Invasive Endotyping in Patients With Angina and No Obstructive Coronary Artery Disease: A Randomized Controlled Trial.

Autor:	Sidik NP; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom., Stanley B; Robertson Centre for Biostatistics, School of Health and Wellbeing (B.S., R.Y., A. McConnachie), University of Glasgow, Glasgow, United Kingdom., Sykes R; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom., Morrow AJ; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom., Bradley CP; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom., McDermott M; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom., Ford TJ; Department of Cardiology, Gosford Hospital, Central Coast, Australia (T.J.F.).; Faculty of Medicine, The University of Newcastle, Australia (T.J.F.)., Roditi G; Department of Radiology, NHS Greater Glasgow and Clyde Health Board, Glasgow, United Kingdom (G.R., D.S.)., Hargreaves A; Department of Cardiology, Forth Valley Royal Hospital, Larbert, United Kingdom (A.H.)., Stobo D; Department of Radiology, NHS Greater Glasgow and Clyde Health Board, Glasgow, United Kingdom (G.R., D.S.)., Adams J; Department of Cardiology, Queen Elizabeth University Hospital, Glasgow, United Kingdom (J.A., J.B., D. Corcoran, N.N.L.)., Byrne J; Department of Cardiology, Queen Elizabeth University Hospital, Glasgow, United Kingdom (J.A., J.B., D. Corcoran, N.N.L.)., Mahrous A; Raigmore Hospital, Inverness, United Kingdom (A. Mahrous)., Young R; Robertson Centre for Biostatistics, School of Health and Wellbeing (B.S., R.Y., A. McConnachie), University of Glasgow, Glasgow, United Kingdom., Carrick D; Department of Cardiology, University Hospital Hairmyres, East Kilbride, United Kingdom (D. Carrick, R.M.)., McGeoch R; Department of Cardiology, University Hospital Hairmyres, East Kilbride, United Kingdom (D. Carrick, R.M.)., Corcoran D; Department of Cardiology, Queen Elizabeth University Hospital, Glasgow, United Kingdom (J.A., J.B., D. Corcoran, N.N.L.)., Lang NN; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom.; Department of Cardiology, Queen Elizabeth University Hospital, Glasgow, United Kingdom (J.A., J.B., D. Corcoran, N.N.L.)., Heggie R; Health Economics and Health Technology Assessment, School of Health and Wellbeing (R.H., O.W.), University of Glasgow, Glasgow, United Kingdom., Wu O; Health Economics and Health Technology Assessment, School of Health and Wellbeing (R.H., O.W.), University of Glasgow, Glasgow, United Kingdom., McEntegart MB; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom.; Department of Cardiology, Columbia University Medical Center, New York (M.B.M.)., McConnachie A; Robertson Centre for Biostatistics, School of Health and Wellbeing (B.S., R.Y., A. McConnachie), University of Glasgow, Glasgow, United Kingdom., Berry C; West of Scotland Heart and Lung Centre, NHS Golden Jubilee, Glasgow, United Kingdom (N.P.S., R.S., A.J.M., C.P.B., M.M., M.B.M., C.B.).; British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health (N.P.S., R.S., A.J.M., C.P.B., M.M., N.N.L., M.B.M., C.B.), University of Glasgow, Glasgow, United Kingdom.
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2024 Jan 02; Vol. 149 (1), pp. 7-23. Date of Electronic Publication: 2023 Oct 05.
DOI:	10.1161/CIRCULATIONAHA.123.064751
Abstrakt:	Background: We investigated the usefulness of invasive coronary function testing to diagnose the cause of angina in patients with no obstructive coronary arteries. Methods: Outpatients referred for coronary computed tomography angiography in 3 hospitals in the United Kingdom were prospectively screened. After coronary computed tomography angiography, patients with unobstructed coronary arteries, and who consented, underwent invasive endotyping. The diagnostic assessments included coronary angiography, fractional flow reserve (patient excluded if ≤0.80), and, for those without obstructive coronary artery disease, coronary flow reserve (abnormal <2.0), index of microvascular resistance (abnormal ≥25), and intracoronary infusion of acetylcholine (0.182, 1.82, and 18.2 μg/mL; 2 mL/min for 2 minutes) to assess for microvascular and coronary spasm. Participants were randomly assigned to disclosure of the results of the coronary function tests to the invasive cardiologist (intervention group) or nondisclosure (control group, blinded). In the control group, a diagnosis of vasomotor angina was based on medical history, noninvasive tests, and coronary angiography. The primary outcome was the between-group difference in the reclassification rate of the initial diagnosis on the basis of coronary computed tomography angiography versus the final diagnosis after invasive endotyping. The Seattle Angina Questionnaire summary score and Treatment Satisfaction Questionnaire for Medication were secondary outcomes. Results: Of 322 eligible patients, 250 (77.6%) underwent invasive endotyping; 19 (7.6%) had obstructive coronary disease, 127 (55.0%) had microvascular angina, 27 (11.7%) had vasospastic angina, 17 (7.4%) had both, and 60 (26.0%) had no abnormality. A total of 231 patients (mean age, 55.7 years; 64.5% women) were randomly assigned and followed up (median duration, 19.9 [12.6-26.9] months). The clinician diagnosed vasomotor angina in 51 (44.3%) patients in the intervention group and in 55 (47.4%) patients in the control group. After randomization, patients in the intervention group were 4-fold (odds ratio, 4.05 [95% CI, 2.32-7.24]; P <0.001) more likely to be diagnosed with a coronary vasomotor disorder; the frequency of this diagnosis increased to 76.5%. The frequency of normal coronary function (ie, no vasomotor disorder) was not different between the groups before randomization (51.3% versus 50.9%) but was reduced in the intervention group after randomization (23.5% versus 50.9%, P <0.001). At 6 and 12 months, the Seattle Angina Questionnaire summary score in the intervention versus control groups was 59.2±24.2 (2.3±16.2 change from baseline) versus 60.4±23.9 (4.6±16.4 change) and 63.7±23.5 (4.7±14.7 change) versus 66.0±19.3 (7.9±17.1 change), respectively, and not different between groups (global P =0.36). Compared with the control group, global treatment satisfaction was higher in the intervention group at 12 months (69.9±22.8 versus 61.7±26.9, P =0.013). Conclusions: For patients with angina and no obstructive coronary arteries, a diagnosis informed by invasive functional assessment had no effect on long-term angina burden, whereas treatment satisfaction improved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03477890. Competing Interests: Disclosures Dr Berry is employed by the University of Glasgow, which holds consultancy and research agreements with companies that have interests in the management of angina. The companies include Abbott Vascular, AstraZeneca, Auxilius Pharma, Boehringer Ingelheim, Coroventis, HeartFlow, Novartis, Siemens Healthcare, Therox, and Valo Health. Dr McEntegart provides consultancy for Biosensors, Boston Scientific, Shockwave Medical and Teleflex, and has received honoraria from Biosensors, Boston Scientific and Medtronic. Dr Ford provides consultancy for Abbott Vascular. None of the other authors have any potential conflicts of interest.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu