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JACC Cardiovasc Interv. 2019;12(20):2035-2046.

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

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제1저자 김지혜 · 교신저자 구본권

소속 (56)
  1. Division of Cardiology, Department of Internal Medicine, VHS Medical Center, Seoul, South Korea.
  2. Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University, Seoul, South Korea; Institute on Aging, Seoul National University, Seoul, South Korea. Electronic address: bkkoo@snu.ac.kr.
  3. Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.
  4. Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
  5. Department of Medicine, Inje University Ilsan Paik Hospital, Daehwa-dong, South Korea.
  6. Department of Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea.
  7. Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan Hospital, Ulsan, South Korea.
  8. Hammersmith Hospital, Imperial College London, London, United Kingdom.
  9. Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Universidad Complutense de Madrid, Madrid, Spain.
  10. Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.
  11. King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.
  12. Colorado Heart and Vascular, Lakewood, Colorado.
  13. Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal.
  14. Royal North Shore Hospital, Sydney, Australia.
  15. Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.
  16. Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
  17. Hospital Santa Maria, Lisbon, Portugal.
  18. Royal Brompton Hospital, Imperial College London, London, United Kingdom; University of Florence, Florence, Italy.
  19. Pauls Stradins Clinical University Hospital, Riga, Latvia.
  20. Conquest Hospital, St Leonards-on-Sea, United Kingdom.
  21. Sana Klinikum Lichtenberg, Lichtenberg, Germany.
  22. Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.
  23. Sunninghill Hospital, Johannesburg, South Africa.
  24. University Magna Graecia, Catanzaro, Italy.
  25. Imelda Hospital, Bonheiden, Belgium.
  26. Stony Brook University Medical Center, New York, New York.
  27. John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.
  28. Ain Shams University, Cairo, Egypt.
  29. Fukuyama Cardiovascular Hospital, Fukuyama, Japan.
  30. Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.
  31. Helsinki University Hospital, Helsinki, Finland.
  32. Flinders University, Adelaide, Australia.
  33. Gifu Heart Center, Gifu, Japan.
  34. Amphia Hospital, Breda, the Netherlands.
  35. Catholic University of the Sacred Heart, Rome, Italy.
  36. AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.
  37. University Hospital Verona, Verona, Italy.
  38. Emory University, Atlanta, Georgia.
  39. MonashHeart, Monash University, Melbourne, Australia.
  40. Veterans Affairs Long Beach Healthcare System, Long Beach, California.
  41. Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.
  42. Royal Devon and Exeter Hospital, University of Exeter, Exeter, United Kingdom.
  43. Washington University School of Medicine in St. Louis, St. Louis, Missouri.
  44. Aichi Medical University Hospital, Aichi, Japan.
  45. Royal Bournemouth General Hospital, Bournemouth, United Kingdom.
  46. Tokyo Medical University, Tokyo, Japan.
  47. Essex Cardiothoracic Centre, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.
  48. Institut Coeur Poumon, Lille University Hospital, Lille, France; UMR INSERM 1011, Centre Hospitalier Universitaire de Lille et de Institut Pasteur de Lille, Université de Lille, Lille, France.
  49. VU University Medical Center, Amsterdam, the Netherlands.
  50. Hospital Garcia de Horta, Lisbon, Portugal.
  51. Antwerp University Hospital, Antwerp, Belgium.
  52. Prince Charles Hospital, Brisbane, Australia.
  53. Fukuoka Sannou Hospital, Fukuoka, Japan.
  54. Cedars-Sinai Heart Institute, Los Angeles, California.
  55. St. Michaels Hospital, Toronto, Canada.
  56. Duke University, Durham, Norh Carolina.

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).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Keywords

clinical outcomefractional flow reserveinstantaneous wave-free ratiosex

Comment · 정정

그 밖의 정보
출판 형태
Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
저널
JACC. Cardiovascular interventions · eISSN 1876-7605
MeSH
Acute Coronary Syndrome / diagnosis / mortality / physiopathology / therapy · Aged · Cardiac Catheterization* · Cause of Death · Coronary Artery Disease / diagnosis / mortality / physiopathology / therapy · Coronary Stenosis / diagnosis / mortality / physiopathology / therapy · Coronary Vessels / physiopathology · Female · Fractional Flow Reserve, Myocardial* · Health Status Disparities* · Healthcare Disparities* · Humans · Male · Middle Aged · Predictive Value of Tests · Recurrence · Risk Factors · ST Elevation Myocardial Infarction / diagnosis / mortality / physiopathology / therapy · Sex Factors · Time Factors · Treatment Outcome
연구비
Medical Research Council G1100443
데이터
ClinicalTrials.gov: NCT02053038