Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial

American Heart Journal

Volumn 170, Issue 5, 2015, Pages 945-950

  Götberg, Matthias ^a   Christiansen, Evald H ^b   Gudmundsdottir, Ingibjörg ^c   Sandhall, Lennart ^d   Omerovic, Elmir ^e   James, Stefan K ^f   Erlinge, David ^a   Fröbert, Ole ^g  

^a LUND UNIVERSITY   (Sweden)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c REYKJAVIK UNIVERSITY   (Iceland)

^d HELSINGBORG HOSPITAL   (Sweden)

^e Sahlgrenska University   (Sweden)

^f UPPSALA UNIVERSITY   (Sweden)

^g Örebro University   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE CORONARY SYNDROME; ADULT; ARTICLE; CAUSE OF DEATH; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; CORONARY ARTERY RECANALIZATION; DIAGNOSTIC TEST ACCURACY STUDY; DISEASE SEVERITY; FRACTIONAL FLOW RESERVE; HEMODYNAMIC PARAMETERS; HUMAN; INSTANTANEOUS WAVE FREE RATIO; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STABLE ANGINA PECTORIS; AGED; ANGIOCARDIOGRAPHY; CLINICAL TRIAL; FEMALE; FOLLOW UP; MALE; PATHOPHYSIOLOGY; PERCUTANEOUS CORONARY INTERVENTION; PHYSIOLOGY; PROCEDURES; PROSPECTIVE STUDY; RADIOGRAPHY; RECEIVER OPERATING CHARACTERISTIC; REGISTER; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ACUTE CORONARY SYNDROME; AGED; CORONARY ANGIOGRAPHY; FEMALE; FOLLOW-UP STUDIES; FRACTIONAL FLOW RESERVE, MYOCARDIAL; HUMANS; MALE; PERCUTANEOUS CORONARY INTERVENTION; PROSPECTIVE STUDIES; REGISTRIES; ROC CURVE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84954229158     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2015.07.031     Document Type: Article

References (22)

1. P.A. Tonino, B. De Bruyne, N.H. Pijls, and et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention N Engl J Med 360 2009 213 224
2. B. De Bruyne, N.H. Pijls, B. Kalesan, and et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease N Engl J Med 367 2012 991 1001
3. G.J. Bech, B. De Bruyne, N.H. Pijls, and et al. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial Circulation 103 2001 2928 2934
4. G.N. Levine, E.R. Bates, J.C. Blankenship, and et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions J Am Coll Cardiol 58 2011 e44 e122
5. Task Force on Myocardial Revascularization of the European Society of C, the European Association for Cardio-Thoracic S, European Association for Percutaneous Cardiovascular I, and et al. Guidelines on myocardial revascularization Eur Heart J 31 2010 2501 2555
6. P.B. Dattilo, A. Prasad, E. Honeycutt, and et al. Contemporary patterns of fractional flow reserve and intravascular ultrasound use among patients undergoing percutaneous coronary intervention in the United States: insights from the National Cardiovascular Data Registry J Am Coll Cardiol 60 2012 2337 2339
7. S. Sen, J. Escaned, I.S. Malik, and et al. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study J Am Coll Cardiol 59 2012 1392 1402
8. R. Petraco, J. Escaned, S. Sen, and et al. Classification performance of instantaneous wave-free ratio (iFR) and fractional flow reserve in a clinical population of intermediate coronary stenoses: results of the ADVISE registry EuroIntervention 9 2013 91 101
9. A. Jeremias, A. Maehara, P. Genereux, and et al. Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study J Am Coll Cardiol 63 2014 1253 1261
10. S. Sen, K.N. Asrress, S. Nijjer, and et al. Diagnostic classification of the instantaneous wave-free ratio is equivalent to fractional flow reserve and is not improved with adenosine administration. Results of CLARIFY (Classification Accuracy of Pressure-Only Ratios Against Indices Using Flow Study) J Am Coll Cardiol 61 2013 1409 1420
11. R. Petraco, T.P. van de Hoef, S. Nijjer, and et al. Baseline Instantaneous Wave-Free Ratio as a Pressure-Only Estimation of Underlying Coronary Flow Reserve: Results of the JUSTIFY-CFR Study (Joined Coronary Pressure and Flow Analysis to Determine Diagnostic Characteristics of Basal and Hyperemic Indices of Functional Lesion Severity-Coronary Flow Reserve) Circ Cardiovasc Interv 7 2014 492 502
12. O. Frobert, B. Lagerqvist, T. Gudnason, and et al. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale Am Heart J 160 2010 1042 1048
13. O. Frobert, B. Lagerqvist, G.K. Olivecrona, and et al. Thrombus aspiration during ST-segment elevation myocardial infarction N Engl J Med 369 2013 1587 1597
14. B. De Bruyne, N.H. Pijls, E. Barbato, and et al. Intracoronary and intravenous adenosine 5′-triphosphate, adenosine, papaverine, and contrast medium to assess fractional flow reserve in humans Circulation 107 2003 1877 1883
15. R.W. Makuch, and R.M. Simon Sample size considerations for non-randomized comparative studies J Chronic Dis 33 1980 175 181
16. N.H. Pijls, W.F. Fearon, P.A. Tonino, and et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study J Am Coll Cardiol 56 2010 177 184
17. S. Gaur, H.G. Bezerra, J.F. Lassen, and et al. Fractional flow reserve derived from coronary CT angiography: variation of repeated analyses J Cardiovasc Comput Tomogr 8 2014 307 314
18. M. Meuwissen, M. Siebes, J.A. Spaan, and et al. Rationale of combined intracoronary pressure and flow velocity measurements Z Kardiol 91 Suppl. 3 2002 108 112
19. M. Meuwissen, M. Siebes, S.A. Chamuleau, and et al. Hyperemic stenosis resistance index for evaluation of functional coronary lesion severity Circulation 106 2002 441 446
20. T.P. van de Hoef, M. Meuwissen, J. Escaned, and et al. Head-to-head comparison of basal stenosis resistance index, instantaneous wave-free ratio, and fractional flow reserve: diagnostic accuracy for stenosis-specific myocardial ischaemia EuroIntervention 2014 10.4244/EIJY14M08-17 [pii: 20130905-03, Epub ahead of print]
21. R. Petraco, R. Al-Lamee, M. Gotberg, and et al. Real-time use of instantaneous wave-free ratio: results of the ADVISE in-practice: an international, multicenter evaluation of instantaneous wave-free ratio in clinical practice Am Heart J 168 2014 739 748
22. M.S. Lauer, and R.B. D'Agostino Sr. The randomized registry trial - the next disruptive technology in clinical research? N Engl J Med 369 2013 1579 1581