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Received: 27 May 2017

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Accepted: 15 January 2018

DOI: 10.1002/ccd.27525

ORIGINAL STUDIES

Fractional flow reserve guided percutaneous coronary intervention results in reduced ischemic myocardium and improved outcomes Abhishek C. Sawant, MD, MPH1*

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Aishwarya Bhardwaj, MD1* |

Kinjal Banerjee, MBBS2 | Yash Jobanputra, MBBS2 | Arnav Kumar, MD2 | Parth Parikh, MD2 | Krishna C. Kandregula, MBBS2 | Kanhaiya Poddar, MBBS2 | Stephen G. Ellis, MD2 | Ravi Nair, MD2 | John Corbelli, MD1 | Samir Kapadia, MD2 1 Department of Medicine, Division of Cardiology, State University of New York at Buffalo, and Buffalo VA Healthcare System, Buffalo, New York 2

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio Correspondence Samir Kapadia, MD, Professor of Medicine, Director Cardiac Catheterization Laboratory, Cleveland Clinic, 9500 Euclid, J2-3 Cleveland, OH 44195. Email: [email protected]

Abstract Objectives: To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiographyguided PCI. Background: Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. Methods: We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. Results: Mean age was 63 6 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P 5 .12) and perforation (0% vs. 0%, P 5 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P 5 .04) and adjusted [OR 5 0.58 (95% CI: 0.34–0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P 5 .02) to have ischemia and had lower (5.9% vs. 21.1%, P < .001) ischemic burden (moderate-severe ischemia) on post-PCI stress testing. Presence of ischemia post-PCI remained a strong predictor of MACE [OR 5 2.14 (95%CI: 1.28–3.60)] with worse survival compared to those without ischemia (HR 5 1.63 (95% CI: 1.06–2.51). Conclusion: Compared with angiography-guided PCI, FFR-guided PCI results in less repeat revascularization and a lower incidence of post PCI ischemia translating into improved survival, without an increase in complications. KEYWORDS

fractional flow reserve, ischemia, stress testing

*Dr’s Sawant and Bhardwaj contributed equally to this study.

Catheter Cardiovasc Interv. 2018;1–9.

wileyonlinelibrary.com/journal/ccd

C 2018 Wiley Periodicals, Inc. V

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SAWANT

1 | INTRODUCTION

ET AL.

measurement of FFR from 2009 to 2014. Data were collected using standardized definitions, which conform to the definitions and stand-

In the past 30 years, percutaneous coronary intervention (PCI) has

ards of the American College of Cardiology’s National Cardiovascular

become the cornerstone in revascularization of coronary artery disease

Data Registry (ACC-NCDR) [9]. Quality checks of the data are periodi-

(CAD). With advancements in technology, our understanding of the

cally conducted for completeness and accuracy [10]. The patients who

pathophysiology of coronary artery stenosis has led to a shift in deci-

underwent FFR measurement during PCI were propensity-matched for

sion making in performing PCI in the setting of CAD. Where in the

baseline clinical characteristics with patients who underwent PCI dur-

past, this decision relied on data limited to the anatomic/visual appear-

ing the same period without FFR assessment. All patients had under-

ance of a coronary arterial narrowing, we are now able to synergize the

gone post-procedure noninvasive ischemic evaluation.

anatomic appearance of a stenosis with an assessment of the hemodynamic significance of the stenosis by the use of fractional flow reserve (FFR). FFR has emerged as a safe, cost-effective, and accurate method for identifying the functional significance of a stenosis during coronary angiography [1]. Two large randomized trials demonstrated that utilization of FFR for PCI was associated with improved clinical outcomes, reduced complications, and improved functional status [2,3]. Studies have also demonstrated that functionally nonsignificant lesions identified by FFR can be deferred without PCI with good outcomes [4]. The utilization of FFR has been increasing exponentially as shown by the nationwide inpatient sample database discharge codes [5]. However, to date the procedure remains underutilized due to lack of experience, increased procedural time, increased radiation dose, and technical difficulties in interpretation and application of its findings [6]. The presence of myocardial ischemic burden has been shown to be an independent predictor of adverse outcomes in stable CAD [7]. A

2.2 | Clinical characterization Clinical, laboratory, noninvasive, and angiographic data were obtained on all the patients according to the ACC-NCDR standardized definitions described above [9]. Detailed clinical data including prior cardiac history, comorbid conditions, and cardiac risk factors including tobacco use were collected on each patient. Noninvasive data, including electrocardiographic and echocardiographic variables with assessment of left ventricular ejection fraction were obtained. Detailed angiographic data collected per ACC-NCDR standardized definitions included type of sedation, primary arterial access site, angiographic findings, PCI, and additional procedures performed, as well as post-procedure complications including MI, stroke, and bleeding requiring transfusion.

2.3 | Ischemia evaluation

sub-study by the Clinical Outcomes Utilizing Revascularization and

Ischemic evaluation was performed noninvasively within 6 months

Aggressive Drug Evaluation (COURAGE) investigators demonstrated

prior to the procedure and up to 12 months post procedure. Noninva-

that  5% improvement in left-ventricular ischemia after revasculariza-

sive ischemic evaluation included exercise or pharmacological nuclear

tion was associated with significant reduction in the risk of death and

single photon emission computerized tomography (SPECT), exercise or

myocardial infarction (MI) [8]. Additionally, the presence of residual

pharmacological positron emission tomography (PET) testing, and exer-

ischemia was also shown to be associated with adverse outcomes.

cise or pharmacological stress echocardiography. The images were

Since FFR-guided PCI results in revascularization based upon functional

evaluated using a 17-segment model. Ischemic burden was calculated

severity of a lesion, it would be intuitive that FFR-guided PCI would

after subtracting rest from stress total perfusion defect (TPD), which

result in lower ischemic burden post revascularization compared with

has been previously validated [8,11]. The presence of mild ischemia

angiography-guided PCI alone and this reduced ischemic burden using

was defined as involvement of 5% of ischemic myocardium, moderate

FFR-guided PCI would also translate to reduced risk of major adverse

ischemia was defined as that involving 5% to 9% of ischemic myocar-

cardiac outcomes (MACE) including death, MI, stroke, and revasculari-

dium, and severe ischemia was defined as involvement of  10% ische-

zation. Nonetheless, data supporting the use of FFR-guided PCI in

mic myocardium [12]. The interpretation of stress tests was performed

reducing ischemic burden is currently lacking in scientific literature.

by staff cardiologists who were not directly involved in patient care.

Utilizing the dataset of patients undergoing PCI at the Cleveland Clinic, we sought to determine if FFR-guided PCI compared with

For stress echocardiography presence of  3 ischemic segments was considered as a threshold for presence of moderate ischemia [13].

angiography-guided PCI is associated with: (1) reduced risk of postprocedural MACE; (2) differences in procedural risks; (3) reduced ischemic burden post-revascularization; and (4) improved outcomes and reduced risk of MACE in those patients where FFR-guided PCI resulted in reduction of post-PCI ischemic burden.

2 | METHODS 2.1 | Study population

2.4 | Outcomes measures The date of PCI at our institution was defined as the beginning of the observational period. Follow-up was ascertained by chart review and we recorded the dates at which events occurred. Mortality data were obtained from medical records or from the U.S. Social Security Death Index database (last inquiry in December 2014). The primary outcomes included all-cause mortality, stroke and repeat revascularization within one year post procedure. Occurrence of stroke was defined as a focal

Data were obtained from our prospective PCI database and included all

neurologic deficit, from a nontraumatic cause, lasting at least 24 hours

patients who were  18 years old and underwent PCI with

and

categorized

as

ischemic

(with

or

without

hemorrhagic

SAWANT

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ET AL.

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transformation), hemorrhagic, or of uncertain type (in the case of

of ischemia post-PCI and (2) absence of ischemia on post-PCI stress

patients who did not undergo brain imaging or in whom an autopsy

testing. Comparisons between curves were made using a log-rank test.

was not performed). All procedures were approved and monitored by

Statistical analysis was performed using STATA v13.0 (StataCorp, Col-

Cleveland Clinic Institutional Review Board with a waiver of individual

lege Station, Texas). A P-value of