Author + information
- Received June 30, 2016
- Revision received November 12, 2016
- Accepted November 17, 2016
- Published online November 6, 2017.
- Michael T. Lu, MDa,∗ (, )
- Maros Ferencik, MD, PhDa,b,
- Rhonda S. Roberts, MSPHc,
- Kerry L. Lee, PhDc,
- Alexander Ivanov, BSa,
- Elizabeth Adami, BSa,
- Daniel B. Mark, MD, MPHc,
- Farouc A. Jaffer, MD, PhDa,
- Jonathon A. Leipsic, MDd,
- Pamela S. Douglas, MDc and
- Udo Hoffmann, MD, MPHa
- aMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
- bOregon Health & Science University, Portland, Oregon
- cDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- dDepartment of Radiology, St Paul's Hospital and the University of British Columbia, Vancouver, British Columbia, Canada
- ↵∗Address for correspondence:
Dr. Michael T. Lu, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, Massachusetts 02114.
Objectives The purpose of this study was to determine whether noninvasive fractional flow reserve derived from computed tomography (FFRCT) predicts coronary revascularization and outcomes and whether its addition improves efficiency of referral to invasive coronary angiography (ICA) after coronary computed tomography angiography (CTA).
Background FFRCT may improve the efficiency of an anatomic CTA strategy for stable chest pain.
Methods This observational cohort study included patients with stable chest pain in the PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) trial referred to ICA within 90 days after CTA. FFRCT was measured at a blinded core laboratory, and FFRCT results were unavailable to caregivers. We determined the agreement of FFRCT (positive if ≤0.80) with stenosis on CTA and ICA (positive if ≥50% left main or ≥70% other coronary artery), and predictive value for a composite of coronary revascularization or major adverse cardiac events (death, myocardial infarction, or unstable angina). We retrospectively assessed whether adding FFRCT ≤0.80 as a gatekeeper could improve efficiency of referral to ICA, defined as decreased rate of ICA without ≥50% stenosis and increased ICA leading to revascularization.
Results FFRCT was calculated in 67% (181 of 271) of eligible patients (mean age 62 years; 36% women). FFRCT was discordant with stenosis in 31% (57 of 181) for CTA and 29% (52 of 181) for ICA. Most patients undergoing coronary revascularization had an FFRCT of ≤0.80 (91%; 80 of 88). An FFRCT of ≤0.80 was a significantly better predictor for revascularization or major adverse cardiac events than severe CTA stenosis (HR: 4.3 [95% confidence interval [CI]: 2.4 to 8.9] vs. 2.9 [95% CI: 1.8 to 5.1]; p = 0.033). Reserving ICA for patients with an FFRCT of ≤0.80 could decrease ICA without ≥50% stenosis by 44%, and increase the proportion of ICA leading to revascularization by 24%.
Conclusions In this hypothesis-generating study of patients with stable chest pain referred to ICA from CTA, an FFRCT of ≤0.80 was a better predictor of revascularization or major adverse cardiac events than severe stenosis on CTA. Adding FFRCT may improve efficiency of referral to ICA from CTA alone.
- computational fluid dynamics
- coronary angiography
- coronary artery disease
- coronary computed tomography angiography
- fractional flow reserve
This work was supported by an investigator-initiated grant from HeartFlow, Inc., Redwood City, California. The parent PROMISE trial was supported by National Heart, Lung, and Blood Institute grants R01HL098237, R01HL098236, R01HL098305, and R01HL098235. Dr. Lu’s effort was supported by the American Roentgen Ray Society Scholarship. Dr. Ferencik’s effort was supported by the American Heart Association Fellow to Faculty Award. Dr. Mark has received grant support from Eli Lilly, Bristol-Myers Squibb, Gilead Sciences, AGA Medical, Merck, Oxygen Biotherapeutics, and AstraZeneca; and personal fees from Medtronic, CardioDx, and St. Jude Medical. Dr. Jaffer has received grant support from Siemens and Canon USA; and is a consultant for Abbott Vascular and Boston Scientific. Dr. Leipsic is a consultant for Edwards Lifesciences, Samsung, Philips, Pi-Cardia, Circle CVI, GE Healthcare, and HeartFlow. Dr. Douglas has received grants from HeartFlow and GE HealthCare. Dr. Hoffmann has received grants from HeartFlow and Siemens Healthcare; and is a consultant to HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The funding sources had no role in the design of the study, data analysis, or decision to submit the manuscript. The content of this manuscript is solely the responsibility of the authors and does not necessarily reflect the views of HeartFlow or the National Heart, Lung, and Blood Institute.
- Received June 30, 2016.
- Revision received November 12, 2016.
- Accepted November 17, 2016.
- 2017 American College of Cardiology Foundation