CT Angiography Followed by Invasive Angiography in Patients With Moderate or Severe Ischemia-Insights From the ISCHEMIA Trial.

OBJECTIVES

This study aimed to examine the concordance of coronary computed tomographic angiography (CCTA) assessment of coronary anatomy and invasive coronary angiography (ICA) as the reference standard in patients enrolled in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches).

BACKGROUND

Performance of CCTA compared with ICA has not been assessed in patients with very high burdens of stress-induced ischemia and a high likelihood of anatomically significant coronary artery disease (CAD). A blinded CCTA was performed after enrollment to exclude patients with left main (LM) disease or no obstructive CAD before randomization to an initial conservative or invasive strategy, the latter guided by ICA and optimal revascularization.

METHODS

Rates of concordance were calculated on a per-patient basis in patients randomized to the invasive strategy. Anatomic significance was defined as ≥50% diameter stenosis (DS) for both modalities. Sensitivity analyses using a threshold of ≥70% DS for CCTA or considering only CCTA images of good-to-excellent quality were performed.

RESULTS

In 1,728 patients identified by CCTA as having no LM disease ≥50% and at least single-vessel CAD, ICA confirmed 97.1% without LM disease ≥50%, 92.2% with at least single-vessel CAD and no LM disease ≥50%, and only 4.9% without anatomically significant CAD. Results using a ≥70% DS threshold or only CCTA of good-to-excellent quality showed similar overall performance.

CONCLUSIONS

CCTA before randomization in ISCHEMIA demonstrated high concordance with subsequent ICA for identification of patients with angiographically significant disease without LM disease.

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support And Author Disclosures This project was funded by National Institutes of Health (NIH) grants U01HL105907, U01HL105462, and U01HL105561 (NCT01471522). Dr. Mancini has received grants from National Heart, Lung and Blood Institute. Dr. Leipsic has served as consultant and has reported stock options in HeartFlow and CIRCLE CVI; has received a research grant from GE Healthcare. Dr. Budoff has received grant support from General Electric. Dr. Hague has received grants from National Heart, Lung and Blood Institute. Dr. Min has received grants from National Heart, Lung, and Blood Institute, support from Cleerly Inc., grants and other support from GE Healthcare, and support from Arineta. Ms. Stevens has received grants from National Heart, Lung and Blood Institute. Dr. Reynolds has received grants from National Heart, Lung and Blood Institute and nonfinancial support from Abbott Vascular, Siemens, and BioTelemetry. Drs. O’Brien, Shaw, Manjunath, Mavromatis, Demkow, Lopez-Sendon, Chernyavskiy, Gosselin,. Schuelenz, Devlin, and Chauhan have received grants from National Heart, Lung and Blood Institute. Dr. Bangalore has received grants from National Heart, Lung and Blood Institute; and has served on advisory boards for Abbott Vascular, Pfizer, Amgen, Biotronik, Meril, Reata Pharmaceuticals, and Abbott Vascular. Dr. Hochman has served as Principal Investigator for the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, for which—in addition to support by a National Heart, Lung, and Blood Institute grant—devices and medications were provided by Abbott Vascular, Medtronic Inc., St. Jude Medical Inc., Volcano Corporation, Arbor Pharmaceuticals LLC, AstraZeneca, Merck Sharp and Dohme Corp., Omron Healthcare Inc.; and has received financial support from Arbor Pharmaceuticals LLC and AstraZeneca. Dr. Maron has received grants from National Heart, Lung, and Blood Institute.