Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

Chee Hae Kim; Bon-Kwon Koo; Hakim-Moulay Dehbi; Joo Myung Lee; Joon-Hyung Doh; Chang-Wook Nam; Eun-Seok Shin; Christopher M. Cook; Rasha Al-Lamee; Ricardo Petraco; Sayan Sen; Iqbal S. Malik; Sukhjinder S. Nijjer; Hernán Mejía-Rentería; Eduardo Alegria-Barrero; Ali Alghamdi; John Altman; S. rgio B. Baptista; Ravinay Bhindi; Waldemar Bojara; Salvatore Brugaletta; Pedro Canas Silva; Carlo di Mario; Andrejs Erglis; Robert T. Gerber; Olaf Going; Tobias Härle; Farrel Hellig; Ciro Indolfi; Luc Janssens; Allen Jeremias; Rajesh K. Kharbanda; Ahmed Khashaba; Yuetsu Kikuta; Florian Krackhardt; Mika Laine; Sam J. Lehman; Hitoshi Matsuo; Martijin Meuwissen; Giampaolo Niccoli; Jan J. Piek; Flavo Ribichini; Habib Samady; James Sapontis; Arnold H. Seto; Murat Sezer; Andrew S. P. Sharp; Jasvindar Singh; Hiroaki Takashima; Suneel Talwar; Nobuhiro Tanaka; Kare Tang; Eric van Belle; Niels van Royen; Hugo Vinhas; Christiaan J. Vrints; Darren Walters; Hiroyoshi Yokoi; Bruce Samuels; Christopher Buller; Manesh R. Patel; Patrick W. Serruys; Javier Escaned; Justin E. Davies

doi:https://doi.org/10.1016/j.jcin.2019.06.035

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

Chee Hae Kim, Bon-Kwon Koo, Hakim-Moulay Dehbi, Joo Myung Lee, Joon-Hyung Doh, Chang-Wook Nam, Eun-Seok Shin, Christopher M. Cook, Rasha Al-Lamee, Ricardo Petraco, Sayan Sen, Iqbal S. Malik, Sukhjinder S. Nijjer, Hernán Mejía-Rentería, Eduardo Alegria-Barrero, Ali Alghamdi, John Altman, S. rgio B. Baptista, Ravinay Bhindi, Waldemar BojaraSalvatore Brugaletta, Pedro Canas Silva, Carlo di Mario, Andrejs Erglis, Robert T. Gerber, Olaf Going, Tobias Härle, Farrel Hellig, Ciro Indolfi, Luc Janssens, Allen Jeremias, Rajesh K. Kharbanda, Ahmed Khashaba, Yuetsu Kikuta, Florian Krackhardt, Mika Laine, Sam J. Lehman, Hitoshi Matsuo, Martijin Meuwissen, Giampaolo Niccoli, Jan J. Piek, Flavo Ribichini, Habib Samady, James Sapontis, Arnold H. Seto, Murat Sezer, Andrew S. P. Sharp, Jasvindar Singh, Hiroaki Takashima, Suneel Talwar, Nobuhiro Tanaka, Kare Tang, Eric van Belle, Niels van Royen, Hugo Vinhas, Christiaan J. Vrints, Darren Walters, Hiroyoshi Yokoi, Bruce Samuels, Christopher Buller, Manesh R. Patel, Patrick W. Serruys, Javier Escaned, Justin E. Davies

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

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Abstract

Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)– and fractional flow reserve (FFR)–guided revascularization strategies. Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038)

Original language	English
Pages (from-to)	2035-2046
Journal	JACC. Cardiovascular interventions
Volume	12
Issue number	20
DOIs	https://doi.org/10.1016/j.jcin.2019.06.035
Publication status	Published - 28 Oct 2019

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Kim, C. H., Koo, B.-K., Dehbi, H.-M., Lee, J. M., Doh, J.-H., Nam, C.-W., Shin, E.-S., Cook, C. M., Al-Lamee, R., Petraco, R., Sen, S., Malik, I. S., Nijjer, S. S., Mejía-Rentería, H., Alegria-Barrero, E., Alghamdi, A., Altman, J., Baptista, S. R. B., Bhindi, R., ... Davies, J. E. (2019). Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy. JACC. Cardiovascular interventions, 12(20), 2035-2046. https://doi.org/10.1016/j.jcin.2019.06.035

@article{fff817822ff84ac08a8daa643875e0ac,

title = "Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy",

abstract = "Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)– and fractional flow reserve (FFR)–guided revascularization strategies. Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038)",

author = "Kim, {Chee Hae} and Bon-Kwon Koo and Hakim-Moulay Dehbi and Lee, {Joo Myung} and Joon-Hyung Doh and Chang-Wook Nam and Eun-Seok Shin and Cook, {Christopher M.} and Rasha Al-Lamee and Ricardo Petraco and Sayan Sen and Malik, {Iqbal S.} and Nijjer, {Sukhjinder S.} and Hern{\'a}n Mej{\'i}a-Renter{\'i}a and Eduardo Alegria-Barrero and Ali Alghamdi and John Altman and Baptista, {S. rgio B.} and Ravinay Bhindi and Waldemar Bojara and Salvatore Brugaletta and Silva, {Pedro Canas} and {di Mario}, Carlo and Andrejs Erglis and Gerber, {Robert T.} and Olaf Going and Tobias H{\"a}rle and Farrel Hellig and Ciro Indolfi and Luc Janssens and Allen Jeremias and Kharbanda, {Rajesh K.} and Ahmed Khashaba and Yuetsu Kikuta and Florian Krackhardt and Mika Laine and Lehman, {Sam J.} and Hitoshi Matsuo and Martijin Meuwissen and Giampaolo Niccoli and Piek, {Jan J.} and Flavo Ribichini and Habib Samady and James Sapontis and Seto, {Arnold H.} and Murat Sezer and Sharp, {Andrew S. P.} and Jasvindar Singh and Hiroaki Takashima and Suneel Talwar and Nobuhiro Tanaka and Kare Tang and {van Belle}, Eric and {van Royen}, Niels and Hugo Vinhas and Vrints, {Christiaan J.} and Darren Walters and Hiroyoshi Yokoi and Bruce Samuels and Christopher Buller and Patel, {Manesh R.} and Serruys, {Patrick W.} and Javier Escaned and Davies, {Justin E.}",

year = "2019",

month = oct,

day = "28",

doi = "https://doi.org/10.1016/j.jcin.2019.06.035",

language = "English",

volume = "12",

pages = "2035--2046",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "20",

}

Kim, CH, Koo, B-K, Dehbi, H-M, Lee, JM, Doh, J-H, Nam, C-W, Shin, E-S, Cook, CM, Al-Lamee, R, Petraco, R, Sen, S, Malik, IS, Nijjer, SS, Mejía-Rentería, H, Alegria-Barrero, E, Alghamdi, A, Altman, J, Baptista, SRB, Bhindi, R, Bojara, W, Brugaletta, S, Silva, PC, di Mario, C, Erglis, A, Gerber, RT, Going, O, Härle, T, Hellig, F, Indolfi, C, Janssens, L, Jeremias, A, Kharbanda, RK, Khashaba, A, Kikuta, Y, Krackhardt, F, Laine, M, Lehman, SJ, Matsuo, H, Meuwissen, M, Niccoli, G, Piek, JJ, Ribichini, F, Samady, H, Sapontis, J, Seto, AH, Sezer, M, Sharp, ASP, Singh, J, Takashima, H, Talwar, S, Tanaka, N, Tang, K, van Belle, E, van Royen, N, Vinhas, H, Vrints, CJ, Walters, D, Yokoi, H, Samuels, B, Buller, C, Patel, MR, Serruys, PW, Escaned, J & Davies, JE 2019, 'Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy', JACC. Cardiovascular interventions, vol. 12, no. 20, pp. 2035-2046. https://doi.org/10.1016/j.jcin.2019.06.035

TY - JOUR

T1 - Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

AU - Kim, Chee Hae

AU - Koo, Bon-Kwon

AU - Dehbi, Hakim-Moulay

AU - Lee, Joo Myung

AU - Doh, Joon-Hyung

AU - Nam, Chang-Wook

AU - Shin, Eun-Seok

AU - Cook, Christopher M.

AU - Al-Lamee, Rasha

AU - Petraco, Ricardo

AU - Sen, Sayan

AU - Malik, Iqbal S.

AU - Nijjer, Sukhjinder S.

AU - Mejía-Rentería, Hernán

AU - Alegria-Barrero, Eduardo

AU - Alghamdi, Ali

AU - Altman, John

AU - Baptista, S. rgio B.

AU - Bhindi, Ravinay

AU - Bojara, Waldemar

AU - Brugaletta, Salvatore

AU - Silva, Pedro Canas

AU - di Mario, Carlo

AU - Erglis, Andrejs

AU - Gerber, Robert T.

AU - Going, Olaf

AU - Härle, Tobias

AU - Hellig, Farrel

AU - Indolfi, Ciro

AU - Janssens, Luc

AU - Jeremias, Allen

AU - Kharbanda, Rajesh K.

AU - Khashaba, Ahmed

AU - Kikuta, Yuetsu

AU - Krackhardt, Florian

AU - Laine, Mika

AU - Lehman, Sam J.

AU - Matsuo, Hitoshi

AU - Meuwissen, Martijin

AU - Niccoli, Giampaolo

AU - Piek, Jan J.

AU - Ribichini, Flavo

AU - Samady, Habib

AU - Sapontis, James

AU - Seto, Arnold H.

AU - Sezer, Murat

AU - Sharp, Andrew S. P.

AU - Singh, Jasvindar

AU - Takashima, Hiroaki

AU - Talwar, Suneel

AU - Tanaka, Nobuhiro

AU - Tang, Kare

AU - van Belle, Eric

AU - van Royen, Niels

AU - Vinhas, Hugo

AU - Vrints, Christiaan J.

AU - Walters, Darren

AU - Yokoi, Hiroyoshi

AU - Samuels, Bruce

AU - Buller, Christopher

AU - Patel, Manesh R.

AU - Serruys, Patrick W.

AU - Escaned, Javier

AU - Davies, Justin E.

PY - 2019/10/28

Y1 - 2019/10/28

N2 - Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)– and fractional flow reserve (FFR)–guided revascularization strategies. Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038)

AB - Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)– and fractional flow reserve (FFR)–guided revascularization strategies. Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038)

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U2 - https://doi.org/10.1016/j.jcin.2019.06.035

DO - https://doi.org/10.1016/j.jcin.2019.06.035

M3 - Article

C2 - 31648764

SN - 1936-8798

VL - 12

SP - 2035

EP - 2046

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

IS - 20

ER -

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

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