Journal
JACC-CARDIOVASCULAR IMAGING
Volume 12, Issue 7, Pages 1303-1312Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcmg.2018.09.018
Keywords
coronary computed tomographic angiography; invasive coronary angiography; major adverse cardiac events; stable ischemic heart disease
Funding
- GE Healthcare (Princeton, New Jersey)
- Leading Foreign Research Institute Recruitment Program of the National Research Foundation of Korea, Ministry of Science, ICT & Future Planning (Seoul, Korea)
- Leading Foreign Research Institute Recruitment Program through the National Research Foundation of Korea - Ministry of Science, ICT & Future Planning [2012027176]
- Dalio Foundation
- National Institutes of Health
- GE Healthcare
- GE
- Bracco
- Bayer
- Medtronic
- Heartflow
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OBJECTIVES This study compared the safety and diagnostic yield of a selective referral strategy using coronary computed tomographic angiography (CCTA) compared with a direct referral strategy using invasive coronary angiography (ICA) as the index procedure. BACKGROUND Among patients presenting with signs and symptoms suggestive of coronary artery disease (CAD), a sizeable proportion who are referred to ICA do not have a significant, obstructive stenosis. METHODS In a multinational, randomized clinical trial of patients referred to ICA for nonemergent indications, a selective referral strategy was compared with a direct referral strategy. The primary endpoint was noninferiority with a multiplicative margin of 1.33 of composite major adverse cardiovascular events (blindly adjudicated death, myocardial infarction, unstable angina, stroke, urgent and/or emergent coronary revascularization or cardiac hospitalization) at a median follow-up of 1-year. RESULTS At 22 sites, 823 subjects were randomized to a selective referral and 808 to a direct referral strategy. At 1 year, selective referral met the noninferiority margin of 1.33 (p = 0.026) with a similar event rate between the randomized arms of the trial (4.6% vs. 4.6%; hazard ratio: 0.99; 95% confidence interval: 0.66 to 1.47). Following CCTA, only 23% of the selective referral arm went on to ICA, which was a rate lower than that of the direct referral strategy. Coronary revascularization occurred less often in the selective referral group compared with the direct referral to ICA (13% vs. 18%; p < 0.001). Rates of normal ICA were 24.6% in the selective referral arm compared with 61.1% in the direct referral arm of the trial (p < 0.001). CONCLUSIONS In stable patients with suspected CAD who are eligible for ICA, the comparable 1-year major adverse cardiovascular events rates following a selective referral and direct referral strategy suggests that both diagnostic approaches are similarly effective. In the selective referral strategy, the reduced use of ICA was associated with a greater diagnostic yield, which supported the usefulness of CCTA as an efficient and accurate method to guide decisions of ICA performance. (Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization [CONSERVE]; NCT01810198) Published by Elsevier on behalf of the American College of Cardiology Foundation.
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