Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

Javier Escaned; Nicola Ryan; Hernán Mejía-Rentería; Christopher M. Cook; Hakim Moulay Dehbi; Eduardo Alegria-Barrero; Ali Alghamdi; Rasha Al-Lamee; John Altman; Alphonse Ambrosia; Sérgio B. Baptista; Maria Bertilsson; Ravinay Bhindi; Mats Birgander; Waldemar Bojara; Salvatore Brugaletta; Christopher Buller; Fredrik Calais; Pedro Canas Silva; Jörg Carlsson; Evald H. Christiansen; Mikael Danielewicz; Carlo Di Mario; Joon Hyung Doh; Andrejs Erglis; David Erlinge; Robert T. Gerber; Olaf Going; Ingibjörg Gudmundsdottir; Tobias Härle; Dario Hauer; Farrel Hellig; Ciro Indolfi; Lars Jakobsen; Luc Janssens; Jens Jensen; Allen Jeremias; Amra Kåregren; Ann Charlotte Karlsson; Rajesh K. Kharbanda; Ahmed Khashaba; Yuetsu Kikuta; Florian Krackhardt; Bon Kwon Koo; Sasha Koul; Mika Laine; Sam J. Lehman; Pontus Lindroos; Iqbal S. Malik; Michael Maeng; Hitoshi Matsuo; Martijn Meuwissen; Chang Wook Nam; Giampaolo Niccoli; Sukhjinder S. Nijjer; Hans Olsson; Sven Erik Olsson; Elmir Omerovic; Georgios Panayi; Ricardo Petraco; Jan J. Piek; Flavo Ribichini; Habib Samady; Bruce Samuels; Lennart Sandhall; James Sapontis; Sayan Sen; Arnold H. Seto; Murat Sezer; Andrew S.P. Sharp; Eun Seok Shin; Jasvindar Singh; Hiroaki Takashima; Suneel Talwar; Nobuhiro Tanaka; Kare Tang; Eric Van Belle; Niels van Royen; Christoph Varenhorst; Hugo Vinhas; Christiaan J. Vrints; Darren Walters; Hiroyoshi Yokoi; Ole Fröbert; Manesh R. Patel; Patrick Serruys; Justin E. Davies; Matthias Götberg

doi:10.1016/j.jcin.2018.05.029

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

Javier Escaned, Nicola Ryan, Hernán Mejía-Rentería, Christopher M. Cook, Hakim Moulay Dehbi, Eduardo Alegria-Barrero, Ali Alghamdi, Rasha Al-Lamee, John Altman, Alphonse Ambrosia, Sérgio B. Baptista, Maria Bertilsson, Ravinay Bhindi, Mats Birgander, Waldemar Bojara, Salvatore Brugaletta, Christopher Buller, Fredrik Calais, Pedro Canas Silva, Jörg CarlssonEvald H. Christiansen, Mikael Danielewicz, Carlo Di Mario, Joon Hyung Doh, Andrejs Erglis, David Erlinge, Robert T. Gerber, Olaf Going, Ingibjörg Gudmundsdottir, Tobias Härle, Dario Hauer, Farrel Hellig, Ciro Indolfi, Lars Jakobsen, Luc Janssens, Jens Jensen, Allen Jeremias, Amra Kåregren, Ann Charlotte Karlsson, Rajesh K. Kharbanda, Ahmed Khashaba, Yuetsu Kikuta, Florian Krackhardt, Bon Kwon Koo, Sasha Koul, Mika Laine, Sam J. Lehman, Pontus Lindroos, Iqbal S. Malik, Michael Maeng, Hitoshi Matsuo, Martijn Meuwissen, Chang Wook Nam, Giampaolo Niccoli, Sukhjinder S. Nijjer, Hans Olsson, Sven Erik Olsson, Elmir Omerovic, Georgios Panayi, Ricardo Petraco, Jan J. Piek, Flavo Ribichini, Habib Samady, Bruce Samuels, Lennart Sandhall, James Sapontis, Sayan Sen, Arnold H. Seto, Murat Sezer, Andrew S.P. Sharp, Eun Seok Shin, Jasvindar Singh, Hiroaki Takashima, Suneel Talwar, Nobuhiro Tanaka, Kare Tang, Eric Van Belle, Niels van Royen, Christoph Varenhorst, Hugo Vinhas, Christiaan J. Vrints, Darren Walters, Hiroyoshi Yokoi, Ole Fröbert, Manesh R. Patel, Patrick Serruys, Justin E. Davies, Matthias Götberg

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

121 Scopus citations

Abstract

Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.

Original language	English
Pages (from-to)	1437-1449
Number of pages	13
Journal	JACC: Cardiovascular Interventions
Volume	11
Issue number	15
DOIs	https://doi.org/10.1016/j.jcin.2018.05.029
State	Published - Aug 13 2018

Keywords

ACS
FFR
SAP
coronary physiology
deferral of revascularization
iFR

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10.1016/j.jcin.2018.05.029

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Escaned, J., Ryan, N., Mejía-Rentería, H., Cook, C. M., Dehbi, H. M., Alegria-Barrero, E., Alghamdi, A., Al-Lamee, R., Altman, J., Ambrosia, A., Baptista, S. B., Bertilsson, M., Bhindi, R., Birgander, M., Bojara, W., Brugaletta, S., Buller, C., Calais, F., Silva, P. C., ... Götberg, M. (2018). Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes. JACC: Cardiovascular Interventions, 11(15), 1437-1449. https://doi.org/10.1016/j.jcin.2018.05.029

@article{d448f5dee8bf43da9c4a31f9c9520bae,

title = "Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes",

abstract = "Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.",

keywords = "ACS, FFR, SAP, coronary physiology, deferral of revascularization, iFR",

author = "Javier Escaned and Nicola Ryan and Hern{\'a}n Mej{\'i}a-Renter{\'i}a and Cook, {Christopher M.} and Dehbi, {Hakim Moulay} and Eduardo Alegria-Barrero and Ali Alghamdi and Rasha Al-Lamee and John Altman and Alphonse Ambrosia and Baptista, {S{\'e}rgio B.} and Maria Bertilsson and Ravinay Bhindi and Mats Birgander and Waldemar Bojara and Salvatore Brugaletta and Christopher Buller and Fredrik Calais and Silva, {Pedro Canas} and J{\"o}rg Carlsson and Christiansen, {Evald H.} and Mikael Danielewicz and {Di Mario}, Carlo and Doh, {Joon Hyung} and Andrejs Erglis and David Erlinge and Gerber, {Robert T.} and Olaf Going and Ingibj{\"o}rg Gudmundsdottir and Tobias H{\"a}rle and Dario Hauer and Farrel Hellig and Ciro Indolfi and Lars Jakobsen and Luc Janssens and Jens Jensen and Allen Jeremias and Amra K{\aa}regren and Karlsson, {Ann Charlotte} and Kharbanda, {Rajesh K.} and Ahmed Khashaba and Yuetsu Kikuta and Florian Krackhardt and Koo, {Bon Kwon} and Sasha Koul and Mika Laine and Lehman, {Sam J.} and Pontus Lindroos and Malik, {Iqbal S.} and Michael Maeng and Hitoshi Matsuo and Martijn Meuwissen and Nam, {Chang Wook} and Giampaolo Niccoli and Nijjer, {Sukhjinder S.} and Hans Olsson and Olsson, {Sven Erik} and Elmir Omerovic and Georgios Panayi and Ricardo Petraco and Piek, {Jan J.} and Flavo Ribichini and Habib Samady and Bruce Samuels and Lennart Sandhall and James Sapontis and Sayan Sen and Seto, {Arnold H.} and Murat Sezer and Sharp, {Andrew S.P.} and Shin, {Eun Seok} and Jasvindar Singh and Hiroaki Takashima and Suneel Talwar and Nobuhiro Tanaka and Kare Tang and {Van Belle}, Eric and {van Royen}, Niels and Christoph Varenhorst and Hugo Vinhas and Vrints, {Christiaan J.} and Darren Walters and Hiroyoshi Yokoi and Ole Fr{\"o}bert and Patel, {Manesh R.} and Patrick Serruys and Davies, {Justin E.} and Matthias G{\"o}tberg",

note = "Publisher Copyright: {\textcopyright} 2018 The Authors",

year = "2018",

month = aug,

day = "13",

doi = "10.1016/j.jcin.2018.05.029",

language = "English",

volume = "11",

pages = "1437--1449",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

number = "15",

}

Escaned, J, Ryan, N, Mejía-Rentería, H, Cook, CM, Dehbi, HM, Alegria-Barrero, E, Alghamdi, A, Al-Lamee, R, Altman, J, Ambrosia, A, Baptista, SB, Bertilsson, M, Bhindi, R, Birgander, M, Bojara, W, Brugaletta, S, Buller, C, Calais, F, Silva, PC, Carlsson, J, Christiansen, EH, Danielewicz, M, Di Mario, C, Doh, JH, Erglis, A, Erlinge, D, Gerber, RT, Going, O, Gudmundsdottir, I, Härle, T, Hauer, D, Hellig, F, Indolfi, C, Jakobsen, L, Janssens, L, Jensen, J, Jeremias, A, Kåregren, A, Karlsson, AC, Kharbanda, RK, Khashaba, A, Kikuta, Y, Krackhardt, F, Koo, BK, Koul, S, Laine, M, Lehman, SJ, Lindroos, P, Malik, IS, Maeng, M, Matsuo, H, Meuwissen, M, Nam, CW, Niccoli, G, Nijjer, SS, Olsson, H, Olsson, SE, Omerovic, E, Panayi, G, Petraco, R, Piek, JJ, Ribichini, F, Samady, H, Samuels, B, Sandhall, L, Sapontis, J, Sen, S, Seto, AH, Sezer, M, Sharp, ASP, Shin, ES, Singh, J, Takashima, H, Talwar, S, Tanaka, N, Tang, K, Van Belle, E, van Royen, N, Varenhorst, C, Vinhas, H, Vrints, CJ, Walters, D, Yokoi, H, Fröbert, O, Patel, MR, Serruys, P, Davies, JE & Götberg, M 2018, 'Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes', JACC: Cardiovascular Interventions, vol. 11, no. 15, pp. 1437-1449. https://doi.org/10.1016/j.jcin.2018.05.029

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes. / Escaned, Javier; Ryan, Nicola; Mejía-Rentería, Hernán et al.
In: JACC: Cardiovascular Interventions, Vol. 11, No. 15, 13.08.2018, p. 1437-1449.

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

TY - JOUR

T1 - Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

AU - Escaned, Javier

AU - Ryan, Nicola

AU - Mejía-Rentería, Hernán

AU - Cook, Christopher M.

AU - Dehbi, Hakim Moulay

AU - Alegria-Barrero, Eduardo

AU - Alghamdi, Ali

AU - Al-Lamee, Rasha

AU - Altman, John

AU - Ambrosia, Alphonse

AU - Baptista, Sérgio B.

AU - Bertilsson, Maria

AU - Bhindi, Ravinay

AU - Birgander, Mats

AU - Bojara, Waldemar

AU - Brugaletta, Salvatore

AU - Buller, Christopher

AU - Calais, Fredrik

AU - Silva, Pedro Canas

AU - Carlsson, Jörg

AU - Christiansen, Evald H.

AU - Danielewicz, Mikael

AU - Di Mario, Carlo

AU - Doh, Joon Hyung

AU - Erglis, Andrejs

AU - Erlinge, David

AU - Gerber, Robert T.

AU - Going, Olaf

AU - Gudmundsdottir, Ingibjörg

AU - Härle, Tobias

AU - Hauer, Dario

AU - Hellig, Farrel

AU - Indolfi, Ciro

AU - Jakobsen, Lars

AU - Janssens, Luc

AU - Jensen, Jens

AU - Jeremias, Allen

AU - Kåregren, Amra

AU - Karlsson, Ann Charlotte

AU - Kharbanda, Rajesh K.

AU - Khashaba, Ahmed

AU - Kikuta, Yuetsu

AU - Krackhardt, Florian

AU - Koo, Bon Kwon

AU - Koul, Sasha

AU - Laine, Mika

AU - Lehman, Sam J.

AU - Lindroos, Pontus

AU - Malik, Iqbal S.

AU - Maeng, Michael

AU - Matsuo, Hitoshi

AU - Meuwissen, Martijn

AU - Nam, Chang Wook

AU - Niccoli, Giampaolo

AU - Nijjer, Sukhjinder S.

AU - Olsson, Hans

AU - Olsson, Sven Erik

AU - Omerovic, Elmir

AU - Panayi, Georgios

AU - Petraco, Ricardo

AU - Piek, Jan J.

AU - Ribichini, Flavo

AU - Samady, Habib

AU - Samuels, Bruce

AU - Sandhall, Lennart

AU - Sapontis, James

AU - Sen, Sayan

AU - Seto, Arnold H.

AU - Sezer, Murat

AU - Sharp, Andrew S.P.

AU - Shin, Eun Seok

AU - Singh, Jasvindar

AU - Takashima, Hiroaki

AU - Talwar, Suneel

AU - Tanaka, Nobuhiro

AU - Tang, Kare

AU - Van Belle, Eric

AU - van Royen, Niels

AU - Varenhorst, Christoph

AU - Vinhas, Hugo

AU - Vrints, Christiaan J.

AU - Walters, Darren

AU - Yokoi, Hiroyoshi

AU - Fröbert, Ole

AU - Patel, Manesh R.

AU - Serruys, Patrick

AU - Davies, Justin E.

AU - Götberg, Matthias

PY - 2018/8/13

Y1 - 2018/8/13

N2 - Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.

AB - Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.

KW - ACS

KW - FFR

KW - SAP

KW - coronary physiology

KW - deferral of revascularization

KW - iFR

UR - http://www.scopus.com/inward/record.url?scp=85050687646&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2018.05.029

DO - 10.1016/j.jcin.2018.05.029

M3 - Article

C2 - 30093050

AN - SCOPUS:85050687646

SN - 1936-8798

VL - 11

SP - 1437

EP - 1449

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 15

ER -

Escaned J, Ryan N, Mejía-Rentería H, Cook CM, Dehbi HM, Alegria-Barrero E et al. Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes. JACC: Cardiovascular Interventions. 2018 Aug 13;11(15):1437-1449. doi: 10.1016/j.jcin.2018.05.029

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

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