Routine pressure wire assessment versus conventional angiography in the management of patients with coronary artery disease: The RIPCORD 2 Trial
Routine pressure wire assessment versus conventional angiography in the management of patients with coronary artery disease: The RIPCORD 2 Trial
Background: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. Methods: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. Results: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). Conclusions: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01070771.
coronary angiography, costs and cost analysis, physiology, quality of life, randomized controlled trial
687-698
Stables, R
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Mullen, L
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Elguindy, M
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Nicholas, Z
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Aboul-Enien, Y
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Kemp, I
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O'Kane, P
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Hobson, A
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Johnson, T.
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Khan, S.
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Wheatcroft, S.
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Garg, S.
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Zaman, A.
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Mamas, Mamas A.
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Nolan, J.
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Jadhav, S.
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Berry, C.
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Watkins, S.
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Hildick-Smith, D.
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Gunn, J.
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Conway, D.
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Hoye, A.
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Fazal, I.
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Hanratty, C.
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De Bruyne, B.
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Curzen, Nicholas
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30 August 2022
Stables, R
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Mullen, L
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Elguindy, M
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Nicholas, Z
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Aboul-Enien, Y
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Kemp, I
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O'Kane, P
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Hobson, A
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Johnson, T.
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Khan, S.
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Wheatcroft, S.
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Garg, S.
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Zaman, A.
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Mamas, Mamas A.
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Nolan, J.
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Jadhav, S.
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Berry, C.
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Watkins, S.
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Hildick-Smith, D.
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Gunn, J.
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Conway, D.
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Hoye, A.
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Fazal, I.
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Hanratty, C.
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De Bruyne, B.
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Curzen, Nicholas
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Stables, R, Mullen, L, Elguindy, M, Nicholas, Z, Aboul-Enien, Y, Kemp, I, O'Kane, P, Hobson, A, Johnson, T., Khan, S., Wheatcroft, S., Garg, S., Zaman, A., Mamas, Mamas A., Nolan, J., Jadhav, S., Berry, C., Watkins, S., Hildick-Smith, D., Gunn, J., Conway, D., Hoye, A., Fazal, I., Hanratty, C., De Bruyne, B. and Curzen, Nicholas
(2022)
Routine pressure wire assessment versus conventional angiography in the management of patients with coronary artery disease: The RIPCORD 2 Trial.
Circulation, 146 (9), .
(doi:10.1161/CIRCULATIONAHA.121.057793).
Abstract
Background: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. Methods: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. Results: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). Conclusions: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01070771.
Text
RIPCORD2_Circulation_ChangesTracked_20220531
- Accepted Manuscript
More information
Accepted/In Press date: 14 June 2022
e-pub ahead of print date: 10 August 2022
Published date: 30 August 2022
Additional Information:
Funding Information:
Dr Berry is employed by the University of Glasgow, which holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Causeway Therapeutics, Coroventis, Genentech, GSK, HeartFlow, Menarini, Neovasc, Siemens Healthcare, and Valo Health. Dr Mamas has received unrestricted educational grants from Terumo, Boston Scientific, Abbott, and Medtronic in the past 24 months. Dr De Bruyne has a consulting relationship with Boston Scientific, Abbott Vascular, CathWorks, Siemens, and Coroventis Research; receives research grants from Abbott Vascular, Coroventis Research, Cathworks, and Boston Scientific; and holds minor equities in Philips-Volcano, Siemens, GE Healthcare, Edwards Life Sciences, HeartFlow, Opsens, and Celiad. Dr Curzen has received unrestricted grants from HeartFlow, Boston Scientific, and Beckmann Coulter; speaker fees/consultancy from HeartFlow, Boston Scientific, Abbott, and Edwards; and travel sponsorship from HeartFlow, Biosensors, Edwards, and Medtronic. Dr Stables has received unrestricted grants from Medtronic and BioLife; speaker fees/consultancy from Boston Scientific, Abbott, Medtronic, and Edwards; and travel sponsorship from Boston Scientific. Dr Wheatcroft has received speaker fees/consultancy from AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, and Novo Nordisk and travel sponsorship from Abbott Vascular, Boston Scientific, and Medtronic. The other authors report no conflicts.
Funding Information:
The trial was investigator-initiated and funded by an unrestricted research grant from Boston Scientific Corporation. Dr Berry is supported by the British Heart Foundation ((RE/18/6134217)
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
Keywords:
coronary angiography, costs and cost analysis, physiology, quality of life, randomized controlled trial
Identifiers
Local EPrints ID: 467626
URI: http://eprints.soton.ac.uk/id/eprint/467626
ISSN: 0009-7322
PURE UUID: fbaa4960-2743-4990-82fa-72f60fc53c59
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Date deposited: 15 Jul 2022 19:21
Last modified: 17 Mar 2024 07:23
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Contributors
Author:
R Stables
Author:
L Mullen
Author:
M Elguindy
Author:
Z Nicholas
Author:
Y Aboul-Enien
Author:
I Kemp
Author:
P O'Kane
Author:
A Hobson
Author:
T. Johnson
Author:
S. Khan
Author:
S. Wheatcroft
Author:
S. Garg
Author:
A. Zaman
Author:
Mamas A. Mamas
Author:
J. Nolan
Author:
S. Jadhav
Author:
C. Berry
Author:
S. Watkins
Author:
D. Hildick-Smith
Author:
J. Gunn
Author:
D. Conway
Author:
A. Hoye
Author:
I. Fazal
Author:
C. Hanratty
Author:
B. De Bruyne
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