Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation

Summary

The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (\<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts. This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.

Timeline

Start

2022-01-21

Primary completion

2024-06-30

Completion

2025-06-30

Publications

• Background Jimenez Diaz VA, Lozano I, Tello Montoliu A, Baz Alonso JA, Iniguez Romo A. Is There a Link Between Stroke, Anticoagulation, and Platelet Reactivity?: The Multifactorial Stroke Mechanism Following TAVR. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2560-2561. doi: 10.1016/j.jcin.2019.10.004. No abstract available.
• Background Jimenez Diaz VA, Lozano I, Baz Alonso JA, Calvo Iglesias F, Iniguez Romo A. HALT After TAVR: Searching the Bases, Finding the Cusp. JACC Cardiovasc Interv. 2019 May 13;12(9):894-895. doi: 10.1016/j.jcin.2019.02.011. No abstract available.
• Background Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Iniguez Romo A. Reply: The REAC-TAVI Trial: Better Antiplatelet Therapy, Less Haze on the Horizon. JACC Cardiovasc Interv. 2019 Apr 22;12(8):803-804. doi: 10.1016/j.jcin.2019.02.038. No abstract available.
• Background Jimenez Diaz VA, Baz Alonso JA, Estevez Ojea O, Serantes Combo A, Rodriguez Paz CM, Iniguez Romo A. Real-Time Detection of an Acute Cerebral Thrombotic Occlusion During a Transcatheter Valve Intervention. JACC Cardiovasc Interv. 2018 Jul 9;11(13):e103-e104. doi: 10.1016/j.jcin.2018.03.048. Epub 2018 Jun 13. No abstract available.
• Background Kim WK, Pellegrini C, Ludwig S, Mollmann H, Leuschner F, Makkar R, Leick J, Amat-Santos IJ, Dorr O, Breitbart P, Jimenez Diaz VA, Dabrowski M, Rudolph T, Avanzas P, Kaur J, Toggweiler S, Kerber S, Ranosch P, Regazzoli D, Frank D, Landes U, Webb J, Barbanti M, Purita P, Pilgrim T, Liska B, Tabata N, Rheude T, Seiffert M, Eckel C, Allali A, Valvo R, Yoon SH, Werner N, Nef H, Choi YH, Hamm CW, Sinning JM. Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1578-1590. doi: 10.1016/j.jcin.2021.05.007.
• Background Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30.
• 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.
• Results Trejo-Velasco B, Cruz-Gonzalez I, Tello-Montoliu A, Baz-Alonso JA, Salvadores PJ, Moreno R, Romaguera R, Molina-Navarro E, Paredes-Galan E, De-Miguel-Castro A, Bastos-Fernandez G, Ortiz-Saez A, Fernandez-Barbeira S, Iniguez-Romo A, Jimenez-Diaz VA. Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial. J Invasive Cardiol. 2020 Dec;32(12):446-452. doi: 10.25270/jic/20.00167. Epub 2020 Aug 10.
• Results Trejo-Velasco B, Tello-Montoliu A, Cruz-Gonzalez I, Moreno R, Baz-Alonso JA, Salvadores PJ, Romaguera R, Molina-Navarro E, Paredes-Galan E, Fernandez-Barbeira S, Ortiz-Saez A, Bastos-Fernandez G, De Miguel-Castro A, Figueiras-Guzman A, Iniguez-Romo A, Jimenez-Diaz VA. Impact of Comorbidities and Antiplatelet Regimen on Platelet Reactivity Levels in Patients Undergoing Transcatheter Aortic Valve Implantation. J Cardiovasc Pharmacol. 2021 Sep 1;78(3):463-473. doi: 10.1097/FJC.0000000000001075.

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