Summary

• In a prospective cohort study, after propensity score matching, the number of thromboembolic events was 6 in the XARELTO group and 3 in the warfarin group (odds ratio [OR], 2.01; 95% confidence interval [CI], 0.50-8.07), and the number of major bleeding events was 3 in the XARELTO group and 4 in the warfarin group (OR, 0.75; 95% CI, 0.17-3.36).¹
• In a prospective randomized study, the incidence of asymptomatic cerebral microthromboembolism and hemopericardium was similar among patients undergoing atrial fibrillation (AF) ablation and receiving edoxaban, XARELTO, and warfarin. The incidence of asymptomatic cerebral micro-thromboembolism was higher in the low-dose group than in the normal-dose group in patients receiving novel oral anticoagulants (NOACs).²
• VENTURE-AF^3,4 demonstrated XARELTO was associated with a low and similar incidence of periprocedural major bleeding and thromboembolic events as compared to vitamin-K antagonists (VKAs).
• Results from a systematic review and meta-analysis of peri-procedural anticoagulation in patients undergoing catheter ablation (CA) of AF found XARELTO had similar efficacy and safety compared with VKA.⁵
• In a prospective, single-center, observational study conducted in patients undergoing AF ablation on uninterrupted VKA vs uninterrupted and interrupted NOACs, NOACs were associated with a significant increase in the incidence of cerebral lesions.⁶
• Results of a single-center study did not find significant differences in the peri-interventional complications between uninterrupted anticoagulation therapies of NOACs and VKA during AF ablation procedures.⁷
• Results of an observational, prospective registry study showed that the rates of thromboembolic complications and bleeding were not significantly different during the periprocedural use of apixaban and XARELTO in patients who had undergone AF ablation.⁸
• Based on the results of a multicenter, observational, prospective registry, uninterrupted XARELTO therapy was as safe and efficacious as warfarin in preventing bleeding and thromboembolic events in patients undergoing AF ablation.⁹
• In a retrospective study, after propensity score matching, thrombosis occurred in 7 (0.9%) patients in the XARELTO group and 11 (1.4%) in the dabigatran group (OR, 1.580; 95% CI, 0.609-4.097; P=0.343), and total bleeding occurred in 85 (11.0%) patients in the XARELTO group and 82 (10.6%) in the dabigatran group (OR, 0.961; 95% CI, 0.679-1.324; P=0.806).¹⁰
• In a post hoc analysis of ROCKET AF patients undergoing electrical cardioversion (ECV), pharmacologic cardioversion (PCV), or AF ablation, the incidence of stroke or systemic embolism was comparable between XARELTO and warfarin after cardioversion or AF ablation procedures.¹¹
• XARELTO may increase intraprocedural heparin requirements and the time to reach target activated clotting time (ACT) relative to warfarin, but the mechanism is unclear.^12,13
• Additional citations identified during a literature search are included in the REFERENCES section for your review.^14-24

CLINICAL STUDIES

Prospective Studies

Dong et al (2022)¹ conducted a prospective cohort study to evaluate the efficacy and safety of XARELTO and dabigatran (standard dose and low dose) vs warfarin in patients with nonvalvular atrial fibrillation (NVAF) scheduled for first-time CA using the China Atrial Fibrillation registry from April 2013 to December 2018.

• Efficacy outcomes included thromboembolic complications (ischemic stroke, transient ischemic attack [TIA], and peripheral arterial thromboembolism), and safety outcomes included a composite of clinically relevant major bleeding and non-major bleeding events.
• Overall, 3385 patients were included in the study, of whom 718 (21.2%) were on XARELTO, 1896 (56.0%) were on warfarin, and 771 (22.8%) were on dabigatran.
• Before propensity score matching, thromboembolic events occurred in 6 (0.84%), 11 (0.58%), and 9 (1.17%) patients in the XARELTO, warfarin, and dabigatran groups, respectively.
• Before propensity score matching, major bleeding events occurred in 20 patients, of whom 3 (0.42%) were in the XARELTO group, 14 (0.74%) in the warfarin group, and 3 (0.39%) in the dabigatran group. Non-major bleeding complications occurred in 52 (7.24%) patients in the XARELTO group, 94 (4.96%) in the warfarin group, and 36 (4.67%) in the dabigatran group.
• For efficacy and safety outcomes, see Table: Thromboembolic and Safety Outcomes After Propensity Score Matching.

Yoshimoto et al (2020)² conducted a prospective randomized study to compare the incidence of asymptomatic cerebral micro-thromboembolism and hemopericardium after AF ablation in patients receiving periprocedural edoxaban, XARELTO, and warfarin; patients receiving normal- and low-dose edoxaban and XARELTO were also compared with each other.

• A total of 170 patients with AF (edoxaban, n=61; XARELTO, n=63; warfarin, n=46) were enrolled; 36 patients received low-dose and 88 received normal-dose edoxaban and XARELTO.
• No symptomatic cerebral infarctions were observed.
• Asymptomatic cerebral micro-thromboembolism was reported in 12 (21.1%) patients receiving edoxaban, 5 (8.6%) patients receiving XARELTO, and 8 (21.1%) patients receiving warfarin, with no significant differences between the 3 groups. The outcomes are presented in Table: Comparison of Complications Between Edoxaban, XARELTO, and Warfarin.

• The incidence of asymptomatic cerebral micro-thromboembolism was higher in the lowdose NOAC group than in the normal-dose NOAC group (25.7% vs 10.0%; P<0.05). The outcomes are presented in Table: Comparison of Complications Between Low-Dose and High-Dose NOACs.

VENTURE-AF^3,4 was a prospective, randomized, open-label, multicenter study designed to evaluate the safety of uninterrupted XARELTO or VKA in nonvalvular AF patients undergoing CA. Patients were randomized to receive XARELTO 20 mg (preferably with the evening meal) or uninterrupted VKA (international normalized ratio [INR] of 2.0 to 3.0) for at least 3 weeks prior to CA (delayed CA strategy) or for 1 to 7 days if an immediate transesophageal echocardiography or intracardiac echocardiography demonstrated absence of an intracardiac thrombus. During CA, patients received IV heparin titrated to an ACT of 300-400 seconds. After CA, the next dose of XARELTO was administered at least 6 hours after homeostasis was established and study drug was continued for 30±5 days.

• Primary Endpoint: Incidence of major bleeding events within 30 ± 5 days after CA measured by at least 1 of 3 adjudicated definitions: International Society on Thrombosis and Hemostasis (ISTH) criteria, Thrombosis in Myocardial Infarction (TIMI) criteria, and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO).
• Secondary Endpoints: Composite and individual components of myocardial infarction (MI), ischemic stroke, non-central nervous system (non-CNS) systemic embolism, and vascular death.
• A total of 248 patients were randomized (intent-to-treat [ITT]), 244 patients received ≥1 dose of the assigned study drug (safety population), 221 patients underwent CA (per-protocol population), and 213 patients completed the study.²⁵ Baseline characteristics were similar between groups.
• All the patients received heparin on the day of the CA. The mean total units of heparin administered to achieve a target of ACT range was 26% higher for patients on XARELTO compared to warfarin (13,871 ± 6516 and 10,964 ± 5912; P<0.001).
• There was one major bleeding event in the VKA group compared with none in the XARELTO group (0.4%). Non-major bleeding events occurred in 22 patients in the XARELTO group and in 17 patients in the VKA group, with the most frequent being procedure-attributable complications such as hematoma (8 with XARELTO and 10 with VKA).
• A total of 2 thromboembolic events (1 ischemic stroke, 1 vascular death; 0.8%) occurred in the VKA treatment group after the ablation. None were reported in the XARELTO group.
• The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs 18) and any other procedure-attributable events (5 vs 5) were similar between XARELTO and VKA.
• The number of serious adverse events leading to drug discontinuation (1 vs 3) and leading to hospitalization (11 vs 17) were comparable between XARELTO and VKA.

Vamos et al (2016)⁵ conducted a meta-analysis consisting of 15 observational studies and one randomized controlled trial published between January 2010 and April 2015. The analysis pooled a total of 7400 patients undergoing AF ablation, with 1994 patients on XARELTO and the remainder on VKA therapy.

• The majority of studies utilized a XARELTO dose of 15 or 20 mg once daily which was discontinued 24-48 hours prior to the procedure with or without unfractionated heparin (UFH)/low-molecular-weight heparin (LMWH) bridging. XARELTO was generally resumed 12 hours after ablation.
• The primary efficacy endpoint was the composite of symptomatic thromboembolic events including ischemic stroke, TIA, or systemic thromboembolism. The primary safety endpoint was major bleeding rates based mainly on the ISTH criteria.
• Of the 15 studies reporting efficacy data, a total of 23 thromboembolic events were recorded (XARELTO 4/1954; VKA 19/5219) [95% CI 0.16-1.01, P=0.052].
• All studies reported major bleeding events, which were observed in 1.15% of XARELTO (23/1994) and 1.66% of VKA-treated (90/5406) patients (95% CI 0.46-1.21, P=0.23).
• Minor bleeding was reported in 14 of 16 studies; event rates were 4.96% with XARELTO (87/1753) and 4.12% with VKA (165/4009) [95% CI 0.63-1.11, P=0.22].
• There was 1 fatal complication reported in each treatment group: a ruptured cerebral aneurysm in the XARELTO group and a vascular death in the VKA group.

Christoph et al (2021)⁷ conducted a single-center study to investigate peri-interventional complications during AF ablation procedures (pericardial effusion, TIA, stroke, access complications) between uninterrupted anticoagulation regimens of NOACs (including XARELTO, apixaban, and dabigatran) and VKA in a real-world setting.

• Primary Endpoint: The occurrence of peri-interventional complications during AF ablation procedures between NOAC and VKA regimens.
• Secondary Endpoints:
  • Changes of hemoglobin levels as marker of peri-interventional blood loss.
  • Doses of acquired heparin to reach the target ACT and the mean ACT.
• A total of 442 patients (NOAC, n=246; VKA, n=196) were included in the study.
  • Demographics were well balanced between groups except for significant older age, higher CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years [doubled], diabetes mellitus, prior Stroke or transient ischemic attack or thromboembolism [doubled], vascular disease) score, and higher HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly) score in the VKA patients. The NOAC group had significantly higher incidence of diabetes.
• No significant difference in peri-interventional complications was identified between the two groups.
  • AF-ablation was performed without complications in 93.9% (184/196) of patients in the VKA group and 96.3% (237/246) of patients in the NOAC group.
    • There were 3 cases of pericardial effusion in both the NOAC and VKA groups.
    • The VKA group presented with 1 TIA and 1 stroke while the NOAC group observed 1 TIA and no strokes.
    • Similar access site complications (pseudoaneurysm or arteriovenous [AV]-fistula) were conducted in both groups (VKA=7/196 [3.6%] versus NOAC=5/246 [2.0%]).
• No statistical difference (P=0.397) comparing both groups was observed related to the change in hemoglobin levels as a marker for peri-interventional blood loss.
• Both apixaban (13240±3280 units) and XARELTO (12161±3467 units) needed significantly higher doses of heparin to reach target ACT compared to VKA group (10301±3054 units).
• The measured ACTs were significantly lower in both apixaban (265±54 s) and XARELTO (281±161 s) compared to the VKA and dabigatran group (VKA: 299±54 s; dabigatran: 312±49 s).

Petzl et al (2020)⁶ conducted a prospective, single-center, observational study to compare the incidence of cerebral thromboembolic lesions after AF ablation and to identify the clinical and procedural risk factors in patients on uninterrupted VKA vs uninterrupted and interrupted NOACs (including XARELTO, apixaban, dabigatran, and edoxaban). An additional subgroup analysis was conducted to compare the individual NOAC with VKA. Of the 421 patients included in the study, 184 (43.7%) received VKA, and 237 (56.3%) received NOAC.

• Cerebral lesions during pulmonary vein isolation were observed in 55 (13.1%) patients; 3 patients experienced symptomatic stroke (apixaban, n=2; XARELTO, n=1), and the remaining 52 patients experienced clinically silent cerebral lesions.
  • The incidence of cerebral embolic lesions was significantly higher in the NOAC group compared with the VKA group (16.0% vs 9.2%; P=0.04).
  • The incidence of cerebral embolic lesions with individual NOACs compared with VKA was 15.8% for XARELTO (P=0.104), 15.3% for apixaban (P=0.164), 18.3% for dabigatran (P=0.055), and 10.0% for edoxaban (P=0.936).
• NOAC was interrupted in 38% of patients for a maximum of 24-36 hours; the incidence of cerebral lesions was similar in both the uninterrupted and the minimally interrupted NOAC groups.
• In a multivariate analysis, NOACs were significantly associated with an increase in cerebral lesions (OR, 1.876; 95% CI, 1.003-4.11; P=0.044).

Hansen et al (2016)²⁶ conducted a prospective, single center, non-randomized study to assess the safety of periprocedural interruption of NOACs prior to and 3-months following CA of AF. Of the 234 patients evaluated, 38 (16%) received XARELTO 20 mg daily therapy. The mean CHA₂DS₂-VASc and HAS-BLED scores were 1 (intermediate) and 0.7 (low), respectively.

• All NOACs were interrupted 24 hours before ablation and reinstated within 2 hours after without LMWH or UFH bridging.
• There were no reports of bleeding or thromboembolic events periprocedurally, except for one pericardial effusion, or during the 3-month follow-up period. A

Pillarisetti et al (2020)⁸ conducted an observational, prospective registry study to compare bleeding and thromboembolic complications in consecutive patients who underwent AF ablation and received apixaban and XARELTO in the periprocedural setting. A total of 56 patients received apixaban and 302 patients received XARELTO.

• No significant difference was observed in the rate of the composite endpoint of thromboembolism and bleeding between the 2 groups (apixaban vs XARELTO, 7.1% vs 6.2%; P=0.7).
• No thromboembolic complications were reported in the apixaban group. In the XARELTO group, 1 patient each experienced a TIA and an ischemic stroke within 60 days (0.6%) (P=not significant).
• Other outcomes are presented in Table: Comparison of Outcomes Between Apixaban and XARELTO.

Lakkireddy et al (2014)⁹ conducted an observational, prospective registry study of patients to evaluate the feasibility and safety of XARELTO during AF ablation. 642 patients (321 equally matched in each group) in 8 centers in North America were randomized to receive uninterrupted XARELTO or warfarin as a periprocedural anticoagulant. All patients received UFH as part of the ablation procedure.

• Of the 321 patients in the XARELTO group, 315 received 20 mg daily and 6 received 15 mg daily for at least 30 days prior to CA, including the night prior to the procedure. These patients were not bridged with UFH or LMWH periprocedurally. XARELTO was resumed on the evening of the procedure 3 hours following hemostasis.
• Patients in the warfarin group received warfarin for 30 days, regardless of the INR value at the time of the procedure. Warfarin therapy was not interrupted periprocedurally. Outpatient monitoring of INR was performed once weekly for at least 3 weeks prior to procedure to ensure therapeutic anticoagulation (INR, 2-3).
• Bleeding complications included pericardial effusions and hematomas. TIAs and cerebrovascular accidents were identified as thromboembolic events after intracranial bleeding was ruled out. Major bleeding was defined as bleeding severe enough to require transfusion, hematomas requiring surgical intervention, and pericardial bleeding needing drainage
• Patients in the warfarin group had slightly higher mean HAS BLED score than patients in the XARELTO group (1.70±1.0 vs 1.47±0.9, respectively; P=0.032). Other baseline characteristics were similar.
• From the last dose of XARELTO to the start of the procedure, the mean time was 16 ± 5 hours, and the mean time for resumption of the dose was 5.6 ± 2 hours posthemostasis.
• See Table: Comparison of Complications Between XARELTO and Warfarin.

Retrospective Studies

Wu et al (2023)²⁷ conducted a retrospective cohort study to evaluate the prognostic differences between patients receiving direct oral anticoagulants (DOACs) (XARELTO and dabigatran) without radiofrequency ablation (RFA) and those undergoing RFA between January 2016 and December 2020.

• The primary outcomes were major bleeding; total bleeding; thrombosis; all-cause death; and the composite endpoint of total bleeding, thrombosis, and all-cause death.
• A total of 6137 patients were included, of whom 2661 underwent RFA at baseline and 3476 did not undergo RFA.
• For clinical outcomes, see Table: Clinical Outcomes of DOACs in Patients With RFA After Propensity Score Matching

Stepanyan et al (2014)²⁸ evaluated the risk of bleeding and thromboembolic complications associated with NOAC use in a retrospective analysis of patients undergoing AF ablation between January 2011 and September 2013.

• Patients were grouped by peri-procedural regimen: uninterrupted warfarin with therapeutic INR, interrupted dabigatran, or interrupted XARELTO. During the procedure, UFH was administered to maintain target ACT>350 seconds.
• XARELTO and dabigatran were initiated ≥1 week prior to the procedure; the last dose of XARELTO was administered the evening 2 days prior and the last dose of dabigatran was administered the morning 1 day prior to the procedure.
• For both NOAC groups, heparin was initiated 6 hours following the procedure. NOACs were resumed the morning after. Patients were followed for at least 30 days for complications.
• Primary endpoint: any bleeding or thromboembolic complication within 30 days post-procedure.
• There were 301 patients included in the study (XARELTO 98, dabigatran 89, warfarin 114) and baseline characteristics were similar among groups.
• Thromboembolic events occurred in 2 patients and bleeding events occurred in 17 patients; there was no significant difference in the combined thromboembolic/bleeding risk among the groups (warfarin vs dabigatran vs XARELTO; 6.2% vs 6.7% vs 6.0%, P=0.82).
  • There was no significant difference in thromboembolic events between groups (P=0.74) or in bleeding events between groups (P=0.66).

Piccini et al (2013)¹¹ conducted a post-hoc analysis of ROCKET AF to describe the outcomes associated with cardioversion and AF ablation in patients treated with XARELTO and warfarin.

• Patients with plans for elective cardioversion or restoration of sinus rhythm during the screening period were excluded from enrollment. However, following study entry, patients who required cardioversion due to hemodynamic instability, progressive heart failure, or refractory symptoms despite optimal medical therapy could undergo cardioversion or AF ablation per study protocol. Procedures to treat AF were captured in the case report form.
• Study sites recorded all AF ablations (surgical or catheter-based), ECV, and PCV, including the dates of the procedures.
• For the overall study population, the median patient age at randomization was 73 years, the median CHADS₂ (congestive heart failure, hypertension, age≥75 years, diabetes mellitus, previous stroke/transient ischemic attack [double weight]) score was 3.0, 52% had prior stroke or TIA, and 81% had persistent AF. Patients who underwent cardioversion or AF ablation were younger (median age 69), more often Caucasian, more commonly had paroxysmal AF, a higher prevalence of sleep apnea, and were more frequently taking amiodarone or another antiarrhythmic agent. The patient characteristics were similar among patients who did and did not undergo cardioversion or ablation in the 2 treatment arms (XARELTO vs. warfarin).
• Results: Over a median follow-up of 2.1 years, 321 patients had a total of 460 on- treatment cardioversion or AF ablation procedures. A total of 143 patients underwent 181 ECV procedures, 142 patients underwent 194 PCV procedures, and 79 patients underwent 85 AF ablation procedures.
• During the trial, the overall incidence of ECV, PCV, or AF ablation was 1.45 per 100 patient years (n=321). The rate of cardioversion/ablation was 1.44 per 100 patient years in the warfarin group (n=161) and 1.46 per 100 patient years in the XARELTO group (n=160).
• On the day of ECV, PCV, or AF ablation, 256/321 (80%) were taking randomized study medication. Only 24 patients (XARELTO, n=12; warfarin, n=12) received LMWH within 24 hours of ECV, PCV, or AF ablation.
• In the first 30-days after ECV, PCV, or AF ablation: The rate of strokes or systemic emboli was 0.93% and the mortality rate was 1.25%; The rate of major and non-major clinically relevant bleeding was 2.18% compared with 9.97% at baseline.
• The hazards of hospitalization (hazard ratio [HR]=2.01, 95% CI, 1.51-2.68; P<0.0001) and major and non-major clinically relevant bleeding (HR=1.51, 95% CI, 1.12-2.05, P=0.0072) were greater following cardioversion or ablation, however, there were no differences between the treatment groups.
• See Table: Outcomes After ECV, PCV, or CA According to Randomized Treatment for post-procedural outcomes.
• The results were similar when the analysis was restricted to those patients taking study medication on the day of the procedure (Table: Outcomes After ECV, PCV, or CA Among Those Taking Study Drug on the Day of Procedure).

Kochhauser et al (2014)²⁹ conducted a retrospective comparison of the outcomes after cardioversion or AF ablation in patients taking XARELTO, dabigatran, or warfarin at the time of procedure. Only the results of AF ablation are presented here.

• All patients undergoing ablation (XARELTO, n=141; dabigatran, n=220; warfarin, n=319) needed ≥4 weeks of therapeutic anticoagulation prior to and 3 months following the procedure. Ablation patients were followed for a median of 12 months.
  • For patients on XARELTO and dabigatran, therapy was discontinued 24 hours prior to the procedure and resumed 8 hours after sheath removal and continued for a minimum of 3 months.
  • For patients on warfarin, therapy was discontinued 4 days prior to ablation and bridged with LMWH for 2 days. Warfarin was restarted on the same day as ablation.
• In patients undergoing ablation, there were no significant differences between the groups for any of the thromboembolic or bleeding outcomes.
  • Within 30 days after the procedure, there were no strokes reported. There were 2 acute TIAs reported (warfarin 1; dabigatran 1; P=0.11).
  • Within 30 days after procedure, there were 7 acute clinically important bleeds (warfarin 4; dabigatran 2; XARELTO 1; P=0.23).
  • Within 30 days after procedure there were 12 acute clinically not important bleeds (warfarin 6; dabigatran 5; XARELTO 1; P=0.06).

Armbruster et al (2015)¹² performed a retrospective cohort study from a prospective AF ablation registry to evaluate the safety of NOACs compared with uninterrupted warfarin for AF ablation. 374 patients were analyzed in the study (61 XARELTO, 123 dabigatran, 17 apixaban, and 173 warfarin).

• Prior to the first transseptal puncture, intravenous heparin was initiated. Patients were titrated to achieve an ACT of ≥350 seconds. Oral anticoagulation was restarted on the evening of the procedure if uncomplicated.
• The composite frequency of major hemorrhage and thrombotic adverse outcomes (primary endpoint) was 1.6% in the XARELTO group, 3.3% in the dabigatran group, 0% in the apixaban group, and 4% in the warfarin group; the difference between groups was not significant.
• The rate of total adverse outcomes was 14.8% with XARELTO, 8.1% with dabigatran, 5.9% with apixaban, and 19.1% with warfarin. The difference was only significant between warfarin and dabigatran (P=0.009).
• For minor hemorrhage, the difference was only significant between the warfarin and dabigatran groups (15% vs 5.7%, P=0.012).
• The average dose of heparin required to reach the goal ACT was 15,000 units for XARELTO, 12,900 units for dabigatran, 14,700 for apixaban, and 5,600 units for warfarin (P<0.001).
• The average time for heparin to reach the goal ACT was significantly longer for all NOACs compared with warfarin.

Nagao et al (2015)¹³ retrospectively examined the change in the intraoperative ACT value in response to heparin among 869 patients using warfarin, dabigatran, XARELTO, or apixaban who underwent radiofrequency CA for AF between April 2012 and August 2014. Periprocedural complications among each anticoagulant agent were also studied.

• The proportion of patients reaching target ACT after the initial intraprocedural heparin bolus was lower in the dabigatran and apixaban group than in the warfarin and XARELTO groups (36% and 26% vs. 84% and 78%, respectively; P<0.001).
• The time required to achieve target ACT >300 seconds was longer in the dabigatran and apixaban groups than in the warfarin and XARELTO groups (60 and 70 minutes vs. 8 and 9 minutes, respectively; P<0.001)
• The intraprocedural UFH requirement was higher in the apixaban group than in the warfarin, dabigatran, and XARELTO groups (71±28 U/kg/h vs 51±21, 59±20, and 57±15 U/kg/h, respectively; P<0.001).
• There were no differences in bleeding and/or thromboembolic complications between any of the groups.
• The mechanisms explaining differences in intraprocedural heparin requirements and time to reach target ACT relative to warfarin are unclear and require further investigation.

Dillier et al (2014)³⁰ evaluated the safety of continuous periprocedural XARELTO (15-20 mg daily; n=272) compared to phenprocoumon (INR 2-3; n=272) during left atrial CA in a retrospective, single-center registry analysis. Both groups received oral anticoagulation ≥4 weeks prior to and did not interrupt therapy for the procedure.

• 57% of patients received XARELTO 2-6 hours prior to the procedure and 43% of patients received XARELTO 6-12 hours prior to the procedure.
• XARELTO or phenprocoumon was given 24 hours after the last intake periprocedurally and continued for ≥3 months.
• Safety endpoint: composite of bleeding, thromboembolic events, and death during hospitalization.
• There were no deaths or thromboembolic complications in either group.
• The prevalence of total bleeding complications was 8% in the XARELTO group and 13% in the phenprocoumon group (P=0.09)
• The composite endpoint of bleeding and embolic complications was also not significantly different between groups (XARELTO 8%, phenprocoumon 13%, P=0.09).
• The prevalence of major and minor bleeding complications was similar between groups.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 08 November 2024.