Javier Escaned1, Nicola Ryan1, Hernán Mejía-Rentería1, Christopher M Cook2, Hakim-Moulay Dehbi3, Eduardo Alegria-Barrero4, Ali Alghamdi5, Rasha Al-Lamee2, John Altman6, Alphonse Ambrosia7, Sérgio B Baptista8, Maria Bertilsson9, Ravinay Bhindi10, Mats Birgander11, Waldemar Bojara12, Salvatore Brugaletta13, Christopher Buller14, Fredrik Calais15, Pedro Canas Silva16, Jörg Carlsson17, Evald H Christiansen18, Mikael Danielewicz19, Carlo Di Mario20, Joon-Hyung Doh21, Andrejs Erglis22, David Erlinge11, Robert T Gerber23, Olaf Going24, Ingibjörg Gudmundsdottir25, Tobias Härle26, Dario Hauer27, Farrel Hellig28, Ciro Indolfi29, Lars Jakobsen18, Luc Janssens30, Jens Jensen31, Allen Jeremias32, Amra Kåregren33, Ann-Charlotte Karlsson34, Rajesh K Kharbanda35, Ahmed Khashaba36, Yuetsu Kikuta37, Florian Krackhardt38, Bon-Kwon Koo39, Sasha Koul11, Mika Laine40, Sam J Lehman41, Pontus Lindroos42, Iqbal S Malik2, Michael Maeng18, Hitoshi Matsuo43, Martijn Meuwissen44, Chang-Wook Nam45, Giampaolo Niccoli46, Sukhjinder S Nijjer2, Hans Olsson19, Sven-Erik Olsson47, Elmir Omerovic48, Georgios Panayi27, Ricardo Petraco2, Jan J Piek49, Flavo Ribichini50, Habib Samady51, Bruce Samuels52, Lennart Sandhall47, James Sapontis53, Sayan Sen2, Arnold H Seto54, Murat Sezer55, Andrew S P Sharp56, Eun-Seok Shin57, Jasvindar Singh58, Hiroaki Takashima59, Suneel Talwar60, Nobuhiro Tanaka61, Kare Tang62, Eric Van Belle63, Niels van Royen64, Christoph Varenhorst65, Hugo Vinhas66, Christiaan J Vrints67, Darren Walters68, Hiroyoshi Yokoi69, Ole Fröbert15, Manesh R Patel70, Patrick Serruys71, Justin E Davies72, Matthias Götberg11. 1. Hospital Clínico San Carlos, IDISSC, and Universidad Complutense de Madrid, Madrid, Spain. 2. Hammersmith Hospital, Imperial College London, London, United Kingdom. 3. CRUK & UCL Cancer Trials Centre, University College London, London, United Kingdom. 4. Hospital Universitario de Torrejón and Universidad Francisco de Vitoria, Madrid, Spain. 5. King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia. 6. Colorado Heart and Vascular, Lakewood, Colorado. 7. Mesa, Arizona. 8. Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal. 9. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 10. Royal North Shore Hospital, Sydney, Australia. 11. Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden. 12. Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany. 13. Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. 14. St. Michaels Hospital, Toronto, Ontario, Canada. 15. Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden. 16. Hospital Santa Maria, Lisbon, Portugal. 17. Kalmar County Hospital, and Linnaeus University, Faculty of Health and Life Sciences, Kalmar, Sweden. 18. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 19. Department of Cardiology, Karlstad Hospital, Karlstad, Sweden. 20. Royal Brompton Hospital, Imperial College London, United Kingdom, and University of Florence, Florence, Italy. 21. Inje University Ilsan Paik Hospital, Daehwa-Dong, South Korea. 22. Pauls Stradins Clinical University Hospital, Riga, Latvia. 23. Conquest Hospital, St. Leonards-on-Sea, United Kingdom. 24. Sana Klinikum Lichtenberg, Lichtenberg, Germany. 25. Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland. 26. Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany. 27. Departments of Cardiology and Medical and Health Sciences, Linköping University, Linköping, Sweden. 28. Sunninghill Hospital, Johannesburg, South Africa. 29. University Magna Graecia, Catanzaro, Italy. 30. Imelda Hospital, Bonheiden, Belgium. 31. Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and Unit of Cardiology, Capio S:t Görans Sjukhus, Stockholm, and Department of Medicine, Sundsvall Hospital, Sundsvall, Sweden. 32. Stony Brook University Medical Center, Stony Brook, New York. 33. Department of Internal Medicine, Västmanland Hospital Västerås, Västerås, Sweden. 34. Department of Cardiology, Halmstad Hospital, Halmstad, Sweden. 35. John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom. 36. Ain Shams University, Cairo, Egypt. 37. Fukuyama Cardiovascular Hospital, Fukuyama, Japan. 38. Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany. 39. Seoul National University Hospital, Seoul, South Korea. 40. Helsinki University Hospital, Helsinki, Finland. 41. Flinders University, Adelaide, Australia. 42. Department of Cardiology, St. Göran Hospital, Stockholm, Sweden. 43. Gifu Heart Center, Gifu, Japan. 44. Amphia Hospital, Breda, the Netherlands. 45. Keimyung University Dongsan Medical Center, Daegu, South Korea. 46. Catholic University of the Sacred Heart, Rome, Italy. 47. Departments of Cardiology and Radiology, Helsingborg Hospital, Helsingborg, Sweden. 48. Department of Cardiology, Sahlgrenska University Gothenburg, Sweden. 49. AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands. 50. University Hospital Verona, Verona, Italy. 51. Emory University, Atlanta, Georgia. 52. Cedars-Sinai Heart Institute, Los Angeles, California. 53. MonashHeart and Monash University, Melbourne, Australia. 54. Veterans Affairs Long Beach Healthcare System, Long Beach, California. 55. Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey. 56. Royal Devon and Exeter Hospital and University of Exeter, Exeter, United Kingdom. 57. Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea. 58. Washington University School of Medicine, St. Louis, Missouri. 59. Aichi Medical University Hospital, Aichi, Japan. 60. Royal Bournemouth General Hospital, Bournemouth, United Kingdom. 61. Tokyo Medical University, Tokyo, Japan. 62. Essex Cardiothoracic Centre, Basildon and Anglia Ruskin University, Chelmsford, United Kingdom. 63. Institut Coeur Poumon, Lille University Hospital, and INSERM Unité 1011, Lille, France. 64. VU University Medical Center, Amsterdam, the Netherlands. 65. Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 66. Hospital Garcia de Horta, Lisbon, Portugal. 67. Antwerp University Hospital, Antwerp, Belgium. 68. Prince Charles Hospital, Brisbane, Australia. 69. Fukuoka Sannou Hospital, Fukuoka, Japan. 70. Duke University, Durham, North Carolina. 71. Department of Cardiology, Imperial College London, London, United Kingdom. 72. Hammersmith Hospital, Imperial College London, London, United Kingdom. Electronic address: justindavies@heart123.com.
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.
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.
Authors: Tim P van de Hoef; Joo Myung Lee; Mauro Echavarria-Pinto; Bon-Kwon Koo; Hitoshi Matsuo; Manesh R Patel; Justin E Davies; Javier Escaned; Jan J Piek Journal: Nat Rev Cardiol Date: 2020-05-14 Impact factor: 32.419
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Authors: Roberto Scarsini; Dimitrios Terentes-Printzios; Giovanni Luigi De Maria; Flavio Ribichini; Adrian Banning Journal: Interv Cardiol Date: 2020-06-04