Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study

Pamela S Douglas, Gianluca Pontone, Mark A Hlatky, Manesh R Patel, Bjarne L Norgaard, Robert A Byrne, Nick Curzen, Ian Purcell, Matthias Gutberlet, Gilles Rioufol, Ulrich Hink, Herwig Walter Schuchlenz, Gudrun Feuchtner, Martine Gilard, Daniele Andreini, Jesper M Jensen, Martin Hadamitzky, Karen Chiswell, Derek Cyr, Alan Wilk, Furong Wang, Campbell Rogers, Bernard De Bruyne, PLATFORM Investigators, Antonio Bartorelli, Daniele Andreini, Maurio Pepi, Erika Bertella, Saima Mushtaq, Virginia Beltrama, Andrea Baggiano, Sara Gaur, Lone Romby, Jette R Broderson, Lene Hjelm, Robert Byrne, Elena Guerra, Oliver Husser, Tobias Koppara, Jonathan Nadjiri, Martin Hadamitzky, Janina Winogradow, Janika Repp, Severin Weigand, Fritz Wimbaur, Raphazza Lohaus, Philipp Montz Rumpf, Elke Lorenz, Gisela Schoemig, Karin Hosl, Judith Ruf, Nick Curzen, James Shambrook, Simon Corbett, Iain Simpson, Alison Calver, James Wilkinson, Zoe Nicholas, Judith Ann Radmore, Bryony Tyrell, Claire Elridge, Rayner Lacoste, Ian Purcell, Rajiv Das, Iftikhar Haq, Azfar Ghaus Zaman, I Spyridopoulos, Alan Bagnall, J Ahmed, Alla Narytnyk, Jennifer Adams-Hall, Leslie Bremner, Susan Hetherington, Sarah Lamb, Angela Phillipson, Rebecca Wilson, Kathryn Procter, Samantha Jones, Victoria Andrianna Richardson, Louise Quinn, Vera Wealleans, Sarah Rowling, Chris Price, Matthias Gutberlet, Lukas Lehmkuhl, Michael Woinke, Gerhard Schuler, Daniel Urban, Christian Lücke, Fabian Juhrich, Kathrin Luderer, Jacqueline Fohlisch, Carola Dohnert, Gilles Rioufol, Gérard Finet, Philippe Douek, Yvonne Varillon, Delphine Laval, Adeline Mansuy, Pauline Renaudin, Muriel Rageade, Ulrich Hink, Karl Kreitner, Alexander Jabs, Yang Yang, Tommaso Gori, Bärbel Kaesberger, Herwig Schuchlenz, Dieter Botegal, Martin Genger, Peter Zechner, Wolfgang Weihs, Peter Kullnig, Walter Kau, Stefan Weikl, Gudrun Feuchtner, Guy Friedrich, Fabian Plank, Martine Gilard, Jacques Boschat, Philippe Castellant, Romain Didier, Françoise Martin, Pamela S Douglas, Bernard De Bruyne, Mark Hlatky, B L Norgaard, Manesh Patel, Gianluca Pontone, Campbell Rogers, Manesh Patel, Manesh Patel, W Schuyler Jones, Rohan Shah, Gary Dunn, Alicia Lowe, Beth Martinez, Auben Debus, Judi Jaeger, Furong Wang, Alan Wilk, Pamela S Douglas, Gianluca Pontone, Mark A Hlatky, Manesh R Patel, Bjarne L Norgaard, Robert A Byrne, Nick Curzen, Ian Purcell, Matthias Gutberlet, Gilles Rioufol, Ulrich Hink, Herwig Walter Schuchlenz, Gudrun Feuchtner, Martine Gilard, Daniele Andreini, Jesper M Jensen, Martin Hadamitzky, Karen Chiswell, Derek Cyr, Alan Wilk, Furong Wang, Campbell Rogers, Bernard De Bruyne, PLATFORM Investigators, Antonio Bartorelli, Daniele Andreini, Maurio Pepi, Erika Bertella, Saima Mushtaq, Virginia Beltrama, Andrea Baggiano, Sara Gaur, Lone Romby, Jette R Broderson, Lene Hjelm, Robert Byrne, Elena Guerra, Oliver Husser, Tobias Koppara, Jonathan Nadjiri, Martin Hadamitzky, Janina Winogradow, Janika Repp, Severin Weigand, Fritz Wimbaur, Raphazza Lohaus, Philipp Montz Rumpf, Elke Lorenz, Gisela Schoemig, Karin Hosl, Judith Ruf, Nick Curzen, James Shambrook, Simon Corbett, Iain Simpson, Alison Calver, James Wilkinson, Zoe Nicholas, Judith Ann Radmore, Bryony Tyrell, Claire Elridge, Rayner Lacoste, Ian Purcell, Rajiv Das, Iftikhar Haq, Azfar Ghaus Zaman, I Spyridopoulos, Alan Bagnall, J Ahmed, Alla Narytnyk, Jennifer Adams-Hall, Leslie Bremner, Susan Hetherington, Sarah Lamb, Angela Phillipson, Rebecca Wilson, Kathryn Procter, Samantha Jones, Victoria Andrianna Richardson, Louise Quinn, Vera Wealleans, Sarah Rowling, Chris Price, Matthias Gutberlet, Lukas Lehmkuhl, Michael Woinke, Gerhard Schuler, Daniel Urban, Christian Lücke, Fabian Juhrich, Kathrin Luderer, Jacqueline Fohlisch, Carola Dohnert, Gilles Rioufol, Gérard Finet, Philippe Douek, Yvonne Varillon, Delphine Laval, Adeline Mansuy, Pauline Renaudin, Muriel Rageade, Ulrich Hink, Karl Kreitner, Alexander Jabs, Yang Yang, Tommaso Gori, Bärbel Kaesberger, Herwig Schuchlenz, Dieter Botegal, Martin Genger, Peter Zechner, Wolfgang Weihs, Peter Kullnig, Walter Kau, Stefan Weikl, Gudrun Feuchtner, Guy Friedrich, Fabian Plank, Martine Gilard, Jacques Boschat, Philippe Castellant, Romain Didier, Françoise Martin, Pamela S Douglas, Bernard De Bruyne, Mark Hlatky, B L Norgaard, Manesh Patel, Gianluca Pontone, Campbell Rogers, Manesh Patel, Manesh Patel, W Schuyler Jones, Rohan Shah, Gary Dunn, Alicia Lowe, Beth Martinez, Auben Debus, Judi Jaeger, Furong Wang, Alan Wilk

Abstract

Aims: In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFRCT) is unknown.

Methods and results: At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing (n = 287) or CTA/FFR(CT) (n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFR(CT)-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR(CT) arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53-69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFR(CT) results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR(CT)) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR(CT) arms.

Conclusions: Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD.

Keywords: Angina; Coronary computed tomographic angiography; Fractional flow reserve; Non-invasive testing.

© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Enrolment, allocation, and follow-up of the study patients. NI, non-invasive; ICA, invasive coronary angiography; FFRCT, computation of fractional flow reserve from coronary computed tomographic angiography data; CTA, computed tomographic angiography; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting. *One subject withdrew consent for use of any of his/her data. In keeping with relevant national law, this subject is not included in any data listing or analysis.
Figure 2
Figure 2
Determination of the rate of invasive catheterization without obstructive coronary artery disease. NI, non-invasive; ICA, invasive coronary angiography; Obs CAD, obstructive coronary artery disease; FFRCT, computation of fractional flow reserve from coronary computed tomographic angiography data.

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