Comparison of Ticagrelor Versus Clopidogrel on Cerebrovascular Microembolic Events and Platelet Inhibition during Transcatheter Aortic Valve Implantation
Section snippets
Methods
The PTOLEMAIOS study (ClinicalTrials Identifier: NCT02989558) was a 2-center, prospective, open label, randomized, controlled clinical trial. Consecutive patients with symptomatic severe native aortic valve stenosis deemed at high risk for surgical aortic valve replacement (logistic EuroSCORE ≥18) or inoperable were included. We excluded patients with a history of atrial fibrillation, those receiving anticoagulation, who had received antiplatelet therapy other than aspirin within 7 days before
Results
During the study, 150 consecutive patients with severe symptomatic aortic stenosis were evaluated for participation. Sixty were excluded based on exclusion criteria (Supplementary Appendix). Ninety patients were randomized and good quality TCD recordings were obtained during TAVI in 84, 42 of whom were assigned to aspirin and clopidogrel and 42 to aspirin and ticagrelor. In both the 90 and the 84 remaining participants, baseline demographic, and clinical characteristics were evenly distributed
Discussion
To the best of our knowledge, this is the first study comparing the number of cerebral microembolization as detected by HITS in TAVI patients on aspirin and then randomized to ticagrelor or to clopidogrel. The achieved platelet inhibition with ticagrelor was greater than that with clopidogrel throughout the study, the total number of HITS during TAVI was lower in the ticagrelor group, and the extent of platelet inhibition was significantly correlated with the number of HITS.
We observed a high
Role of the funder/sponsor
Astra Zeneca, the funder of the study, had no role in the collection, management, or interpretation of the data, or the statistical analysis; the funder reviewed the manuscript but was not involved in the writing or approval of the manuscript or the decision to submit the manuscript for publication.
Availability of data and material (data transparency)
All the data of the trial are available upon request.
Code availability
The scripts for the statistical analysis and graphs are available upon request.
Ethics approval
The study was conducted in accordance with the ethical principles for medical research of the Declaration of Helsinki, International Conference on Harmonization (ICH) /Good Clinical Practice (GCP), the European Union Clinical Trials Directive, and Greek legislation. The study protocol was approved by the hospitals’ Ethics Committee and Institutional Review Board, the National Ethics Committee (NEC), and the National Organization of Medicines (NOM). Safety updates were provided according to
Consent to participate
All subjects gave informed consent previous to participating.
Consent for publication
All authors have read and have consented for publication of this manuscript.
Declaration of competing interests
The authors declare the following financial interests/personal relations which may be considered as potential competing interests: Manolis Vavuranakis reports financial support was provided by Astra Zeneca. Manolis Vavuranakis reports a relation with Medtronic that includes: consulting or advisory and employment. Manolis Vavuranakis reports a relation with Abbot Laboratories that includes: consulting or advisory and employment. Konstantinos Toutouzas reports a relation with Medtronic that
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Funding/Support: This work was supported by Astra Zeneca.
Acknowledgments: We would like to sincerely thank Dr. Gary Gerstenblith for his careful review of the manuscript and Dimitra Latsou, PhD from Pharmecons Easy Access for her contribution regarding data analysis.
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These authors equally contributed to the study