N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention.

BACKGROUND

In stable coronary artery disease, 30% to 60% of patients remain symptomatic despite successful revascularization. Perhaps not all symptoms reported by a patient with myocardial ischemia are, in fact, angina.

OBJECTIVES

This study sought to determine whether independent symptom verification using a placebo-controlled ischemic stimulus could distinguish which patients achieve greatest symptom relief from percutaneous coronary intervention (PCI).

METHODS

ORBITA-STAR was a multicenter, n-of-1, placebo-controlled study in patients undergoing single-vessel PCI for stable symptoms. Participants underwent 4 episodes (60 seconds each) of low-pressure balloon occlusion across their coronary stenosis, randomly paired with 4 episodes of placebo inflation. Following each episode, patients reported the similarity of the induced symptom in comparison with their usual symptom. The similarity score ranged from -10 (placebo replicated the symptom more than balloon occlusion) to +10 (balloon occlusion exactly replicated the symptom). The primary endpoint was the ability of the similarity score to predict symptom relief with PCI.

RESULTS

Fifty-one patients were recruited, aged 62.9 ± 8.6 years. The median fractional flow reserve was 0.68 (Q1-Q3: 0.57-0.79), and the instantaneous wave-free ratio was 0.80 (Q1-Q3: 0.48-0.89). The median similarity score was 3 (Q1-Q3: 0.875-5.25). The similarity score was a strong predictor of symptom improvement following PCI: a patient with an upper quartile similarity score of 5.25 was significantly more likely to have lower angina frequency at follow-up (OR: 8.01; 95% credible interval: 2.39-15.86) than a patient with a lower quartile similarity score of 0.875 (OR: 1.31; 95% credible interval: 0.71-1.99), Pr

CONCLUSIONS

Similarity score powerfully predicted symptom improvement from PCI. These data lay the foundation for independent symptom mapping to target PCI to those patients most likely to benefit. (Systematic Trial of Angina Assessment Before Revascularization [ORBITA-STAR]; NCT04280575).

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This work has received support from the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Imperial College British Heart Foundation Centre of Research Excellence. Dr Rajkumar has received a Clinical Research Training Fellowship from the Medical Research Council; has received speaker fees from Menarini; and has received consulting fees from Philips. Dr Foley has received a Clinical Research Training Fellowship from the Medical Research Council; and has received speaker fees from Menarini and Philips. Dr Ahmed-Jushuf has received a Clinical Research Training Fellowship from the Medical Research Council. Dr Simader has received sponsorship from Servier. Dr Sen has received speaker and consulting fees from Philips, Medtronic, Recor, and AstraZeneca. Dr Petraco has received consulting fees from Philips and Abbott. Dr Nijjer has received speaker fees from Philips Volcano, Pfizer, Bayer, AstraZeneca, Boehringer Ingelheim, and Amarin. Dr Dungu has received grants from Medtronic and Abbott; has received sponsorship from Vascular Perspectives, Boston Scientific, Medtronic, and Abbott; and has received speaker honoraria from AstraZeneca, Pfizer, Bristol Myers Squibb, and Novartis. Dr Kotecha has received honoraria from Bayer and Janssen. Dr Cole holds shares in Mycardium AI. Dr Howard holds shares in Mycardium AI. Dr Keeble has served on the advisory boards of 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 Al-Lamee has received an Intermediate Research Fellowship from the British Heart Foundation [FS/ICRF/22/26051]; has served on the advisory boards of Janssen Pharmaceuticals, Abbott, and Philips; and has received speaker honoraria 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.