Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial

• Published in: JACC. Cardiovascular imaging Vol. 12; no. 7 Pt 2; p. 1303
• Main Authors: Chang, Hyuk-Jae, Lin, Fay Y, Gebow, Dan, An, Hae Young, Andreini, Daniele, Bathina, Ravi, Baggiano, Andrea, Beltrama, Virginia, Cerci, Rodrigo, Choi, Eui-Young, Choi, Jung-Hyun, Choi, So-Yeon, Chung, Namsik, Cole, Jason, Doh, Joon-Hyung, Ha, Sang-Jin, Her, Ae-Young, Kepka, Cezary, Kim, Jang-Young, Kim, Jin-Won, Kim, Sang-Wook, Kim, Woong, Pontone, Gianluca, Valeti, Uma, Villines, Todd C, Lu, Yao, Kumar, Amit, Cho, Iksung, Danad, Ibrahim, Han, Donghee, Heo, Ran, Lee, Sang-Eun, Lee, Ji Hyun, Park, Hyung-Bok, Sung, Ji-Min, Leflang, David, Zullo, Joseph, Shaw, Leslee J, Min, James K
• Format: Journal Article
• Language: English
• Published: United States 01.07.2019
• Subjects: Aged; Asia; Computed Tomography Angiography; Coronary Angiography - methods; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Europe; Female; Humans; Male; Middle Aged; North America; Predictive Value of Tests; Prognosis; Referral and Consultation; Time Factors; Asia; North America; Europe; major adverse cardiac events; invasive coronary angiography; stable ischemic heart disease; coronary computed tomographic angiography
• ISSN: 1876-7591; 1876-7591
• DOI: 10.1016/j.jcmg.2018.09.018

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. 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. 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. 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). 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).