Author + information
- Received November 22, 2014
- Revision received January 6, 2015
- Accepted January 11, 2015
- Published online March 24, 2015.
- Usman Baber, MD, MS∗,
- Roxana Mehran, MD∗,
- Samantha Sartori, PhD∗,
- Mikkel Malby Schoos, MD, PhD†,
- Henrik Sillesen, MD, DMSc†,
- Pieter Muntendam, MD‡,
- Mario J. Garcia, MD§,
- John Gregson, PhD‖,
- Stuart Pocock, PhD‖,
- Erling Falk, MD, DMSc¶ and
- Valentin Fuster, MD, PhD∗∗ ()
- ∗Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York
- †Department of Vascular Surgery, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark
- ‡scPharmaceuticals, Lexington, Massachusetts
- §Division of Cardiology, Montefiore Medical Center, Bronx, New York
- ‖London School of Hygiene and Tropical Medicine, London, United Kingdom
- ¶Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
- ↵∗Reprint requests and correspondence:
Dr. Valentin Fuster, Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Background Although recent studies suggest that measuring coronary artery calcification (CAC) may be superior to indirect atherosclerotic markers in predicting cardiac risk, there are limited data evaluating imaging-based biomarkers that directly quantify atherosclerosis in different vascular beds performed in a single cohort.
Objectives The BioImage Study (A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population) sought to identify imaging biomarkers that predict near-term (3-year) atherothrombotic events.
Methods The BioImage Study enrolled 5,808 asymptomatic U.S. adults (mean age: 69 years, 56.5% female) in a prospective cohort evaluating the role of vascular imaging on cardiovascular risk prediction. All patients were evaluated by CAC and novel 3-dimensional carotid ultrasound. Plaque areas from both carotid arteries were summed as the carotid plaque burden (cPB). The primary endpoint was the composite of major adverse cardiac events (MACE) (cardiovascular death, myocardial infarction, and ischemic stroke). A broader secondary MACE endpoint also included all-cause death, unstable angina, and coronary revascularization.
Results Over a median follow-up of 2.7 years, MACE occurred in 216 patients (4.2%), of which 82 (1.5%) were primary events. After adjustment for risk factors, and compared with individuals without any cPB, hazard ratios for MACE were 0.78 (95% confidence interval [CI]: 0.31 to 1.91), 1.45 (95% CI: 0.67 to 3.14), and 2.36 (95% CI: 1.13 to 4.92) with increasing cPB tertile, with similar results for CAC. Net reclassification significantly improved with either cPB (0.23) or CAC (0.25). MACE rates increased simultaneously with higher levels of both cPB and CAC.
Conclusions Detection of subclinical carotid or coronary atherosclerosis improves risk predictions and reclassification compared with conventional risk factors, with comparable results for either modality. Cost-effective analyses are warranted to define the optimal roles of these complementary techniques. (BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population; NCT00738725)
The High-Risk Plaque Initiative is a pre-competitive industry collaboration funded by BG Medicine, Abbott Vascular, AstraZeneca, Merck & Co., Philips, and Takeda. Dr. Mehran has received institutional research grant support from AstraZeneca, The Medicines Company, Bristol-Myers Squibb/Sanofi, and Lilly/Daiichi Sankyo; consulting fees from Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen Pharmaceuticals, Maya Medical, Merck & Co., Regado Biosciences, and Sanofi; and serves on the advisory boards of Covidien, Janssen Pharmaceuticals, Merck & Co., Endothelix, Inc., and Sanofi. Dr. Sillesen has received honoraria from Cardoz, Philips, Novartis, and Takeda. Dr. Muntendam is a former employee of BG Medicine, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Tasneem Naqvi, MD, served as Guest Editor for this paper.
- Received November 22, 2014.
- Revision received January 6, 2015.
- Accepted January 11, 2015.
- American College of Cardiology Foundation