scholarly journals Impact of Poststenting Fractional Flow Reserve on Long-Term Clinical Outcomes

Author(s):  
Roberto Diletti ◽  
Kaneshka Masdjedi ◽  
Joost Daemen ◽  
Laurens J.C. van Zandvoort ◽  
Tara Neleman ◽  
...  

Background: Fractional flow reserve (FFR)-guided treatment has been demonstrated to improve percutaneous coronary intervention (PCI) results. However, little is known on the long-term impact of low post-PCI FFR. Methods: This is a large prospective all comers study evaluating the impact of post-PCI FFR on clinical outcomes. All patients undergoing successful PCI were eligible for enrollment. FFR measurements were performed immediately after PCI when the operator considered the angiographic result acceptable and final. No further action was undertaken based on the post-PCI result. Suboptimal post-PCI FFR was defined as FFR<0.90. The primary end point was major adverse cardiac events, a composite of cardiac death, any myocardial infarction, or any revascularization at 2-year follow-up. Secondary end points were target vessel revascularizations and stent thrombosis and the separate components of the primary end point. Results: A total of 1000 patients were enrolled. Post-PCI FFR was successfully measured in 1165 vessels from 959 patients. A poststenting FFR<0.90 was observed in 440 vessels (37.8%). A total of 399 patients had at least 1 vessel with FFR<0.90 post-PCI. At 2-year follow-up, a patient level analysis showed no association between post-PCI FFR and major adverse cardiac event (hazard ratio [HR], 1.08 [95% CI, 0.73–1.60], P =0.707), cardiac death (HR, 1.55 [95% CI, 0.72–3.36], P =0.261), any myocardial infarction (HR, 1.53 [95% CI, 0.78–3.02], P =0.217). A vessel level analysis showed a higher rate of target vessel revascularization (HR, 1.91 [95% CI, 1.06–3.44], P =0.030) and a tendency toward higher rate of stent thrombosis (HR, 2.89 [95% CI, 0.88–9.48], P =0.081) with final post-PCI FFR<0.90. Conclusions: Suboptimal post-PCI FFR has only a moderate impact on major adverse cardiac event but coronary arteries with a post-PCI FFR<0.90 have a higher rate of target vessel revascularization.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Kuramitsu ◽  
H Matsuo ◽  
H Takashima ◽  
H Yokoi ◽  
N Tanaka

Abstract Background The safety of deferral of revascularization based on instantaneous wave-free ratio (iFR) is established in randomized controlled trials. However, there is little data regarding long-term outcomes after deferral of revascularization based on iFR in real-world practice. Purpose We sought to assess clinical outcomes after deferral of revascularization based on iFR in clinical practice as compared with those based on fractional flow reserve (FFR). Methods This is a post hoc analysis of the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry), in which 1262 patients with 1447 lesions deferred the revascularization based on FFR. Of these, both FFR and iFR were measured in 399 patients with 452 lesions. The patients were classified into the two groups: the iFR group (iFR &gt;0.89; 308 patients with 348 lesions) and the FFR group (FFR &gt;0.80; 740 patients with 855 lesions). The primary study endpoint was the 3-year target vessel failure (TVF) including cardiac death, target-vessel related myocardial infarction (TVMI), and clinically driven target vessel revascularization (CDTVR). Results Mean iFR was 0.96±0.04 in the iFR group. Mean FFR was significantly lower in the iFR group than in the FFR group (0.87±0.05 vs. 0.89±0.05, p=0.002). The iFR group included 35 lesions (11.4%) with FFR ≤0.80. At 3 years, the rate of TVF on a lesion basis were not significantly different between the iFR and FFR groups (8.8% vs. 6.1%, p=0.10), whereas CDTVR rate was significantly higher in the iFR group than in the FFR group (8.5% vs. 5.3%, p=0.044). Cardiac death and TVMI on a patient basis rarely occurred in both groups during the 3-year follow-up (0.33% vs. 0.77%, p=0.47; 0.66% vs. 0.56%, p=0.85, respectively). Conclusion At 3 years, TVF rate in deferred lesions was numerically higher in the iFR group than in the FFR group, driven by a higher rate of CDTVR. However, cardiac death and TVMI was very rare in both groups, highlighting the safety of both iFR- and FFR-based deferral of revascularization in daily practice. Funding Acknowledgement Type of funding source: None


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Josep Rodès-Cabau ◽  
Javier Courtis ◽  
Jean-Michel Potvin ◽  
Melanie Côté ◽  
Jean-Pierre Dery ◽  
...  

Background: Limited data exist on the use of fractional flow reserve (FFR) measurements to guide clinical decisions in patients with intermediate left main coronary artery (LMCA) stenosis. Objectives: To evaluate the usefulness of FFR measurements to guide the clinical decision in patients with intermediate LMCA stenosis and to determine the predictors of major adverse cardiac events [MACE] (cardiac death, myocardial infarction, coronary revascularization) in such cases. Methods: A total of 142 consecutive patients (mean age 62 ± 10 yrs) with intermediate LMCA stenosis (mean percent diameter stenosis 42 ± 13%) were included. All patients underwent FFR measurement after intracoronary (ic) administration of adenosine at a dose ≥30 μg. Special care was taken in cases with ostial lesions to pull the catheter out of the LMCA after adenosine administration. The clinical decisions were based on FFR as follows: coronary revascularization was recommended if FFR was <0.75, medical treatment if FFR was >0.80, and individualized decision based on additional clinical data if FFR was between 0.75 and 0.80. The occurrence of MACE was evaluated at 14 ± 11 months follow-up. Results: Mean FFR was 0.81 ± 0.09 after the administration of a mean dose of 176 ± 99 μg of ic adenosine. Based on FFR results, sixty patients (42%) underwent coronary revascularization and 82 patients (58%) received medical treatment. At follow-up, the incidence of MACE related to the LMCA stenosis was 13% in the medical treatment group and 7% in the coronary revascularization group (p=0.27). The incidence of cardiac death and myocardial infarction was 7% in both groups (p=1.0). In the medical treatment group, patients with MACE had received a lower dose of ic adenosine (86 ± 57 μg vs. 167 ± 102 μg, OR: 1.39 for each decrease of 30 μg of ic adenosine, 95% CI 1.02–1.89, p=0.04) and were more frequently diabetics (55% vs. 21%, OR: 4.40, 95% CI 1.17–16.42, p=0.02). Conclusions: FFR measurement is helpful in guiding the decision as to whether to revascularize patients with intermediate LMCA stenosis. However, diabetic patients remain at higher risk, and higher doses than previously recommended of ic adenosine should be used in the evaluation of LMCA to avoid cardiac events due to underestimation of stenosis severity.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Takafumi Yamane ◽  
Koichi Tamita ◽  
Noriomi Kimura ◽  
Shunsuke Funakoshi ◽  
Kite Kim ◽  
...  

Background: Many studies have demonstrated that deferral of percutaneous coronary intervention (PCI) on the basis of a myocardial fractional flow reserve (FFR) ≥0.75 is associated with a very low coronary event rate. However, some groups have empirically chosen the cut-off value of 0.80 rather than 0.75 for decision to defer PCI and the FFR measurement between 0.75 and 0.80 has been established as a grey zone. The aim of this study was to evaluate the long-term clinical outcomes of patients with moderate coronary lesions and FFR measurements between 0.75 and 0.80. Methods: The study included 125 anigiographically moderate coronary lesions (>50% diameter stenosis by visual assessment) in 125 patients but in whom the PCI was deferred on the basis of an FFR ≥ 0.75. The FFR was calculated as the ratio of mean distal pressure divided by the proximal pressure during hyperemia. Patients were divided into two groups according to the result of FFR: ≥ 0.80 (n=99, group 1) and between 0.75 and 0.79 (n=26, group 2). We evaluated the long-term major adverse cardiovascular events (MACE) related and unrelated to the FFR-evaluated lesion. Results: During a follow-up period of 82 ± 29 months (mean ± SD), The Kaplan-Meier event-free survival curves showed that group 2 was poorer than group 1 in prognosis (p=0.0148). The incidence of MACE unrelated FFR-evaluated lesion in group 1 was equivalent to that in group 2 (p=0.96). Conclusions: In patients with moderate coronary lesions and borderline FFR measurements, deferral of PCI was associated with a higher rate of MACE related to the FFR-evaluated lesion. FFR cut-off point of 0.80 instead of 0.75 may be more appropriate for deferring PCI.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Di Gioia ◽  
N Soto Flores ◽  
D Franco ◽  
I Colaiori ◽  
J Sonck ◽  
...  

Abstract Background In diabetic patients with multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) has shown long-term benefits in mortality over percutaneous coronary revascularization (PCI). Nevertheless, the impact of fractional flow reserve (FFR)-guided PCI on clinical outcomes has never been investigated in these patients. Purpose To evaluate the long-term (5-year) clinical outcome of diabetic patients with MVD treated with FFR-guided PCI compared to CABG. Methods From February 2010 to February 2018, all diabetic patients undergoing coronary angiography in one centre (n=4622) were screened for inclusion. The inclusion criterion was presence of at least two-vessels CAD defined as with diameters stenosis ≥50%. In case of intermediate coronary stenosis (%DS 30–70%), FFR was performed at the discretion of the operator. Revascularization was performed when FFR ≤0.80. Exclusion criteria were ST-elevation myocardial infarction, prior CABG, and moderate or severe valvular heart dysfunction. To account for confounders, we compared outcomes by calculating an adjusted Kaplan-Meier estimator using inverse probability of treatment weighting (IPTW). Propensity score variables included age, sex, smoking habit, hypertension, hyperlipidemia, insulin therapy, family history of CAD, chronic obstructive pulmonary disease (COPD), glomerular filtration rate (GFR), prior myocardial infarction, peripheral vascular disease (PVD), admission for NSTEMI, ejection fraction, number of angiographic stenotic vessels. Odds ratios were calculated using generalized linear models (GLM). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE), defined as all-cause death, myocardial infarction and stroke. Secondary endpoints were the individual component of MACCE and any repeated revascularization. Results A total of 538 diabetic patients with MVD were included in the analysis. Among them, 317 (59%) patients underwent CABG and 221 (41%) FFR-guided PCI. Patients treated with FFR-guided PCI had more often COPD as compared to patients in the CABG-group, but patients treated with CABG had lower GFR, more PVD, higher number of angiographic stenotic vessels (2.8±0.4 vs. 2.5±0.5; p<0.01) and higher Syntax score (20±7 vs. 14±6; p<0.01) as compared to the FFR-guided PCI group. Clinical follow-up was obtained in 95% of the patients at a median follow-up of 5 years. The incidence of MACCE was similar in the CABG and in the FFR-guided PCI group [27% vs. 29%; OR (95% CI) 1.05 (0.68–1.63); p=0.74]. No differences were found in the individual components of MACCE. Repeat revascularization was more frequent in the FFR-guided PCI group than in the CABG group [27% vs. 7%; OR (95% CI) 4.3 (2.35–7.9); p<0.01]. Conclusions In diabetic patients with MVD undergoing FFR-guided PCI, no differences in major adverse events were observed at a median follow-up of 5 years compared with CABG.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F C Commandeur ◽  
P J Slomka ◽  
M Goeller ◽  
X Chen ◽  
S Cadet ◽  
...  

Abstract Background/Introduction Machine learning (ML) allows objective integration of clinical and imaging data for the prediction of events. ML prediction of cardiovascular events in asymptomatic subjects over long-term follow-up, utilizing quantitative CT measures of coronary artery calcium (CAC) and epicardial adipose tissue (EAT) have not yet been evaluated. Purpose To analyze the ability of machine learning to integrate clinical parameters with coronary calcium and EAT quantification in order to improve prediction of myocardial infarction (MI) and cardiac death in asymptomatic subjects. Methods We assessed 2071 consecutive subjects [1230 (59%) male, age: 56.049.03] from the EISNER (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) trial with long-term follow-up after non-enhanced cardiac CT. CAC (Agatston) score, age-and-gender-adjusted CAC percentile, and aortic calcium scores were obtained. EAT volume and density were quantified using a fully automated deep learning method. Extreme gradient boosting, a ML algorithm, was trained using demographic variables, plasma lipid panel measurements, risk factors as well as CAC, aortic calcium and EAT measures from CAC CT scans. ML was validated using 10-fold cross validation; event prediction was evaluated using area-under-receiver operating characteristic curve (AUC) analysis and Cox proportional hazards regression. Optimal ML cut-point for risk of MI and cardiac death was determined by highest Youden's index (sensitivity + specificity – 1). Results At 152 years' follow-up, 76 events of MI and/or cardiac death had occurred. ML obtained a significantly higher AUC than the ASCVD risk and CAC score in predicting events (ML: 0.81; ASCVD: 0.76, p<0.05; CAC: 0.75, p<0.01, Figure A). ML performance was mostly driven by age, ASCVD risk and calcium as shown by the variable importance (Figure B); however, all variables with non-zero gain contributed to the ML performance. ML achieved a sensitivity and specificity of 77.6% and 73.5%, respectively. For an equal specificity, ASCVD and CAC scores obtained a sensitivity of 61.8% and 67.1%, respectively. High ML risk was associated with a high risk of suffering an event by Cox regression (HR: 9.25 [95% CI: 5.39–15.87], p<0.001; survival curves in Figure C). The relationships persisted when adjusted for age, gender, CAC, CAC percentile, aortic calcium score, and ASCVD risk score; with a hazard ratio of 3.42 for high ML risk (HR: 3.42 [95% CI: 1.54–7.57], p=0.002). Conclusion(s) Machine learning used to integrate clinical and quantitative imaging-based variables significantly improves prediction of MI and cardiac death in asymptomatic subjects undergoing CAC assessment, compared to standard risk assessment methods. Acknowledgement/Funding NHLBI 1R01HL13361, Bundesministerium für Bildung und Forschung (01EX1012B), Dr. Miriam and Sheldon G. Adelson Medical Research Foundation


Heart ◽  
2018 ◽  
Vol 104 (17) ◽  
pp. 1432-1438 ◽  
Author(s):  
Joëlle Elias ◽  
Ivo M van Dongen ◽  
Truls Råmunddal ◽  
Peep Laanmets ◽  
Erlend Eriksen ◽  
...  

BackgroundDuring primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO.MethodsThe Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO. Patients were randomised to either CTO-PCI or CTO-No PCI. The primary end point of the current study was occurrence of major adverse cardiac events (MACE): cardiac death, coronary artery bypass grafting and MI. Other end points were 1-year left ventricular function (LVF); LV-ejection fraction and LV end-diastolic volume and angina status.ResultsThe median long-term follow-up was 3.9 (2.1–5.0) years. MACE was not significantly different between both arms (13.5% vs 12.3%, HR 1.03, 95% CI 0.54 to 1.98; P=0.93). Cardiac death was more frequent in the CTO-PCI arm (6.0% vs 1.0%, P=0.02) with no difference in all-cause mortality (12.9% vs 6.2%, HR 2.07, 95% CI 0.84 to 5.14; P=0.11). One-year LVF did not differ between both arms. However, there were more patients with freedom of angina in the CTO-PCI arm at 1 year (94% vs 87%, P=0.03).ConclusionsIn this randomised trial involving patients with STEMI with a concurrent CTO, CTO-PCI was not associated with a reduction in long-term MACE compared to CTO-No PCI. One-year LVF was comparable between both treatment arms. The finding that there were more patients with freedom of angina after CTO-PCI at 1-year follow-up needs further investigation.Clinical trial registrationEXPLORE trial number NTR1108 www.trialregister.nl.


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