Author + information
- Received November 9, 2014
- Revision received December 23, 2014
- Accepted January 1, 2015
- Published online June 1, 2015.
- Gregg W. Stone, MD∗,†∗ (, )
- Akiko Maehara, MD∗,†,
- James E. Muller, MD‡,
- David G. Rizik, MD§,
- Kendrick A. Shunk, MD‖,
- Ori Ben-Yehuda, MD∗,†,
- Philippe Genereux, MD†,¶,
- Ovidiu Dressler, MD†,
- Rupa Parvataneni, MS†,
- Sean Madden, PhD‡,
- Priti Shah, MS‡,
- Emmanouil S. Brilakis, MD, PhD#,
- Annapoorna S. Kini, MD∗∗,
- CANARY Investigators
- ∗Columbia University Medical Center and New York-Presbyterian Hospital, New York, New York
- †The Cardiovascular Research Foundation, New York, New York
- ‡InfraReDx Inc., Burlington, Massachusetts
- §Scottsdale Healthcare, Scottsdale, Arizona
- ‖San Francisco Veterans Affairs Medical Center, San Francisco, California
- ¶Hôpital du Sacré-Cœur de Montréal, Montréal, Québec, Canada
- #North Texas Veterans Affairs Medical Center, Dallas, Texas
- ∗∗Mount Sinai Hospital, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, The Cardiovascular Research Foundation, 111 E. 59th Street, 11th Floor, New York, New York 10022.
Objectives This study sought to determine whether pre–percutaneous coronary intervention (PCI) plaque characterization using near-infrared spectroscopy identifies lipid-rich plaques at risk of periprocedural myonecrosis and whether these events may be prevented by the use of a distal protection filter during PCI.
Background Lipid-rich plaques may be prone to distal embolization and periprocedural myocardial infarction (MI) in patients undergoing PCI.
Methods Patients undergoing stent implantation of a single native coronary lesion were enrolled in a multicenter, prospective trial. Near-infrared spectroscopy and intravascular ultrasound were performed at baseline, and lesions with a maximal lipid core burden index over any 4-mm length (maxLCBI4mm) ≥600 were randomized to PCI with versus without a distal protection filter. The primary endpoint was periprocedural MI, defined as troponin or a creatine kinase-myocardial band increase to 3 or more times the upper limit of normal.
Results Eighty-five patients were enrolled at 9 U.S. sites. The median (interquartile range) maxLCBI4mm was 448.4 (274.8 to 654.4) pre-PCI and decreased to 156.0 (75.6 to 312.6) post-PCI (p < 0.0001). Periprocedural MI developed in 21 patients (24.7%). The maxLCBI4mm was higher in patients with versus without MI (481.5 [425.6 to 679.6] vs. 371.5 [228.9 to 611.6], p = 0.05). Among 31 randomized lesions with maxLCBI4mm ≥600, there was no difference in the rates of periprocedural MI with versus without the use of a distal protection filter (35.7% vs. 23.5%, respectively; relative risk: 1.52; 95% confidence interval: 0.50 to 4.60, p = 0.69).
Conclusions Plaque characterization by near-infrared spectroscopy identifies lipid-rich lesions with an increased likelihood of periprocedural MI after stent implantation, presumably due to distal embolization. However, in this pilot randomized trial, the use of a distal protection filter did not prevent myonecrosis after PCI of lipid-rich plaques.
The names of the investigators, institutions, and research organizations participating in the CANARY trial are provided in Online Appendix 1. Dr. Stone is a past consultant for Boston Scientific, Volcano, and InfraReDx. Dr. Maehara is a consultant for Boston Scientific and ACIST; and has received speaker fees from St. Jude Medical. Drs. Muller and Madden and Ms. Shah are full-time employees of InfraReDx. Dr. Brilakis has served as a consultant and has received speaker honoraria from St. Jude, Terumo, Asahi, Abbott Vascular, Elsevier, Somahlution, and Boston Scientific; has received research support from Guerbet and InfraReDx; and that his spouse is an employee of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 9, 2014.
- Revision received December 23, 2014.
- Accepted January 1, 2015.
- American College of Cardiology Foundation