Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial

Layland, Jamie; Oldroyd, Keith G.; Curzen, Nick; Sood, Arvind; Balachandran, Kanarath; Das, Raj; Junejo, Shahid Ahmed; Ahmed, Nadeem; Lee, Matthew M Y; Shaukat, Aadil; O’Donnell, Anna; Nam, Julian; Briggs, Andrew; Henderson, Robert A.; McConnachie, Alex; Berry, Colin; Hannah, Andrew; Stewart, Andrew; Metcalfe, M. J.; Norrie, John; Chowdhary, Saqib; Clark, Andrew L.; Baird, Gordon C.; Ford, Ian

doi:10.1093/eurheartj/ehu338

Cited by 253 publications

(191 citation statements)

References 29 publications

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“…We based the sample size on an assumed annual rate of primary end-point events of 8.5% in a population that includes a mix of patients with either stable coronary disease or acute coronary syndromes 15 ; given this rate, we calculated that a sample size of 2305 patients would provide the trial with 90% power to detect the noninferiority of iFR to FFR, with the use of a noninferiority margin of 3.4 percentage points for the difference in risk, at a type I error rate of 5%. To allow for attrition, the target sample size was set at 2500 patients.…”

Section: Discussionmentioning

confidence: 99%

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

et al. 2017

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BACKGROUNDCoronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. METHODSWe randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. RESULTSAt 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, −0.2 percentage points; 95% confidence interval [CI], −2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P = 0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P = 0.001). CONCLUSIONSCoronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. ( Use of Instantaneous Wave-free R atio in PCI F or the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1,2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3-5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6,7 Consequently, FFR is now included in the appropriate-use criteria for coronary angiography and in the American College of Cardiology-American Heart Association-European Society of Cardiology guidelines; despite these recommendations, its adoption remains limited. [8][9][10] FFR must be measured during maximal hyperemia, which is typically induced with the administration of a potent intravenous or intracoronary vasodilator, such as adenosine. 11 Several studies have...

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Section: Discussionmentioning

confidence: 99%

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

et al. 2017

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“…Recent studies have suggested however that FFR may be accurate in unstable angina. The FAMOUS NSTEMI CMR (Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcome in Unstable Coronary Syndromes Cardiac Magnetic Resonance) sub‐study showed excellent diagnostic accuracy of FFR <0.80 (92%) for predicting ischemia 24. Furthermore, in the pivotal COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 32% of patients presented an unstable angina 25.…”

Section: Discussionmentioning

confidence: 99%

Specific Pharmacological Profile of A _2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease

Paganelli

Resseguier

Marlinge

et al. 2018

JAHA

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BackgroundThe rapid and reliable exclusion of myocardial revascularization is a major unmet clinical need in patients with suspected coronary artery disease (CAD) and non‐contributive electrocardiography and troponin. Non‐invasive tests have high rates of false positives and negatives, and there is no biomarker to assess myocardial ischemia. The presence of spare adenosine A2A receptors (A2 AR)—characterized by a high dissociation constant/half maximal effective concentration (KD/EC 50) ratio—expressed on peripheral blood mononuclear cells (PBMC) has been associated with ischemia during exercise stress testing in patients with CAD. In this work, we investigated the diagnostic accuracy of spare A2 AR versus fractional flow reserve (FFR) in patients with suspected CAD.Methods and ResultsSixty patients with suspected CAD, but non‐contributive electrocardiography and troponin, were consecutively enrolled in this prospective study. The binding (KD), functional response (cyclic adenosine monophosphate [cAMP] production; EC 50) on PBMC A2 AR were compared with FFR results. Patients were divided into 3 groups: 17 (group 1) with normal coronary angiography (n=13) or stenosis <20% (n=4); 21 with CAD and non‐significant FFR (group 2); and 22 with CAD and significant FFR (group 3). Median KD/EC 50 was 6‐fold higher in group 3 (4.20; interquartile range: 2.81–5.00) than group 2 (0.66; interquartile range: 0.47–1.25) and 7‐fold higher than group 1 (0.60; interquartile range: 0.30–0.66).ConclusionsIn patients with suspected CAD and non‐contributive electrocardiography and troponin, the absence of spare A2 AR on PBMC may help to rule out myocardial ischemia.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03218007.

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“…35 Certainly in STEMI, microvascular responsiveness changes over time, showing significant worsening of FFR in nonculprit vessels when repeated measurements are made 1 day after STEMI and more so at 6 months. 36 The FAMOUS-NSTEMI study 37 was designed, but not powered, to assess the differences in health outcomes when both culprit and nonculprit vessels undergo FFR-guided treatment vs. angiographic-guidance during NSTEMI. The study group was 350 NSTEMI patients with 706 stenoses (≥30% severity) amenable to revascularization who had 704 FFR measurements and were randomized to FFR-guided or angiographic-guided PCI (FFR was not disclosed); 430 (61.1%) stenoses had FFR ≤0.80 and 80% of each arm had at least 1 physiologically significant vessel.…”

Section: Ffr In Acute Coronary Syndromes (Acss)mentioning

confidence: 99%

Advances in Coronary Physiology

Nijjer

Sen

Petraco

et al. 2015

Circ J

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Pressure-wire technology, most typically fractional flow reserve (FFR), has provided interventional cardiologists with a means of determining the physiological importance of a stenosis during angiography. There has been renewed interest in coronary physiology in the light of guideline recognition, ongoing clinical research and new technologies changing the paradigm of how assessment is performed in the catheter laboratory. We reflect on FFR, with regards the potential effects of changing hemodynamics on FFR and the latest evidence with regards to outcomes. We also review the instantaneous wave-free ratio (iFR), a new pressure-only index, measured at rest, that is under active evaluation in several international randomized controlled trials. We review the accumulated evidence and discuss the important physiological concepts between pressure and flow that underlie the approach to using resting indices. Finally we investigate future developments, including physiological mapping with iFR-Pullback and the potential to predict the hemodynamic effect of stenting. (Circ J 2015; 79: 1172 -1184

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Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial

Cited by 253 publications

References 29 publications

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Specific Pharmacological Profile of A _2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease

Advances in Coronary Physiology

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Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial

Cited by 253 publications

References 29 publications

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Specific Pharmacological Profile of A 2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease

Advances in Coronary Physiology

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Specific Pharmacological Profile of A _2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease