Hyuk-Jae Chang1, Fay Y Lin2, Dan Gebow3, Hae Young An4, Daniele Andreini5, Ravi Bathina6, Andrea Baggiano5, Virginia Beltrama5, Rodrigo Cerci7, Eui-Young Choi8, Jung-Hyun Choi9, So-Yeon Choi10, Namsik Chung4, Jason Cole11, Joon-Hyung Doh12, Sang-Jin Ha13, Ae-Young Her14, Cezary Kepka15, Jang-Young Kim16, Jin-Won Kim17, Sang-Wook Kim18, Woong Kim19, Gianluca Pontone5, Uma Valeti20, Todd C Villines21, Yao Lu2, Amit Kumar2, Iksung Cho18, Ibrahim Danad22, Donghee Han23, Ran Heo24, Sang-Eun Lee4, Ji Hyun Lee23, Hyung-Bok Park25, Ji-Min Sung4, David Leflang3, Joseph Zullo3, Leslee J Shaw26, James K Min27. 1. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea. Electronic address: hjchang@yuhs.ac. 2. Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York. 3. MDDX, San Francisco, California. 4. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea. 5. Centro Cardiologico Monzino, IRCCS, Milan, Italy. 6. CARE Hospital and FACTS Foundation, Hyderabad, India. 7. Quanta Diagnostico Nuclear, Curitiba, Brazil. 8. Gangnam Severance Hospital, Seoul, South Korea. 9. Pusan National University Hospital, Busan, South Korea. 10. Ajou University Hospital, Gyeonggi-do, South Korea. 11. Cardiology Associates of Mobile, Mobile, Alabama. 12. Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea. 13. Gangneung Asan Hospital, Gangwon-do, South Korea. 14. Kangwon National University Hospital, Gangwon-do, South Korea. 15. Institute of Cardiology, Warsaw, Poland. 16. Wonju Severance Hospital, Gangwon-do, South Korea. 17. Korea University Guro Hospital, Seoul, South Korea. 18. Chung-Ang University Hospital, Seoul, South Korea. 19. Yeungnam University Hospital, Daegu, South Korea. 20. University of Minnesota, Minneapolis, Minnesota. 21. Walter Reed Medical Center, Bethesda, Maryland. 22. Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York; VU Medical Center, Amsterdam, the Netherlands. 23. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York. 24. Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 25. Myongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea. 26. Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York. Electronic address: https://twitter.com/lesleejshaw. 27. Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York. Electronic address: jkm2001@med.cornell.edu.
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). Published by Elsevier Inc.
RCT Entities:
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 Inc.
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