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

Hyuk-Jae Chang, Fay Y Lin, Dan Gebow, Hae Young An, Daniele Andreini, Ravi Bathina, Andrea Baggiano, Virginia Beltrama, Rodrigo Cerci, Eui-Young Choi, Jung-Hyun Choi, So-Yeon Choi, Namsik Chung, Jason Cole, Joon-Hyung Doh, Sang-Jin Ha, Ae-Young Her, Cezary Kepka, Jang-Young Kim, Jin-Won KimSang-Wook Kim, Woong Kim, Gianluca Pontone, Uma Valeti, Todd C Villines, Yao Lu, Amit Kumar, Iksung Cho, Ibrahim Danad, Donghee Han, Ran Heo, Sang-Eun Lee, Ji Hyun Lee, Hyung-Bok Park, Ji-Min Sung, David Leflang, Joseph Zullo, Leslee J Shaw, James K Min

Research output: Contribution to journalArticlepeer-review

Abstract

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).

Original languageEnglish
JournalJACC. Cardiovascular imaging
DOIs
Publication statusE-pub ahead of print - Dec 6 2018

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