Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial.
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).
['Jimenez Diaz|Victor Alfonso|VA|', 'Tello-Montoliu|Antonio|A|', 'Moreno|Raul|R|', 'Cruz Gonzalez|Ignacio|I|', 'Baz Alonso|Jose Antonio|JA|', 'Romaguera|Rafael|R|', 'Molina Navarro|Eduardo|E|', 'Juan Salvadores|Pablo|P|', 'Paredes Galan|Emilio|E|', 'De Miguel Castro|Antonio|A|', 'Bastos Fernandez|Guillermo|G|', 'Ortiz Saez|Alberto|A|', 'Fernandez Barbeira|Saleta|S|', 'Raposeiras Roubin|Sergio|S|', 'Ocampo Miguez|Juan|J|', 'Serra Peñaranda|Antonio|A|', 'Valdes Chavarri|Mariano|M|', 'Cequier Fillat|Angel|A|', 'Calvo Iglesias|Francisco|F|', 'Iñiguez Romo|Andres|A|']
D000368:Aged D000369:Aged, 80 and over D001021:Aortic Valve D001024:Aortic Valve Stenosis D001241:Aspirin D001792:Blood Platelets D000077144:Clopidogrel D004351:Drug Resistance D004359:Drug Therapy, Combination D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D010865:Pilot Projects D010975:Platelet Aggregation Inhibitors D011446:Prospective Studies D012042:Registries D013030:Spain D000077486:Ticagrelor D013997:Time Factors D016896:Treatment Outcome
transcatheter aortic valve replacement aortic stenosis high platelet reactivity VerifyNow antithrombotic therapy