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Original Investigation
January 8, 2020

Usefulness of Routine Fractional Flow Reserve for Clinical Management of Coronary Artery Disease in Patients With Diabetes

Author Affiliations
  • 1Département de Cardiologie, Institut Coeur-Poumon, Centre Hospitalier Universitaire de Lille, Lille, France
  • 2Institut national de la santé et de la recherche médicale INSERM U1011, Lille-II-University, Lille, France
  • 3Serviço de Cardiologia, Hospital Prof Doutor Fernando da Fonseca, Amadora, Portugal
  • 4University Clinic of Cardiology–Faculty of Medicine at University of Lisbon, Lisbon, Portugal
  • 5Statistical Department, St. Jude Medical Inc, St Paul, Minnesota
  • 6Serviço de Cardiologie, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal
  • 7Serviço de Cardiologia, Hospital Santa Marta–Centro Hospitalar Lisboa Central, Lisboa, Portugal
  • 8Department de Cardiologia, Clinique Sainte Clotilde, Saint Denis de la Réunion, France
  • 9Serviço de Cardiologia, Hospital Garcia de Orta, Almada, Portugal
  • 10Department de Cardiologie, Centre Hospitalar Universitaire, La Timone, Marseille, France
  • 11Serviço de Cardiologia, Centro Hospitalar Universitário, Coimbra, Coimbra, Portugal
  • 12Department of Cardiologie, Centre Hospitalar Universitaire Mondor, Créteil, France
  • 13Serviço de Cardiologia, Hospital Divino Espirito Santo, Ponta Delgada, Portugal
  • 14Department de Cardiologie, Centre Hospitalier d'Annecy, Annecy, France
  • 15Serviço de Cardiologia, Hospital Geral dos Covões–Centro Hospitalar Coimbra, Coimbra, Portugal
  • 16Department of Cardiologie, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer–Hôpital Sainte Musse, Toulon, France
  • 17Serviço de Cardiologia, Hospital Santa Maria–Centro Hospitalar Lisboa Norte, Lisboa, Portugal
  • 18Department de Cardiologie, Centre Hospitalier Haguenau, Haguenau, France
  • 19Serviço de Cardiologia, Hospital de Braga, Braga, Portugal
  • 20Department of Cardiologie, Hôpital de la Croix-Rousse, Lyon, France
  • 21Serviço de Cardiologia, Hospital São Teotónio, Viseu, Portugal
  • 22Institut Pasteur de Lille, Institut national de la santé et de la recherche médicale INSERM, Lille, France
  • 23Department of Cardiologie, Hôpital Lariboisière, Paris, France
  • 24Department of Cardiologie, Centre Hospitalier Valence, Valence, France
  • 25Serviço de Cardiologia, Centro Hospitalar Setúbal, Setúbal, Portugal
  • 26Department of Cardiologie, Hôpital Albert Schweizer, Colmar, France
  • 27Serviço de Cardiologia, Hospital Santo André–Centro Hospitalar Leiria-Pombal, Leiria, Portugal
  • 28Serviço de Cardiologia, Hospital Dr Nélio Mendonça, Funchal, Portugal
  • 29Serviço de Cardiologia, Hospital Geral Santo António–Centro Hospitalar do Porto, Porto, Portugal
  • 30Department of Cardiologie, Centre Hospitalier La Durance, Avignon, France
  • 31Serviço de Cardiologia, Centro Hospitalar São João, Porto, Portugal
  • 32Department of Cardiologie, Centre Hospitalier Amiens Sud, Amiens, France
  • 33Serviço de Cardiologia, Centro Hospitalar Tâmega e Sousa, Penafiel, Portugal
  • 34Serviço de Cardiologia, Centro Hospitalar Trás-os-Montes e Alto Douro–Unidade Hospitalar Vila Real, Vila Real, Portugal
  • 35Serviço de Cardiologia, Hospital Espírito Santo, Évora, Portugal
  • 36Department of Cardiologie, Hôpital Privé d'Antony, Antony, France
  • 37Serviço de Cardiologia, Hospital de Santa Cruz–Centro Hospitalar de Lisboa Ocidental, Carnaxide, Portugal
JAMA Cardiol. Published online January 8, 2020. doi:10.1001/jamacardio.2019.5097
Key Points

Question  What are the usefulness, rate of major adverse cardiovascular events (MACE), and clinical outcomes of routinely integrating fractional flow reserve in the management strategy for patients with diabetes who undergo coronary angiography?

Findings  In this cross-sectional study of 1983 patients, overall reclassification by fractional flow rate was high and similar in patients with diabetes (41.2%) and patients without diabetes (37.5%); however, reclassification from medical treatment to revascularization was more frequent among patients with diabetes. The rate of 1-year MACE was similar in reclassified (9.7%) and nonreclassified (12.0%) patients with diabetes, and the rate of MACE of patients deferred based on fractional flow reserve was similar among those with and without diabetes.

Meaning  The findings suggest that management strategies guided by fractional flow reserve, including revascularization deferral, may be useful for patients with diabetes.

Abstract

Importance  Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned.

Objective  To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography.

Design, Setting, and Participants  This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018.

Main Outcomes and Measures  Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year.

Results  Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status.

Conclusions and Relevance  Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.

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