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

Официальное название

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial

Обзор

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.

Вмешательства

• Препарат Ticagrelor 60mg
  Ticagrelor 60mg BID after TAVI

Первичные конечные точки

• Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI. [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Efficacy endpoint: Subclinical valve thrombosis [Срок оценки: 3 and 12 months]
• Safety endpoint: Major bleeding [Срок оценки: 12 months]
• Patient-oriented composite endpoints [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Provision of informed consent prior to any study specific procedures.
• Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
• Patients with degenerative symptomatic severe aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:

• Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl) or 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin.
• Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.
• Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study.
• Successful TAVI performed by any vascular access.
• Patients who are not participating in any other clinical trial or research study (registries allowed).

Критерии исключения

• Patients under chronic oral anticoagulation for any specific pathology.
• Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.
• History of overt major bleeding or intracranial hemorrhage.
• Active pathological bleeding.
• History of ischemic stroke within the last 30 days prior TAVI.
• Patients with documented severe hepatic insufficiency.
• Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
• Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study.
• Patients randomized in another clinical trial with an investigational product or device over the past 30 days.
• Patients who cannot attend follow-up visits scheduled in the study.
• History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Alvaro Cunqueiro — Vigo

Публикации

• 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. PMID 31857029
• 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. PMID 31072513
• 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. PMID 31000022
• 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. PMID 29908965
• 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, Sinnin PMID 34294400
• 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 w PMID 32865376
• 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 Transcathete PMID 30621974
• 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 PMID 32771996

Идентификаторы

NCT: NCT05283356 · REAC-TAVI 2 · 2021-003927-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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