Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial

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.

Routine Use of Pressure Wire as an Adjunct to Diagnostic Angiography; Comparison of Resources Utilization in the Catheterization Laboratory: A Sub-Study of RIPCORD 2

“…They found that more targeted invasive management can reduce healthcare resource costs without compromising patient outcomes which drove them to conclude that FFR-guided management of NSTEMI may be a cost-effective strategy over standard angiography. Unlike the results of the RIPCORD 2 trial [14], the cost savings they found were due to absolute, but non-significant, reductions in length of stay and health events such as revascularizations, re-hospitalizations, myocardial infarction and stroke events. However, due to the small sample size and the need for longer follow up, there still remains considerable decision uncertainty [16].…”

“…The study proved that, over a one year follow up period, routine systematic FFR use was cost neutral compared with angiographic guidance alone and was not associated with significant differences in quality of life or angina status after 1 year of follow up. These costs were calculated based on the NHS Tariff system and included the costs starting from the index procedure and all subsequent hospital admissions, outpatient visits, and accident and emergency department attendance over the following year [14]. * Group 0 includes n=3 cross-over patients initially randomized to FFR group.…”

“…The design and principal results of RIPCORD 2 have been published [13,14]. In brief, the study included 1100 patients recruited from 17 UK centers who presented with stable angina or stabilized acute coronary syndrome (ACS) in the period between September 2016 and June 2018.…”

“…However, the impact of routine systematic use of pressure wire at the stage of diagnostic angiography on resources utilization in catheterization laboratory (cath lab) has not been widely studied. This issue was examined in the recently published RIPCORD 2 trial [13,14]. This sub-analysis of RIPCORD 2 will focus on comparing resource utilization in cath lab between patients who had invasive angiography only versus invasive angiography with routine performance of FFR.…”

Fractional Flow Reserve-Guided Coronary Revascularization: Evidence from Randomized and Non-Randomized Studies

“…According to European and American recommendations, FFR should be used in patients without documented evidence of myocardial ischemia and/or patients with intermediate coronary lesions [ 5 , 6 ]. After the positive results produced in the one-year data of the “Fractional Flow Reserve Versus Angiography for Multivessel Evaluation” (FAME) study [ 7 ], several randomized clinical trials (RCTs) [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ] and non-randomized [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ] studies investigated the effectiveness of FFR in improving clinical outcomes. Overall, despite data from non-randomized studies strongly supporting the benefit of an FFR-guided revascularization strategy compared to isolated angiography in terms of the clinical endpoint, several RCTs have reported conflicting results.…”