TY - JOUR
T1 - The challenges of a randomised placebo-controlled trial of CTO PCI vs. placebo with optimal medical therapy
T2 - The ORBITA-CTO pilot study design and protocol
AU - Khan, Sarosh
AU - Fawaz, Samer
AU - Simpson, Rupert
AU - Robertson, Craig
AU - Kelly, Paul
AU - Mohdnazri, Shah
AU - Tang, Kare
AU - Cook, Christopher M.
AU - Gallagher, Sean
AU - O’Kane, Peter
AU - Spratt, James
AU - Brilakis, Emmanouil S.
AU - Karamasis, Grigoris V.
AU - Al-Lamee, Rasha
AU - Keeble, Thomas R.
AU - Davies, John R.
N1 - Publisher Copyright:
2023 Khan, Fawaz, Simpson, Robertson, Kelly, Mohdnazri, Tang, Cook, Gallagher, O'Kane, Spratt, Brilakis, Karamasis, Al-Lamee, Keeble and Davies.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - chronic coronary artery disease
KW - chronic coronary syndrome (CCS)
KW - chronic total occlusion (CTO)
KW - percutaneous coronary intervention (CTO)
KW - stable angina
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U2 - 10.3389/fcvm.2023.1172763
DO - 10.3389/fcvm.2023.1172763
M3 - Article
C2 - 37206100
AN - SCOPUS:85159894061
SN - 2297-055X
VL - 10
JO - Frontiers in Cardiovascular Medicine
JF - Frontiers in Cardiovascular Medicine
M1 - 1172763
ER -