Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CADA Randomized, Controlled, Open-Label Trial
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Author + information
- Hyuk-Jae Chang, MD, PhDa,∗∗ (hjchang{at}yuhs.ac),
- Fay Y. Lin, MDb,
- Dan Gebow, PhDc,
- Hae Young An, BSa,
- Daniele Andreini, MD, PhDd,
- Ravi Bathina, MDe,
- Andrea Baggiano, MDd,
- Virginia Beltrama, MDd,
- Rodrigo Cerci, MDf,
- Eui-Young Choi, MDg,
- Jung-Hyun Choi, MDh,
- So-Yeon Choi, MDi,
- Namsik Chung, MD, PhDa,
- Jason Cole, MDj,
- Joon-Hyung Doh, MDk,
- Sang-Jin Ha, MDl,
- Ae-Young Her, MDm,
- Cezary Kepka, MDn,
- Jang-Young Kim, MDo,
- Jin-Won Kim, MDp,
- Sang-Wook Kim, MDq,
- Woong Kim, MDr,
- Gianluca Pontone, MD, PhDd,
- Uma Valeti, MDs,
- Todd C. Villines, MDt,
- Yao Lu, MSb,
- Amit Kumar, MSb,
- Iksung Cho, MDq,
- Ibrahim Danad, MDb,u,
- Donghee Han, MDa,b,
- Ran Heo, MDv,
- Sang-Eun Lee, MDa,
- Ji Hyun Lee, MDa,b,
- Hyung-Bok Park, MDw,
- Ji-min Sung, PhDa,
- David Leflang, BAc,
- Joseph Zullo, BAc,
- Leslee J. Shaw, PhDb@lesleejshaw and
- James K. Min, MDb,∗ (jkm2001{at}med.cornell.edu)
- aSeverance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea
- bDalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York
- cMDDX, San Francisco, California
- dCentro Cardiologico Monzino, IRCCS, Milan, Italy
- eCARE Hospital and FACTS Foundation, Hyderabad, India
- fQuanta Diagnostico Nuclear, Curitiba, Brazil
- gGangnam Severance Hospital, Seoul, South Korea
- hPusan National University Hospital, Busan, South Korea
- iAjou University Hospital, Gyeonggi-do, South Korea
- jCardiology Associates of Mobile, Mobile, Alabama
- kInje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea
- lGangneung Asan Hospital, Gangwon-do, South Korea
- mKangwon National University Hospital, Gangwon-do, South Korea
- nInstitute of Cardiology, Warsaw, Poland
- oWonju Severance Hospital, Gangwon-do, South Korea
- pKorea University Guro Hospital, Seoul, South Korea
- qChung-Ang University Hospital, Seoul, South Korea
- rYeungnam University Hospital, Daegu, South Korea
- sUniversity of Minnesota, Minneapolis, Minnesota
- tWalter Reed Medical Center, Bethesda, Maryland
- uVU Medical Center, Amsterdam, the Netherlands
- vAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
- wMyongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea
- ↵∗Address for correspondence:
Dr. James K. Min, Department of Radiology and Medicine, Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, 413 E. 69th Street, Suite 108, New York, New York 10021. - ↵∗∗Dr. Hyuk-Jae Chang, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, South Korea.
Graphical abstract
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)
- coronary computed tomographic angiography
- invasive coronary angiography
- major adverse cardiac events
- stable ischemic heart disease
Footnotes
This trial was supported by an investigator-initiated unrestricted grant from GE Healthcare (Princeton, New Jersey) and the Leading Foreign Research Institute Recruitment Program of the National Research Foundation of Korea, Ministry of Science, ICT & Future Planning (Seoul, Korea). Drs. H.J. Chang and N.S. Chung were supported by a grant (Grant No. 2012027176) from the Leading Foreign Research Institute Recruitment Program through the National Research Foundation of Korea, funded by the Ministry of Science, ICT & Future Planning. Dr. Min is supported by the Dalio Foundation, National Institutes of Health, and GE Healthcare. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Dr. Pontone has received research grants and speaker fees from GE, Bracco, Bayer, Medtronic, and Heartflow. Dr. Min serves on the scientific advisory board of Arineta and GE Healthcare; and has an equity interest in Cleerly. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Jagat Narula, MD, served as Guest Editor for this paper.
- Received August 15, 2018.
- Revision received September 4, 2018.
- Accepted September 19, 2018.
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