Coronary interventions

A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial

EuroIntervention 2022;17:1490-1497. DOI: 10.4244/EIJ-D-21-00649

Alexandra Nowbar
Alexandra N. Nowbar1,2, MBBS, BSc; Christopher Rajkumar1,2, MBBS, BSc; Michael Foley1,2, MBBS, BSc; Fiyyaz Ahmed-Jushuf1,2, MBBS, MRCP; James P. Howard1,2, MA, MBBChir; Henry Seligman1,2, MBBS, MA; Ricardo Petraco1,2, MBBS, PhD; Sayan Sen2, MBBS, PhD; Sukhjinder S. Nijjer2, BSc, PhD, MBChB; Matthew J. Shun-Shin1,2, PhD, BMBCh; Thomas R. Keeble3,4, MBBS, MD, BSc; Afzal Sohaib5, MBBS, PhD; David Collier6, MBBS, PhD; Patrick McVeigh1, BA, MSc; Frank E. Harrell7, PhD; Darrel P. Francis1,2, MD, MA, MBBChir; Rasha K. Al-Lamee1,2, MBBS, MA, PhD
1. National Heart and Lung Institute, Imperial College London, London, United Kingdom; 2. Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom; 3. Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, Essex, United Kingdom; 4. Medical Technology Research Centre, School of Medicine, Anglia Ruskin University, Chelmsford, Essex, United Kingdom; 5. Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom; 6. William Harvey Research Institute, Queen Mary University of London, London, United Kingdom; 7. Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA

Percutaneous coronary intervention (PCI) is frequently performed for stable angina. However, the first blinded trial, ORBITA, did not show a placebo-controlled increment in exercise time in patients with single-vessel disease, at 6 weeks, on maximal antianginal therapy. ORBITA-2 will assess the placebo-controlled efficacy of PCI on angina frequency in patients with single- or multivessel disease, at 12 weeks, on no antianginal therapy. ORBITA-2 is a double-blind placebo-controlled trial randomising participants with (i) angina at presentation, (ii) documented angina during the 2-week pre-randomisation symptom assessment phase, (iii) objective evidence of ischaemia, (iv) single- or multivessel disease, and (v) clinical eligibility for PCI. At enrolment, antianginals will be stopped, and angina questionnaires completed. Participants will record their symptoms on a smartphone application daily throughout the trial and will undergo exercise treadmill testing and stress echocardiography at pre-randomisation. They will then undergo coronary angiography with unblinded invasive physiology assessment. Eligible participants will then be sedated to a deep level of conscious sedation and randomised 1:1 between PCI and placebo. After the 12-week blinded follow-up period, they will return for questionnaires, exercise testing and stress echocardiography assessment. If angina becomes intolerable, antianginals will be introduced using a prespecified medication protocol. The primary outcome is an angina symptom score using an ordinal clinical outcome scale for angina. Secondary outcomes include exercise treadmill time, angina frequency, angina severity and quality of life. Trial registration: ClinicalTrials.gov: NCT03742050

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