FFR-guided Percutaneous Coronary Intervention Research Articles

Treatment strategy modification and its implication on the medical cost of fractional flow reserve-guided percutaneous coronary intervention in Japan

BackgroundFractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) could improve outcome compared with angiography-guided PCI. However, the economic impact of FFR-guided PCI remains largely unknown in the medical system in Japan. We evaluated the impact of treatment strategy modification by FFR measurement on the direct medical cost using a model analysis with a decision tree model in Japan. MethodsFor the clinical parameters set in the model, the findings from CVIT-DEFER registry were adopted. Cost parameters were considered on the assumption that coronary angiography, FFR measurement, and the treatment are performed at Diagnosis Procedure combination (DPC) hospitals, and the costs were calculated based on the medical fee reimbursement systems in Japan. ResultsThe probability of deferral of PCI in patients who were allocated to PCI based on coronary angiography was set as 90.1% based on the CVIT-DEFER registry. In the model analysis, the cost of tests was increased by 185,660 JPY per patient by the addition of FFR measurement, but the cost of treatment with PCI was reduced by 561,425 JPY per patient, and the entire cost of treatment was reduced by 322,675 JPY, resulting in the expected reduction in the total expected medical cost by 137,015 JPY per patient. ConclusionUnder contemporary Japanese practice, FFR-guided PCI has potential to reduce the medical cost by effective reassessment of coronary stenosis and reducing inappropriate application of PCI.

Comparison of Fractional Flow Reserve-Guided Revascularization Strategies in Isolated Proximal Left Anterior Descending Coronary Artery Disease

The data about FFR-guided revascularization in isolated proximal LAD disease are limited and studies comparing long-term outcomes of FFR-guided PCI versus FFR-guided CABG in single-vessel proximal LAD disease are lacking. We aimed to assess the 4-year long-term safety and effectiveness of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) and FFR-guided coronary artery bypass graft surgery (CABG) for the treatment of proximal left anterior descending (LAD) lesions. The study included 129 patients with functionally significant (FFR ≤ 0.80) isolated proximal LAD stenosis (PCI, 88 patients vs. CABG, 41). Clinical endpoints were assessed by Kaplan-Meier method and compared by the log-rank test. At a mean follow-up time of 47 ± 12 months, a higher incidence of myocardial infarction in the PCI group (PCI: 32% vs. CABG: 15%; p = 0.003) and a higher incidence of stroke in the CABG group (CABG: 3 (7%) vs. PCI 0 (0%); p = 0.031) were observed. However, there were no significant differences in the primary composite endpoint, death and target vessel revascularization between PCI and CABG groups. The PCI and CABG in isolated proximal LAD lesions yielded similar long-term outcomes regarding the primary composite clinical endpoints. However, stroke was more frequent in the CABG group than in the PCI group.

Ischemia-based Coronary Revascularization: Beyond Anatomy and Fractional Flow Reserve.

Treatment strategies for patients with coronary artery disease (CAD) should be based on objective evidence of inducible ischemia in the subtended myocardium to improve clinical outcomes, symptoms, and cost-effectiveness. Fractional flow reserve (FFR) is the most verified index to-date for invasively evaluating lesion-specific myocardial ischemia. Favorable results from large clinical trials that applied FFR-guided percutaneous coronary intervention (PCI) prompted changes in coronary revascularization guidelines to emphasize the importance of this ischemia-based strategy using invasive coronary physiology. However, the frequency of functional evaluations is lacking in daily practice, and visual assessment still dominates treatment decisions in CAD patients. Despite recent efforts to integrate functional and anatomical assessments for coronary stenosis, there is considerable discordance between the 2 modalities, and the diagnostic accuracy of simple parameters obtained from current imaging tools is not satisfactory to determine functional significance. Although evidence that supports or justifies anatomy-guided PCI is more limited, and FFR-guided PCI is currently recommended, it is important to be aware of conditions and factors that influence FFR for accurate interpretation and application. In this article, we review the limitations of the current anatomy-derived evaluation of the functional significance of coronary stenosis, detail considerations for the clinical utility of FFR, and discuss the importance of an integrated physiologic approach to determine treatment strategies for CAD patients.

Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial

BackgroundCoronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. Trial designComparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective, randomized clinical trial. A total of 1,700 consecutive patients with intermediate stenosis (40%-70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the predefined criteria for revascularization; FFR ≤ 0.80 in the FFR-guided group and Minimal Lumen Area (MLA) ≤3 mm2 (or 3 mm2<MLA ≤4 mm2 and plaque burden >70%) in the IVUS-guided group. The primary end point is the patient-oriented composite outcome, which is a composite of all-cause death, myocardial infarction, and any repeat revascularization at 24months after randomization. We will test noninferiority of current standard FFR-guided PCI strategy compared with IVUS-guided decision for PCI and stent optimization strategy. ConclusionThe FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis.

Should fraction flow reserve be considered an important decision-making tool to stratify patients with stable coronary artery disease for percutaneous coronary intervention?: A meta-analysis.

Background:Nowadays, fraction flow reserve (FFR) is being discussed in every percutaneous coronary intervention (PCI) capable hospitals. Owing to recent development in the medical field, FFR-guided PCI should be able to find a place in Interventional Cardiology. At present, the importance of FFR to stratify patients who require PCI has seldom systematically been investigated. In this analysis, we aimed to compare the major adverse cardiac events (MACEs) mainly in patients with stable coronary artery disease (CAD) to whom PCI was recommended and deferred respectively based on the FFR value.Methods:Electronic databases were searched for studies comparing FFR-recommended versus FFR-deferred coronary stenting. Long-term MACEs, mortality, and myocardial infarction (MI) were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the analyses were carried out by the latest version of the RevMan software.Results:A total number of 1753 patients (670 patients were revascularized, whereas 1083 patients were deferred from revascularization based on the FFR value) were analyzed. Current results showed MACEs and MI were significantly higher in the FFR-recommended PCI group with OR 1.34 (95% CI: 1.05–1.72; P = .02) and OR 1.73 (95% CI: 1.19–2.51; P = .004, I2 = 0%), respectively. However, mortality was similarly manifested with OR 1.23 (95% CI: 0.92–1.63; P = .16, I2 = 0%).Conclusion:Significantly higher MACEs were observed in patients to whom PCI was recommended compared to those patients who were deferred from undergoing PCI based on the FFR values. Therefore, FFR might indeed be an important decision-making procedural tool, which should be used to stratify stable CAD patients with an advanced disease and who are qualified candidates for PCI. Further research should confirm this hypothesis.

Fractional flow reserve (FFR)-based therapy in patients presenting with acute coronary syndrome: Current data and everyday practice.

Fractional flow reserve (FFR) is an evidence-based diagnostic tool of physiological significance of coronary artery stenosis in patients with stable coronary artery disease (CAD). Due to microvascular dysfunction in acute coronary syndrome (ACS), information obtained from FFR assessment could be less reliable and, thus, its clinical role remains controversial. Indeed, results of currently published studies are essentially discrepant. Only a few randomized clinical trials have been performed showing the efficacy of FFR-guided percutaneous coronary intervention in ACS. Consequently, its role in acute scenarios remains substantially understudied. Herein, is presented the current state of knowledge re-garding FFR use in ACS setting. (Cardiol J 2017; 24, 4: 426-435).

The Impact of Fractional Flow Reserve-Guided Coronary Revascularization in Patients with Coronary Stenoses of Intermediate Severity.

Previous studies have shown that the use of fractional flow reserve (FFR) in addition to angiography significantly reduced the rate of all major adverse cardiovascular events (MACE). However, this practice has not been widely accepted and limited outcome data exist about FFR-guided percutaneous coronary intervention (PCI) in Taiwan. The aim of the present study was to evaluate the possible impact of FFR-guided PCI in coronary stenoses of intermediate severity. We performed a retrospective case-control study on 443 cases of intermediate coronary stenoses in 206 patients recruited from our computerized database. The study patients were divided into two groups: the FFR group (n = 101) and the angiography group (n = 105), matched with age, gender, clinical and angiographic lesion characteristics. In the angiography group, the indicated lesions had been treated with PCI by angiographic or anatomical assessment, whereas those patients in the FFR group underwent PCI of indicated lesions only if the FFR was < 0.80. The primary end point was the MACE rate regarding death, nonfatal myocardial infarction (MI), and target vessel failure at a mean follow-up of 418 days. The MACE rate was similar in both groups (6% in the angiography group and 3% in the FFR group, p = 0.06). However, FFR-guided PCI strategy prevented unnecessary revascularization in up to 75% of patients, and markedly reduced costs of the index hospitalization. Moreover, multivariate analysis found that the use of drug-eluting stent and statin therapy, and the presence of family history of premature coronary artery disease and periprocedural MI are independent predictors of clinical outcomes. FFR-guided intervention, compared to angiography-guided intervention for Taiwanese patients with coronary stenoses of intermediate severity, achieved similar clinical outcomes and provided cost-savings.

Fractional flow reserve: a clinical perspective

Fractional flow reserve (FFR) is a reference invasive diagnostic test to assess the physiological significance of an epicardial coronary artery stenosis. FFR-guided percutaneous coronary intervention in stable coronary artery disease has been assessed in three seminal clinical trials and the indications for FFR assessment are expanding into other clinical scenarios. In this article we review the theoretical, experimental and clinical basis for FFR measurement. We place FFR measurement in the context of the comprehensive invasive assessment of coronary physiology in patients presenting with known or suspected angina pectoris in daily clinical practice, and review the recent developments in FFR assessment.

Comparing the adverse clinical outcomes associated with fraction flow reserve-guided versus angiography-guided percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials.

BackgroundRecently published randomized controlled trials have shown different results compared to the Fraction Flow Reserve Versus Angiography for Multi-vessel Evaluation (FAME) study. Therefore, this current analysis aimed to compare the adverse clinical outcomes associated with Fraction Flow Reserve (FFR)-guided versus standard angiography-guided Percutaneous Coronary Intervention (PCI) using a large number of randomized patients.MethodsPubMed/Medline, EMBASE and the Cochrane library were searched for studies comparing FFR-guided with angiography-guided PCI. Mortality, Myocardial Infarction (MI), repeated revascularization and Major Adverse Cardiac Events (MACEs) at any follow up period following PCI were considered as the clinical endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were calculated and the analyses were carried out by the RevMan 5.3 software. Ethical approval was not necessary for this type of study.ResultsA total number of 2138 patients (1080 patients with FFR-guided versus 1058 patients with angiography-guided PCI) were included. Results of this analysis showed mortality not to be significantly different between FFR-guided and angiography-guided PCI with OR: 0.70, 95% CI: 0.39 – 1.25; P = 0.22, I2 = 0%. Total repeated revascularization and Target Lesion Revascularization were also similarly manifested with OR: 0.82, 95% CI: 0.60 – 1.13; P = 0.22, I2 = 0% and OR: 0.88, 95% CI: 0.43 – 1.80; P = 0.73, I2 = 0% respectively. In addition, MACEs were also not significantly lower in the FFR-guided PCI group with OR: 0.82, 95% CI: 0.64 – 1.06; P = 0.13, I2 = 0%. However, FFR-guided PCI was associated with a significantly lower rate of re-infarction with OR: 0.67, 95% CI: 0.47 – 0.96; P = 0.03, I2 = 0%.ConclusionFFR-guided PCI was not associated with significantly higher adverse clinical outcomes when compared to angiography-guided PCI. A significantly lower rate of re-infarction associated with FFR-guided PCI could show an important benefit. However, due to the limited number of patients analyzed, this hypothesis should further be confirmed in future trials.

Prognostic role of multiple biomarkers in stable patients undergoing fractional flow reserve-guided coronary angioplasty.

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI), along with optimal medical therapy, improves clinical outcome by targeting ischemia-inducing stenosis. Yet, plaque progression or stent failure may cause recurring cardiac events. We assessed the potential prognostic role of different inflammatory biomarkers, known to be associated with plaque progression or stent failure, in patients undergoing FFR-guided PCI. We prospectively enrolled 169 stable angina patients with intermediate coronary stenosis at angiography undergoing FFR-guided PCI. PCI was performed if FFR was 0.80 or less, deferred if FFR was more than 0.80. Serum baseline levels of high-sensitivity C-reactive protein (hs-CRP), eosinophil cationic protein (ECP), cystatin-C (Cys-C), and thromboxane A2 (TXA2) were assessed. Rate of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, recurrent myocardial infarction, and target vessel revascularization (TVR), was evaluated. PCI was performed in 78 patients (46%) (mean age 69 ± 10 years, men 73%) and deferred in 91 patients (54%) (mean age 64 ± 11 years, men 53%). Mean clinical follow-up was 31 ± 11 months. Within the PCI group, patients with MACE (n = 14 [18%]) had significantly higher ECP levels than those without (14.4 [9.3-19.5] vs. 4.9 [2.8-10.9] mg/l, P < 0.001), and ECP was a significant predictor of MACE (hazard ratio: 1.05, 95% confidence interval [1.01-1.09], P = 0.021). Within the deferred group, patients with MACE (n = 8 [9%]) had significantly higher CRP levels than those without (15 [6.5-31.9] vs. 1.6 [0.9-2.9] mg/l, P < 0.001) and CRP was a significant predictor of MACE (hazard ratio: 1.04, 95% confidence interval [1.01-1.07], P = 0.015). Cys-C and TXA2 were not significantly different between the two groups. Assessing inflammatory biomarkers allows the identification of patients remaining at residual higher risk of MACE after FFR-guided PCI.

Myocardial Perfusion Imaging and Fractional Flow Reserve-Therapeutic Strategy Based on Myocardial Ischemia Evaluation in Patients with Coronary Artery Disease.

Indications for percutaneous coronary intervention (PCI) among patients with stable coronary artery disease (CAD) have historically been decided after morphological evaluation using coronary angiography (CAG). Recently, the importance of physiological evaluation has been recognized using either myocardial perfusion imaging (MPI) or fractional flow reserve (FFR). The results of the recent COURAGE trial showed that PCI did not improve mortality rates in medically optimized patients with stable CAD. However, a nuclear sub-study of that trial in which participants underwent MPI before and after PCI+ optimal medical therapy (OMT), found a greater reduction in ischemia compared with OMT alone. Moreover, the unadjusted risk for death or myocardial infarction in patients with ischemia reduction was lower. In contrast, the FAME study indicated that FFR-guided PCI improved the outcomes of patients with multi-vessel CAD compared with angiography-guided PCI. The FAME II study also indicated the validity of FFR-guided PCI. Thus, FFR evaluation of ischemia is becoming more popular worldwide from the viewpoint of intervention. Both MPI and FFR reflect physiological ischemia, but their findings do not necessarily match up. One reason is that MPI reflects myocardial ischemia whereas FFR reflects coronary artery ischemia. Thus, cardiologists regard the findings of these modalities conflicting when considering practicality and diagnostic accuracy. This article compares the features of MPI and FFR and discusses an appropriate strategy with which to evaluate CAD.

Fractional Flow Reserve-guided Percutaneous Coronary Intervention: Standing the Test of Time

Percutaneous coronary intervention (PCI) improves symptoms and prognosis in ischemia-inducing, functionally significant, coronary lesions. Use of fractional flow reserve allows physicians to investigate the ischemia-inducing potential of a specific lesion and can be used to guide coronary revascularization, especially in multivessel coronary artery disease. Fractional flow reserve-guided PCI has been extensively investigated. Results show that deferral of stenting in non-significant lesions is safe, whereas deferral of stenting in functionally significant lesions worsens outcome. FFR-guided PCI improves outcome in multivessel disease over angiography-guided PCI. Until recently, there was little known about the long-term outcome of FFR-guided revascularization and its validity in acute coronary syndromes. This review aims to address the new evidence regarding long-term appropriateness of FFR-guided PCI, the need for hyperemia to evaluate functional severity, and the use of FFR in acute coronary syndromes.

Reducing Microvascular Dysfunction in Revascularized Patients with ST-Elevation Myocardial Infarction by Off-Target Properties of Ticagrelor versus Prasugrel. Rationale and Design of the REDUCE-MVI Study

Microvascular injury is present in a large proportion of patients with ST-elevation myocardial infarction (STEMI) despite successful revascularization. Ticagrelor potentially mitigates this process by exerting additional adenosine-mediated effects. This study aims to determine whether ticagrelor is associated with a better microvascular function compared to prasugrel as maintenance therapy after STEMI. A total of 110 patients presenting with STEMI and additional intermediate stenosis in another coronary artery will be studied after successful percutaneous coronary intervention (PCI) of the infarct-related artery. Patients will be randomized to treatment with ticagrelor or prasugrel for 1 year. FFR-guided PCI of the non-infarct-related artery will be performed at 1 month. Microvascular function will be assessed by measurement of the index of microcirculatory resistance (IMR) in the infarct-related artery and non-infarct-related artery, immediately after primary PCI and after 1 month. The REDUCE-MVI study will establish whether ticagrelor as a maintenance therapy may improve microvascular function in patients after revascularized STEMI.

The Prognostic Value of Residual Coronary Stenoses After Functionally Complete Revascularization

BackgroundThe residual SYNTAX score (RSS) and SYNTAX revascularization index (SRI) quantitatively assess angiographic completeness of revascularization for patients with multivessel coronary artery disease. Whether residual angiographic disease remains of prognostic importance after “functionally” complete revascularization with fractional flow reserve (FFR) guidance is unknown. ObjectivesThis study sought to investigate the prognostic value of the RSS and SRI after FFR-guided functionally complete revascularization. MethodsFrom the FFR-guided percutaneous coronary intervention (PCI) cohort of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial, the RSS and SRI were calculated in 427 patients after functionally complete revascularization. The RSS was defined as the SYNTAX score (SS) recalculated after PCI. The SRI was calculated as: 100 × (1 − RSS/baseline SS) (%). We compared differences in 1- and 2-year outcomes among patients with RSS of 0, >0 to 4, >4 to 8, and >8, and with SRI of 100%, 50% to <100%, and 0 to <50%. ResultsThe mean baseline SS, RSS, and SRI were 14.4 ± 7.2, 6.5 ± 5.8, and 55.1 ± 32.5%, respectively. Major adverse cardiac events (MACE) at 1 year occurred in 53 patients (12.4%). Patients with MACE had higher SS than those without (18.0 [interquartile range (IQR): 11.0 to 21.0] vs. 12.0 [IQR: 9.0 to 18.0], p = 0.001), but had similar RSS and SRI after PCI (RSS: 6.0 [IQR: 3.0 to 10.0] vs. 5.0 [IQR: 2.0 to 9.5], p = 0.51 and SRI: 60.0% [IQR: 40.9% to 78.9%] vs. 58.8% [IQR: 26.7% to 81.8%], p = 0.24, respectively). Kaplan-Meier analysis showed similar 1-year incidence of MACE with RSS/SRI stratifications (log-rank p = 0.55 and p = 0.54, respectively). Results were similar with 2-year outcome data analysis. ConclusionsAfter functionally complete revascularization with FFR guidance, residual angiographic lesions that are not functionally significant do not reflect residual ischemia or predict a worse outcome, supporting functionally complete, rather than angiographically complete, revascularization. (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [FAME]; NCT00267774)

Long-term outcome of FFR-guided PCI for stable coronary artery disease in daily clinical practice: a propensity score-matched landmark analysis.

Our aim was to investigate the strength of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) in daily practice. For this study, 3,512 patients with stable CAD and at least one 50-89% coronary stenosis were identified; those patients thought to require PCI (n=1,716) were selected. Of these, 962 (56%) were treated based on angiography (XA) alone, whereas 754 patients (44%) had an FFR-guided treatment. In the latter group, 321 patients (43%) were reallocated to another treatment, predominantly medical treatment. After propensity score matching, the number of indicated lesions was 957 in the XA-guided group and 947 in the FFR-guided group. FFR guidance resulted in PCI deferral in 462 lesions (48.8%). In a seven-day landmark analysis, the rate of periprocedural myocardial infarction (MI) was less than half in the FFR-guided group (p>0.05). For the eight-day to four-year follow-up period, FFR guidance resulted in a significantly lower rate of the combined endpoint of death/MI (hazard ratio [HR] 0.63) and MI-driven target lesion revascularisation (HR 0.35). This large, retrospective study shows that performing FFR has a significant impact on therapeutic strategy and demonstrates the favourable long-term outcome of FFR-guided PCI in an "all-comers" population of patients with stable CAD in daily clinical practice.

Fractional Flow Reserve Assessment of a Significant Coronary Stenosis Masked by a Downstream Serial Lesion.

Fractional flow reserve (FFR) has been recognized as an effective tool to determine functional significance in intermediate coronary lesions and FFR-guided percutaneous coronary intervention (PCI) improves clinical outcomes. However, hemodynamic interaction between serial stenoses within one coronary artery complicates the assessment of functional severity of each individual lesion. We present a case in which FFR measurement by intracoronary bolus injection of adenosine helps to make appropriate revascularization decision in serial stenoses when the procedures are performed systemically and properly.

The impact of left ventricular ejection fraction on fractional flow reserve: Insights from the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) trial

BackgroundFractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) significantly improves outcomes compared with angio-guided PCI in patients with multivessel coronary artery disease. However, there is a theoretical concern that in patients with reduced left ventricular ejection fraction (EF) FFR may be less accurate and FFR-guided PCI less beneficial. MethodsFrom the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) trial database, we compared FFR values between patients with reduced EF (both ≤40%, n=90 and ≤50%, n=252) and preserved EF (>40%, n=825 and >50%, n=663) according to the angiographic stenosis severity. We also compared differences in 1year outcomes between FFR- vs. angio-guided PCI in patients with reduced and preserved EF. ResultsBoth groups had similar FFR values in lesions with 50–70% stenosis (p=0.49) and with 71–90% stenosis (p=0.89). The reduced EF group had a higher mean FFR compared to the preserved EF group across lesions with 91–99% stenosis (0.55 vs. 0.50, p=0.02), although the vast majority of FFR values remained ≤0.80. There was a similar reduction in the composite end point of death, nonfatal myocardial infarction, and repeat revascularization with FFR-guided compared to angio-guided PCI for both the reduced (14.5% vs. 19.0%, relative risk=0.76, p=0.34) and the preserved EF group (13.8 vs. 17.0%, relative risk=0.81, p=0.25). The results were similar with an EF cutoff of 40%. ConclusionReduced EF has no influence on the FFR value unless the stenosis is very tight, in which case a theoretically explainable, but clinically irrelevant overestimation might occur. As a result, FFR-guided PCI remains beneficial regardless of EF.

Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial

In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up. The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥ 18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774. After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75-1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001). The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients. St Jude Medical, Friends of the Heart Foundation, and Medtronic.

Fractional Flow Reserve Guided Percutaneous Coronary Intervention Improves Clinical Outcome with Reduced Cost in Contemporary Clinical Practice.

Background:Fractional flow reserve (FFR) is currently considered as the gold standard for evaluating the functional significance of coronary stenosis. However, its potential benefits in real-world practice remain unknown in China. This study aimed to test the hypothesis that the use of FFR is associated with improved outcome and reduced cost in Chinese real-world clinical practice.Methods:A retrospective cohort study was carried out using the database of Second Affiliated Hospital of Zhejiang University, a tertiary and high-volume center in China. Clinical events were compared using the Cox proportional hazards model during a median follow-up of 13 months.Results:The study cohort consisted of 366 consecutive patients referred for coronary revascularization with adjunct FFR and 366 matched controls, from 2010 to 2014. Major adverse cardiac events (MACEs) (death, myocardial infarction, repeated revascularization, or hospitalization for angina) at 4 years were found in 12.0% of angiography-guided patients and 4.9% in the FFR-guided group (P < 0.001). The mean number of implanted stents was significantly lower in FFR treated subjects (0.52 ± 0.82 stents) compared with the angiography-guided group (0.93 ± 0.96 stents) (P < 0.001). No difference in overall costs at initial hospitalization was observed between angiography-guided percutaneous coronary intervention (PCI) compared with FFR-guided PCI (RMB 33,000 Yuan, range: RMB 7393–44,700 Yuan) versus RMB 21,200 Yuan (RMB 19,100–47,100 Yuan) (P = 0.54). However, costs for MACEs during follow-up were significantly reduced in the FFR-guided arm (P < 0.001).Conclusions:In the contemporary clinical practice, FFR-guided PCI is associated with decreased use of stents, improved clinical outcome, and reduced costs, compared with angiography-guided PCI.

Cost–effectiveness of fractional flow reserve-guided percutaneous coronary intervention

In recent years, fractional flow reserve (FFR) has become accepted as a clinically effective tool for guiding decisions about percutaneous coronary intervention (PCI). FFR poses a unique alternative to stress testing or angiography-guided PCI, in that it can interrogate the ischemic potential of an individual vessel on an impromptu basis once an angiogram is in progress, offering immediate data for decision making. With its recent greater adoption across the USA, its cost–effectiveness has become an important consideration. There have been a few key analyses over the last decade demonstrating the cost–effectiveness of FFR-guided PCI; we review the major cost–effectiveness analyses, showing the economic utility of FFR-guided PCI for the modern interventionalist.