Change in angiogram-derived management strategy of patients with chest pain when some FFR data are available: How consistent is the effect?




Abstract


Background


The assessment of patients presenting with angina using invasive angiography alone is imperfect. By contrast, fractional flow reserve (FFR) allows for assessment of lesion-specific ischemia, which is predictive of clinical outcome. A series of studies has demonstrated that the availability of FFR data at the time of diagnostic angiography leads to significant differences in the management of those patients.


Hypothesis: The objective of this paper is to assess the consistency in the difference in management resulting from an FFR-directed versus and angiogram-directed strategy in appropriate observational and randomized trials.


Methods


A methodical search was made using MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane library, PubMed, Science Direct, and Web of Science.


Results


Eight studies were identified using the eligibility criteria. A total of 2468 patients were recommended to have optimal medical therapy (OMT) alone after initial angiographic assessment but, after FFR results were available, a total of 716 (29.0%) were referred for revascularization (PCI 626 patients [25.36%]; CABG 90 patients [3.64%]). Similarly, 3766 patients were originally committed to PCI after initial angiography: of these 1454 patients (38.61%) were reconsidered to be suitable for OMT alone and 71 individuals (1.8%) were deemed suitable for CABG after FFR data were available. Further, of 366 patients referred for CABG based on angiographic data, the availability of FFR data changed the final decision to OMT alone in 65 patients (17.76%) and PCI in 51 patients (13.9%). Overall, the angiogram-derived management was changed in 22%–48% of these study populations when FFR data were available.


Conclusions


Some use of FFR during coronary angiography alters the angiogram-directed management in a remarkably consistent manner. These data suggest that routine use of FFR at the diagnostic angiogram would improve patient care.



Introduction


It is now well established that assessment of patients presenting with cardiac-sounding chest pain based upon angiography alone is flawed . Specifically, the coronary anatomy at angiography does not inevitably reflect the presence and extent of myocardial ischemia, which is recognized as the best indicator of the cause of symptoms and near term prognosis, and thus represents the clearest target for revascularization . This is due to a discrepancy between the anatomical assessment of lesion severity and the presence or absence of lesion-level ischemia . Lesion-level ischemia is measured by pressure wire assessment using fractional flow reserve (FFR). The ability of FFR measurement to predict clinical outcome has been established in a variety of randomized clinical trials. In the deferral of percutaneous coronary intervention (DEFER) study, the practice of deferring percutaneous coronary intervention (PCI) in lesions that had been identified as requiring PCI based upon angiographic appearances, but were FFR negative, was shown to be safe and associated with a better clinical outcome than stenting them . Furthermore, in patients who had been listed for multi-vessel PCI, the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) trial demonstrated a reduced incidence of the combined clinical endpoint of death, non-fatal myocardial infarction, and repeat revascularization at 1 year, as well as lower cost, in an FFR-directed strategy compared to an angiogram-directed approach, despite fewer lesions being stented . Fractional Flow Reserve Guided Percutaneous Coronary Intervention Plus Optimal Medical Therapy Versus Optimal Medical Therapy (FAME 2) trial subsequently demonstrated a reduced rate of unplanned revascularization in patients with FFR positive lesions who were stented compared to a cohort treated with optimal medical therapy alone .


Despite these robust data, the uptake of FFR in routine clinical practice has been lower than expected in patients already being considered for PCI, with rates as low as 6.6% reported in large PCI registries . Furthermore, a series of predominantly observational studies has been published that demonstrate the ability of FFR to modify the management of patients who are undergoing diagnostic angiography for the investigation of chest pain (i.e., at an earlier stage in their management pathway .


The aim of this paper is to describe the degree to which some use of FFR affects the angiography-derived management strategy for patients in these studies.





Methods



Eligibility criteria


Using the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines published studied were recognized that describe the effect of the availability of FFR on an angiogram-derived management of patients being investigated for chest pain.



Search strategy


A methodical search was made using MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane library, PubMed, Science Direct, and Web of Science to October 2016. We used the following search MeSH terms: acute coronary syndrome; angina; coronary angiography; fractional flow reserve or pressure wire assessment; decision making; and outcome assessment. No language restrictions were made. The references of the included publications and relevant review articles were checked for additional relevant studies.



Study selection and data extraction


Three reviewers (VN, MM and NC) independently checked all titles and abstracts for studies potentially meeting the inclusion criteria. The full reports of these studies were retrieved, and we analyzed these studies in a qualitative manner in order to describe the number of patients involved, clinical setting, effect of FFR on assessment of lesion level significance and effect of FFR on angiogram-derived management plan.



Quality assessment


The quality of publications was rated using the Quality Assessment Tool for Case Series Studies based on the National Heart, Lung, and Blood Institute (NHLBI) .





Methods



Eligibility criteria


Using the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines published studied were recognized that describe the effect of the availability of FFR on an angiogram-derived management of patients being investigated for chest pain.



Search strategy


A methodical search was made using MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane library, PubMed, Science Direct, and Web of Science to October 2016. We used the following search MeSH terms: acute coronary syndrome; angina; coronary angiography; fractional flow reserve or pressure wire assessment; decision making; and outcome assessment. No language restrictions were made. The references of the included publications and relevant review articles were checked for additional relevant studies.



Study selection and data extraction


Three reviewers (VN, MM and NC) independently checked all titles and abstracts for studies potentially meeting the inclusion criteria. The full reports of these studies were retrieved, and we analyzed these studies in a qualitative manner in order to describe the number of patients involved, clinical setting, effect of FFR on assessment of lesion level significance and effect of FFR on angiogram-derived management plan.



Quality assessment


The quality of publications was rated using the Quality Assessment Tool for Case Series Studies based on the National Heart, Lung, and Blood Institute (NHLBI) .





Results



Description of studies included in analysis


Eight studies have been identified that fit our prespecified criteria. The studies were published between 2007 and 2016 and report data derived from between 200 and 3093 patients ( Fig. 1 ). Seven of the studies were observational and 1 was randomized . Seven were derived from invasive angiography and intracoronary FFR measurement and one study is based on CT coronary angiography and FFR CT . In 4 studies the patients were elective only, in 1 study only acute coronary syndrome patients were included and in 3 there was a mixture. The angiographic lesion characteristics representing triggers for FFR measurement varied (range: ≥30% up to ≤90%) between studies, as did the number of vessels targeted (range: further assessment of at least one intermediate lesion to FFR of all vessels of a diameter that was suitable for PCI) ( Table 1 ).




Fig. 1


PRISMA flow diagram of included publications.


Table 1

Clinical characteristics of the publications included in the systematic review.












































































Name Country Study type Study period Inclusion criteria Exclusion criteria Year
Sant’Anna et al. Brazil Prospective October 2004
to April 2005
Elective PCI Transmural acute myocardial infarction (AMI) in the last 7 days, chronic total occlusion, or angiographically significant left main disease 2007
Curzen et al. The RIPCORD Study United Kingdom Prospective NA Stable cardiac-sounding CP included the presence in any epicardial vessel of ≥2.25 mm diameter of a
≥30% stenosis
Failure to provide written informed consent, participation in other clinical studies, previous CABG, acute coronary syndrome at presentation, diagnostic angiography or PCI within the previous 12 months, contraindication to adenosine, severe valve disease, serum creatinine >180
μmol/L, and life-threatening comorbidity
2014
Nakamura et al. CVIT-DEFER Registry Japan Prospective December 2012 and September 2013 Angiographically intermediate to moderate coronary stenosis and in whom FFR was clinically indicated NA 2014
Layland et al. FAMOUS-NSTEMI trial United Kingdom Prospective October 2011 to May 2013 NSTEMI and with at least one risk factor for coronary artery disease (e.g., diabetes mellitus)
within 72 h of the index episode of myocardial ischemia or if there
was a history of recurrent ischemic symptoms within 5 days. ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually
Presence of ischemic symptoms that
were not controlled by medical therapy, hemodynamic instability, MI with persistent ST elevation, intolerance to anti-platelet drugs, ineligible for coronary revascularization, a treatment plan for non-coronary heart surgery (e.g., valve surgery), a history of prior CABG, angiographic evidence of severe (e.g., diffuse calcification), a life expectancy, 1 year and an inability to give informed consent
2014
Van Belle et al. FFR-R3F study France Prospective October 2008 to June 2010 NA NA 2014
Baptista et al. POST-IT Multicenter Registry Portugal Prospective March 2012 to November 2013 NA Unwillingness to provide written informed consent and life expectancy
<1 year because of known noncardiovascular comorbidity
2016
De Backer et al. Denmark Prospective 1 July 2010 and 30 June 2014 Stable angina pectoris
(AP) and at least one 50%–89% coronary stenosis were selected.
NA 2016
Curzen et al. The FFRCT RIPCORD Study United Kingdom Prospective NA Stable cardiac-sounding CP included the presence in any epicardial vessel of ≥2.25 mm diameter of a
≥30% stenosis
Failure to provide written informed consent, participation in other clinical studies, previous CABG, acute coronary syndrome at presentation, diagnostic angiography or PCI within the previous 12 months, contraindication to adenosine, severe valve disease, serum creatinine >180 μmol/L, and life-threatening comorbidity 2016


































































































































Name No. patients % Female Mean age, years Follow up period Setting Diabetes mellitus % Multivessel disease Unstable angina
pectoris
ACS% FFR limit Stenosis limit Number of diameter stenosis
>70%
Sant’Anna et al. 250 38% 61 NA Elective 23% 70% 7% 0% 0.75 >50% 327
Curzen et al. The RIPCORD Study 200 25% 64 NA Elective NA NA NA 0 0.8 >30% 68
Nakamura et al. CVIT-DEFER Registry 3093 26.2 69.5 NA Elective and ACS 37.7 34.8 7.2 1.4 0.8 50%–90% NA
Layland et al. FAMOUS- NSTEMI trial 350 24.6 62.3 12 months ACS 14.8 29 0 100 0.8 >30% 63.1
Van Belle et al. FFR-R3F study 1075 24.70% 64.7 12 months Elective and ACS 35.8 47.6 NA 19.5 0.8 35%–65% NA
Baptista et al. POST-IT Multicenter Registry 918 23.7 65.1 12 months Elective and ACS 35 37.5 4.4 35.4 0.75–0.8 Intermediate 31.9
De Backer et al. 1716 28.8 64.5 23.2 months Elective 23.8 32.5 0 0 0.8 50%–89% 74
Curzen et al. The FFRCT RIPCORD Study 200 NA NA Elective NA NA NA 0 0.8 >70% 126



Quality assessment in included studies


Quality Assessment Tool for Case Series Studies was used to gauge the quality of evidence and all studies were of good quality. Their detailed evaluation has been tabulated in Table 2 .



Table 2

Quality assessment of the studies


















































































































Criteria Sant’Anna et al. Curzen et al. The RIPCORD Study Nakamura et al. CVIT-DEFER Registry Layland et al. FAMOUS-NSTEMI trial Belle et al. FFR-R3F study Baptista et al. POST-IT study Backer et al. Curzen et al. The FFRCT RIPCORD Study
1. Was the study question or objective clearly stated? Yes Yes Yes Yes Yes Yes Yes Yes
2. Was the study population clearly and fully described, including a case definition? Yes Yes Yes Yes Yes Yes Yes Yes
3. Were the cases consecutive? Yes Yes Yes Yes Yes Yes Yes Yes
4. Were the subjects comparable? Yes Yes Yes Yes Yes Yes Yes Yes
5. Was the intervention clearly described? Yes Yes Yes Yes Yes Yes Yes Yes
6. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants? Yes Yes Yes Yes Yes Yes Yes Yes
7. Was the length of follow-up adequate? NA NA NA Yes Yes Yes Yes NA
8. Were the statistical methods well described? Yes Yes Yes Yes Yes Yes Yes Yes
9. Were the results well described? Yes Yes Yes Yes Yes Yes Yes Yes
Quality rating Good Good Good Good Good Good Good Good

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Nov 13, 2017 | Posted by in CARDIOLOGY | Comments Off on Change in angiogram-derived management strategy of patients with chest pain when some FFR data are available: How consistent is the effect?

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