Fractional Flow Reserve to Determine the Appropriateness of Angioplasty in Moderate Coronary Stenosis: A Randomized Trial

Background—PTCA of a coronary stenosis without documented ischemia at noninvasive stress testing is often performed, but its benefit is unproven. Coronary pressure–derived fractional flow reserve (FFR) is an invasive index of stenosis severity that is a reliable substitute for noninvasive stress testing. A value of 0.75 identifies stenoses with hemodynamic significance. Methods and Results—In 325 patients for whom PTCA was planned and who did not have documented ischemia, FFR of the stenosis was measured. If FFR was >0.75, patients were randomly assigned to deferral (deferral group; n=91) or performance (performance group; n=90) of PTCA. If FFR was <0.75, PTCA was performed as planned (reference group; n=144). Clinical follow-up was obtained at 1, 3, 6, 12, and 24 months. Event-free survival was similar between the deferral and performance groups (92% versus 89% at 12 months and 89% versus 83% at 24 months) but was significantly lower in the reference group (80% at 12 months and 78% at 24 months). In addi...

[1]  Ronald J. Prineas,et al.  The Minnesota code manual of electrocardiographic findings : standards and procedures for measurement and classification , 1982 .

[2]  V. Fuster,et al.  Angiographic progression of coronary artery disease and the development of myocardial infarction. , 1988, Journal of the American College of Cardiology.

[3]  W. Santamore,et al.  Can coronary angiography predict the site of a subsequent myocardial infarction in patients with mild-to-moderate coronary artery disease? , 1988, Circulation.

[4]  T. Ryan.  Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). , 1988, Journal of the American College of Cardiology.

[5]  R. Wilson,et al.  Effects of adenosine on human coronary arterial circulation. , 1990, Circulation.

[6]  M. Kern,et al.  Intravenous adenosine: continuous infusion and low dose bolus administration for determination of coronary vasodilator reserve in patients with and without coronary artery disease. , 1991, Journal of the American College of Cardiology.

[7]  P. Hartigan,et al.  A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators. , 1992, The New England journal of medicine.

[8]  P. Hartigan,et al.  A Comparison of Angioplasty With Medical Therapy in the Treatment of Single-Vessel Coronary Artery Disease , 1992 .

[9]  B Meier,et al.  Relation of the site of acute myocardial infarction to the most severe coronary arterial stenosis at prior angiography. , 1992, The American journal of cardiology.

[10]  N. Schork,et al.  Analysis of Coronary Angioplasty Practice in the United States With an Insurance‐Claims Data Base , 1993, Circulation.

[11]  Thomas J. Ryan,et al.  Guidelines for Percutaneous Transluminal Coronary Angioplasty A Report of the American Heart Association/American College of Cardiology Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty) , 1993, Circulation.

[12]  A Bol,et al.  Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. , 1994, Circulation.

[13]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[14]  B. Chaitman,et al.  Clinical outcome of deferring angioplasty in patients with normal translesional pressure-flow velocity measurements. , 1995, Journal of the American College of Cardiology.

[15]  P. H. van der Voort,et al.  Fractional flow reserve. A useful index to evaluate the influence of an epicardial coronary stenosis on myocardial blood flow. , 1995, Circulation.

[16]  F. Pileggi,et al.  The Medicine, Angioplasty or Surgery Study (MASS): a prospective, randomized trial of medical therapy, balloon angioplasty or bypass surgery for single proximal left anterior descending artery stenoses. , 1995, Journal of the American College of Cardiology.

[17]  E. Topol,et al.  The myth of the myocardial 'infarctlet' during percutaneous coronary revascularization procedures. , 1996, Circulation.

[18]  P. H. van der Voort,et al.  Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. , 1996, The New England journal of medicine.

[19]  W. Wijns,et al.  Long-term follow-up after deferral of percutaneous transluminal coronary angioplasty of intermediate stenosis on the basis of coronary pressure measurement. , 1998, Journal of the American College of Cardiology.

[20]  Antonio Colombo,et al.  Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II) , 1998, The Lancet.

[21]  M. Leon,et al.  Long-term follow-up after percutaneous transluminal coronary angioplasty was not performed based on intravascular ultrasound findings: importance of lumen dimensions. , 1999, Circulation.

[22]  D. Waters,et al.  Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. Atorvastatin versus Revascularization Treatment Investigators. , 1999, The New England journal of medicine.

[23]  J. Murray,et al.  ACC/AHA guidelines for coronary angiography. A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on Coronary Angiography). Developed in collaboration with the Society for Cardiac Angiography and Interventions. , 1999, Journal of the American College of Cardiology.

[24]  D. Baim,et al.  Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. , 1999, The New England journal of medicine.

[25]  R. Rothenberg,et al.  Ischemic heart disease , 2000 .

[26]  MasayukiAbe,et al.  Diastolic Fractional Flow Reserve to Assess the Functional Severity of Moderate Coronary Artery Stenoses , 2000 .

[27]  N Doba,et al.  Diastolic Fractional Flow Reserve to Assess the Functional Severity of Moderate Coronary Artery Stenoses: Comparison With Fractional Flow Reserve and Coronary Flow Velocity Reserve , 2000, Circulation.

[28]  B. Zaret,et al.  Contributions of nuclear cardiology to diagnosis and prognosis of patients with coronary artery disease. , 2000, Circulation.