publisher's version: |
https://doi.org/10.3389/fcvm.2023.1172763 |
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