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Randomized Controlled Trial
. 2025 May 13;85(18):1740-1753.
doi: 10.1016/j.jacc.2025.02.034.

Ischemia on Dobutamine Stress Echocardiography Predicts Efficacy of PCI: Results From the ORBITA-2 Trial

Fiyyaz Ahmed-Jushuf  1 , Michael J Foley  1 , Christopher A Rajkumar  1 , Shayna Chotai  1 , Florentina A Simader  2 , Danqi Wang  2 , Krzysztof Macierzanka  2 , Joban Sehmi  3 , Gajen Kanaganayagam  4 , Guy Lloyd  5 , Niall Keenan  6 , Nina Bual  2 , John R Davies  7 , Thomas R Keeble  7 , Peter D O'Kane  8 , Peter Haworth  9 , Helen Routledge  10 , Tushar Kotecha  11 , Rupert Williams  12 , Jehangir Din  8 , Sukhjinder S Nijjer  1 , Nick Curzen  13 , Manas Sinha  14 , Neil Ruparelia  15 , Reto Gamma  16 , James C Spratt  12 , Graham D Cole  1 , Frank E Harrell Jr  17 , James P Howard  1 , Darrel P Francis  1 , Matthew J Shun-Shin  18 , Rasha K Al-Lamee  1 ; ORBITA-2 Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Ischemia on Dobutamine Stress Echocardiography Predicts Efficacy of PCI: Results From the ORBITA-2 Trial

Fiyyaz Ahmed-Jushuf et al. J Am Coll Cardiol. .

Abstract

Background: ORBITA-2 (The Placebo-Controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina) found that percutaneous coronary intervention (PCI) relieved angina in patients with single-vessel and multivessel stable coronary artery disease (CAD) on little or no antianginal medication. Whereas symptom characteristics and invasive physiological assessments can predict PCI efficacy, the role of noninvasive imaging with dobutamine stress echocardiography (DSE) remains unclear.

Objectives: This DSE-stratified secondary analysis of ORBITA-2 investigates the relationship between ischemia, assessed by DSE, and the placebo-controlled efficacy of PCI.

Methods: Participants with angina, single-vessel or multivessel CAD, and ischemia were enrolled. Following discontinuation of antianginal medications, patients were evaluated prerandomization using the ORBITA-app, questionnaires, DSE, and exercise treadmill testing. Stress echocardiography scores were calculated for each left ventricular segment at peak stress, with normal, hypokinetic, akinetic, dyskinetic, and aneurysmal segments scoring 0 to 4, respectively. Bayesian proportional odds modeling was used.

Results: Prerandomization DSE data were available for 262 patients. The median age was 65.5 years (Q1-Q3: 59-71 years), and 208 (79.4%) were male. At baseline, the median stress echocardiography score was 1.42 in the PCI group (n = 133) and 1.00 in the placebo group (n = 129), with an overall median score of 1.25 (Q1-Q3: 0.33-2.92). Higher stress echocardiography scores were strongly associated with greater placebo-controlled improvements in angina symptom score following PCI (OR: 1.23; 95% credible interval [CrI]: 1.13-1.35; Pr(interaction) > 99.9%). Higher scores also predicted significant reduction in daily angina episodes (OR: 1.36; 95% CrI: 1.24-1.49; Pr(interaction) > 99.9%), as well as improvement in the Seattle Angina Questionnaire angina frequency score (8.22; 95% CrI: 0.96-15.50; Pr(interaction) = 98.7%), and Seattle Angina Questionnaire quality of life score (8.95; 95% CrI: 2.05-16.00; Pr(interaction) = 99.3%). The relationship between stress echocardiography score and reduction in daily angina episodes remained consistent, irrespective of symptom characteristics.

Conclusions: In patients with single- and multivessel stable CAD on little or no antianginal medication, the placebo-controlled efficacy of PCI was predicted by the degree of ischemia detected on DSE. The greater the burden of baseline ischemia, the greater the improvement in symptoms and quality of life with PCI.

Keywords: angina; coronary artery disease; ischemia; percutaneous coronary intervention; placebo-controlled trial; stress echocardiography.

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Conflict of interest statement

Funding Support and Author Disclosures ORBITA-2 was an investigator-initiated trial sponsored by Imperial College London. The trial was funded by grants from National Institute for Health and Care Research Imperial Biomedical Research Centre, Medical Research Council, British Heart Foundation, National Institute for Health and Care Research, and the Imperial Coronary Flow Trust. Philips Volcano supplied the coronary pressure wires. Dr Ahmed-Jushuf has received speaker fees from Philips Volcano. Dr Foley has received speaker fees from Menarini; and has received consulting and speaker fees from Shockwave Medical, Inc and Philips. Dr Rajkumar has received speaker fees from Menarini and Novartis; has received consulting fees from Philips; and has received shares from Mycardium AI. Dr Chotai has received sponsorship from Servier Pharmaceuticals. Dr Simader has received a sponsorship from Servier Pharmaceuticals. Dr Keenan has received shares from Mycardium AI. Dr Davies has received grants from Medtronic and Abbott; has received sponsorship from Vascular Perspectives, Boston Scientific, Medtronic and Abbott; and has received speaker fees from AstraZeneca, Pfizer, Bristol Myers Squibb, and Novartis. Dr Keeble has served on advisory boards for Abbott Vascular and SMT; and has received institutional research funding from Terumo, Medtronic, Boston Scientific, Abbott Vascular, Philips Volcano, and Cardionovum. Dr O’Kane has received speaker fees from Abbott Vascular, Biosensors, Boston Scientific, HeartFlow, Medtronic, Philips, Shockwave, and Terumo. Dr Kotecha has received honoraria from Bayer and Janssen. Dr Din has received speaker fees from Philips and Vascular Perspective. Dr Nijjer has received speaker fees from Philips Volcano, Pfizer, Bayer, AstraZeneca, Boehringer Ingelheim, and Amarin. Dr Curzen has received grants from Beckman Coulter, Inc, Boston Scientific Corporation, Haemonetics Corporation, and HeartFlow Inc; and has received speaker fees from HeartFlow. Dr Spratt has received speaker fees from Boston Scientific Corporation and Shockwave Medical, Inc. Dr Howard has received shares in Mycardium AI; and has received a grant from the British Heart Foundation. Dr Cole has received shares in Mycardium AI. Dr Shun-Shin has received shares in Mycardium AI. Dr Al-Lamee has served on advisory boards for Janssen Pharmaceuticals, Abbott, and Philips; and has received speaker fees from Abbott, Philips, Medtronic, Servier, Omniprex, and Menarini. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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