TY - JOUR
T1 - Antithrombotic therapy and bleeding events after aortic valve replacement with a novel bioprosthesis
AU - Klautz, Robert J. M.
AU - Vriesendorp, Michiel D.
AU - Dagenais, Francois
AU - Labrousse, Louis
AU - Bapat, Vinayak
AU - Moront, Michael G.
AU - Misfeld, Martin
AU - Gearhart, Elizabeth
AU - Kappetein, A. Pieter
AU - Sabik, Joseph F.
N1 - Funding Information: This study was funded by Medtronic. Dr Klautz receives research support from Medtronic, consultation and proctoring fees from Medtronic and LivaNova, and participates in speakers bureaus for Medtronic, LivaNova, and Edwards Lifesciences. Dr Vriesendorp receives research support from Medtronic. Dr Dagenais is a consultant, speaker, and trainer for Medtronic. Dr Bapat is a consultant for Medtronic and Boston Scientific and has received speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and LivaNova. Dr Moront is a consultant, speaker, and trainer for Medtronic, a consultant for Edwards Lifesciences, and a consultant for LSI. Ms Gearhart and Dr Kappetein are employees of Medtronic. Dr Sabik receives research support from Edwards Lifesciences (local principal investigator for Intuity Trial) and Abbott (North American principal investigator for EXCEL Trial); is an advisory board member for Medtronic and LivaNova; teaches educational courses for Medtronic; and is a consultant to Medtronic, Edwards, and Sorin. All other authors have nothing to disclose with regard to commercial support. Funding Information: This study was funded by Medtronic . Dr Klautz receives research support from Medtronic , consultation and proctoring fees from Medtronic and LivaNova, and participates in speakers bureaus for Medtronic, LivaNova, and Edwards Lifesciences. Dr Vriesendorp receives research support from Medtronic . Dr Dagenais is a consultant, speaker, and trainer for Medtronic. Dr Bapat is a consultant for Medtronic and Boston Scientific and has received speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and LivaNova. Dr Moront is a consultant, speaker, and trainer for Medtronic, a consultant for Edwards Lifesciences, and a consultant for LSI. Ms Gearhart and Dr Kappetein are employees of Medtronic. Dr Sabik receives research support from Edwards Lifesciences (local principal investigator for Intuity Trial) and Abbott (North American principal investigator for EXCEL Trial); is an advisory board member for Medtronic and LivaNova; teaches educational courses for Medtronic; and is a consultant to Medtronic, Edwards, and Sorin. All other authors have nothing to disclose with regard to commercial support. Ryan Palmer contributed to study design and management. Jessica Halverson provided study management. Julie Linick provided editorial support under the direction of the lead author and reviewed the manuscript for data accuracy. All are employees of Medtronic. Publisher Copyright: © 2019 Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - Objective: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial for the Avalus valve (Medtronic, Minneapolis, Minn) to examine whether this end point remains relevant for the evaluation of bioprostheses. Methods: Patients (n = 1115) underwent aortic valve replacement. Bleeding and thromboembolic event episodes in patients within 3 years postimplant were analyzed for frequency, timing, and severity, focusing on patients taking antiplatelet/anticoagulant medications at the time of the event. Clinical and hemodynamic outcomes are also reported. Results: At 3 years, the Kaplan-Meier cumulative probability estimate of all-cause death was 7.2% (cardiac, 3.6%; valve-related, 1.1%). The Kaplan-Meier cumulative probability estimates of all and major hemorrhage were 8.7% and 5.2%, respectively. Ninety-nine bleeding events occurred in 86 patients: most occurred >30 days postsurgery. Among the 51 late major bleeds, in 5 cases the patients were taking anticoagulant/antiplatelet medication for prophylaxis after surgical aortic valve replacement at the time of the event, whereas the remaining patients were taking medications for other reasons. Age (hazard ratio, 1.035; 95% confidence interval, 1.004-1.068), peripheral vascular disease (hazard ratio, 2.135; 95% confidence interval, 1.106-4.122), renal dysfunction (hazard ratio, 1.920; 95% confidence interval, 1.055-3.494), and antithrombotic medication use at the time of the event (hazard ratio, 1.417; 95% confidence interval, 1.048-1.915) were associated with late bleeds (major and minor). Conclusions: Overall clinical outcomes demonstrated low mortality and few complications except for major bleeding. Most bleeding events occurred >30 days after surgery and in patients taking antiplatelet and/or anticoagulation for indications other than postimplant prophylaxis.
AB - Objective: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial for the Avalus valve (Medtronic, Minneapolis, Minn) to examine whether this end point remains relevant for the evaluation of bioprostheses. Methods: Patients (n = 1115) underwent aortic valve replacement. Bleeding and thromboembolic event episodes in patients within 3 years postimplant were analyzed for frequency, timing, and severity, focusing on patients taking antiplatelet/anticoagulant medications at the time of the event. Clinical and hemodynamic outcomes are also reported. Results: At 3 years, the Kaplan-Meier cumulative probability estimate of all-cause death was 7.2% (cardiac, 3.6%; valve-related, 1.1%). The Kaplan-Meier cumulative probability estimates of all and major hemorrhage were 8.7% and 5.2%, respectively. Ninety-nine bleeding events occurred in 86 patients: most occurred >30 days postsurgery. Among the 51 late major bleeds, in 5 cases the patients were taking anticoagulant/antiplatelet medication for prophylaxis after surgical aortic valve replacement at the time of the event, whereas the remaining patients were taking medications for other reasons. Age (hazard ratio, 1.035; 95% confidence interval, 1.004-1.068), peripheral vascular disease (hazard ratio, 2.135; 95% confidence interval, 1.106-4.122), renal dysfunction (hazard ratio, 1.920; 95% confidence interval, 1.055-3.494), and antithrombotic medication use at the time of the event (hazard ratio, 1.417; 95% confidence interval, 1.048-1.915) were associated with late bleeds (major and minor). Conclusions: Overall clinical outcomes demonstrated low mortality and few complications except for major bleeding. Most bleeding events occurred >30 days after surgery and in patients taking antiplatelet and/or anticoagulation for indications other than postimplant prophylaxis.
KW - antiplatelet/anticoagulant-related bleeding
KW - aortic tissue valves
KW - surgical aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85076247523&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jtcvs.2019.10.095
DO - https://doi.org/10.1016/j.jtcvs.2019.10.095
M3 - Article
C2 - 31864696
SN - 0022-5223
VL - 161
SP - 66-75.e4
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 1
ER -