BACKGROUND: The novel oral anticoagulants (NOACs) are used for stroke prevention in atrial fibrillation (AF), but their safety and efficacy in the periablation period are not well established. Additionally, no standard procedure for managing periprocedural and intraprocedural anticoagulation has been established.
OBJECTIVE: To evaluate the frequency of hemorrhagic and thrombotic events as well as periprocedural management strategies of NOACs compared with warfarin as anticoagulation therapy for AF ablation.
METHODS: This was a retrospective cohort study from a prospective AF ablation registry maintained at a large, academic medical center.
RESULTS: A total of 374 cases (173 warfarin, 123 dabigatran, 61 rivaroxaban, and 17 apixaban) were included in the analysis. The overall hemorrhagic/thrombotic event rate was 14.2 % (major hemorrhage 2.7%, minor hemorrhage 11.2%, thrombotic stroke 0.5%). The frequency of minor hemorrhage was significantly higher with warfarin compared with dabigatran (15% vs 5.7%, P = 0.012). The average heparin dose required to reach the goal activated clotting time (ACT) was 5600 units for warfarin, 12 900 units for dabigatran (P < 0.001), 15 100 units for rivaroxaban (P < 0.001), and 14 700 units for apixaban (P < 0.001). The average time in minutes to reach the goal ACT was significantly longer, compared with warfarin, for dabigatran (57 vs 28, P < 0.001), rivaroxaban (63 vs 28, P < 0.001), and apixaban (72 vs 28, P < 0.001).
CONCLUSIONS: Compared with warfarin, periprocedural anticoagulation with dabigatran resulted in fewer minor hemorrhages and total adverse events after AF ablation. Patients anticoagulated with NOACs required larger doses of heparin and took longer to reach the goal ACT compared with patients anticoagulated with warfarin.
BACKGROUND: There is a paucity of data that compare traditional vitamin K antagonist (VKA) with novel oral anticoagulant regimens in periprocedural management of cardioversion or ablation of atrial fibrillation (AF). We sought to compare outcomes of use of VKA, dabigatran (DABI), and rivaroxaban (RIVA) anticoagulation around the time of intervention.
METHODS: We studied consecutive patients undergoing cardioversion or ablation of AF at our centre from October 2010 to October 2013. There were 3 different anticoagulation groups: warfarin (VKA), DABI, and RIVA. Safety was assessed according to number of strokes, transient ischemic attacks (TIAs), and clinically important and not important bleeding events.
RESULTS: Baseline characteristics were well balanced between the groups. Average follow-up was 6 months (± 4 months). A total of 901 patients who underwent cardioversion were studied (VKA [n = 471], DABI [n = 288] and RIVA [n = 141]). In these patients there were no strokes seen during follow-up and 2 TIAs in the DABI group. Bleeding rates were low, with no significant difference between the 3 groups. A total of 680 patients who underwent ablation were studied (VKA [n = 319], DABI [n = 220] and RIVA [n = 171]). There were no strokes reported during follow-up and 3 TIAs: 2 in the VKA group and 1 in the DABI group not resulting in a significant difference between the groups. Bleeding rates were low, with no significant difference between the groups.
CONCLUSIONS: Overall, there was a low incidence of adverse events for all anticoagulation regimens. Warfarin, DABI, and RIVA use around the time of the procedure are safe and reasonable options for patients who undergo cardioversion or AF ablation.
BACKGROUND: The new oral anticoagulants (NOAC), dabigatran and rivaroxaban, have been demonstrated to be at least equivalent to warfarin for preventing cardiac thromboembolism (TE) in patients with atrial fibrillation (AF). However, there is limited data regarding use around catheter ablation (CA) procedures.
OBJECTIVE: We evaluated the risk of bleeding and TE complications associated with NOAC use during AF ablation.
METHODS: Consecutive patients undergoing AF ablation between January 2011 and 6 September 2013 were grouped based on peri-procedural anticoagulation regimen: (1) uninterrupted warfarin with therapeutic INR (WARF), n = 114, (2) dabigatran, n = 89, or (3) rivaroxaban, n = 98. NOACs were held for 24 h (dabigatran) or 36 h (rivaroxaban) prior to the procedure. Heparin infusion was initiated 6 h post-procedure for the NOAC groups; NOACs were resumed the morning after the procedure. Antral PVI was performed with activated clotting time (ACT) maintained >300 s. TE or bleeding complications during ablation and through 30 days were compared.
RESULTS: Three hundred and one patients underwent ablation for paroxysmal (71%) or persistent (29%) AF. International Normalization Ratio (INR) for the WARF group was 2.0 ± 0.5. Baseline characteristics were similar among the groups. There were two TE events (asymptomatic cerebral emboli and TIA), and there were 17 bleeding events (large hematoma n = 4; pericardial effusion n = 6; persistent hematuria n = 1; pseudoaneurism/AV fistula n = 6). Of the six pericardial effusions, three required drainage. There was no significant difference in combined TE/bleeding risk among the groups (WARF vs. dabigatran vs. rivaroxaban; 6.2% vs. 6.7% vs. 6.0%; p = 0.82) CONCLUSIONS: In this group of AF patients undergoing CA, use of peri-procedure dabigatran or rivaroxaban compared to uninterrupted warfarin did not lead to an increase in bleeding or TE complications.
AIMS: X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.
METHODS AND RESULTS: We assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1-5 days after randomization) or delayed (3-8 weeks) cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15-1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early cardioversion (0.71%) and one following delayed cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early cardioversion (1.08%) and two following delayed cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to cardioversion compared with VKAs (P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21-2.67).
CONCLUSION: Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.
NAME OF THE TRIAL REGISTRY: Clinicaltrials.gov;
TRIAL REGISTRATION NUMBER: NCT01674647.
OBJECTIVES: The purpose of this study was to evaluate the feasibility and safety of uninterrupted rivaroxaban therapy during atrial fibrillation (AF) ablation.
BACKGROUND: Optimal periprocedural anticoagulation strategy is essential for minimizing bleeding and thromboembolic complications during and after AF ablation. The safety and efficacy of uninterrupted rivaroxaban therapy as a periprocedural anticoagulant for AF ablation are unknown.
METHODS: We performed a multicenter, observational, prospective study of a registry of patients undergoing AF ablation in 8 centers in North America. Patients taking uninterrupted periprocedural rivaroxaban were matched by age, sex, and type of AF with an equal number of patients taking uninterrupted warfarin therapy who were undergoing AF ablation during the same period.
RESULTS: A total of 642 patients were included in the study, with 321 in each group. Mean age was 63 ± 10 years, with 442 (69%) males and 328 (51%) patients with paroxysmal AF equally distributed between the 2 groups. Patients in the warfarin group had a slightly higher mean HAS- BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score (1.70 ± 1.0 vs. 1.47 ± 0.9, respectively; p = 0.032). Bleeding and embolic complications occurred in 47 (7.3%) and 2 (0.3%) patients (both had transient ischemic attacks) respectively. There were no differences in the number of major bleeding complications (5 [1.6%] vs. 7 [1.9%], respectively; p = 0.772), minor bleeding complications (16 [5.0%] vs. 19 [5.9%], respectively; p = 0.602), or embolic complications (1 [0.3%] vs. 1 [0.3%], respectively; p = 1.0) between the rivaroxaban and warfarin groups in the first 30 days.
CONCLUSIONS: Uninterrupted rivaroxaban therapy appears to be as safe and efficacious in preventing bleeding and thromboembolic events in patients undergoing AF ablation as uninterrupted warfarin therapy.
BACKGROUND: This study aimed to evaluate the safety of continuous periprocedural rivaroxaban administration during left atrial radiofrequency ablation (RFA) in comparison with uninterrupted oral vitamin K antagonist administration. Data about the use of rivaroxaban in the setting of left atrial RFA procedures are lacking.
METHODS AND RESULTS: The study cohort included 544 patients (mean age, 63±10 years) who underwent left atrial RFA procedures between February 2012 and May 2013. All patients (n=272) receiving uninterrupted periprocedural rivaroxaban 15 or 20 mg/d before the procedure (rivaroxaban) were matched by age, sex, and type of rhythm disorder with an equal number of patients managed with uninterrupted vitamin K antagonist phenprocoumon (international normalized ratio, 2-3). During RFA, heparin was given intravenously to maintain an activated clotting time at 270 to 300 s. The safety end point was a composite of bleeding, thromboembolic events, and death. There were no thromboembolic complications and no deaths in either group. The prevalence of major bleeding complications was similar in both groups (1 tamponade in RivG and 1 groin hematoma requiring transfusion in phenprocoumon). Minor bleeding complications occurred equally in both groups (20 of 272; 7% in the rivaroxaban versus 33 of 272, 12% in the phenprocoumon; P=0.08). In multivariable analyses, female sex was associated with a greater risk of complications (odds ratio, 1.96; 95% confidence interval, 1.10-3.49).
CONCLUSIONS: In patients undergoing left atrial RFA, continuous periprocedural rivaroxaban use seems to be as safe as uninterrupted periprocedural phenprocoumon administration.
Journal»Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS: The recent availability of the novel oral anticoagulants (NOACs) may have led to a change in the anticoagulation regimens of patients referred to catheter ablation of atrial fibrillation (AF). Preliminary data exist concerning dabigatran, but information regarding the safety and efficacy of rivaroxaban in this setting is currently scarce.
METHODS AND RESULTS: Of the 556 consecutive eligible patients (age 61.0 ± 9.6; 74.6% men; 61.2% paroxysmal AF) undergoing AF catheter ablation in our centre (October 2012 to September 2013) and enroled in a systematic standardized 30-day follow-up period: 192 patients were under vitamin K antagonists (VKAs), 188 under rivaroxaban, and 176 under dabigatran. Peri-procedural mortality and significant systemic or pulmonary thromboembolism (efficacy outcome), as well as bleeding events (safety outcome) during the 30 days following the ablation were evaluated according to anticoagulation regimen. During a 12-month time interval, the use of the NOACs in this population rose from <10 to 70%. Overall, the rate of events was low with no significant differences regarding: thrombo-embolic events in 1.3% (VKA 2.1%; rivaroxaban 1.1%; dabigatran 0.6%; P = 0.410); major bleeding in 2.3% (VKA 4.2%; rivaroxaban 1.6%; dabigatran 1.1%; P = 0.112), and minor bleeding 1.4% (VKA 2.1%; rivaroxaban 1.6%; dabigatran 0.6%; P = 0.464). No fatal events were observed.
CONCLUSION: The use of the NOAC in patients undergoing catheter ablation of AF has rapidly evolved (seven-fold) over 1 year. These preliminary data suggest that rivaroxaban and dabigatran in the setting of catheter ablation of AF are efficient and safe, compared with the traditional VKA.
Journal»Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS: Atrial fibrillation ablation requires peri-procedural oral anticoagulation (OAC) to prevent thromboembolic events. There are several options for OAC. We evaluate peri-procedural AF ablation complications using a variety of peri-procedural OACs.
METHODS AND RESULTS: We examined peri-procedural OAC and groin, bleeding, and thromboembolic complications for 2334 consecutive AF ablations using open irrigated-tip radiofrequency (RF) catheters. Pre-ablation OAC was warfarin in 1113 (47.7%), dabigatran 426 (18.3%), rivaroxaban 187 (8.0%), aspirin 472 (20.2%), and none 136 (5.8%). Oral anticoagulation was always interrupted and intraprocedural anticoagulation was unfractionated heparin (activated clotting time, ACT = 237 ± 26 s). Pre- and post-OAC drugs were the same for 1591 (68.2%) and were different for 743 (31.8%). Following ablation, 693 (29.7%) were treated with dabigatran and 291 (12.5%) were treated with rivaroxaban. There were no problems changing from one OAC pre-ablation to another post-ablation. Complications included 12 (0.51%) pericardial tamponades [no differences for dabigatran (P = 0.457) or rivaroxaban (P = 0.163) compared with warfarin], 12 (0.51%) groin complications [no differences for rivaroxaban (P = 0.709) and fewer for dabigatran (P = 0.041) compared with warfarin]. Only 5 of 2334 (0.21%) required blood transfusions. There were two strokes (0.086%) and no transient ischaemic attacks (TIAs) in the first 48 h post-ablation. Three additional strokes (0.13%), and two TIAs (0.086%) occurred from 48 h to 30 days. Only one stroke had a residual deficit. Compared with warfarin, the neurologic event rate was not different for dabigatran (P = 0.684) or rivaroxaban (P = 0.612).
CONCLUSION: Using interrupted OAC, low target intraprocedural ACT, and irrigated-tip RF, the rate of peri-procedural groin, haemorrhagic, and thromboembolic complications was extremely low. There were only minimal differences between OACs. Low-risk patients may remain on aspirin/no OAC pre-ablation. There are no problems changing from one OAC pre-ablation to another post-ablation.
INTRODUCTION: In recent years, several novel anticoagulants have been approved for the prevention of thromboembolic strokes as an alternative to warfarin in patients with atrial arrhythmias. Studies have evaluated these medications in patients undergoing radiofrequency ablation, yet no data exists to evaluate the bleeding risk in patients undergoing cryoballoon ablation procedures.
METHODS: Patients that underwent either cryoballoon ablation alone or with additional radiofrequency ablation over the past 3 years were included in the study. Patients were stratified into one of three subsets based on type of anticoagulation (warfarin, dabigatran, or rivaroxaban). Bleeding complications during the first 48 h and first 2 weeks following the ablation were recorded. Major complications were defined as hemorrhage requiring blood products or need for vascular intervention. Minor complications included prolonged bleeding from catheter insertion site, development of ecchymosis, or hematoma formation. Intraprocedural activated clotting times (ACT) were assessed and compared.
RESULTS: A total of 217 patients met inclusion criteria of which 87 (40.1 %) patients were on warfarin, 90 (41.5 %) patients on dabigatran, and 40 (18.4 %) patients on rivaroxaban. The overall bleeding complication rate was 12.0 %. All complications occurred within the first 48 h post-ablation. Nine (10.3 %) complications occurred in the warfarin subset, ten (11.1 %) in the rivaroxaban subset, and seven (17.5 %) in the dabigatran subset (p = 0.49). The warfarin and dabigatran subsets had higher average ACT levels (424.9 versus 406.5) compared to the rivaroxaban subset (393.4; p < 0.01). Subanalyses found no difference in bleeding complications based on procedure type.
CONCLUSION: Bleeding complications post-ablation were similar for warfarin, dabigatran, and rivaroxaban in patients undergoing cryoballoon ablation. Compared with radiofrequency ablation, cryoablation does not place patients at an increased bleeding risk.
The novel oral anticoagulants (NOACs) are used for stroke prevention in atrial fibrillation (AF), but their safety and efficacy in the periablation period are not well established. Additionally, no standard procedure for managing periprocedural and intraprocedural anticoagulation has been established.
OBJECTIVE:
To evaluate the frequency of hemorrhagic and thrombotic events as well as periprocedural management strategies of NOACs compared with warfarin as anticoagulation therapy for AF ablation.
METHODS:
This was a retrospective cohort study from a prospective AF ablation registry maintained at a large, academic medical center.
RESULTS:
A total of 374 cases (173 warfarin, 123 dabigatran, 61 rivaroxaban, and 17 apixaban) were included in the analysis. The overall hemorrhagic/thrombotic event rate was 14.2 % (major hemorrhage 2.7%, minor hemorrhage 11.2%, thrombotic stroke 0.5%). The frequency of minor hemorrhage was significantly higher with warfarin compared with dabigatran (15% vs 5.7%, P = 0.012). The average heparin dose required to reach the goal activated clotting time (ACT) was 5600 units for warfarin, 12 900 units for dabigatran (P < 0.001), 15 100 units for rivaroxaban (P < 0.001), and 14 700 units for apixaban (P < 0.001). The average time in minutes to reach the goal ACT was significantly longer, compared with warfarin, for dabigatran (57 vs 28, P < 0.001), rivaroxaban (63 vs 28, P < 0.001), and apixaban (72 vs 28, P < 0.001).
CONCLUSIONS:
Compared with warfarin, periprocedural anticoagulation with dabigatran resulted in fewer minor hemorrhages and total adverse events after AF ablation. Patients anticoagulated with NOACs required larger doses of heparin and took longer to reach the goal ACT compared with patients anticoagulated with warfarin.
