Anders Wanhainen1, Kevin Mani1, Joel Kullberg2,3, Sverker Svensjö1,4, Adam Bersztel1,5, Lars Karlsson1,6, Jan Holst7, Anders Gottsäter7, Anneli Linné8, Peter Gillgren8, Marcus Langenskiöld9,10, Rebecka Hultgren11, Joy Roy11, Nils-Peter Gilgen1,12, Håkan Ahlström2,3, Frank A Lederle13, Martin Björck1. 1. Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden. 2. Department of Surgical Sciences, Radiology, Uppsala University, Uppsala SE-75185, Sweden. 3. Antaros Medical, BioVenture Hub, Pepparedsleden 1, Mölndal SE-43183, Sweden. 4. Department of Surgery, Falun County Hospital, Falun SE-79182, Sweden. 5. Department of Vascular Surgery, Västerås county hospital, Västerås SE-72335, Sweden. 6. Department of Surgery, Gävle County Hospital, Gävle SE-80188, Sweden. 7. Department of Vascular Diseases, Malmö University Hospital, Malmö SE-21421, Sweden. 8. Department of Surgery, Vascular Surgery and Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm SE-11883, Sweden. 9. Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg SE-41345, Sweden. 10. Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Gothenburg SE-41345, Sweden. 11. Department of Vascular Surgery, Karolinska University Hospital, Stockholm SE-17164, Sweden. 12. Department of Surgery, Mälarsjukhuset, Eskilstuna SE-63349, Sweden. 13. Department of Medicine (III-0), Veterans Affairs Medical Center, One Veterans Drive, Minneapolis, Minnesota 55417, USA.
Abstract
AIMS: To evaluate if ticagrelor, an effective platelet inhibitor without known non-responders, could inhibit growth of small abdominal aortic aneurysms (AAAs). METHODS AND RESULTS: In this multi-centre randomized controlled trial, double-blinded for ticagrelor and placebo, acetylic salicylic acidnaïve patients with AAA and with a maximum aortic diameter 35-49 mm were included. The primary outcome was mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months compared with baseline. Secondary outcomes include AAA-diameter growth rate and intraluminal thrombus (ILT) volume enlargement rate. A total of 144 patients from eight Swedish centres were randomized (72 in each group). MRI AAA volume increase was 9.1% for the ticagrelor group and 7.5% for the placebo group (P = 0.205) based on intention-to-treat analysis, and 8.5% vs. 7.4% in a per-protocol analysis (P = 0.372). MRI diameter change was 2.5 mm vs. 1.8 mm (P = 0.113), US diameter change 2.3 mm vs. 2.2 mm (P = 0.778), and ILT volume change 12.9% vs. 10.4% (P = 0.590). CONCLUSION: In this RCT, platelet inhibition with ticagrelor did not reduce growth of small AAAs. Whether the ILT has an important pathophysiological role for AAA growth cannot be determined based on this study due to the observed lack of thrombus modulating effect of ticagrelor. TRIAL REGISTRATION: The TicAAA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02070653. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: To evaluate if ticagrelor, an effective platelet inhibitor without known non-responders, could inhibit growth of small abdominal aortic aneurysms (AAAs). METHODS AND RESULTS: In this multi-centre randomized controlled trial, double-blinded for ticagrelor and placebo, acetylic salicylic acid naïve patients with AAA and with a maximum aortic diameter 35-49 mm were included. The primary outcome was mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months compared with baseline. Secondary outcomes include AAA-diameter growth rate and intraluminal thrombus (ILT) volume enlargement rate. A total of 144 patients from eight Swedish centres were randomized (72 in each group). MRI AAA volume increase was 9.1% for the ticagrelor group and 7.5% for the placebo group (P = 0.205) based on intention-to-treat analysis, and 8.5% vs. 7.4% in a per-protocol analysis (P = 0.372). MRI diameter change was 2.5 mm vs. 1.8 mm (P = 0.113), US diameter change 2.3 mm vs. 2.2 mm (P = 0.778), and ILT volume change 12.9% vs. 10.4% (P = 0.590). CONCLUSION: In this RCT, platelet inhibition with ticagrelor did not reduce growth of small AAAs. Whether the ILT has an important pathophysiological role for AAA growth cannot be determined based on this study due to the observed lack of thrombus modulating effect of ticagrelor. TRIAL REGISTRATION: The TicAAA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02070653. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Jonathan Golledge; Clare Arnott; Joseph Moxon; Helen Monaghan; Richard Norman; Dylan Morris; Qiang Li; Greg Jones; Justin Roake; Matt Bown; Bruce Neal Journal: Trials Date: 2021-12-27 Impact factor: 2.279
Authors: Craig N Morrell; Doran Mix; Anu Aggarwal; Rohan Bhandari; Matthew Godwin; Phillip Owens; Sean P Lyden; Adam Doyle; Krystin Krauel; Matthew T Rondina; Amy Mohan; Charles J Lowenstein; Sharon Shim; Shaun Stauffer; Vara Prasad Josyula; Sara K Ture; David I Yule; Larry E Wagner; John M Ashton; Ayman Elbadawi; Scott J Cameron Journal: J Clin Invest Date: 2022-05-02 Impact factor: 19.456