Author + information
- Received January 22, 2009
- Revision received May 5, 2009
- Accepted May 15, 2009
- Published online July 1, 2009.
- Sergio Waxman, MD⁎,⁎ (, )
- Simon R. Dixon, MD†,
- Philippe L'Allier, MD‡,
- Jeffrey W. Moses, MD§,
- John L. Petersen, MD∥,
- Donald Cutlip, MD¶,
- Jean-Claude Tardif, MD‡,
- Richard W. Nesto, MD⁎,
- James E. Muller, MD#,
- Michael J. Hendricks, BS#,
- Stephen T. Sum, PhD#,
- Craig M. Gardner, PhD#,
- James A. Goldstein, MD†,
- Gregg W. Stone, MD§ and
- Mitchell W. Krucoff, MD∥
Reprint requests and correspondence:
Dr. Sergio Waxman, Lahey Clinic, 41 Mall Road, Burlington, Massachusetts 01805
Objectives To determine whether catheter-based near-infrared spectroscopy (NIRS) signals obtained with a novel catheter-based system from coronaries of patients are similar to those from autopsy specimens and to assess initial safety of NIRS device.
Background An intravascular NIRS system for detection of lipid core-containing plaques (LCP) has been validated in human coronary autopsy specimens. The SPECTACL (SPECTroscopic Assessment of Coronary Lipid) trial was a parallel first-in-human multicenter study designed to demonstrate the applicability of the LCP detection algorithm in living patients.
Methods Intracoronary NIRS was performed in patients undergoing percutaneous coronary intervention. Acquired spectra were blindly compared with autopsy NIRS signals with multivariate statistics. To meet the end point of spectral similarity, at least two-thirds of the scans were required to have >80% of spectra similar to the autopsy spectra.
Results A total of 106 patients were enrolled; there were no serious adverse events attributed to NIRS. Spectroscopic data could not be obtained in 17 (16%) patients due to technical limitations, leaving 89 patients for analysis. Spectra from 30 patients were unblinded to test the calibration of the LCP detection algorithm. Of the remaining 59 blinded cases, after excluding 11 due to inadequate data, spectral similarity was demonstrated in 40 of 48 spectrally adequate scans (83% success rate, 95% confidence interval: 70% to 93%, median spectral similarity/pullback: 96%, interquartile range 10%). The LCP was detected in 58% of 60 spectrally similar scans from both cohorts.
Conclusions This intravascular NIRS system safely obtained spectral data in patients that were similar to those from autopsy specimens. These results demonstrate the feasibility of invasive detection of coronary LCP with this novel system. (SPECTACL: SPECTroscopic Assessment of Coronary Lipid; NCT00330928)
InfraReDx, Inc. was the sole source of funding for this study. Dr. Waxman consulted for InfraReDx before initiating the study. Drs. Muller, Gardner, Sum, and Mr. Hendricks are employees of InfraReDx. Dr. Goldstein is a consultant for InfraReDx and equity owner. Drs. Krucoff and Stone are consultants for InfraReDx.
- Received January 22, 2009.
- Revision received May 5, 2009.
- Accepted May 15, 2009.
- American College of Cardiology Foundation