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Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

ABSTRACT: Importance:Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated. Objective:To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial. Design, Setting, and Participants:The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015. Interventions:According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred. Main Outcomes and Measures:The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups. Results:Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n?=?477 of 844] vs 46.6% [n?=?402 of 863]; P?

SUBMITTER: DEFINE-FLAIR Trial Investigators

PROVIDER: S-EPMC6646975 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Lee Joo Myung JM Choi Ki Hong KH Koo Bon-Kwon BK Dehbi Hakim-Moulay HM Doh Joon-Hyung JH Nam Chang-Wook CW Shin Eun-Seok ES Cook Christopher M CM Al-Lamee Rasha R Petraco Ricardo R Sen Sayan S Malik Iqbal S IS Nijjer Sukhjinder S SS Mejía-Rentería Hernán H Alegria-Barrero Eduardo E Alghamdi Ali A Altman John J Baptista Sérgio B SB Bhindi Ravinay R Bojara Waldemar W Brugaletta Salvatore S Silva Pedro Canas PC Di Mario Carlo C Erglis Andrejs A Gerber Robert T RT Going Olaf O Härle Tobias T Hellig Farrel F Indolfi Ciro C Janssens Luc L Jeremias Allen A Kharbanda Rajesh K RK Khashaba Ahmed A Kikuta Yuetsu Y Krackhardt Florian F Laine Mika M Lehman Sam J SJ Matsuo Hitoshi H Meuwissen Martijin M Niccoli Giampaolo G Piek Jan J JJ Ribichini Flavo F Samady Habib H Sapontis James J Seto Arnold H AH Sezer Murat M Sharp Andrew S P ASP Singh Jasvindar J Takashima Hiroaki H Talwar Suneel S Tanaka Nobuhiro N Tang Kare K Van Belle Eric E van Royen Niels N Vinhas Hugo H Vrints Christiaan J CJ Walters Darren D Yokoi Hiroyoshi H Samuels Bruce B Buller Chris C Patel Manesh R MR Serruys Patrick P Escaned Javier J Davies Justin E JE

JAMA cardiology 20190901 9

<h4>Importance</h4>Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated.<h4>Objective</h4>To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenos ...[more]

PMID: 31314045

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Project description:Background Quantitative flow ratio ( QFR ) has a high diagnostic accuracy in assessing functional stenoses relevance, as judged by fractional flow reserve ( FFR ). However, its diagnostic performance has not been thoroughly evaluated using instantaneous wave-free ratio ( iFR ) or coronary flow reserve as the reference standard. This study sought to evaluate the diagnostic performance of QFR using other reference standards beyond FFR . Methods and Results We analyzed 182 patients (253 vessels) with stable ischemic heart disease and 82 patients (105 nonculprit vessels) with acute myocardial infarction in whom coronary stenoses were assessed with FFR , iFR, and coronary flow reserve. Contrast QFR analysis of interrogated vessels was performed in blinded fashion by a core laboratory, and its diagnostic performance was evaluated with respect to the other invasive physiological indices. Mean percentage diameter stenosis, FFR , iFR , coronary flow reserve, and QFR were 53.1±19.0%, 0.80±0.13, 0.88±0.12, 3.14±1.30, and 0.81±0.14, respectively. QFR showed higher correlation ( r=0.863 with FFR versus 0.740 with iFR , P<0.001), diagnostic accuracy (90.8% versus 81.3%, P<0.001), and discriminant function (area under the curve=0.953 versus 0.880, P<0.001) when FFR was used as a reference standard than when iFR was used as the reference standard. However, when coronary flow reserve was used as an independent reference standard, FFR , iFR , and QFR showed modest discriminant function (area under the curve=0.682, 0.765, and 0.677, respectively) and there were no significant differences in diagnostic accuracy among FFR , iFR , and QFR (65.4%, 70.6%, and 64.9%; all P values in pairwise comparisons >0.05, overall comparison P=0.061). Conclusions QFR has a high correlation and agreement with respect to both FFR and iFR , although it is better when FFR is used as the comparator. As a pressure-derived index not depending on wire or adenosine, QFR might be a promising tool for improving the adoption rate of physiology-based revascularization in clinical practice.

Project description:BACKGROUND:There has been a gradual upward creep of revascularization thresholds for both fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR), before the clinical outcome trials for both indices. The increase in revascularization that has potentially resulted is at odds with increasing evidence questioning the benefits of revascularizing stable coronary disease. Using an independent invasive reference standard, this study primarily aimed to define optimal thresholds for FFR and iFR and also aimed to compare the performance of iFR, FFR, and resting distal coronary pressure (Pd)/central aortic pressure (Pa). METHODS AND RESULTS:Pd and Pa were measured in 75 patients undergoing coronary angiography±percutaneous coronary intervention with resting Pd/Pa, iFR, and FFR calculated. Doppler average peak flow velocity was simultaneously measured and hyperemic stenosis resistance calculated as hyperemic stenosis resistance=Pa-Pd/average peak flow velocity (using hyperemic stenosis resistance >0.80 mm?Hg/cm per second as invasive reference standard). An FFR threshold of 0.75 had an optimum diagnostic accuracy (84%), whereas for iFR this was 0.86 (76%). At these thresholds, the discordance in classification between indices was 11%. The accuracy of contemporary thresholds (FFR, 0.80; iFR, 0.89) was significantly lower (78.7% and 65.3%, respectively) with a 25% rate of discordance. The optimal threshold for Pd/Pa was 0.88 (77.3% accuracy). When comparing indices at optimal thresholds, FFR showed the best diagnostic performance (area under the curve, 0.91 FFR versus 0.79 iFR and 0.77 Pd/Pa, P=0.002). CONCLUSIONS:Contemporary thresholds provide suboptimal diagnostic accuracy compared with an FFR threshold of 0.75 and iFR threshold of 0.86 (cutoffs in derivation studies). Whether more rigorous thresholds would result in selecting populations gaining greater symptom and prognostic benefit needs assessing in future trials of physiology-guided revascularization.

Project description:Background The FiGARO (FFR versus iFR in Assessment of Hemodynamic Lesion Significance, and an Explanation of Their Discrepancies) trial is a prospective registry searching for predictors of fractional flow reserve/instantaneous wave-free ratio (FFR/iFR) discrepancy. Methods and Results FFR/iFR were analyzed using a Verrata wire, and coronary flow reserve was analyzed using a Combomap machine (both Philips-Volcano). The risk polymorphisms for endothelial nitric oxide synthase and for heme oxygenase-1 were analyzed. In total, 1884 FFR/iFR measurements from 1564 patients were included. The FFR/iFR discrepancy occurred in 393 measurements (20.9%): FFRp (positive)/iFRn (negative) type (264 lesions, 14.0%) and FFRn/iFRp (129 lesions, 6.8%) type. Coronary flow reserve was measured in 343 lesions, correlating better with iFR (R=0.56, P<0.0001) than FFR (R=0.36, P<0.0001). The coronary flow reserve value in FFRp/iFRn lesions (2.24±0.7) was significantly higher compared with both FFRp/iFRp (1.39±0.36), and FFRn/iFRn lesions (1.8±0.64, P<0.0001). Multivariable logistic regression analysis confirmed (1) sex, age, and lesion location in the right coronary artery as predictors for FFRp/iFRn discrepancy; and (2) hemoglobin level, smoking, and renal insufficiency as predictors for FFRn/iFRp discrepancy. The FFRn/iFRp type of discrepancy was significantly more frequent in patients with both risk types of polymorphisms (endothelial nitric oxide synthaser+heme oxygenase-1r): 8 patients (24.2%) compared with FFRp/iFRn type of discrepancy: 2 patients (5.9%), P=0.03. Conclusions Predictors for FFRp/iFRn discrepancy were sex, age, and location in the right coronary artery. Predictors for FFRn/iFRp were hemoglobin level, smoking, and renal insufficiency. The risk type of polymorphism in endothelial nitric oxide synthase and heme oxygenase-1 genes was more frequently found in patients with FFRn/iFRp type of discrepancy. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT03033810.

Dataset Information

Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Publications

Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

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