Author + information
- Received July 18, 2018
- Revision received September 17, 2018
- Accepted October 2, 2018
- Published online January 7, 2019.
- Victor Alfonso Jimenez Diaz, MD, MPHa,b,∗ (, )
- Antonio Tello-Montoliu, MD, PhDc,d,
- Raul Moreno, MDe,
- Ignacio Cruz Gonzalez, MD, PhDd,f,
- Jose Antonio Baz Alonso, MDa,
- Rafael Romaguera, MDg,
- Eduardo Molina Navarro, MDh,
- Pablo Juan Salvadores, Pharma, MPHb,i,
- Emilio Paredes Galan, MD, PhDa,
- Antonio De Miguel Castro, MDa,
- Guillermo Bastos Fernandez, MDa,
- Alberto Ortiz Saez, MDa,
- Saleta Fernandez Barbeira, MDa,
- Sergio Raposeiras Roubin, MD, PhDa,
- Juan Ocampo Miguez, MDa,
- Antonio Serra Peñaranda, MD, PhDj,
- Mariano Valdes Chavarri, MD, PhDc,d,
- Angel Cequier Fillat, MD, PhDd,g,
- Francisco Calvo Iglesias, MD, PhDa and
- Andres Iñiguez Romo, MD, PhDa,d
- aCardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain
- bCardiovascular Research Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain
- cCardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain
- dCentro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain
- eCardiology Department, Hospital Universitario La Paz, Madrid, Spain
- fCardiology Department, Hospital Universitario de Salamanca, Salamanca, Spain
- gCardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain
- hCardiology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain
- iCardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain
- jCardiology Department, Hospital Universitario San Pau, Barcelona, Spain
- ↵∗Address for correspondence:
Dr. Victor A. Jimenez Diaz, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Estrada Clara Campoamor 341, Vigo 36312, Spain.
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)
- antithrombotic therapy
- aortic stenosis
- high platelet reactivity
- transcatheter aortic valve replacement
This is an investigator-initiated trial, sponsored by the Spanish Society of Cardiology, and supported by AstraZeneca. Data monitoring, data entry, database maintenance, statistical analysis, and drafting and submission of the final manuscript was exclusively performed by the investigators. AstraZeneca played no role in the design of the study, data analysis, data interpretation, writing of the report, or in the decision to submit for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 18, 2018.
- Revision received September 17, 2018.
- Accepted October 2, 2018.
- 2019 The Authors