Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial
Rodney H Stables, Liam J Mullen, Mostafa Elguindy, Zoe Nicholas, Yousra H Aboul-Enien, Ian Kemp, Peter O'Kane, Alex Hobson, Thomas W Johnson, Sohail Q Khan, Stephen B Wheatcroft, Scot Garg, Azfar G Zaman, Mamas A Mamas, James Nolan, Sachin Jadhav, Colin Berry, Stuart Watkins, David Hildick-Smith, Julian Gunn, Dwayne Conway, Angels Hoye, Iftikhar A Fazal, Colm G Hanratty, Bernard De Bruyne, Nick Curzen, Rodney H Stables, Liam J Mullen, Mostafa Elguindy, Zoe Nicholas, Yousra H Aboul-Enien, Ian Kemp, Peter O'Kane, Alex Hobson, Thomas W Johnson, Sohail Q Khan, Stephen B Wheatcroft, Scot Garg, Azfar G Zaman, Mamas A Mamas, James Nolan, Sachin Jadhav, Colin Berry, Stuart Watkins, David Hildick-Smith, Julian Gunn, Dwayne Conway, Angels Hoye, Iftikhar A Fazal, Colm G Hanratty, Bernard De Bruyne, Nick Curzen
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.
Keywords: coronary angiography; costs and cost analysis; physiology; quality of life; randomized controlled trial.
Source: PubMed