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OUTCOMES OF TEMPORARY INTERRUPTIONS OF RIVAROXABAN OR WARFARIN IN PATIENTS WITH ATRIAL FIBRILLATION IN THE ROCKET AF TRIAL
E316 JACC March 12, 2013 Volume 61, Issue 10
Arrhythmias Outcomes of Temporary Interruptions of Rivaroxaban or Warfarin in Patients with Atrial Fibrillation in the ROCKET AF Trial Oral Contributions West, Room 3009 Sunday, March 10, 2013, 8:30 a.m.-8:45 a.m.
Session Title: Joint Session of the Heart Rhythm Society and the American College of Cardiology: Anticoagulation in Atrial Fibrillation Management Questions with New Anticoagulants Abstract Category: 4. Arrhythmias: AF/SVT Presentation Number: 914-5 Authors: Matthew W. Sherwood, Anne Hellkamp, Manesh Patel, Jonathan Piccini, Yuliya Lokhnygina, James Douketis, Richard Becker, Kenneth Mahaffey, Keith Fox, Robert Califf, Duke Clinical Research Institute, Durham, NC, USA Purpose: Temporary interruption (TI) of oral anticoagulation (OAC) is common in patients with atrial fibrillation (AF). The characteristics of patients with TI and association of TI with clinical events are not well understood. Methods: We evaluated baseline characteristics, management, and outcomes from 3 days post-TI to 3 days after restart of OAC during TI (3-30 days) during the ROCKET AF study. Results: In 14236 patients, 4693 (33%) had 7557 TI (4164 in warfarin vs. 3393 rivaroxaban treatment group). Of those with TI, the median (IQR) age was 73 (66,78) years and mean (SD) CHADS2 score was 3.4 (0.9). The median duration of TI was 5 (4,9) days. In TI patients, 63% had 1, 24% had 2, and 13% had >3 TI. Clinical characteristics were similar in TI and non-TI patients. Only 7% (n=555) of TI involved bridging therapy (86% LMWH, 10.5% aspirin, 3.4% clopidogrel) for a median of 6 (4,10) days. Those bridged had higher mean CHADS2 score (3.5 vs. 3.3; p<0.01), were more commonly on OAC before trial entry (75 vs. 63%; p<0.01), and less commonly on aspirin during the trial (31 vs. 37%; p=0.01). Strokes occurred in 0.2% of rivaroxaban and warfarin treated patients during TI, while 1.5% in both groups developed major or clinically relevant non-major (CRNM) bleeding (Table). Conclusions: In a large, international cohort of patients with nonvalvular AF, TI of OAC is common and bridging therapy is infrequently used. In relation to TI, the proportion of patients who had stroke or bleeding was similar in those assigned to rivaroxaban or warfarin. Temporary
Interruption
% with event (N)
Rivaroxaban (n=2,165)
Warfarin (n=2,528)
Unadjusted p
Stroke/Systemic Embolism Death MI Major or CRNM Bleeding Minimal Bleeding
0.2% (5) 0% (0) 0.2% (5) 1.5% (32) 0.3% (6)
0.2% (5) 0.04% (1) 0.1% (3) 1.5% (39) 0.4% (10)
0.75 NA 0.32 0.90 0.55
Arrhythmias Outcomes of Temporary Interruptions of Rivaroxaban or Warfarin in Patients with Atrial Fibrillation in the ROCKET AF Trial Oral Contributions West, Room 3009 Sunday, March 10, 2013, 8:30 a.m.-8:45 a.m.
Session Title: Joint Session of the Heart Rhythm Society and the American College of Cardiology: Anticoagulation in Atrial Fibrillation Management Questions with New Anticoagulants Abstract Category: 4. Arrhythmias: AF/SVT Presentation Number: 914-5 Authors: Matthew W. Sherwood, Anne Hellkamp, Manesh Patel, Jonathan Piccini, Yuliya Lokhnygina, James Douketis, Richard Becker, Kenneth Mahaffey, Keith Fox, Robert Califf, Duke Clinical Research Institute, Durham, NC, USA Purpose: Temporary interruption (TI) of oral anticoagulation (OAC) is common in patients with atrial fibrillation (AF). The characteristics of patients with TI and association of TI with clinical events are not well understood. Methods: We evaluated baseline characteristics, management, and outcomes from 3 days post-TI to 3 days after restart of OAC during TI (3-30 days) during the ROCKET AF study. Results: In 14236 patients, 4693 (33%) had 7557 TI (4164 in warfarin vs. 3393 rivaroxaban treatment group). Of those with TI, the median (IQR) age was 73 (66,78) years and mean (SD) CHADS2 score was 3.4 (0.9). The median duration of TI was 5 (4,9) days. In TI patients, 63% had 1, 24% had 2, and 13% had >3 TI. Clinical characteristics were similar in TI and non-TI patients. Only 7% (n=555) of TI involved bridging therapy (86% LMWH, 10.5% aspirin, 3.4% clopidogrel) for a median of 6 (4,10) days. Those bridged had higher mean CHADS2 score (3.5 vs. 3.3; p<0.01), were more commonly on OAC before trial entry (75 vs. 63%; p<0.01), and less commonly on aspirin during the trial (31 vs. 37%; p=0.01). Strokes occurred in 0.2% of rivaroxaban and warfarin treated patients during TI, while 1.5% in both groups developed major or clinically relevant non-major (CRNM) bleeding (Table). Conclusions: In a large, international cohort of patients with nonvalvular AF, TI of OAC is common and bridging therapy is infrequently used. In relation to TI, the proportion of patients who had stroke or bleeding was similar in those assigned to rivaroxaban or warfarin. Temporary
Interruption
% with event (N)
Rivaroxaban (n=2,165)
Warfarin (n=2,528)
Unadjusted p
Stroke/Systemic Embolism Death MI Major or CRNM Bleeding Minimal Bleeding
0.2% (5) 0% (0) 0.2% (5) 1.5% (32) 0.3% (6)
0.2% (5) 0.04% (1) 0.1% (3) 1.5% (39) 0.4% (10)
0.75 NA 0.32 0.90 0.55