Eur Heart J. 2015 Dec 14;36(47):3359-67. doi: 10.1093/eurheartj/ehv444. Epub 2015 Sep 1.

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.

Douglas PS¹, Pontone G², Hlatky MA³, Patel MR⁴, Norgaard BL⁵, Byrne RA⁶, Curzen N⁷, Purcell I⁸, Gutberlet M⁹, Rioufol G¹⁰, Hink U¹¹, Schuchlenz HW¹², Feuchtner G¹³, Gilard M¹⁴, Andreini D², Jensen JM⁵, Hadamitzky M⁶, Chiswell K⁴, Cyr D⁴, Wilk A¹⁵, Wang F¹⁵, Rogers C¹⁵, De Bruyne B¹⁶; PLATFORM Investigators.

Collaborators (117)

Bartorelli A, Andreini D, Pepi M, Bertella E, Mushtaq S, Beltrama V, Baggiano A, Gaur S, Romby L, Broderson JR, Hjelm L, Byrne R, Guerra E, Husser O, Koppara T, Nadjiri J, Hadamitzky M, Winogradow J, Repp J, Weigand S, Wimbaur F, Lohaus R, Rumpf PM, Lorenz E, Schoemig G, Hosl K, Ruf J, Curzen N, Shambrook J, Corbett S, Simpson I, Calver A, Wilkinson J, Nicholas Z, Radmore JA, Tyrell B, Elridge C, Lacoste R, Purcell I, Das R, Haq I, Zaman AG, Spyridopoulos I, Bagnall A, Ahmed J, Narytnyk A, Adams-Hall J, Bremner L, Hetherington S, Lamb S, Phillipson A, Wilson R, Procter K, Jones S, Richardson VA, Quinn L, Wealleans V, Rowling S, Price C, Gutberlet M, Lehmkuhl L, Woinke M, Schuler G, Urban D, Lücke C, Juhrich F, Luderer K, Fohlisch J, Dohnert C, Rioufol G, Finet G, Douek P, Varillon Y, Laval D, Mansuy A, Renaudin P, Rageade M, Hink U, Kreitner K, Jabs A, Yang Y, Gori T, Kaesberger B, Schuchlenz H, Botegal D, Genger M, Zechner P, Weihs W, Kullnig P, Kau W, Weikl S, Feuchtner G, Friedrich G, Plank F, Gilard M, Boschat J, Castellant P, Didier R, Martin F, Douglas PS, De Bruyne B, Hlatky M, Norgaard BL, Patel M, Pontone G, Rogers C, Patel M, Patel M, Jones WS, Shah R, Dunn G, Lowe A, Martinez B, Debus A, Jaeger J, Wang F, Wilk A.

Author information

1: Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA pamela.douglas@duke.edu.
2: Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
3: Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.
4: Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA.
5: Department of Cardiology, Aarhus University Hospital, Aarhus Skejby, Denmark.
6: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
7: University Hospital Southampton NHS Trust, Southampton, UK.
8: Freeman Hospital, Newcastle upon Tyne, UK.
9: University of Leipzig Heart Centre, Leipzig, Germany.
10: Hospices Civils de Lyon and CARMEN INSERM 1060, Lyon, France.
11: Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany.
12: LKH Graz West, Graz, Austria.
13: Department of Radiology, Innsbruck Medical University, Innsbruck, Austria.
14: Department of Cardiology, Cavale Blanche Hospital, Brest, France.
15: HeartFlow, Redwood City, CA, USA.
16: Cardiovascular Centre Aalst, Aalst, Belgium.

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.