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 FFRCT: 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 WilkFurong Wang, Campbell Rogers, Bernard De Bruyne

Research output: Contribution to journalArticle

222 Citations (Scopus)

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/FFRCT (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 (FFRCT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFRCT 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/FFRCT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFRCT) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFRCT 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.

Original languageEnglish
Pages (from-to)3359-3367
Number of pages9
JournalEuropean Heart Journal
Volume36
Issue number47
DOIs
Publication statusPublished - Dec 14 2015

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Coronary Artery Disease
Patient Care
Angiography
Coronary Angiography
Chest Pain
Patient Selection
Pathologic Constriction
Myocardial Infarction
Confidence Intervals

Keywords

  • Angina
  • Coronary computed tomographic angiography
  • Fractional flow reserve
  • Non-invasive testing

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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 FFRCT: Outcome and resource impacts study. / Douglas, Pamela S.; Pontone, Gianluca; Hlatky, Mark A.; Patel, Manesh R.; Norgaard, Bjarne L.; Byrne, Robert A.; Curzen, Nick; Purcell, Ian; Gutberlet, Matthias; Rioufol, Gilles; Hink, Ulrich; Schuchlenz, Herwig Walter; Feuchtner, Gudrun; Gilard, Martine; Andreini, Daniele; Jensen, Jesper M.; Hadamitzky, Martin; Chiswell, Karen; Cyr, Derek; Wilk, Alan; Wang, Furong; Rogers, Campbell; De Bruyne, Bernard.

In: European Heart Journal, Vol. 36, No. 47, 14.12.2015, p. 3359-3367.

Research output: Contribution to journalArticle

Douglas, PS, Pontone, G, Hlatky, MA, Patel, MR, Norgaard, BL, Byrne, RA, Curzen, N, Purcell, I, Gutberlet, M, Rioufol, G, Hink, U, Schuchlenz, HW, Feuchtner, G, Gilard, M, Andreini, D, Jensen, JM, Hadamitzky, M, Chiswell, K, Cyr, D, Wilk, A, Wang, F, Rogers, C & De Bruyne, B 2015, '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 FFRCT: Outcome and resource impacts study', European Heart Journal, vol. 36, no. 47, pp. 3359-3367. https://doi.org/10.1093/eurheartj/ehv444
Douglas, Pamela S. ; Pontone, Gianluca ; Hlatky, Mark A. ; Patel, Manesh R. ; Norgaard, Bjarne L. ; Byrne, Robert A. ; Curzen, Nick ; Purcell, Ian ; Gutberlet, Matthias ; Rioufol, Gilles ; Hink, Ulrich ; Schuchlenz, Herwig Walter ; Feuchtner, Gudrun ; Gilard, Martine ; Andreini, Daniele ; Jensen, Jesper M. ; Hadamitzky, Martin ; Chiswell, Karen ; Cyr, Derek ; Wilk, Alan ; Wang, Furong ; Rogers, Campbell ; De Bruyne, Bernard. / 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 FFRCT: Outcome and resource impacts study. In: European Heart Journal. 2015 ; Vol. 36, No. 47. pp. 3359-3367.
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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/FFRCT (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 (FFRCT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12{\%}) in the CTA/FFRCT 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/FFRCT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13{\%} (CTA/FFRCT) and 6{\%} (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFRCT 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.",
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T1 - Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease

T2 - The prospective longitudinal trial of FFRCT: Outcome and resource impacts study

AU - Douglas, Pamela S.

AU - Pontone, Gianluca

AU - Hlatky, Mark A.

AU - Patel, Manesh R.

AU - Norgaard, Bjarne L.

AU - Byrne, Robert A.

AU - Curzen, Nick

AU - Purcell, Ian

AU - Gutberlet, Matthias

AU - Rioufol, Gilles

AU - Hink, Ulrich

AU - Schuchlenz, Herwig Walter

AU - Feuchtner, Gudrun

AU - Gilard, Martine

AU - Andreini, Daniele

AU - Jensen, Jesper M.

AU - Hadamitzky, Martin

AU - Chiswell, Karen

AU - Cyr, Derek

AU - Wilk, Alan

AU - Wang, Furong

AU - Rogers, Campbell

AU - De Bruyne, Bernard

PY - 2015/12/14

Y1 - 2015/12/14

N2 - 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/FFRCT (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 (FFRCT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFRCT 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/FFRCT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFRCT) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFRCT 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.

AB - 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/FFRCT (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 (FFRCT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFRCT 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/FFRCT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFRCT) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFRCT 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.

KW - Angina

KW - Coronary computed tomographic angiography

KW - Fractional flow reserve

KW - Non-invasive testing

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