Omar Abdul-Jawad Altisent1, Eric Durand2, Antonio J Muñoz-García3, Luis Nombela-Franco4, Asim Cheema5, Joelle Kefer6, Enrique Gutierrez7, Luis M Benítez8, Ignacio J Amat-Santos9, Vicenç Serra10, Helene Eltchaninoff2, Sami M Alnasser5, Jaime Elízaga7, Antonio Dager8, Bruno García Del Blanco10, Maria Del Rosario Ortas-Nadal1, Josep Ramon Marsal11, Francisco Campelo-Parada1, Ander Regueiro1, Maria Del Trigo1, Eric Dumont1, Rishi Puri1, Josep Rodés-Cabau12. 1. Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 2. Cardiology Department, University Hospital of Rouen, Hospital Charles Nicolle, Rouen, France. 3. Cardiology Department, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain. 4. Cardiology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain. 5. Cardiology Department, St. Michael's Hospital, Toronto University, Toronto, Ontario, Canada. 6. Cardiology Department, Saint Luc University Hospital, Brussels, Belgium. 7. Cardiology Department, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain. 8. Cardiology Department, Clìnica de Occidente de Cali, Valle del Cauca, Colombia. 9. Cardiology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 10. Cardiology Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. 11. Cardiology Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain; CIBER of Epidemiology and Public Health (CIBERESP), Barcelona, Spain. 12. Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
Abstract
OBJECTIVES: The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF). BACKGROUND: Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce. METHODS: A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. RESULTS: During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated. CONCLUSIONS: In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.
OBJECTIVES: The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF). BACKGROUND: Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce. METHODS: A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. RESULTS: During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated. CONCLUSIONS: In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.