TY - JOUR
T1 - Bleeding Outcomes after Left Atrial Appendage Closure Compared with Long-Term Warfarin A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience
AU - Price, Matthew J.
AU - Reddy, Vivek Y.
AU - Valderrábano, Miguel
AU - Halperin, Jonathan L.
AU - Gibson, Douglas N.
AU - Gordon, Nicole
AU - Huber, Kenneth C.
AU - Holmes, David R.
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/12/28
Y1 - 2015/12/28
N2 - Objectives The purpose of this study was to compare the relative risk of major bleeding with left atrial appendage (LAA) closure compared with long-term warfarin therapy. Background LAA closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF). Methods We conducted a pooled, patient-level analysis of the 2 randomized clinical trials that compared WATCHMAN (Boston Scientific, Natick, Massachusetts) LAA closure with long-term warfarin therapy in AF. Results A total of 1,114 patients were included, with a median follow-up of 3.1 years. The overall rate of major bleeding from randomization to the end of follow-up was similar between treatment groups (3.5 events vs. 3.6 events per 100 patient-years; rate ratio [RR]: 0.96; 95% confidence interval [CI]: 0.66 to 1.40; p = 0.84). LAA closure significantly reduced bleeding >7 days post-randomization (1.8 events vs. 3.6 events per 100 patient-years; RR: 0.49; 95% CI: 0.32 to 0.75; p = 0.001), with the difference emerging 6 months after randomization (1.0 events vs. 3.5 events per 100 patient-years; RR: 0.28; 95% CI: 0.16 to 0.49; p < 0.001), when patients assigned to LAA closure were able to discontinue adjunctive oral anticoagulation and antiplatelet therapy. The reduction in bleeding with LAA closure was directionally consistent across all patient subgroups. Conclusions There was no difference in the overall rate of major bleeding in patients assigned to LAA closure compared with extended warfarin therapy over 3 years of follow-up. However, LAA closure significantly reduced bleeding beyond the procedural period, particularly once adjunctive pharmacotherapy was discontinued. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF.
AB - Objectives The purpose of this study was to compare the relative risk of major bleeding with left atrial appendage (LAA) closure compared with long-term warfarin therapy. Background LAA closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF). Methods We conducted a pooled, patient-level analysis of the 2 randomized clinical trials that compared WATCHMAN (Boston Scientific, Natick, Massachusetts) LAA closure with long-term warfarin therapy in AF. Results A total of 1,114 patients were included, with a median follow-up of 3.1 years. The overall rate of major bleeding from randomization to the end of follow-up was similar between treatment groups (3.5 events vs. 3.6 events per 100 patient-years; rate ratio [RR]: 0.96; 95% confidence interval [CI]: 0.66 to 1.40; p = 0.84). LAA closure significantly reduced bleeding >7 days post-randomization (1.8 events vs. 3.6 events per 100 patient-years; RR: 0.49; 95% CI: 0.32 to 0.75; p = 0.001), with the difference emerging 6 months after randomization (1.0 events vs. 3.5 events per 100 patient-years; RR: 0.28; 95% CI: 0.16 to 0.49; p < 0.001), when patients assigned to LAA closure were able to discontinue adjunctive oral anticoagulation and antiplatelet therapy. The reduction in bleeding with LAA closure was directionally consistent across all patient subgroups. Conclusions There was no difference in the overall rate of major bleeding in patients assigned to LAA closure compared with extended warfarin therapy over 3 years of follow-up. However, LAA closure significantly reduced bleeding beyond the procedural period, particularly once adjunctive pharmacotherapy was discontinued. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF.
KW - WATCHMAN
KW - atrial fibrillation
KW - bleeding
KW - left atrial appendage
KW - left atrial appendage closure
UR - http://www.scopus.com/inward/record.url?scp=84952874862&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84952874862&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2015.08.035
DO - 10.1016/j.jcin.2015.08.035
M3 - Article
C2 - 26627989
AN - SCOPUS:84952874862
SN - 1936-8798
VL - 8
SP - 1925
EP - 1932
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 15
ER -