Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial

• Published in: JACC. Cardiovascular interventions Vol. 12; no. 1; pp. 22 - 32
• Main Authors: Jimenez Diaz, Victor Alfonso, Tello-Montoliu, Antonio, Moreno, Raul, Cruz Gonzalez, Ignacio, Baz Alonso, Jose Antonio, Romaguera, Rafael, Molina Navarro, Eduardo, Juan Salvadores, Pablo, Paredes Galan, Emilio, De Miguel Castro, Antonio, Bastos Fernandez, Guillermo, Ortiz Saez, Alberto, Fernandez Barbeira, Saleta, Raposeiras Roubin, Sergio, Ocampo Miguez, Juan, Serra Peñaranda, Antonio, Valdes Chavarri, Mariano, Cequier Fillat, Angel, Calvo Iglesias, Francisco, Iñiguez Romo, Andres
• Format: Journal Article
• Language: English
• Published: United States 14-01-2019
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - blood; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Aspirin - administration & dosage; Aspirin - adverse effects; Blood Platelets - drug effects; Blood Platelets - metabolism; Clopidogrel - administration & dosage; Clopidogrel - adverse effects; Drug Resistance; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pilot Projects; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Prospective Studies; Registries; Spain; Ticagrelor - administration & dosage; Ticagrelor - adverse effects; Time Factors; Treatment Outcome; Spain; transcatheter aortic valve replacement; VerifyNow; aortic stenosis; antithrombotic therapy; high platelet reactivity
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2018.10.005

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.
Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence.
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 (P2Y
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.
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.
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).