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

European Heart Journal

Volumn 36, Issue 2, 2015, Pages 100-111

  Layland, Jamie ^a,b   Oldroyd, Keith G ^a   Curzen, Nick ^c   Sood, Arvind ^d   Balachandran, Kanarath ^e   Das, Raj ^f   Junejo, Shahid ^g   Ahmed, Nadeem ^a   Lee, Matthew M Y ^a   Shaukat, Aadil ^a   O'Donnell, Anna ^a   Nam, Julian ^h   Briggs, Andrew ^h   Henderson, Robert ⁱ   McConnachie, Alex ^h   Berry, Colin ^a,b  

^a GOLDEN JUBILEE NATIONAL HOSPITAL   (United Kingdom)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^d HAIRMYRES HOSPITAL   (United Kingdom)

^e ROYAL BLACKBURN HOSPITAL   (United Kingdom)

^f FREEMAN HOSPITAL   (United Kingdom)

^g CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST   (United Kingdom)

^h UNIVERSITY OF GLASGOW   (United Kingdom)

ⁱ NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

Acute coronary syndrome; Coronary revascularization; Fractional flowreserve; Medical therapy; Non ST elevation myocardial infarction

Indexed keywords

ACETYLSALICYLIC ACID; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CLOPIDOGREL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ISOSORBIDE MONONITRATE; LOW MOLECULAR WEIGHT HEPARIN; NICORANDIL; NITRATE; PRASUGREL; TICAGRELOR;

ADULT; ANGIOCARDIOGRAPHY; ARTERY DIAMETER; ARTICLE; CARDIAC PATIENT; CONTROLLED STUDY; CORONARY ARTERY BYPASS SURGERY; CORONARY ARTERY OBSTRUCTION; FEMALE; FRACTIONAL FLOW RESERVE; HEART MUSCLE REVASCULARIZATION; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TIME; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY ANGIOGRAPHY; CORONARY STENOSIS; COST; DIAGNOSTIC IMAGING; ECONOMICS; ELECTROCARDIOGRAPHY; HEALTH CARE PLANNING; HOSPITALIZATION; INTERVENTIONAL RADIOLOGY; MIDDLE AGED; MYOCARDIAL INFARCTION; PATHOPHYSIOLOGY; PHYSIOLOGY; PROCEDURES; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME; UTILIZATION;

CORONARY ANGIOGRAPHY; CORONARY STENOSIS; COSTS AND COST ANALYSIS; ELECTROCARDIOGRAPHY; FEMALE; FRACTIONAL FLOW RESERVE, MYOCARDIAL; HEALTH RESOURCES; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; MYOCARDIAL REVASCULARIZATION; PROSPECTIVE STUDIES; QUALITY OF LIFE; RADIOGRAPHY, INTERVENTIONAL; TREATMENT OUTCOME;

EID: 84923105252     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehu338     Document Type: Article

References (36)

1. Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011;32:2999-3054
2. Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE II, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2011;57:e215-e367
3. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J 2010;31:2501-2555
4. White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predicts the physiologic importance of a coronary stenosis?. N Engl J Med 1984;310:819-824
5. Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol 2010;55:2816-2821
6. Selby JV, Fireman BH, Lundstrom RJ, Swain BE, Truman AF, Wong CC, Froelicher ES, Barron HV, Hlatky MA. Variation among hospitals in coronary-angiography practices and outcomes after myocardial infarction in a large health maintenance organization. N Engl J Med 1996;335:1888-1896
7. Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J, Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med 1996;334:1703-1708
8. Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bär F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol 2007;49:2105-2111
9. Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213-224
10. De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserveguided PCI versus medical therapy in stable coronary disease. N Engl J Med 2012; 367:991-1001
11. Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv 2014. (Epub ahead of print) PubMed PMID: 24642999
12. Uren NG, Crake T, Lefroy DC, de Silva R, Davies GJ, Maseri A. Reduced coronary vasodilator function in infarcted and normal myocardium after myocardial infarction. N Engl J Med 1994;331:222-227
13. Ragosta M, Powers ER, Samady H, Gimple LW, Sarembock IJ, Beller GA. Relationship between extent of residual myocardial viability and coronaryflowreserve in patients with recent myocardial infarction. Am Heart J 2001;141:456-462
14. Potvin JM, Rodés-Cabau J, Bertrand OF, Gleeton O, Nguyen CN, Barbeau G, Proulx G, De Larochellière R, Déry JP, Batalla N, Dana A, Facta A, Roy L. Usefulness of fractional flow reserve measurements to defer revascularization in patients with stable or unstable angina pectoris, non-ST-elevation and ST-elevation acute myocardial infarction, or atypical chest pain. Am J Cardiol 2006;98:289-297
15. Leesar MA, Abdul-Baki T, Akkus NI, Sharma A, Kannan T, Bolli R. Use of fractional flowreserve versus stress perfusion scintigraphy after unstable angina. Effect on duration of hospitalization, cost, procedural characteristics, and clinical outcome. J Am Coll Cardiol 2003;41:1115-1121
16. Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv 2010;3:1274-1281
17. Sels JW, Tonino PA, Siebert U, Fearon WF, Van't Veer M, De Bruyne B, Pijls NH. Fractional flow reserve in unstable angina and non-ST-segment elevation myocardial infarction experience from the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) study. JACC Cardiovasc Interv 2011;4:1183-1189
18. Layland J, Carrick D, McEntegart M, Ahmed N, Payne A, McClure J, Sood A, McGeoch R, MacIsaac A, Whitbourn R, Wilson A, Oldroyd K, Berry C. The vasodilatory capacity of the coronary microcirculation is preserved in selected patients with NSTEMI. Circ Cardiovasc Intervention 2013;6:231-236
19. Berry C, Layland J, Sood A, Curzen NP, Balachandran KP, Das R, Junejo S, Henderson RA, Briggs AH, Ford I, Oldroyd KG. Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial. Am Heart J 2013;166:662-668
20. Hicks KA, Hung HMJ, Mahaffrey KW., et al. Standardized definitions for end point events in cardiovascular trials. http://www.cdisc.org/stuff/contentmgr/files/0/2356ae38ac190ab8ca4ae0b222392b37/misc/cdisc-november-16-2010. Pdf
21. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551-2567
22. Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med 2006;354:379-386
23. Stone GW, Bertrand M, Colombo A, Dangas G, Farkouh ME, Feit F, Lansky AJ, Lincoff AM, Mehran R, Moses JW, Ohman M, White HD. Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: study design and rationale. Am Heart J 2004;148:764-775
24. The EQ-5D-3L health questionnaire. http://www.euroqol.org/eq-5d-products/eq-5d-3l.html
25. National Procurement, Procurement, Commissioning and Facilities. NHS Scotland. http://www.nhsscotlandprocurement.scot.nhs.uk/.
26. NHS Reference Costs 2011-2012. Leeds: Department of Health, 2012. https://www.gov.uk/government/publications/nhs-reference-costs-financial-year- 2011-to-2012
27. Information Services Division Scotland. Theatre - direct cost per hour, by specialty [R142X] [Online]. ISD Scotland, 2012. http://www.isdscotland.org/Health- Topics/Finance/Costs/Detailed-Tables/Theatres.asp
28. Guidelines for Good Clinical Practice in Clinical Trials. http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002416
29. DAMOCLES Study Group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711-722
30. Carrick D, Behan M, Foo F, Christie J, Hillis WS, Norrie J, Oldroyd KG, Berry C. Influence of fractional flow reserve measurement on treatment-decisions in patients with non-ST elevation myocardial infarction. Am J Cardiol 2013;111:45-50
31. Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173: 489-495
32. Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation 1993;87:1354-1367
33. Spaan JA, Piek JJ, Hoffman JI, Siebes M. Physiological basis of clinically used coronary hemodynamic indices. Circulation 2006;113:446-455
34. Uren NG, Crake T, Lefroy DC, de Silva R, Davies GJ, Maseri A. Reduced coronary vasodilator function in infarcted and normal myocardium after myocardial infarction. N Engl J Med 1994;331:222-227
35. Libby P. Mechanisms of acute coronary syndromesand their implications for therapy. N Engl J Med 2013;368:2004-2013
36. Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators, Freij A, Thorsén M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361:1045-1057