WSO December 2023 – Issue 3 - 1225

Moutzouri et al.
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cerebrovascular small vessel disease and cognitive functions
in elderly patients also tended to show a benefit of
statin therapy.12,27 Until now, no study has been conducted
investigating the associations between statin use or lipid
levels with CMBs or ICH in patients with AF, a population
at elevated hemorrhagic risk. Together with the current
available evidence our results suggest that if indicated statin
therapy should not be withheld in these patients because
of fear of bleeding complications.
The major strengths of our study include the prospective
part of the analysis, detailed assessment of statin use (with
time-updated data), uniform MRI protocols for CMBs,
MRI assessment at 2 years follow-up in a large subgroup of
patients, blinded central assessment of brain imaging at
baseline and follow-up, as well as assessment of CMBs
location. The strengths in the analytical design include
adjustment for important covariates as well as very few
missing data.
The study limitations include a possible selection bias in
terms of a healthy volunteer bias, since the main reason for
denying participation was due to complicated study design,
age/health-related issues, and lack of interest; being in
accordance with the underrepresentation of older people in
clinical research.15,36 Furthermore, in our study, the female
population represented a minority (27.6%), which is compatible
with more male patients suffering from AF and,
therefore, reflects an AF population.36,37 Even if the cumulative
use of anticoagulants between both groups was similar,
statin users tended to have a higher use of VKA
compared with DOAC. Based on prior observations suggesting
a higher incidence of CMBs and ICH with VKA
compared with DOAC,33,38 this difference might have disfavored
the statin group, which, however, would still be in
line with our main observation. In all, 70% of the participants
with baseline MRI had also MRI at 2 years, which
may imply possible bias related to availability for followup
MRI. However, the baseline data between participants
having both MRIs versus only baseline MRI were comparable.
Furthermore, one-third of MRIs were performed
using a 1.5 T scanner, which has a lower sensitivity to detect
CMBs. However, follow-up MRI was performed using the
same scanner as baseline and type of scanner was equally
distributed between statin and non-statin users. In any
observational study, there is a danger of residual confounding:
we did not adjust for genetic factors like apoE genotype.39
Finally, the low number of events accounts for low
power for the outcomes of incidence of lobar CMBs and
ICH. Studies with longer follow-up time and data on lobar
CMBs may be necessary.
Conclusion
Statin use and lipid levels are not associated with an
increased risk of CMBs in this population of patients with
AF. The incidental finding of CMBs on brain imaging in
AF patients, without recent stroke or TIA, should not influence
clinical decisions about statin use.
Acknowledgements
The authors thank all the participants from the Swiss-AF cohort.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Disclosures
Aujesky, Drahomir: Swiss National Science Foundation (SNF)
and free drug supply from Bayer SA. Beer, Jürg: Swiss National
Foundation of Science, the Swiss Heart Foundation (SHF), the
Kardio foundation; grant support and consultancy fees to the institution
from Bayer, Sanofi, and Daitchii. Bonati, Leo: SNF, SHF;
unrestricted research grant from AstraZeneca; consultancy or
advisory board fees or speaker's honoraria from Amgen, Bayer,
Bristol-Myers Squibb, Claret Medical; travel grants from
AstraZeneca and Bayer. Conte, Giulio: SNF; speaker fees from
Boston Scientific, and investigator-initiated research grants from
Boston Scientific. Conen, David: consultancy fees from Roche
Diagnostics and Trimedics; speaker fees from Servier and BMS/
Pfizer. Del Giovane, Cinzia: SNF De Marchis, Gian Marco:
SNF, Science Funds of the University Hospital Basel, SHF,
ProPatient Foundation Basel, Bangerter-Rhyner-Stiftung,
Swisslife Jubiläumsstiftung
for Medical Research,
Swiss
Neurological Society, Fondazione Dr Ettore Balli, De Quervain
research grant, Thermo Fisher GmbH, Novartis grant; travel honoraria
by Bayer and BMS/Pfizer; speaker honoraria by Bayer and
Medtronic; consultant honoraria by Bayer and Novartis, member
of the Steering Committee of PACIFIC Stroke. Industry payments
are made to the research fund of the University Hospital Basel.
Fischer, Urs: SNF and the SHF; PI of the ELAN tria; Co-PI of the
DISTAL, TECNO, SWIFT DIRECT and SWITCH trial; grants
from Medtronic (BEYOND SWIFT, SWIFT DIRECT), Stryker,
Rapid medical, Penumbra and Phenox (DISTAL); consultancies
for Medtronic, Stryker, and CSL Behring (fees paid to institution);
participation in an advisory board for Alexion/Portola, Boehringer
Ingelheim, Biogen and Acthera (fees paid to institution); member
of a clinical event committee (CEC) of the COATING study
(Phenox) and member of the data and safety monitoring committee
(DSMB) of the TITAN, LATE_MT and IN EXTREMIS trials;
vice-presidency of the Swiss Neurological Society. Kastner,
Peter: employee of Roche Diagnostics, Germany. Kühne,
Michael: personal fees from Bayer, Böhringer Ingelheim, Pfizer
BMS, Daiichi Sankyo, Medtronic, Biotronik, Boston Scientific,
Johnson&Johnson, Roche; grants from Bayer, Pfizer, Boston
Scientific, BMS, Biotronik. Moschovitis, Giorgio: consultant
fees for participating to advisory boards from Novartis,
AstraZeneca, Bayer, and Böhringer Ingelheim. Osswald, Stefan:
SNF, the SHF, the Foundation for CardioVascular Research Basel;
grants from Roche, Bayer, Novartis, Sanofi AstraZeneca, DaiichiSankyo,
Pfizer. Reichlin, Tobias: consulting honoraria or travel
support from Abbott/SJM, AstraZeneca, Brahms, Bayer, BiosenseWebster,
Medtronic, Pfizer-BMS and Roche (all outside of the
presented work); SNF, the SHF; speaker consulting honoraria or
International Journal of Stroke, 18(10)
WSO December 2023 – Issue 3

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