1. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.

Evaluation of computed tomography in patients with atypical angina or chest pain 
clinically referred for invasive coronary angiography: randomised controlled
trial.

Dewey M(1), Rief M(2), Martus P(3), Kendziora B(2), Feger S(2), Dreger H(2),
Priem S(2), Knebel F(2), Böhm M(2), Schlattmann P(4), Hamm B(2), Schönenberger
E(2), Laule M(2), Zimmermann E(2).

Author information: 
(1)Charité-Universitätsmedizin Berlin, Humboldt-Universität and Freie Universität
zu Berlin, Germany dewey@charite.de.
(2)Charité-Universitätsmedizin Berlin, Humboldt-Universität and Freie Universität
zu Berlin, Germany.
(3)Institute for Clinical Epidemiology and Applied Biometry, Tübingen, Germany.
(4)Institute of Medical Statistics, Computer Sciences and Documentation, Jena,
Germany.

Erratum in
    BMJ. 2016 Nov 29;355:i6420.

OBJECTIVE:  To evaluate whether invasive coronary angiography or computed
tomography (CT) should be performed in patients clinically referred for coronary 
angiography with an intermediate probability of coronary artery disease.
DESIGN:  Prospective randomised single centre trial.
SETTING:  University hospital in Germany.
PARTICIPANTS:  340 patients with suspected coronary artery disease and a clinical
indication for coronary angiography on the basis of atypical angina or chest
pain.
INTERVENTIONS:  168 patients were randomised to CT and 172 to coronary
angiography. After randomisation one patient declined CT and 10 patients declined
coronary angiography, leaving 167 patients (88 women) and 162 patients (78 women)
for analysis. Allocation could not be blinded, but blinded independent
investigators assessed outcomes.
MAIN OUTCOME MEASURE:  The primary outcome measure was major procedural
complications within 48 hours of the last procedure related to CT or angiography.
RESULTS:  Cardiac CT reduced the need for coronary angiography from 100% to 14%
(95% confidence interval 9% to 20%, P<0.001) and was associated with a
significantly greater diagnostic yield from coronary angiography: 75% (53% to
90%) v 15% (10% to 22%), P<0.001. Major procedural complications were uncommon
(0.3%) and similar across groups. Minor procedural complications were less common
in the CT group than in the coronary angiography group: 3.6% (1% to 8%) v 10.5%
(6% to 16%), P=0.014. CT shortened the median length of stay in the angiography
group from 52.9 hours (interquartile range 49.5-76.4 hours) to 30.0 hours
(3.5-77.3 hours, P<0.001). Overall median exposure to radiation was similar
between the CT and angiography groups: 5.0 mSv (interquartile range 4.2-8.7 mSv) 
v 6.4 mSv (3.4-10.7 mSv), P=0.45. After a median follow-up of 3.3 years, major
adverse cardiovascular events had occurred in seven of 167 patients in the CT
group (4.2%) and six of 162 (3.7%) in the coronary angiography group (adjusted
hazard ratio 0.90, 95% confidence interval 0.30 to 2.69, P=0.86). 79% of patients
stated that they would prefer CT for subsequent testing. The study was conducted 
at a University hospital in Germany and thus the performance of CT may be
different in routine clinical practice. The prevalence was lower than expected,
resulting in an underpowered study for the predefined primary outcome.
CONCLUSIONS:  CT increased the diagnostic yield and was a safe gatekeeper for
coronary angiography with no increase in long term events. The length of stay was
shortened by 22.9 hours with CT, and patients preferred non-invasive
testing.Trial registration ClinicalTrials.gov NCT00844220.

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DOI: 10.1136/bmj.i5441 
PMCID: PMC5076567
PMID: 27777234  [Indexed for MEDLINE]

Conflict of interest statement: All authors have completed the ICMJE uniform
disclosure form at www.icmje.org/coi-disclosure.pdf (available on request from
the corresponding author) and declare that (1) MD has support from the Heisenberg
programme of the German Research Foundation for the submitted work; (2) MD has
relationships with Bayer, Bracco, Cardiac MR Academy, European Commission,
European Regional Development Fund, German Foundation of Heart Research, German
Federal Ministry of Education and Research, GE Healthcare, Guerbet, Springer, and
Toshiba; BH has relationships with Bayer, Bracco, GE, Guerbet, Philips, Siemens, 
and Toshiba; (3) their spouses, partners, or children have no financial
relationships that may be relevant to the submitted work; and (4) have no
non-financial interests that may be relevant to the submitted work. Institutional
master research agreements exist with Siemens Medical Solutions, Philips Medical 
Systems, and Toshiba Medical Systems. The terms of these arrangements are managed
by the legal department of Charité–Universitätsmedizin Berlin.