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, Sérgio 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.
N1 - Funding Information:
The DEFINE-FLAIR trial was supported by unrestricted educational grants from Philips (formerly Volcano Corporation) to Imperial College Trials Unit. This substudy received no additional funding. Dr. Bon-Kwon Koo received institutional research grant support from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr. Joo Myung Lee received a research grant support from St. Jude Medical (Abbott Vascular) and Philips Volcano. Drs. Al-Lamee, Cook, Di Mario, Kikuta, and Petraco has received personal fees from Philips Volcano. Dr. Baptista has received grants and consulting fees from Abbott; and has received personal fees from Boston Scientific and Philips Volcano, Opsens Medical, Abbott, and Heartflow. Dr. Härle has received technical support of experimental studies from Philips Volcano. Dr. Jeremias has received personal fees from St. Jude Medical and Philips Volcano. Dr. Khashaba has received other support from Volcano Corporation. Dr. Laine has received grants from Imperial College London. Dr. Nijjer has received grants from the Medical Research Council (United Kingdom); and has received personal fees and nonfinancial support from Philips Volcano. Dr. Buller is a consultant to Abbott Vascular, Philip Volcano, Teleflex Inc., and Soundbite Medical. Dr. Patel has received grants and personal fees from Volcano, AstraZeneca, and Janssen; and has received and personal fees from Bayer. Dr. Piek has received grants and personal fees from Abbott Vascular, Philips Volcano, and Miracor. Dr. Samady has served on the Medical Advisory Board for Philips Volcano; has received institutional research grants from Abbott Vascular, Medtronic, Gilead, and Philips Volcano; and owns equity in SIG and Covanos. Dr. Sen has received grants from Volcano Corporation, AstraZeneca, Medtronic, and Philips; served on the Speakers Bureau for AstraZeneca and Philips; and has received speaker fees from Philips and Pfizer. Dr. Seto has received grant support from and served on the Speakers Bureau for Volcano Corporation, Abbott, and Philips. Dr. Sharp has received personal fees from Philips Volcano and Medtronic. Dr. Singh has received personal fees from Volcano Corporation. Dr. Tanaka has received personal fees from Volcano Corporation (Japan), St. Jude Medical, and Boston Scientific. Dr. Van Belle has received personal fees from Philips Volcano; and has served as a consultant for St. Jude Medical. Dr. van Royen has received grants and personal fees from Abbott, Philips, AstraZeneca, Biotronik, Boston Scientific, Microport, Amgen, Volcano Corporation, and St. Jude Medical. Dr. Vinhas has received personal fees from Volcano Corporation. Dr. Samuel has received consulting/speaker fees from Philips Medical and Abbott Vascular. Dr. Patel has received research grant support from Philips Volcano, Bayer, and Janssen; and served on the advisory board for Bayer and Janssen. Dr. Serruys has received personal fees from Abbott, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sinomedical, Société Europa Digital, and Publishing, Stentys, Svelte, Philips Volcano, St. Jude Medical, Qualimed, and Xeltis. Dr. Escaned has received personal fees from Philips Volcano, Boston Scientific, and Abbott/St. Jude Medical. Dr. Davies has received grants and personal fees from Volcano Corporation, Medtronic, and ReCor Medical; has received personal fees from Imperial College London and AstraZeneca; and has patents WO2011110817 A2, US9339348 B2, WO2015013134 A3, EP3021741 A2, and US20150025330 A1 issued to Imperial College London and licensed to Volcano Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
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.
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.
KW - clinical outcome
KW - fractional flow reserve
KW - instantaneous wave-free ratio
KW - sex
UR - http://www.scopus.com/inward/record.url?scp=85073062022&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2019.06.035
DO - 10.1016/j.jcin.2019.06.035
M3 - Article
C2 - 31648764
AN - SCOPUS:85073062022
SN - 1936-8798
VL - 12
SP - 2035
EP - 2046
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 20
ER -