Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention
Pim A.L. Tonino, M.D., Bernard De Bruyne, M.D., Ph.D., Nico H.J. Pijls, M.D., Ph.D., Uwe Siebert, M.D., M.P.H., Sc.D., Fumiaki Ikeno, M.D., Marcel van `t Veer, M.Sc., Volker Klauss, M.D., Ph.D., Ganesh Manoharan, M.D., Thomas Engstrøm, M.D., Ph.D., Keith G. Oldroyd, M.D., Peter N. Ver Lee, M.D., Philip A. MacCarthy, M.D., Ph.D., William F. Fearon, M.D., for the FAME Study Investigators
Background In patients with multivessel coronary artery diseasewho are undergoing percutaneous coronary intervention (PCI),coronary angiography is the standard method for guiding theplacement of the stent. It is unclear whether routine measurementof fractional flow reserve (FFR; the ratio of maximal bloodflow in a stenotic artery to normal maximal flow), in additionto angiography, improves outcomes.
Methods In 20 medical centers in the United States and Europe,we randomly assigned 1005 patients with multivessel coronaryartery disease to undergo PCI with implantation of drug-elutingstents guided by angiography alone or guided by FFR measurementsin addition to angiography. Before randomization, lesions requiringPCI were identified on the basis of their angiographic appearance.Patients assigned to angiography-guided PCI underwent stentingof all indicated lesions, whereas those assigned to FFR-guidedPCI underwent stenting of indicated lesions only if the FFRwas 0.80 or less. The primary end point was the rate of death,nonfatal myocardial infarction, and repeat revascularizationat 1 year.
Results The mean (±SD) number of indicated lesions perpatient was 2.7±0.9 in the angiography group and 2.8±1.0in the FFR group (P=0.34). The number of stents used per patientwas 2.7±1.2 and 1.9±1.3, respectively (P<0.001).The 1-year event rate was 18.3% (91 patients) in the angiographygroup and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eightpercent of the patients in the angiography group were free fromangina at 1 year, as compared with 81% of patients in the FFRgroup (P=0.20).
Conclusions Routine measurement of FFR in patients with multivesselcoronary artery disease who are undergoing PCI with drug-elutingstents significantly reduces the rate of the composite end pointof death, nonfatal myocardial infarction, and repeat revascularizationat 1 year. (ClinicalTrials.gov number, NCT00267774
[ClinicalTrials.gov]
.)
Source Information
From the Catharina Hospital, Eindhoven, the Netherlands (P.A.L.T., N.H.J.P., M.V.); Cardiovascular Center Aalst, Aalst, Belgium (B.D.B.); University of Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria, and Massachusetts General Hospital, Harvard Medical School, Boston (U.S.); Stanford University Medical Center and Palo Alto Veterans Affairs Health Care Systems, Stanford, CA (F.I., W.F.F.); Medizinische Poliklinik, Campus-Innenstadt, University Hospital, Munich, Germany (V.K.); the Heart Centre, Royal Victoria Hospital, Belfast, United Kingdom (G.M.); Rigshopitalet, Copenhagen (T.E.); Western Infirmary, Glasgow, United Kingdom (K.G.O.); Northeast Cardiology Associates, Bangor, ME (P.N.V.L.); and King's College Hospital, London (P.A.M.).
Address reprint requests to Dr. Pijls at the Department of Cardiology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands, or at nico.pijls{at}inter.nl.net.
Fractional Flow Reserve for Guiding PCI
Brar S. S., Gray W. A., Nagajothi N., Arora R., Khosla S., Garg S., Rademaker T., Serruys P., Pijls N. H.J., Tonino P. A.L., Fearon W. F., the FAME Investigators
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N Engl J Med 2009;
360:2024-2027, May 7, 2009.
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