Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II)

doi:10.1016/j.jcin.2015.01.029

Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II)

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVES: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment.

BACKGROUND: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons.

METHODS: A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report.

RESULTS: The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p < 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses.

CONCLUSIONS: The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).

Original language	English
Pages (from-to)	824-833
Number of pages	10
Journal	JACC. Cardiovascular Interventions
Volume	8
Issue number	6
DOIs	https://doi.org/10.1016/j.jcin.2015.01.029
Publication status	Published - May 2015
Externally published	Yes

Keywords

Adenosine/administration & dosage
Aged
Algorithms
Cardiac Catheterization
Coronary Angiography
Coronary Stenosis/classification
Electrocardiography
Female
Fractional Flow Reserve, Myocardial
Hemodynamics
Humans
Hyperemia/physiopathology
Male
Middle Aged
Predictive Value of Tests
Prognosis
Prospective Studies
Reproducibility of Results
Severity of Illness Index
Signal Processing, Computer-Assisted
Vasodilator Agents/administration & dosage

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@article{dce1d6cc8fa64880a3dc05b372700133,

title = "Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II)",

abstract = "OBJECTIVES: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment.BACKGROUND: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons.METHODS: A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report.RESULTS: The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p < 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses.CONCLUSIONS: The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).",

keywords = "Adenosine/administration & dosage, Aged, Algorithms, Cardiac Catheterization, Coronary Angiography, Coronary Stenosis/classification, Electrocardiography, Female, Fractional Flow Reserve, Myocardial, Hemodynamics, Humans, Hyperemia/physiopathology, Male, Middle Aged, Predictive Value of Tests, Prognosis, Prospective Studies, Reproducibility of Results, Severity of Illness Index, Signal Processing, Computer-Assisted, Vasodilator Agents/administration & dosage",

author = "Javier Escaned and Mauro Echavarr{\'i}a-Pinto and Garcia-Garcia, {Hector M} and {van de Hoef}, {Tim P} and {de Vries}, Ton and Prashant Kaul and Ganesh Raveendran and Altman, {John D} and Kurz, {Howard I} and Johannes Brechtken and Mark Tulli and {Von Birgelen}, Clemens and Schneider, {Joel E} and Khashaba, {Ahmed A} and Allen Jeremias and Jim Baucum and Raul Moreno and Martijn Meuwissen and Gregory Mishkel and {van Geuns}, Robert-Jan and Howard Levite and Ramon Lopez-Palop and Marc Mayhew and Serruys, {Patrick W} and Habib Samady and Piek, {Jan J} and Amir Lerman",

year = "2015",

month = may,

doi = "10.1016/j.jcin.2015.01.029",

language = "English",

volume = "8",

pages = "824--833",

journal = "JACC. Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "6",

}

Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). /.
In: JACC. Cardiovascular Interventions, Vol. 8, No. 6, 05.2015, p. 824-833.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance

T2 - Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II)

AU - Escaned, Javier

AU - Echavarría-Pinto, Mauro

AU - Garcia-Garcia, Hector M

AU - van de Hoef, Tim P

AU - de Vries, Ton

AU - Kaul, Prashant

AU - Raveendran, Ganesh

AU - Altman, John D

AU - Kurz, Howard I

AU - Brechtken, Johannes

AU - Tulli, Mark

AU - Von Birgelen, Clemens

AU - Schneider, Joel E

AU - Khashaba, Ahmed A

AU - Jeremias, Allen

AU - Baucum, Jim

AU - Moreno, Raul

AU - Meuwissen, Martijn

AU - Mishkel, Gregory

AU - van Geuns, Robert-Jan

AU - Levite, Howard

AU - Lopez-Palop, Ramon

AU - Mayhew, Marc

AU - Serruys, Patrick W

AU - Samady, Habib

AU - Piek, Jan J

AU - Lerman, Amir

PY - 2015/5

Y1 - 2015/5

N2 - OBJECTIVES: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment.BACKGROUND: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons.METHODS: A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report.RESULTS: The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p < 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses.CONCLUSIONS: The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).

AB - OBJECTIVES: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment.BACKGROUND: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons.METHODS: A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report.RESULTS: The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p < 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses.CONCLUSIONS: The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).

KW - Adenosine/administration & dosage

KW - Aged

KW - Algorithms

KW - Cardiac Catheterization

KW - Coronary Angiography

KW - Coronary Stenosis/classification

KW - Electrocardiography

KW - Female

KW - Fractional Flow Reserve, Myocardial

KW - Hemodynamics

KW - Humans

KW - Hyperemia/physiopathology

KW - Male

KW - Middle Aged

KW - Predictive Value of Tests

KW - Prognosis

KW - Prospective Studies

KW - Reproducibility of Results

KW - Severity of Illness Index

KW - Signal Processing, Computer-Assisted

KW - Vasodilator Agents/administration & dosage

U2 - 10.1016/j.jcin.2015.01.029

DO - 10.1016/j.jcin.2015.01.029

M3 - Article

C2 - 25999106

SN - 1936-8798

VL - 8

SP - 824

EP - 833

JO - JACC. Cardiovascular Interventions

JF - JACC. Cardiovascular Interventions

IS - 6

ER -