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

22 Citations (Scopus)

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
Pages (from-to)1303-1312
Number of pages10
JournalJACC: Cardiovascular Imaging
Volume12
Issue number7
DOIs
Publication statusPublished - 2019 Jul

Keywords

  • coronary computed tomographic angiography
  • invasive coronary angiography
  • major adverse cardiac events
  • stable ischemic heart disease

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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