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A prospective natural history study of coronary atherosclerosis using fractional flow reserve

A prospective natural history study of coronary atherosclerosis using fractional flow reserve
A prospective natural history study of coronary atherosclerosis using fractional flow reserve

BACKGROUND: In patients with coronary artery disease, clinical outcome depends on the extent of reversible myocardial ischemia. Whether the outcome also depends on the severity of the stenosis as determined by fractional flow reserve (FFR) remains unknown.

OBJECTIVES: This study sought to investigate the relationship between FFR values and vessel-related clinical outcome.

METHODS: We prospectively studied major adverse cardiovascular events (MACE) at 2 years in 607 patients in whom all stenoses were assessed by FFR and who were treated with medical therapy alone. The relationship between FFR and 2-year MACE was assessed as a continuous function. Logistic and Cox proportional hazards regression models were used to calculate the average decrease in the risk of MACE per 0.05-U increase in FFR.

RESULTS: MACE occurred in 272 (26.5%) of 1,029 lesions. Target lesions with diameter stenosis ≥70% were more often present in the MACE group (p < 0.01). Median FFR was significantly lower in the MACE group versus the non-MACE group (0.68 [interquartile range: 0.54 to 0.77] vs. 0.80 [interquartile range: 0.70 to 0.88]; p < 0.01). The cumulative incidence of MACE significantly increased with increasing FFR quartiles. An average decrease in MACE per 0.05-unit increase in FFR was statistically significant even after adjustment for all clinical and angiographic features (odds ratio: 0.81; 95% confidence interval: 0.76 to 0.86]). The strongest increase in MACE occurred for FFR values between 0.80 and 0.60. In multivariable Cox regression analysis, FFR was significantly associated with MACE up to 2 years (hazard ratio: 0.87; 95% confidence interval: 0.83 to 0.91]).

CONCLUSIONS: In patients with stable coronary disease, stenosis severity as assessed by FFR is a major and independent predictor of lesion-related outcome. (FAME II - Fractional Flow Reserve [FFR] Guided Percutaneous Coronary Intervention [PCI] Plus Optimal Medical Treatment [OMT] Verses OMT; NCT01132495).

Atherosclerosis/diagnosis, Coronary Angiography, Coronary Artery Disease/diagnosis, Coronary Vessels/diagnostic imaging, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial/physiology, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/methods, Prognosis, Prospective Studies, Severity of Illness Index, Time Factors
0735-1097
2247-2255
Barbato, Emanuele
50106486-a9cd-4c08-9ee7-74d049a9356d
Toth, Gabor G.
af8702a6-1b7d-4eea-92d0-39e3c3dce06a
Johnson, Nils P.
d6722b29-3562-478c-af15-74927165d6cd
Pijls, Nico H.J.
90717d6e-0756-4d55-ba7f-d4f7377ea048
Fearon, William F.
0cd8b847-758f-4501-bd76-543e630f3179
Tonino, Pim A.L.
f22d79b3-5ee7-4780-b25c-df728ce09a3b
Curzen, Nick
70f3ea49-51b1-418f-8e56-8210aef1abf4
Piroth, Zsolt
987ac008-d51d-4a12-a67c-499766e2fba5
Rioufol, Gilles
87163c97-9ed4-477a-9692-6ac8506fcd9f
Jüni, Peter
1448ad34-a0d4-4faa-962b-abf202246167
De Bruyne, Bernard
6c86ad29-d853-4e59-9633-f536a17efd4e
Barbato, Emanuele
50106486-a9cd-4c08-9ee7-74d049a9356d
Toth, Gabor G.
af8702a6-1b7d-4eea-92d0-39e3c3dce06a
Johnson, Nils P.
d6722b29-3562-478c-af15-74927165d6cd
Pijls, Nico H.J.
90717d6e-0756-4d55-ba7f-d4f7377ea048
Fearon, William F.
0cd8b847-758f-4501-bd76-543e630f3179
Tonino, Pim A.L.
f22d79b3-5ee7-4780-b25c-df728ce09a3b
Curzen, Nick
70f3ea49-51b1-418f-8e56-8210aef1abf4
Piroth, Zsolt
987ac008-d51d-4a12-a67c-499766e2fba5
Rioufol, Gilles
87163c97-9ed4-477a-9692-6ac8506fcd9f
Jüni, Peter
1448ad34-a0d4-4faa-962b-abf202246167
De Bruyne, Bernard
6c86ad29-d853-4e59-9633-f536a17efd4e

Barbato, Emanuele, Toth, Gabor G., Johnson, Nils P., Pijls, Nico H.J., Fearon, William F., Tonino, Pim A.L., Curzen, Nick, Piroth, Zsolt, Rioufol, Gilles, Jüni, Peter and De Bruyne, Bernard (2016) A prospective natural history study of coronary atherosclerosis using fractional flow reserve. Journal of the American College of Cardiology, 68 (21), 2247-2255. (doi:10.1016/j.jacc.2016.08.055).

Record type: Article

Abstract

BACKGROUND: In patients with coronary artery disease, clinical outcome depends on the extent of reversible myocardial ischemia. Whether the outcome also depends on the severity of the stenosis as determined by fractional flow reserve (FFR) remains unknown.

OBJECTIVES: This study sought to investigate the relationship between FFR values and vessel-related clinical outcome.

METHODS: We prospectively studied major adverse cardiovascular events (MACE) at 2 years in 607 patients in whom all stenoses were assessed by FFR and who were treated with medical therapy alone. The relationship between FFR and 2-year MACE was assessed as a continuous function. Logistic and Cox proportional hazards regression models were used to calculate the average decrease in the risk of MACE per 0.05-U increase in FFR.

RESULTS: MACE occurred in 272 (26.5%) of 1,029 lesions. Target lesions with diameter stenosis ≥70% were more often present in the MACE group (p < 0.01). Median FFR was significantly lower in the MACE group versus the non-MACE group (0.68 [interquartile range: 0.54 to 0.77] vs. 0.80 [interquartile range: 0.70 to 0.88]; p < 0.01). The cumulative incidence of MACE significantly increased with increasing FFR quartiles. An average decrease in MACE per 0.05-unit increase in FFR was statistically significant even after adjustment for all clinical and angiographic features (odds ratio: 0.81; 95% confidence interval: 0.76 to 0.86]). The strongest increase in MACE occurred for FFR values between 0.80 and 0.60. In multivariable Cox regression analysis, FFR was significantly associated with MACE up to 2 years (hazard ratio: 0.87; 95% confidence interval: 0.83 to 0.91]).

CONCLUSIONS: In patients with stable coronary disease, stenosis severity as assessed by FFR is a major and independent predictor of lesion-related outcome. (FAME II - Fractional Flow Reserve [FFR] Guided Percutaneous Coronary Intervention [PCI] Plus Optimal Medical Treatment [OMT] Verses OMT; NCT01132495).

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More information

Accepted/In Press date: 31 August 2016
e-pub ahead of print date: 21 November 2016
Published date: 29 November 2016
Keywords: Atherosclerosis/diagnosis, Coronary Angiography, Coronary Artery Disease/diagnosis, Coronary Vessels/diagnostic imaging, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial/physiology, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/methods, Prognosis, Prospective Studies, Severity of Illness Index, Time Factors

Identifiers

Local EPrints ID: 436148
URI: http://eprints.soton.ac.uk/id/eprint/436148
ISSN: 0735-1097
PURE UUID: 018ffcf5-1f9e-43ea-b950-1fe245778ff9

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Date deposited: 29 Nov 2019 17:30
Last modified: 15 Jan 2020 17:41

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Contributors

Author: Emanuele Barbato
Author: Gabor G. Toth
Author: Nils P. Johnson
Author: Nico H.J. Pijls
Author: William F. Fearon
Author: Pim A.L. Tonino
Author: Nick Curzen
Author: Zsolt Piroth
Author: Gilles Rioufol
Author: Peter Jüni
Author: Bernard De Bruyne

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