Dataset Information

Usefulness of Routine Fractional Flow Reserve for Clinical Management of Coronary Artery Disease in 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.

SUBMITTER: Van Belle E

PROVIDER: S-EPMC6990935 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Van Belle Eric E Cosenza Alessandro A Baptista Sergio Bravo SB Vincent Flavien F Henderson John J Santos Lino L Ramos Ruben R Pouillot Christophe C Calé Rita R Cuisset Thomas T Jorge Elisabete E Teiger Emmanuel E Machado Carina C Belle Loic L Costa Marco M Barreau Didier D Oliveira Eduardo E Hanssen Michel M Costa João J Besnard Cyril C Nunes Luis L Dallongeville Jean J Sideris Georgios G Bretelle Christophe C Fonseca Nuno N Lhoest Nicolas N Guardado Jorge J Silva Bruno B Sousa Maria-João MJ Barnay Pierre P Silva João Carlos JC Leborgne Laurent L Rodrigues Alberto A Porouchani Sina S Seca Luís L Fernandes Renato R Dupouy Patrick P Raposo Luís L

JAMA cardiology 20200301 3

<h4>Importance</h4>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.<h4>Objective</h4>To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for ...[more]

PMID: 31913433

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Project description:Amongst patients with suspected obstructive coronary artery disease (CAD), less than a third of patients have obstructive disease on invasive coronary angiography (ICA) and fewer still have flow-limiting obstructive disease as determined by invasive fractional flow reserve (FFR). FFR is a powerful tool in guiding revascularization of flow-limiting lesions which in turn improves clinical outcome in those with haemodynamically significant obstructive disease. However FFR is infrequently performed due to the cost, time and patient discomfort the procedure entails. Further advances in non-invasive imaging has allowed FFR to be derived non-invasively by applying computational fluid dynamic (CFD) modeling to the coronary computed tomography angiography (CCTA) dataset without the need to induce hyperemia or modify the standard CCTA acquisition protocol. FFR derived from CCTA has been shown to have excellent correlation with invasive FFR and remains diagnostically robust in presence of reduced signal-to-noise ratio (SNR), coronary calcification and motion artifact. More recently, new data have emerged evaluating the clinical impact of fractional flow reserve computed tomography (FFRCT) on the assessment and management of patients with stable chest pain. One such study is the Prospective LongitudinAl trial of FFRCT: Outcome and Resource IMpacts (PLATFORM) study which showed an improved patient selection for ICA using CCTA-FFRCT approach by increasing the likelihood of identifying obstructive CAD at ICA amongst those intended for invasive testing. CCTA-FFRCT may therefore serve as efficacious gatekeeper to ICA that enriches the ICA population. The utility of FFRCT has also helped deepened our understanding of CAD. Through CFD modeling, it is now recognized that there are mechanistic forces of wall shear stress (WSS) and axial plaque force acting on coronary plaques. This has created further interest in exploring the possible interplay between these mechanistic forces on the development of coronary plaque and vulnerability of these plaques to rupture.

Project description:BackgroundUnderstanding of the risk conferred by functionally insignificant lesions in multiple coronary vessels is limited. We investigated the prognostic implications of coronary artery disease (CAD) based on 3-vessel fractional flow reserve (FFR).Methods and resultsA total of 1,136 patients underwent FFR measurement in the 3 major epicardial arteries. We defined vessels with "Moderate CAD" as vessels with FFR, 0.81 to 0.87. Patients were classified into Group 1: No apparent CAD (FFR>0.87 in all 3-vessels); Group 2: Single-vessel moderate CAD; Group 3: Multivessel moderate CAD; and Group 4: Functionally significant CAD (FFR≤0.80) in any vessel. The primary end point was 2-year major adverse cardiac events, a composite of cardiac death, myocardial infarction, and ischemia-driven revascularization. Forty-three percent of patients had moderate CAD (Group 2: 403/1136, 35.5%; Group 3: 84/1136, 7.4%). The 2-year risk of major adverse cardiac events was not significantly different between patients with single-vessel moderate CAD and no apparent CAD (2.6 versus 2.6%; HR, 1.1; 95% confidence interval, 0.4%-2.8%; P=0.89). However, patients with multivessel moderate CAD were at significantly higher risk than Group 1 (7.4 versus 2.6%; hazard ratio, 3.3; 95% confidence interval, 1.1%-9.8%; P=0.03). The risk of major adverse cardiac events in patients with multivessel moderate CAD was comparable to that of patients with functionally significant CAD (hazard ratio, 1.2; 95% confidence interval, 0.5%-3.0%; P=0.67). In a multivariable regression model, multivessel moderate CAD was an independent predictor of greater risk of 2-year major adverse cardiac events.ConclusionsGlobal physiologic assessment with FFR measurement of 3 vessels can identify multivessel moderate CAD. The prognostic implication of multivessel moderate CAD appears comparable to that of functionally significant CAD.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01621438.

Project description:Backgroundintravascular ultrasound (IVUS) and fractional flow reserve (FFR) have both been shown to be superior to angiography in optimizing percutaneous coronary intervention (PCI). However, there is still a lack of comparative studies between PCI optimization using physiology and intravascular imaging head-to-head. The aim of this study was to compare the effectiveness of FFR and IVUS PCI optimization strategies on the functional PCI result (assessed with FFR) immediately post-PCI and at 9-12 months after the treatment of long coronary lesions.MethodsThis was a single-center study comparing post-PCI FFR between two different PCI optimization strategies (FFR and IVUS). The study included 154 patients who had hemodynamically significant long lesions, necessitating a stent length of 30 mm or more. The procedural outcomes were functional PCI result immediately post-PCI and at 9-12 months after treatment. Clinical outcomes included target vessel failure (TVF) and functional target vessel restenosis rate during follow-up.ResultsBaseline clinical characteristics and FFR (0.65 [0.55-0.71]) did not differ significantly between the two groups and the left anterior descending artery was treated in 82% of cases. The FFR optimization strategy resulted in a significantly shorter stented segment (49 mm vs. 63 mm, p = 0.001) compared to the IVUS optimization strategy. Although the rates of optimal functional PCI result (FFR > 0.9) did not significantly differ between the FFR and IVUS optimization strategies, a proportion of patients in the FFR group (12%) experienced poor post-PCI functional outcome with FFR values ≤ 0.8, which was not observed in the IVUS group. At the 9-12 month follow-up, 20% of patients in the FFR group had target-vessel-related myocardial ischemia, compared to 6% in the IVUS group. The rates of TVF and functional target vessel restenosis during follow-up were also numerically higher in the FFR optimization group.ConclusionsThe use of FFR PCI optimization strategy in the treatment of long coronary artery lesions is associated with a higher incidence of poor functional PCI result and larger myocardial ischemia burden at follow-up compared to the IVUS optimization strategy. However, this discrepancy did not translate into a statistically significant difference in clinical outcomes. This study highlights the importance of using IVUS to optimize long lesions functional PCI outcomes.

Dataset Information

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

Importance

Objective

Design, setting, and participants

Main outcomes and measures

Results

Conclusions and relevance

Publications

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

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