Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

Summary

The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible. This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.

Timeline

Start

2020-06-23

Primary completion

2021-02-28

Completion

2022-02-28

Publications

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• Background Magnani G, Storey RF, Steg G, Bhatt DL, Cohen M, Kuder J, Im K, Aylward P, Ardissino D, Isaza D, Parkhomenko A, Goudev AR, Dellborg M, Kontny F, Corbalan R, Medina F, Jensen EC, Held P, Braunwald E, Sabatine MS, Bonaca MP. Efficacy and safety of ticagrelor for long-term secondary prevention of atherothrombotic events in relation to renal function: insights from the PEGASUS-TIMI 54 trial. Eur Heart J. 2016 Jan 21;37(4):400-8. doi: 10.1093/eurheartj/ehv482. Epub 2015 Oct 5.
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• Background Jilaihawi H, Asch FM, Manasse E, Ruiz CE, Jelnin V, Kashif M, Kawamori H, Maeno Y, Kazuno Y, Takahashi N, Olson R, Alkhatib J, Berman D, Friedman J, Gellada N, Chakravarty T, Makkar RR. Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis. JACC Cardiovasc Imaging. 2017 Apr;10(4):461-470. doi: 10.1016/j.jcmg.2017.02.005.
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• Background Linke A, Chandrasekhar J, Sartori S, Lefevre T, van Belle E, Schaefer U, Tchetche D, Sardella G, Webb J, Colombo A, Windecker S, Vogel B, Farhan S, Sorrentino S, Sharma M, Snyder C, Asgar A, Dumonteil N, Tamburino C, Hink U, Violini R, Stella P, Bernstein D, Deliargyris E, Hengstenberg C, Baber U, Mehran R, Anthopoulos P, Dangas G; BRAVO-3 Investigators. Effect of valve design and anticoagulation strategy on 30-day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial. Catheter Cardiovasc Interv. 2017 Nov 15;90(6):1016-1026. doi: 10.1002/ccd.27154. Epub 2017 Jul 19.
• Background Collet JP, Berti S, Cequier A, Van Belle E, Lefevre T, Leprince P, Neumann FJ, Vicaut E, Montalescot G. Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial. Am Heart J. 2018 Jun;200:44-50. doi: 10.1016/j.ahj.2018.03.008. Epub 2018 Mar 10.
• Background Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD. Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018 Nov;205:63-69. doi: 10.1016/j.ahj.2018.07.006. Epub 2018 Aug 29.
• Background Mangieri A, Montalto C, Poletti E, Sticchi A, Crimi G, Giannini F, Latib A, Capodanno D, Colombo A. Thrombotic Versus Bleeding Risk After Transcatheter Aortic Valve Replacement: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Oct 22;74(16):2088-2101. doi: 10.1016/j.jacc.2019.08.1032.
• Results Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Baz Alonso JA, Romaguera R, Molina Navarro E, Juan Salvadores P, Paredes Galan E, De Miguel Castro A, Bastos Fernandez G, Ortiz Saez A, Fernandez Barbeira S, Raposeiras Roubin S, Ocampo Miguez J, Serra Penaranda A, Valdes Chavarri M, Cequier Fillat A, Calvo Iglesias F, Iniguez Romo A. Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial. JACC Cardiovasc Interv. 2019 Jan 14;12(1):22-32. doi: 10.1016/j.jcin.2018.10.005.

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