Victor Alfonso Jimenez Diaz1, Antonio Tello-Montoliu2, Raul Moreno3, Ignacio Cruz Gonzalez4, Jose Antonio Baz Alonso5, Rafael Romaguera6, Eduardo Molina Navarro7, Pablo Juan Salvadores8, Emilio Paredes Galan5, Antonio De Miguel Castro5, Guillermo Bastos Fernandez5, Alberto Ortiz Saez5, Saleta Fernandez Barbeira5, Sergio Raposeiras Roubin5, Juan Ocampo Miguez5, Antonio Serra Peñaranda9, Mariano Valdes Chavarri2, Angel Cequier Fillat10, Francisco Calvo Iglesias5, Andres Iñiguez Romo11. 1. Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Cardiovascular Research Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain. Electronic address: victor.alfonso.jimenez.diaz@sergas.es. 2. Cardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain. 3. Cardiology Department, Hospital Universitario La Paz, Madrid, Spain. 4. Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain; Cardiology Department, Hospital Universitario de Salamanca, Salamanca, Spain. 5. Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain. 6. Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain. 7. Cardiology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain. 8. Cardiovascular Research Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain. 9. Cardiology Department, Hospital Universitario San Pau, Barcelona, Spain. 10. Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain; Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain. 11. Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain.
Abstract
OBJECTIVES: The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated withaspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI. BACKGROUND: Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence. METHODS: This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y12 reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued withaspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR. RESULTS:A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR. CONCLUSIONS:HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).
RCT Entities:
OBJECTIVES: The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with aspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI. BACKGROUND: Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence. METHODS: This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y12 reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued with aspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR. RESULTS: A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR. CONCLUSIONS: HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).
Authors: Harold L Dauerman; Christine M DeStephan; Heidi Taatjes Sommer; Kathryn C Kurchena; Michael DeSarno; Erika G Mendoza; Amy Henderson; David J Schneider Journal: J Am Coll Cardiol Date: 2019-08-13 Impact factor: 24.094
Authors: María Eugenia de la Morena-Barrio; Javier Corral; Cecilia López-García; Víctor Alonso Jiménez-Díaz; Antonia Miñano; Pablo Juan-Salvadores; María Asunción Esteve-Pastor; José Antonio Baz-Alonso; Ana María Rubio; Francisco Sarabia-Tirado; Miguel García-Navarro; Juan García-Lara; Francisco Marín; Vicente Vicente; Eduardo Pinar; Sergio José Cánovas; Gonzalo de la Morena Journal: Front Cardiovasc Med Date: 2022-07-22