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. 2020 Mar 1;5(3):272-281.
doi: 10.1001/jamacardio.2019.5097.

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

Eric Van Belle  1   2 , Alessandro Cosenza  1   2 , Sergio Bravo Baptista  3   4 , Flavien Vincent  1   2 , John Henderson  5 , Lino Santos  6 , Ruben Ramos  7 , Christophe Pouillot  8 , Rita Calé  9 , Thomas Cuisset  10 , Elisabete Jorge  11 , Emmanuel Teiger  12 , Carina Machado  13 , Loic Belle  14 , Marco Costa  15 , Didier Barreau  16 , Eduardo Oliveira  17 , Michel Hanssen  18 , João Costa  19 , Cyril Besnard  20 , Luis Nunes  21 , Jean Dallongeville  22 , Georgios Sideris  23 , Christophe Bretelle  24 , Nuno Fonseca  25 , Nicolas Lhoest  26 , Jorge Guardado  27 , Bruno Silva  28 , Maria-João Sousa  29 , Pierre Barnay  30 , João Carlos Silva  31 , Laurent Leborgne  32 , Alberto Rodrigues  33 , Sina Porouchani  1 , Luís Seca  34 , Renato Fernandes  35 , Patrick Dupouy  36 , Luís Raposo  37 ; PRIME-FFR Study Group
Affiliations

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

Eric Van Belle et al. JAMA Cardiol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Van Belle reported receiving personal fees from Abbott (St Jude Medical) and Philips Volcano during the conduct of the study. Dr Baptista reported receiving grants from Abbott during the conduct of the study and receiving personal fees from Abbott, Boston Scientific, Heartflow, and Opsens Medical outside the submitted work. Dr Raposo reported receiving grants, personal fees, and nonfinancial support from Abbott (St Jude Medical) during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart
FFR indicates fractional flow reserve.
Figure 2.
Figure 2.. Rate of Fractional Flow Reserve–Based Reclassification of the Management Strategy Among Patients With and Without Diabetes According to the Management Strategy a Priori
CABG indicates coronary artery bypass graft; PCI, percutaneous coronary intervention.
Figure 3.
Figure 3.. Fractional Flow Reserve (FFR)–Based Decision and Clinical Outcome in the Overall Population of Patients With Diabetes Compared With Patients Without Diabetes
A, One-year outcome of FFR-based reclassification of the treatment strategy was associated with a low rate of major adverse cardiovascular events (all-cause death, myocardial infarction, and revascularization) among patients with diabetes. B, One-year outcome of FFR-based deferral to medical treatment was associated with a low rate of major adverse cardiovascular events among patients with diabetes.
See this image and copyright information in PMC

References

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