Clinical Trials in Radiology
Clinical Trials in Radiology (CT)
Wednesday, February 28
Purpose: Purpose: to examine the clinical outcome of MR-guided focused
ultrasound (MRgFUS) and external-beam radiation therapy (EBRT) in patients
with painful bone metastasis.
Ethics committee approval: This study received institutional ethics committee
approval. All patients provided written informed consent.
Methods and Materials: Patients with solid tumors and one or more bone
metastasis were included. Eligible patients were 18years of age, had
radiologically-proven bone metastasis, could safely undergo both MRgFUS
and radiotherapy and had pain scores 4(on 0-to-10 numeric rating scale).
Participants were randomly assigned (1:1 ratio) to receive MRgFUS or EBRT.
The primary endpoint was treatment response, defined as a reduction of
2points in worst pain by week-4, accompanied by a stable or reduced opioid
dose, compared with baseline. Secondary endpoints assessed average pain,
interference of pain with activities, breakthrough pain, mood, quality of life, and
Results: 233 patients (M:125,F:108) were enrolled and randomly assigned to
MRgFUS(116) and EBRT(117). In the MRgFUS arm, 90 patients(77.6%)
achieved the primary endpoint, compared with 92(78.6%) in the EBRT arm
(adjusted odds ratio, 1.07;p=0.818). There were no significant differences in
average pain, pain interference with activity, breakthrough pain, mood and
quality of life between arms.
Limitations: This work only considers short-term results, assessing primary
and secondary outcomes within the first month after treatment.
Conclusion: The role of MRgFUS in cancer-induced bone pain is comparable
to EBRT, with the advantage of radiation-free and single-session procedure.
MRgFUS is limited to non-spinal locations.
Funding for this study: This study was conducted without any direct
Purpose: To evaluate the clinical benefit of using an electromagnetic
navigation system during CT-guided interventional radiology procedures.
Ethics committee approval: French Sud-Est V ethical committee
Methods and Materials: This study included 455 patients between December
2013 and July 2015 across nine participating hospitals. After randomization,
percutaneous procedures were carried out either under conventional CT
guidance (CT group), or using the additional assistance of IMACTIS-CT®
navigation system (NAV group). The primary outcome was evaluated by a
blinded expert committee. It assessed the safety (number of serious adverse
events), efficiency (number of targets reached) and performance (number of
CT control acquisitions required to reach the target) of CT-guided
Results: All patients (227 patients in NAV group and 228 patients in CT group)
were included in the intention-to-treat analysis. Missing data of 4 patients were
re-coded according to a worst-case scheme in disfavor of navigation. In
noninferiority analysis, NAV system was as safe (CI90 [-0.03;0.032]; c=0.07) and
as efficient (CI90 [-0.03;0.008]; - c=-0.1) as conventional guidance. The
number of CT control demonstrated to be reduced using NAV (5[3;9]) vs CT
Limitations: For 38 patients, the intervention was only partially achieved
according to the initially randomized protocol: in most cases (33/38), radiologist
went back to CT instead of NAV protocol, because of respiratory movements
and/or lack of experience with the navigation system
Conclusion: The use of an electromagnetic navigation system allows to reach
the targets with fewer CT control acquisitions than with conventional CT
Funding for this study: French Ministry of Health.
I. Bricault: Advisory Board; member of the scientific advisory board of Imactis.
T. Penzkofer; Berlin/DE
Randomised clinical trial of portal vein embolisation using n-butylcyanoacrylate vs polyvinyl alcohol particles plus coils for liver hypertrophy before major hepatectomies
J.H.M. Luz1, E. Coimbra1, T. Bilhim1, F.V. Gomes1, N.V. Costa1, M.T. Correia1,
P. Luz2, E. Barroso1; 1Lisbon/PT, 2Rio de Janeiro/BR ()
Purpose: The aim of this study is to compare the efficacy of portal vein
embolisation (PVE) using n-butyl-cyanoacrylate (NBCA) versus polyvinyl
alcohol (PVA) particles plus coils in the induction of liver hypertrophy before
Ethics committee approval: The hospital review board and local ethics
committee approved the study protocol.
Methods and Materials: This is a randomised clinical trial, single site. Eighty
consecutive patients with resectable liver tumors and indication for
preoperative PVE are randomised for one of two arms (40 patients in each
arm). Primary endpoint is to compare the degree of hepatic hypertrophy,
through computed tomography volumetry, at 14 and 28 days after PVE.
Secondary endpoints are the comparative analysis of the two PVE methods
(complications, cost, procedure time, contrast usage and radiation exposure)
and post-operative outcome (accomplishment of the planned surgery, causes
of hepatectomy suspension and liver failure incidence).
Results: PVE with NBCA has shown a higher degree of hypertrophy (left lobe
increase in size was 64 ± 23 % vs. 41 ± 12 with NBCA versus PVA plus coils).
The amount of contrast medium used for the procedure was 111 ± 34 ml and
223 ± 43 ml, for NBCA and PVA plus coils, respectively. The trial is ongoing
Limitations: The trial is not multicentric.
Conclusion: PVE with NBCA seems more effective in promoting liver
hypertrophy. The overall PVE cost, procedure time and contrast media use
was substantially lower through the NBCA approach.
Funding for this study: There was no funding for this trial.
K.A. Hausegger; Klagenfurt/AT
Purpose: Thrombectomy has become the standard of care for acute ischaemic
stroke due to large vessel occlusion. Aim of this study was to compare the
radiological outcomes and time metrics of the various thrombectomy
Ethics committee approval: Approved by the ethics committee of the
University Medical Centre Goettingen.
Methods and Materials: In this retrospective, multicentre study we analysed
the data of 450 patients with occlusion of the anterior circulation, treated in five
high-volume centres from 2013 to 2016. The treatment techniques were
divided in three categories: first-pass use of a large-bore aspiration-catheter;
first-pass use of a stent-retriever; and primary combined approach (PCA) of an
aspirationcatheter and stent-retriever. Primary endpoints were successful
reperfusion and groin to reperfusion time. Secondary endpoints were the
number of attempts and occurrence of emboli in new territory (ENT). The
primary analysis was based on the intention to treat groups (ITT).
Results: The ITT-analysis showed significantly higher reperfusion rates, with
86% of successful reperfusion in the PCA-group compared with 73% in the
aspiration group and 65% in the stent-retriever group. There was no significant
difference in groin to reperfusion time regarding the used technique. The
secondary analysis showed an impact of the technique on the number of
attempts and the occurrence of ENTs. Lowest ENT rates and attempts were
reported with the combined approach.
Limitations: Limitations of our study include the retrospective, observational
design and the non-standardised fashion of thrombectomy, as well as that 73%
of the interventions were analysed by a core-laboratory, while a part of
angiographic outcomes was self-reported by the individual centres.
Conclusion: The combined first-pass deployment of a stent-retriever and an
aspiration-catheter was the most effective technique for reperfusion of anterior
circulation large vessel occlusion. Our results correlate with the latest
singlecentre studies, reporting very high reperfusion rates with PCA variations.
Funding for this study: There was no funding for this study.
J. Fiehler: Consultant; Acandis, Bayer, Boehringer-Ingelheim, Codman,
Covidien, Medtronic, MicroVention, Penumbra, Philips, Sequent, Siemens,
Stryker. Equipment Support Recipient; Medtronic, MicroVention, DFG, EU,
BMBF, BMWi. M. Knauth: Consultant; Siemens, Penumbra, Stryker, Acandis,
Bayer. M. Psychogios: Consultant; Siemens, Penumbra, Stryker.
Purpose: To investigate the safety and effectiveness of paclitaxel-coated
balloons (PCB) for the treatment of dialysis access symptomatic central venous
Ethics committee approval: The above mentioned trial has been approved
by the ethics committee of the University of Patras.
Methods and Materials: Within 20 months (January 2014 to August 2015), 40
dialysis patients [19/40 arteriovenous fistulas (AVF) and 21/40 arteriovenous
grafts (AVG)] with symptomatic central venous stenosis were randomised to
undergo PCB [PCB group, n=20; 14/20m ale; age: 56.7 (25-81)] or
conventional balloon angioplasty [CBA group, n=20; 15/20 male; age: 57
(3381)]. There were 15/20 restenotic lesions in PCB group and 12/20 in CBA
group. In 25/40 cases patients had an ipsilateral catheter insertion in the past.
Primary endpoint was clinically assessed intervention-free period (IFP) of the
treated segment at 6 months, while secondary endpoints included complication
rates during follow-up period and subgroup analysis to identify factors
Results: Mean follow-up period was 180 days (
). No complications were
observed. Median IFP was significantly better in PCB group (PCB group: 179
days vs CBA group: 124.5 days, p=0.026; HR 0.445 CI: 0.217-0.909). There
was no significant difference between AVGs and AVFs (p=0.17), treatment of
de novo vs restenotic lesions (p=0.33) or prior presence of catheter insertion
(p=0.21). In restenotic lesion of PCB group, longitudinal comparison between
treatments also showed a significant difference in favour of PCB treatment
(median IFP in PCB*group 177 vs 91 days in CBA*group, p=0.01; HR 0.338,
Limitations: The major limitations are that we are talking about a single center
randomised control trial with no core lab support.
Conclusion: Paclitaxel-coated balloons had significantly better results
compared to CBA for the treatment of symptomatic central venous stenosis in
dialysis access in this randomised study. Longitudinal comparison of
treatments in the same patients also showed a significant difference in favour
Funding for this study: No funding.
Sky High Stage
Thursday, March 1
Purpose: Breast cancer (BC) radiotherapy (RT) leads to incidental radiation of
the heart, resulting in increased risk of a variety of heart diseases. Identifying
BC patients with the highest-risk of radiation-induced cardiac complications is
crucial for developing strategies for primary and secondary prevention. Within
the European MEDIRAD project (http://www.medirad-project.eu/), the
multicentre prospective EARLY-HEART study aims to identify the most
important cardiac imaging and circulating biomarkers of radiation-induced
cardiovascular changes in the first 2 years after BC RT.
Ethics committee approval: Obtained in the 5 investigating centers.
Methods and Materials: This multicenter study will include 250 female BC
patients aged 40-75 years treated with RT in 5 hospitals (France, Germany,
Netherlands, Portugal, Spain). Compared with baseline cardiac imaging
information evaluated before RT, 2D-speckle-tracking echocardiography and
cardiac magnetic resonance imaging will assess changes in myocardial
function and myocardial tissue anomalies respectively 6 to 24 months after RT,
and computed tomography will assess anatomical changes in coronary arteries
24 months after RT. Blood samples will be collected before RT, at the end of
RT, at 6 and 24 months to identify circulating biomarkers changes. The
relationships between dose distribution to the heart during RT and early
cardiovascular changes will be analysed.
Results: Inclusions started in September 2017 and will provide first results in
Limitations: Only subclinical events are expected during follow-up.
Conclusion: It will identify biomarkers of early heart side effects and improve
understanding of the mechanisms and circumstances that underlie their
Funding for this study: Funding: EU grant n°755523
V.E. Sinitsyn; Moscow/RU
Low-dose chest CT vs conventional chest x-ray prior to cardiac surgery: the CRICKET study
R.P.J. Budde1, A.M. den Harder2, T. Leiner2, P.A. de Jong2, J. Karady3,
C. Chun3, A. Bogers1, P. Horvat-Maurovich3, L. de Heer2; 1Rotterdam/NL,
2Utrecht/NL, 3Budapest/HU ()
Purpose: Embolic calcifications are the most important cause of postoperative
strokes after cardiac surgery. Strokes can be caused by manipulation and
clamping of the aorta during surgery. The aim of this study is to investigate if
improved preoperative knowledge of aortic calcifications acquired with a
lowdose chest CT can prevent postoperative strokes by optimising the surgical
Ethics committee approval: Ethics approval was obtained. All participants
sign informed consent.
Methods and Materials: A prospective multicenter randomised controlled trial
design is used. Inclusion criteria are patients scheduled for cardiac surgery
aged 18 years or older. Exclusion criteria are emergency surgery, a recent
chest/cardiac CT (past three months), unwillingness to be informed about
unrequested findings, concomitant or prior participation in a study with
radiation exposure and pregnancy. Patients (n=1,724) are randomised
between a control arm, which receives routine preoperative work-up including
a chest x-ray, and the intervention arm, which receives an additional non
contrast-enhanced chest CT at a submillisievert radiation dose. Primary
outcome is the postoperative in-hospital stroke rate. Secondary outcomes are
altered surgical approach based on CT findings and cost-effectiveness.
Results: Currently 3 centers are participating and over 500 patients are
included. As of mid 2017, in the largest including center 417 patients were
randomised (207 in the control group and 210 in the intervention group of
which 94% and 86% received the allocated work-up, respectively). In the
combined 238 patients randomised to the CT group, mean radiation exposure
was 0,64 mSv. Ventral calcifications in the aorta were seen in 23% of patients
Limitations: The secondary objective change in surgical approach is
surgeondependent and therefore subjective.
Conclusion: The CRICKET study will determine if it is useful and
costeffective to replace preoperative chest x-ray by low-dose chest CT.
Funding for this study: ZonMW. Project 837001403
J. Bremerich; Basle/CH
Computed tomography (CTA) vs invasive coronary angiography (ICA) in patients with atypical chest pain and suspected coronary artery disease (CAD): gender analysis of a randomised study
M. Bosserdt1, S. Feger1, M. Rief1, D. Preuß1, P. Ibes1, P. Martus2, K. Kofoed3,
M. Laule1, M. Dewey1; 1Berlin/DE, 2Tübingen/DE, 3Copenhagen/DK
Purpose: To investigate if females equally benefit from performing CTA
instead of ICA if they present with atypical chest pain and a clinical indication
Ethics committee approval: By ethics committee of Charité (EA-1-080-08)
and German Federal Office for Radiation Protection (Z5-22462/2-2008-048).
All patients gave written informed consent.
Methods and Materials: This is gender subanalysis of single-center coronary
artery disease management (CAD-Man) study including 329 patients.
Results: Median length of stay was equally reduced in CTA group for females
(30.0 hours, interquartile range [IQR]: 3.3-78.3 vs. ICA group: 53.0 hours, IQR:
49.7-75.3; P=0.002) and males (30.0 hours, IQR: 3.9-71.3 vs. ICA group: 53.0
hours, IQR: 49.1-76.8; P=0.005). Radiation dose was similar in CTA and ICA
group both for females (4.7 mSv, IQR: 3.4-6.6 vs. 5.7 mSv, IQR: 3.0-9.2 mSv;
P=0.41) and males (5.3 mSv, IQR: 4.7-10.6 vs. 6.9 mSv, IQR: 4.4-12.7 mSv;
P=0.98). In CTA group, 19% of males (15/79) but only 3.4% of females (3/88)
had obstructive CAD and required subsequent ICA; P<0.001).
Limitations: The study was performed at a single center in a small number of
Conclusion: This study shows that females equally to males benefit by a
reduced length of stay through initially performing CTA instead of ICA.
Radiation doses were similar in the CTA and ICA group for females and males
while the need for subsequent ICA after CTA was significantly lower for
females compared to males.
Funding for this study: Grant support from the German Research Foundation
through the Heisenberg Programme.
K. Kofoed: Board Member; steering committee of the CORE320 trial.
Equipment Support Recipient; Toshiba Medical Corporation. Investigator;
Principle investigator of the investigator initiated CATCH-2 trial, CSub320 trial.
Research/Grant Support; AP Møller og hustru Chastine McKinney Møllers
Fond, The John and Birthe Meyer Foundation, Research Council of
Rigshopitalet, The University of Copenhagen, The Danish Heart Foundation,
The Lundbeck Foundation, The Danish Agency for Science, Technology and
Innovation by The Danish Council for Strategic Research. Speaker; Speakers
Bureau of Toshiba Medical Systems. M. Dewey: Research/Grant Support;
Heisenberg Program of the DFG for a professorship (DE 1361/14-1), Digital
Health Accelerator of the Berlin Institute of Health, the FP7 Program of the
European Commission for the randomized multicenter DISCHARGE trial
(603266-2, HEALTH-2012.2.4.-2), European Regional Development Fund
(20072013 2/05, 20072013 2/48), German Heart Foundation/German
Foundation of Heart Research (F/23/08, F/27/10), Joint Program from the
German Research Foundation (DFG) and the German Federal Ministry of
Education and Research (BMBF) for meta-analyses (01KG1013, 01KG1110,
01KG1210). Speaker; Toshiba Medical Systems, Guerbet, Cardiac MR
Academy Berlin, Bayer (Schering-Berlex). Other; editor of Coronary CT
Angiography and Cardiac CTboth published by Springer, Institutional master
research agreements exist with Siemens Medical Solutions, Philips Medical
Systems, and Toshiba Medical Systems.
R. Marano; Rome/IT
Effect of coronary computed tomography vs invasive coronary angiography on statin adherence and serum lipid levels in patients with atypical chest pain: a randomised controlled trial
L. Elzenbeck1, S. Feger1, P. Martus2, N. Rieckmann1, K. Stangl1, A. Marek1,
H. Dreger1, M. Beling1, E. Zimmermann1, M. Rief1, B. Chow3,
P. Maurovich- Horvat4, M. Laule1, M. Dewey1; 1Berlin/DE, 2Tübingen/DE,
3Ottawa, BC/CA, 4Budapest/HU ()
Purpose: To determine whether coronary computed tomography angiography
(CTA) compared with invasive coronary angiography (ICA) improves statin
therapy adherence and long-term serum lipids.
Ethics committee approval: By ethics committee (EA-1-080-08) and Federal
Office for Radiation Protection (Z5-22462/2-2008-048). Written informed
consent was given before randomisation.
Methods and Materials: Single-center randomised trial with blinded
observers. 340 patients with a clinical indication for ICA and atypical chest pain
were randomised to CTA or ICA. Statin recommendations were based on
European guidelines. Statin intake and serum lipids were compared.
Results: Baseline lipids were available for 164 of 167 (98%) and 160 of 162
(99%) patients who underwent CTA and ICA, respectively. Follow-up was
available for 155 of 164 (95%) and 141 of 160 patients (88%) leaving 296
(90%) for analysis. Approximately one in four patients were on statin therapy at
baseline (CTA: 37/155 [24%]; ICA: 32/141 [23%]; P=0.46). Statins were
recommended significantly more often to patients without baseline statins in
the CTA group (65% [77/118] vs. 47% [51/109]; P=0.007). Adherence at
followup after 3.3 years (IQR=1.3-4.6) was greater in the CTA group (60% [46/77] vs
39% [20/51]; P=0.03). At long-term follow-up, total cholesterol and low-density
lipoprotein improved in the CTA group (-5.6±22.6%, -4.3±35.5%) but increased
in the ICA group (+2.4±19.8%, +4.6±28.9%; P<0.001, P=0.019).
Limitations: Longer follow-up would be needed to investigate cardiovascular
Conclusion: Coronary CTA resulted in greater adherence to statin
recommendations and improved serum lipids after 3.3 years.
Funding for this study: Grant support through the Heisenberg Programme.
R. Vliegenthart; Groningen/NL
Purpose: The overall risk of trans-rectal prostate biopsy is low, but it is
associated with significant morbidity. In this study, a method for reducing
infectious complications of this procedure is investigated.
Ethics committee approval: Our clinical trial has been approved by Ethics
Committee. All patients signed a written informed consent.
Methods and Materials: In this randomised clinical trial, we prescribed the
prophylactic oral antibiotic (Ciprofloxacin, 500 mg once daily) one day before
performing the prostate needle biopsy, until two days after the procedure in
210 patients with 40-70-year-old age who were candidates for TRUS-guided
prostate biopsy. The enrolled patients were randomly allocated to two equal
groups (105 patients in each one). Systemic oral antibiotic and topical
disinfection of the rectum by povidone-iodine 1% solution were applied for all
patients, while direct intraprostatic injection of antibiotic (Amikacin, 1 ml into
each prostate lobe) was performed just in one of the groups. All of the patients
were followed for 30 days for the development of any symptoms of infection
including fever, pelvic pain, and pyuria.
Results: 210 patients were equally divided into two group. The mean age and
prevalence of comorbidities were not significantly different between two
groups. Serum PSA level and prostate volume also did not have a significant
difference in two groups. Of the patients without intraprostatic injection of
Amikacin, 9 cases (8.6%) developed infectious complications, including lower
urinary tract infection (7 cases) and prostatitis (2 cases). These complications
led to hospitalization in 6 patients. None of the patients who received
intraprostatic antibiotic during TRUS-guided biopsy developed an infection.
The difference between two groups for developing infectious complications
was statistically significant (p =0.003).
Limitations: A multi-centric study with a larger sample volume could provide
more accurate results.
Conclusion: Local prophylactic antibiotic injection during sonography guided
trans-rectal prostate biopsy can significantly reduce the rate of infectious
Funding for this study: There was no funding from industry or a funding
Sky High Stage
Friday, March 2
Purpose: Digital breast tomosynthesis (DBT) has the potential of becoming the
new breast cancer screening modality. It is, however, not known if DBT
screening will change the types of cancers detected. We analysed the tumour
biology of invasive breast cancers detected in the Malmö Breast
Tomosynthesis Screening Trial (MBTST), using the St. Gallen surrogate
subtype classification, clinically used for prognostic and treatment guidance.
Ethics committee approval: The study was approved by the Regional Ethical
Review Board at Lund University (Dnr 2009/770). Written informed consent
Methods and Materials: The MBTST is a prospective, population-based
onearm screening trial comparing one-view DBT with two-view digital
mammography (DM). 14 848 women were enrolled and in total 118 invasive
cancers were detected. The cancers were classified according to St. Gallen;
luminal A-like, luminal B-like HER2-/HER2+, HER2+ and triple negative. The
subtypes were presented by mode of detection; DBT alone compared to all DM
Results: In total, 38 breast cancers were detected with DBT alone (37 with
subtypes): 19 (50%) luminal A-like, 14 (37%) luminal B-like HER2-, 0 (0%)
luminal B-like HER2+, 1 (3%) HER2+ and 3 (8%) triple negative. 80 cancers
were detected with both DBT and DM (n=76) or DM alone (n=4): 37 (46%)
luminal A-like, 34 (42%) luminal B-like HER2-, 1 (1%) luminal B-like HER2+, 3
(4%) HER2+ and 5 (6%) triple negative.
Limitations: The study was performed on an urban Swedish population using
one particular brand of tomosynthesis equipment and might, therefore, not be
generalizable to other populations and to the use of other tomosynthesis
Conclusion: Invasive cancers detected with DBT alone or DM in the MBTST
were of similar subtypes according to the St. Gallen classification indicating
that DBT screening may not alter the treatment predictive and prognostic
panorama of screen-detected cancers.
Funding for this study: Swedish Research Council, Swedish Cancer Society,
Skane county council´s research and development foundation, Medical Faculty
at Lund University (ALF grant), Unilabs Sweden and Siemens Healthineers.
S. Zackrisson: Speaker; Siemens. H. Sartor: Speaker; Siemens. K. Lang:
F.J. Gilbert; Cambridge/UK
Digital breast tomosynthesis vs digital mammography: recallrate by mammographic density, interim analyses
H. Aase1, Å.S. Holen2, B. Hanestad1, S. Hofvind2; 1Bergen/NO, 2Oslo/NO
Purpose: To compare recall rates using synthetic mammography + digital
breast tomosynthesis (SM+DBT) versus digital mammography (DM) in the
Norwegian Breast Cancer Screening Program, stratified by mammographic
Ethics committee approval: The study is approved by the Regional
committees for medical and health research ethics (2015/424) and registered
in Clinical trials.org (NCT02835625).
Methods and Materials: As part of a randomised controlled screening trial
performed in Bergen, 7037 women were screened with SM+DBT and 7052
with DM, January-December 2016. We obtained continuous measures of
volumetric breast density (VBD) using an automated software (Volpara version
1.5.1). Recall rate for positive mammographic findings was calculated for
women who underwent screening with the two techniques, stratified by
quartiles of VBD; (1:< 3.5%; 2: 3.5-5.4%; 3: 5.4-8.8% and 4: >8.8%).
Twoproportion z-tests was used to test for statistical significance between the
Results: Recall rate was statistically significantly lower for SM+DBT (3.0%
[208/7037]) compared to DM (3.6% [254/7052], p=0.03). The recall rate
increased by mammographic density for SM+DBT, from 2.1% for VBD-1 to
4.5% for VBD-4. For DM, the recall rate remained the same for different
quartiles of mammographic density. For DM, the highest recall rate (4.3%) was
observed for VBD-3.
Limitations: The radiologists had limited experience with DBT when the trial
Conclusion: Women screened with SM+DBT had a lower recall rate
compared to those screened with DM. The higher recall rate among women
with dense breast and screened with SM+DBT need to be followed closely
according to cancer detection and rate of false positive screening results.
Funding for this study: The project is funded by the Norwegian Research
E.M. Fallenberg; Berlin/DE
Reduction in infarct volume on CT and functional outcome after endovascular treatment for acute ischaemic stroke: a causal mediation analysis
K. Compagne1, M. Boers2, H. Marquering2, C.B. Majoie2, W. Van Zwam3,
D.W. Dippel1, A. van Es1, A. Van der Lugt1, H. Lingsma1; 1Rotterdam/NL,
2Amsterdam/NL, 3Maastricht/NL ()
Purpose: A potential explanation for the favourable effect of endovascular
treatment (EVT) on functional outcome after acute ischaemic stroke is a
reduction in ischaemic lesion volume (ILV). ILV is strongly related to the
functional outcome. The aim of the present study was to assess to which
extent ILV also explains the effect of EVT on functional outcome.
Ethics committee approval: The study protocol of the MR CLEAN trial was
approved by a central medical ethics committee and the research board of
each participating center. All patients or their legal representatives provided
written informed consent before randomisation.
Methods and Materials: The data of all 500 patients included in the
randomised controlled MR CLEAN trial on the effectiveness of EVT were
evaluated. ILV was assessed on non-contrast CT scan 5 days after stroke. The
functional outcome was the score on the modified Rankin Scale at three
months. We tested the pathway from EVT via ILV to functional outcome with a
mediation model, using ordinal regression, with adjustment for relevant
Results: In total, 452 patients were analysed. EVT patients had better
outcome (acOR 2.01 (95%CI 1.43-2.82). EVT patients had smaller median ILV
(55 mL) than non-EVT patients (80 mL) (absolute difference 25 mL; 95%CI
17.26-44.92). ILV was inversely associated with better outcome (common odds
ratio (cOR) per 10 mL 0.58; 95%CI 0.51-0.66). After adjustment for ILV, the
effect of EVT on the outcome decreased, but remained substantial (acOR 1.80;
95%CI 1.28-2.55). Reduction of ILV explained 16% of the beneficial effect of
EVT on outcome.
Limitations: A limitation of our study is the exclusion of deceased patients in
the first week after onset and therefore missing FIV measurements at 5-7 day
follow-up which is tried to overcome by imputation.
Conclusion: The reduction of ILV by EVT explains only part of the effect on
functional outcome. Before ILV is used as a primary outcome in efficacy trials,
improvement of this potentially valuable outcome measure is needed.
Funding for this study: The MR CLEAN trial was partly funded by the Dutch
Heart Foundation and by unrestricted grants from AngioCare BV,
Medtronic/Covidien/EV3®, MEDAC Gmbh/LAMEPRO, Penumbra Inc.,
Stryker®, and Top Medical/Concentric. The MR CLEAN is registered under
number NTR1804 in the Dutch trial register and under ISRCTN10888758 in the
ISRCTN register. Erasmus Medical Center Rotterdam received funds from
Stryker® for consultations by AvdL, AvE and DD and from Bracco Imaging® for
consultations by DD. Academic Medical Center Amsterdam received funds
from Stryker® for consultations by CM, YR and OB. AB and HM own stock in
Nico-lab B.V. Maastricht University Medical Center received funds from
Stryker® and Cerenovus® for consultations by WZ. AY reports research grants
form Penumbra Inc. and Neuravi Inc., and consultant fees from
Cerenovus/J&J. No other personal disclosures are reported.
C.B. Majoie: Research/Grant Support; Stryker. W. Van Zwam:
Research/Grant Support; Stryker, Codman. D.W. Dippel: Research/Grant
Support; Stryker, Bracco Imaging. A. Van der Lugt: Research/Grant Support;
Purpose: To investigate changes in body composition(BC) parameters
detected by dual-energy X-ray absorptiometry(DXA) in an elderly population
following a one-year dietary intervention to build a predictive model of risk
integrating omics data. The specific aim of this work was to investigate the
degree of correlation between changes in BC and plasma levels of
Ethics committee approval: The 5 centres involved in the study obtained
protocol approval by local Ethics committees. Informed consent was obtained
from research participants at baseline.
Methods and Materials: A total of 1295 volunteers free of major overt
diseases, aged 65 to 79, were enrolled in 5 European countries(Italy, France,
United Kingdom, Netherlands, and Poland). Interview, anthropometric
measurements, whole-body DXA scans, blood, urine and faeces samples were
taken at baseline/T1. Comparison of variables was performed using Wilcoxon
rank-sum test. Correlation analysis was performed using Spearman rank test.
Results: DXA follow-up analysis revealed a significant decrease of fat
mass(FM), fat mass/lean mass (FM/LM) and android FM/LM in the diet group
of the Italian cohort. Plasma level changes of pro-inflammatory marker leptin
were positively correlated with changes in FM (rho=0.179, p=0.048), LM
(rho=0.201, p=0.026) andandroid/gynoid FM (rho=0.193, p=0.033), while the
decrease of android FM/LM was negatively correlated with C-reactive protein
plasma levels(rho=-0.433, p=0.0189).
Limitations: DXA scans were performed with different devices in the 5
Conclusion: BC markers may beuseful to predicta specific inflammatory risk
profile in an elderly population during follow-up.
Funding for this study: This project was supported by the European Union’s
Seventh Framework Program.
An international randomised controlled trial of two interventions for reducing doses for computed tomography through audit feedback and sharing best practices
R. Smith-Bindman1, P. Chu1, Y. Wang1, R. Chung1, A. Einstein2, D. Miglioretti3;
1San Francisco, CA/US, 2New York, NY/US, 3Davis, CA/US
Purpose: Few interventions for reducing radiation doses from CT have been
Ethics committee approval: Approvals received.
Methods and Materials: We evaluated two interventions to optimize CT
radiation effective dose using a randomized trial: a) simple audit comparing
institutional doses with tailored recommendations; b) multicomponent
intervention with audit plus 8-week educational course. We included 1,149,671
CT examinations from 103 institutions (6 countries) between November 2015
and August 2017. Mean effective dose and proportion of high-dose
examinations within anatomic areas following each intervention were
compared to baseline using hierarchical generalized linear models adjusting for
Results: Following the multicomponent intervention, mean dose and
proportion of high dose examinations decreased significantly for all
examination types (p<0.0001): abdomen examinations=2.7 mSv (19%)
reduction in mean effective dose, 45% reduction in high-dose examinations;
chest=0.9 mSv (11%) reduction in mean effective dose, 30% reduction of
highdose examinations; combined chest and abdomen=3.7 mSv, (20%) reduction
in mean effective dose; 57% reduction of high-dose examinations; head=0.10
mSv (5%) reduction in mean effective dose, 19% reduction in high dose
examinations. The simple audit also significantly reduced dose (p<0.05);
however, the magnitudes were smaller than for the multicomponent
intervention. Both interventions were more effective when combined with a
2day in-person educational meeting.
Limitations: All institutions used dose monitoring software demonstrating an
interest in dose optimisation.
Conclusion: Providing detailed feedback to institutions on their CT doses
combined with actionable suggestions and education results in significant
reductions in average CT doses and proportion of high-dose examinations.
Funding for this study: NIH
R. Smith-Bindman: Advisory Board; Bayer. Research/Grant Support;
National Institutes of Health; Patient Centered Outcomes Research Institute.
Prophylactic hydration to prevent contrast-induced nephropathy (AMACING): long-term results of a prospective, randomised, controlled, non-inferiority trial
E.C. Nijssen; Maastricht/NL ()
Purpose: The AMACING trial evaluated the cost and clinical effectiveness of
current clinical practice guidelines on intravascular iodinated contrast material
use. The study population included >90% patients marked as high risk by the
guidelines. The results showed no prophylaxis to be non-inferior to standard
prophylactic intravenous hydration in the prevention of contrast-induced
nephropathy (CIN). The current paper presents the long-term data of the
Ethics committee approval: The Maastricht University Medical Centre
research ethics committee approved the study before first inclusion.
Methods and Materials: AMACING is a prospective, randomised,
parallelgroup, open-label, non-inferiority trial of patients at risk of CIN according to
current guidelines, with eGFR30-59 mL/min/1·73 m² and undergoing elective
procedure requiring iodinated contrast material administration. Between June
17, 2014, and July 17, 2016, 660 consecutive patients were randomly assigned
(1:1) to receive no prophylaxis (n=332) or standard intravenous hydration with
normal saline according to the guidelines (n=328). We excluded patients with
eGFR<30 mL/min/1·73 m², previous dialysis, or no referral for intravenous
hydration. Randomisation was stratified by predefined risk factors. Incidence of
dialysis, mortality and renal function were registered up to 1 year post-contrast
exposure. Subgroup analyses were performed based on pre-defined
stratification risk factors. ClinicalTrials.gov, NCT02106234.
Results: Dialysis was recorded in 2/332 (0.60%) non-hydrated patients and in
2/328 (0.61%) hydrated patients. Absolute difference (no hydration vs
hydration) -0·01% (95%CI -1.19 to 1.18; p=0.9909). 36/332 (10.84%)
nonhydrated patients and 32/328 (9.76%) hydrated patients died within 365 days.
Absolute difference (no hydration vs hydration) +1.01% (95%CI -3.55 to 5.72;
Limitations: See Lancet 2017; 389:1312-22.
Conclusion: Assuming optimal contrast media administration, withholding
prophylaxis for high-risk patients with eGFR>29 mL/min/1·73 m² might be
considered without compromising patient safety.
Funding for this study: Stichting de Weijerhorst.
11 :10 Discussant I. Szikora; Budapest/HU B- 1009 11: 15 Radiologic follow-up of the NU-AGE trial: body composition changes detected by dual-energy x-ray absorptiometry show a correlation with laboratory markers of inflammation D. Mercatelli1, A . Santoro1, G. Guidarelli1, C. Fabbri1, R. Ostan1 , A. Berendsen2 , B. Pietruszka3 , A. jennings4, N. Meunier5 , M. Aparisi Gomez6 , E. Caumon1, S. Fairweather-Tait4 , A. Bialecka3 , C. de Groot7, G. Guglielmi8, G. Battista1, C. franceschi1 , A. Bazzocchi1 ; 1Bologna/IT, 2Wageningen/NL, 3Warsaw/PL, 4Norwich/UK, 5Clermont-Ferrand/FR, 6Auckland/NZ, 7Wageningen/IT, 8Andria/IT ()