SUMMARY

• Published studies on real-world data of apixaban vs XARELTO for venous thromboembolism (VTE) treatment are summarized below.
• In a systematic review and meta-analysis comparing apixaban and XARELTO in real-world settings, no significant difference was reported in recurrent VTE events between the apixaban and XARELTO groups. Additionally, no difference was found between the 2 groups for events of major, intracranial, gastrointestinal (GI), and hospitalized bleeding and death. However, apixaban users reported a 46% lower risk of minor bleeding than XARELTO users.^1,2
• Four retrospective cohort analyses were conducted to evaluate the effectiveness and safety of apixaban and XARELTO in newly diagnosed patients with VTE.^3-6 In a separate cohort study, the safety and efficacy of apixaban and XARELTO were assessed in patients with a prior diagnosis of either deep vein thrombosis (DVT) or pulmonary embolism (PE) on or before the anticoagulation start date.⁷ A prospective analysis evaluated the efficacy and safety of XARELTO vs apixaban in the treatment of patients with acute VTE.⁸
• In another systematic review of studies comparing apixaban with XARELTO in real-world settings, no difference in VTE recurrence was identified between the two treatment groups. Clinically relevant major bleeding occurred in fewer patients in the apixaban group than in the XARELTO group.⁹
• Several studies evaluated the efficacy and safety of apixaban and XARELTO for VTE treatment in specific populations, including young adults, patients with extremes in body weight, fragile patients, and Asian patients.^10-13
• Additional studies summarized below include those analyzing bleeding events,^14,15 and a study reporting the impact of anticoagulant choice on healthcare resource utilization.¹⁶
• Additional citations identified during a literature search are included in the REFERENCES section for your review.^17-28

CLINICAL DATA

Real-world Evidence

Effectiveness and Safety

Liu et al (2022)^1,2 conducted a systematic review and meta-analysis of real-world studies to compare the clinical outcomes between apixaban, XARELTO, edoxaban, and dabigatran in patients with VTE.

• Clinical outcomes included recurrent VTE, death, and different bleeding events, including major, intracranial, GI, hospitalized, and minor bleeding.¹
• Overall, 63,144 patients with VTE from 6 observational studies that reported effectiveness and safety outcomes were included in the meta-analysis.¹
  • No significant difference was reported in recurrent VTE events between the apixaban (n=3011) and XARELTO (n=11,219) groups (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.331.27; P=0.22). Additionally, no difference was found between the 2 groups for events of major, intracranial, GI, and hospitalized bleeding and death (P>0.05).
  • Apixaban users reported a 46% lower risk of minor bleeding than XARELTO users (OR, 0.54; 95% CI, 0.37-0.78; P<0.001).
• Adjusted hazard ratio (HR) was also reported and pooled in the studies.^1,2
  • Apixaban users had a significant reduction in the major (HR, 0.61; P=0.008), minor (HR, 0.56; P<0.0001), and any bleeding (HR, 0.70; P=0.006) risks compared with XARELTO users.
  • No statistical difference was reported between the 2 groups in recurrent VTE events (HR, 1.02; 95% CI, 0.71-1.47; P=0.93).
  • Based on a study that reported results on death, no difference in the risk of death was found between the apixaban and XARELTO groups (HR, 1.11; 95% CI, 0.871.41; P=0.40).

Dawwas et al (2022)³ conducted a retrospective, new-user cohort study using the Optum's deidentified Clinformatics^® Data Mart Database to compare the effectiveness and safety of apixaban and XARELTO in patients with VTE with commercial healthcare coverage (excluding dual Medicare enrollment). A subgroup analysis based on age group (<65 and ≥65 years) was also conducted.

• The primary effectiveness outcome was the incidence of recurrent VTE, a composite of DVT and PE. The primary safety outcome was the incidence of bleeding, a composite of GI and intracranial bleeding.
• 42,143 patients with VTE were included in the cohort.
  • 15,453 were new apixaban users.
  • 15,453 were new XARELTO users.
• 387 events of recurrent VTE were observed among 15,453 apixaban users (8.9 events per 100 person-years [PYs]) compared with 478 events among 15,453 XARELTO users (11.2 events per 100 PYs; adjusted marginal HR, 0.78 [95% CI, 0.69-0.90]).
  • Among apixaban vs XARELTO users, the number of events and incidence rate per 100 PYs of DVT were 369 vs 445 and 8.4 vs 10.5 (adjusted marginal HR, 0.84 [95% CI, 0.73-0.97]), respectively, and those of PE were 18 vs 33 and 0.4 vs 0.7 (adjusted marginal HR, 0.56 [95% CI, 0.31-1.01]), respectively.
• 333 events of bleeding were observed among 15,453 apixaban users (7.6 events per 100 PYs) compared with 459 events among 15,453 XARELTO users (10.7 events per 100 PYs; adjusted marginal HR, 0.70 [95% CI, 0.61-0.80]).
  • Among apixaban vs XARELTO users, the number of events and incidence rate per 100 PYs of GI bleeding were 327 vs 423 and 7.0 vs 9.6 (adjusted marginal HR, 0.66 [95% CI, 0.57-0.76]), respectively, and those of intracranial bleeding were 6 vs 6 and 0.1 vs 0.1 (adjusted marginal HR, 0.79 [95% CI, 0.24-2.57]), respectively.
• In a subgroup analysis, the risk of recurrent VTE and bleeding, respectively, was evaluated in 5867 apixaban and XARELTO users, each, who were <65 years old and 9351 apixaban and XARELTO users, each, who were ≥65 years old.
  • Adjusted HRs (95% CIs) for recurrent VTE and bleeding, respectively, were 0.78 (0.62-0.98; P_interaction=0.64) and 0.77 (0.56-1.06; P_interaction=0.20) in patients aged <65 years and 0.76 (0.64-0.90) and 0.59 (0.50-0.70) in patients aged ≥65 years.

Fukasawa et al (2022)⁴ conducted a retrospective, new-user cohort study using a nationwide hospital-based administrative database provided by Medical Data Vision Co., Ltd. to compare the effectiveness of direct oral anticoagulants (DOACs), including apixaban, XARELTO, and edoxaban, in patients with VTE from April 1, 2008, to July 31, 2020. Patients aged 18-99 years who initiated apixaban, XARELTO, and edoxaban between December 21, 2015, and February 2, 2020 (180 days before the end of the study period) were included in the study.

• The primary effectiveness outcome was the incidence of recurrent VTE, defined as a composite of DVT or PE that occurred subsequent to the index VTE.
• The primary safety outcome was the incidence of a composite of GI bleeding or intracranial hemorrhage (ICH).
• Of the 6959 patients who were eligible, 1998, 1592, and 3369 patients initiated apixaban, XARELTO, and edoxaban, respectively. After the treatment groups were balanced using the matching weights, 1390, 1172, and 1605 initiators of apixaban, XARELTO, and edoxaban, respectively, were generated.
• Results from the weighted analysis are presented below.
  • Among apixaban vs XARELTO users, the number of events and adjusted incidence rate per 10,000 person-days of recurrent VTE were 17 vs 19 and 1.4 (95% CI, 0.9-2.3) vs 1.7 (95% CI, 1.1-2.7), respectively.
  • Among apixaban vs XARELTO users, the number of events and adjusted incidence rate per 10,000 person-days of GI bleeding or ICH requiring a procedure were 14 vs 11 and 1.2 (95% CI, 0.7-2.0) vs 1.0 (95% CI, 0.6-1.8), respectively.
  • Among apixaban vs XARELTO users, the number of events and adjusted incidence rate per 10,000 person-days of GI bleeding or ICH requiring a procedure or hospitalization were 36 vs 30 and 3.1 (95% CI, 2.2-4.3) vs 2.8 (95% CI, 2.0-4.0), respectively.
  • The adjusted incidence rate ratio (IRR) per 10,000 person-days for recurrent VTE for XARELTO vs apixaban was 1.20 (95% CI, 0.69-2.10).
  • The adjusted IRR per 10,000 person-days for GI bleeding or ICH requiring a procedure for XARELTO vs apixaban was 0.83 (95% CI, 0.42-1.64).
  • The adjusted IRR per 10,000 person-days for GI bleeding or ICH requiring a procedure or hospitalization for XARELTO vs apixaban was 0.91 (95% CI, 0.59-1.38).

Dawwas et al (2022)⁵ conducted a retrospective new-user cohort study from Optum's deidentified Clinformatics Data Mart Database to analyze and evaluate the effectiveness and safety of apixaban and XARELTO in newly diagnosed patients with VTE between Jan 1, 2015 and June 30, 2020.

• The primary effectiveness outcome was recurrent VTE, a composite of DVT and PE. The primary safety outcome was a composite of GI and intracranial bleeding.
• 49,900 eligible patients diagnosed with VTE were included in the cohort.
  • 18,618 were new apixaban users.
  • 18,618 were new XARELTO users.
• 475 patients had recurrent VTE among 18,618 apixaban users (8.9 events per 100 PYs) compared with 595 among 18,618 XARELTO users (11.4 events per 100 PYs) (HR, 0.77 [CI, 0.69-0.87]).
  • The absolute reduction in the probability of recurrent VTE with apixaban compared with XARELTO was 0.006 (CI, 0.005-0.011) within 2 months and 0.011 (CI, 0.0110.013) within 6 months of treatment initiation. Results were consistent for apixaban (vs XARELTO) for DVT (HR, 0.85 [CI, 0.74-0.97]) and PE (HR, 0.59 [CI, 0.39-0.91]).
• 386 patients had GI and intracranial bleeding events among 18,618 apixaban users (7.2 events per 100 PYs) compared with 577 among 18,618 XARELTO users (11.0 events per 100 PYs) (HR, 0.60 [CI, 0.53-0.69]).
  • The absolute reduction in the probability of GI and intracranial bleeding with apixaban compared with XARELTO was 0.011 (CI, 0.010-0.011) within 2 months and 0.015 (CI, 0.013-0.015) within 6 months of treatment initiation. Results were consistent for apixaban (vs XARELTO) for GI (HR, 0.60 [CI, 0.53-0.69]) and intracranial (HR, 0.54 [CI, 0.14-1.20]) bleeding.

Jin et al (2021)⁷ conducted a cohort study analyzing data from Optum Clinformatics Data Mart Database to assess the safety and efficacy of apixaban and XARELTO for patients with VTE between 2003 and 2019. Patients with a prior diagnosis of either DVT or PE on or before the anticoagulation start date were included in this study. Patients with a prior diagnosis of atrial fibrillation, ICH or an unruptured intracranial aneurysm were excluded.

• Primary endpoints: death and hospital readmissions for either ICH, non-ICH hemorrhage, or recurrent VTE.
• 225,559 patients treated with either warfarin or a DOAC were included, of whom 34,201 received apixaban and 46,007 received XARELTO.
• Apixaban was not associated with improved survival compared to XARELTO (HR, 1.091; 95% CI, 0.843-1.412). Patients receiving apixaban were significantly less likely to experience a hemorrhagic event while on anticoagulation (HR, 0.581; 95% CI, 0.4450.758).
• Compared to XARELTO, apixaban was associated with decreased non-ICH hemorrhage (subdistribution HR [sHR; emergent hemorrhage]=0.560; 95% CI=0.423-0.741), but not ICH, and recurrent VTE (sHR=0.802, 95% CI=0.651-0.988) risk when adjusting for mortality as a competing risk. This was primarily in emergent readmissions (sHR=0.515, 95% CI=0.372-0.711; sHR [emergent recurrent VTE]=0.636, 95% CI=0.488-0.830).

Dawwas et al (2019)⁶ conducted a retrospective cohort analysis of data from the Truven Health MarketScan commercial and Medicare Supplement claims databases to analyze and evaluate the effectiveness and safety of apixaban and XARELTO in prevention of recurrent VTE and major bleeding events in newly diagnosed patients with VTE between Jan 1, 2014 and Dec 31, 2016. Patients were excluded if they had used any anticoagulation therapy during the 12-months prior to study treatment.

• Primary efficacy outcome: incidence of recurrent VTE (DVT or pulmonary thrombosis).
• Primary safety outcome: incidence of major bleeding events.
• Secondary safety outcome: incidence of minor bleeding.
• 15,254 patients were included in the cohort.
  • 3,091 apixaban users.
  • 12,163 XARELTO users.
• The crude incidence of recurrent VTE was 3 per 100 PYs in the apixaban group and 7 per 100 PYs in the XARELTO group.
  • 25 cases of recurrent VTE among apixaban users and 254 cases among XARELTO users.
• The crude incidence of major bleeding was 3 per 100 PYs in the apixaban group and 6 per 100 PYs in the XARELTO group.
  • 28 cases of major bleeding among apixaban users and 188 cases among XARELTO users.
• The use of apixaban compared with XARELTO was associated with decreased risk of recurrent VTE (HR 0.37 [95% CI 0.24-0.55]; P<0.0001) and major bleeding events (0.54 [0.37-0.82]; P=0.0031).
• For the secondary safety outcome, the incidence of minor bleeding was 20 per 100 PYs in the apixaban group and 34 per 100 PYs in the XARELTO group.
  • The use of apixaban was associated with lower risk of minor bleeding events than use of XARELTO (HR 0.57 [95% CI 0.48-0.67]; P<0.0001).

Bott-Kitslaar et al (2019)⁸ conducted a prospective analysis to compare efficacy and safety of XARELTO vs apixaban for the treatment of acute VTE in consecutive patients enrolled in the Mayo Thrombophilia Clinic Registry between March 1, 2013 and January 30, 2018.

• Primary efficacy outcome: symptomatic, recurrent, adjudicated VTE; primary safety outcome: major bleeding.
• Secondary safety outcomes: clinically relevant nonmajor bleeding.
• Of the 1696 enrolled patients, 600 (38%) were treated with apixaban (n=302, 50%) or XARELTO (n=298, 50%) within the first 14 days of VTE diagnosis and completed ≥3 months of anticoagulant therapy or had an outcome event.
• Seven (2.3%) apixaban-treated patients and 6 (2.0%) XARELTO-treated patients experienced recurrent VTE (adjusted HR, 1.4; 95% CI, 0.5-3.8). There was no confirmed or possible fatal PE.
  • At 3 months of follow-up, the VTE recurrence rate for apixaban vs XARELTO was 1.0% vs 0.7% (P=0.66); at 6 months, the rate was 2.3% vs 1.3% (P=0.37), respectively.
• Major bleeding occurred in 11 (3.6%) apixaban-treated patients and in 9 (3.0%) XARELTO-treated patients (adjusted HR, 1.2; 95% CI, 0.5-3.2).
  • The 3-month major bleeding rate for apixaban- and XARELTO-treated patients was 2.0% in both groups (P=0.98).
• Clinically relevant nonmajor bleeding occurred in 7 (2.3%) apixaban-treated patients and in 20 (6.7%) XARELTO-treated patients (adjusted HR, 0.4; 95% CI, 0.2-0.9).
  • The 3-month clinically relevant nonmajor bleeding rate for apixaban- vs XARELTO-treated patients was 1.0% vs 3.7% (P=0.03).
• The rates of composite major bleeding or clinically relevant nonmajor bleeding were similar (adjusted HR, 0.6; 95% CI, 0.3-1.2).

Aryal et al (2019)⁹ conducted a systematic review of studies to further compare apixaban with XARELTO in patients with acute VTE from multiple studies done in real-world settings.

• Primary efficacy outcome: recurrence of VTE (composite of any recurrent DVT or PE).
• Primary safety outcomes: clinically relevant major bleeding was reported (composite of bleeding requiring intervention or transfusion, cardiac tamponade, or pericardial effusion requiring drainage, retroperitoneal bleeding, intracranial bleed, massive hemoptysis, hemithorax, bleeding requiring extra hospital stay).
• Secondary safety outcomes: minor bleeding.
• Out of 5 selected studies, a total of 45,468 patients were analyzed for the primary efficacy of recurrent VTE and the safety outcomes of major bleeding and minor bleeding events.
• In three studies with 24,401 patients, recurrent VTE of up to 6 months occurred in 56 of 4,897 patients (1.14%) in the apixaban group and 258 of 19,144 patients (1.35%) in the XARELTO group (rate ratio [RR], 0.89; 95% CI, 0.67-1.19; P=0.45; I²=0%)
• Clinically relevant major bleeding occurred in 85 of 11,559 patients (0.74%) in the apixaban group and 350 of 33,909 patients (1.03%) in the XARELTO group (RR, 0.73; 95% CI, 0.58-0.93; P=0.01; I²=0%).
• In a sensitivity analysis of three studies, clinically relevant nonmajor bleeding occurred in 169 of 3417 patients (4.95%) in the apixaban group and 1094 of 12,475 patients (8.77%) in the XARELTO group (RR, 0.59; 95% CI, 0.50-0.70; P=0.01; I²=0%).
• The composite outcomes of major and minor bleeding occurred in 190 of 3417 patients (5.56%) in the apixaban group and 1186 of 12,475 patients (9.51%) in the XARELTO group (RR, 0.60; 95% CI, 0.52-0.70; P=0.01; I²=0%).
• The composite outcomes of VTE and major bleeding occurred in 102 of 4897 patients (2.08%) in the apixaban group and 483 of 19,144 (2.52%) in the XARELTO group (RR, 0.79; 95% CI, 0.58-1.06; P=0.12; I²=38%).

Specific Populations

Tsai et al (2022)¹³ conducted a cohort study using the Chang Gung Research Database to compare the effectiveness and safety of DOACs (XARELTO, apixaban, dabigatran, or edoxaban) in Asian patients who were newly diagnosed and hospitalized with VTE between January 1, 2012, and December 31, 2019.

• The effectiveness and safety clinical outcomes include recurrent VTE and any major  bleeding event (ICH, major GI bleeding, other critical site bleedings, or a hemoglobin decrease of ≥2 g/dL over 24 hours). The primary outcomes were defined as the composite of effectiveness and safety (see Table: Effectiveness and Safety Clinical Outcomes)

DeCamillo et al (2020)¹⁰ conducted a multi-center retrospective case series of young adult patients at two large academic medical centers, to assess the safety of DOACs for VTE therapy between 2015-2016. Patients between the ages of 18-40 when DOAC was initiated were included in this study.

• The assessments included frequency and percentage of ischemic stroke, recurrent VTE, bleeding events (International Society on Thrombosis and Haemostasis [ISTH]) defined as major and clinically relevant nonmajor)
• Fifty-seven patients met the eligibility criteria.
• One (1.8%) patient had a recurrent DVT. The DVT occurred about 12 days after initiating XARELTO, and the patient had reported missing three doses. No patient experienced an ischemic stroke.
• Seven of the 57 patients (12.3%) experienced a bleeding event. Six of the seven patients were being treated with XARELTO. The seventh patient was treated with apixaban and experienced heavy menstrual bleeding that did not qualify as a major or clinically relevant nonmajor bleeding event.
• One (1.8%) bleeding event was categorized as major (patient had heavy menses and required transfusion). The bleeding occurred after 17 days of XARELTO 15 mg twice daily. XARELTO was discontinued in this patient due to the bleeding event and no other anticoagulation therapy was initiated. The other six patients experienced clinically relevant nonmajor bleeding events. Two were GI related while the other four experienced heavy menses.

Trujillo-Santos et al (2020)¹¹ conducted a prospective study using the Registry of patients with VTE (RIETE) database to compare the rates of the composite of VTE recurrences or major bleeding in fragile patients with VTE using XARELTO or apixaban for initial or long-term therapy. Between January 2013 to October 2019, 14,831 fragile patients with acute VTE were recruited, of which 999 patients received DOACs.

• Overall, 711 patients started XARELTO, and 288 patients started apixaban <48 hours after VTE diagnosis; of these patients, 882 were ≥75 years old, 370 had creatinine clearance ≤50 mL/min, and 92 weighed ≤50 kg. In the XARELTO and apixaban groups, 25% and 40% of patients received non-recommended doses, respectively.
• When analyzing patients receiving recommended doses (n=705), there were no differences between treatments in the rate of VTE recurrences (RR 0.99, 95% CI 0.20-4.92), major bleeding (RR, 1.16, 95% CI, 0.24-5.57), the composite outcome (RR, 1.08; 95% CI, 0.35-3.30), or all-cause death (RR, 0.99; 95% CI, 0.32-3.08).
• Multivariable analysis revealed that patients receiving XARELTO in the entire cohort had a non-significantly higher risk for the composite outcome than those receiving apixaban (HR, 1.72; 95% CI, 0.63-4.69). The adjusted HR when only considering patients that received recommended doses was 1.34 (95% CI, 0.35-5.06).

Wysokinski et al (2020)¹² compared VTE recurrence and bleeding in patients with extremes in body weights, <60 kg and >120 kg, to patients with body weight between 60 kg and 120 kg, treated with apixaban or XARELTO. Consecutive patients enrolled in the Mayo Clinic VTE Registry between March 1, 2013, to August 10, 2019, with acute VTE were prospectively followed.

• Among 2577 included patients: there were 2124 (82%) with a body weight between 60 to 120 kg (reference bodyweight; RBW), 223 (8.7%) with a body weight <60 kg (low bodyweight; LBW), and 230 (8.9%) with a body weight >120 kg (high bodyweight; HBW).
• The 3-month incidence of major bleeding among patients treated with apixaban or XARELTO was significantly higher (P=0.03) in patients with LBW (4.4%) compared to the RBW group (1.1%) and remained significant at 6 months (4.4% vs. 1.4%; P=0.05).
• The 3-month incidence of VTE recurrence among patients treated with apixaban or XARELTO was similar in the LBW and HBW groups compared to the RBW group.
• Among patients receiving XARELTO who had cancer, the HBW group had higher VTE recurrence compared to the RBW group (P=0.01).

Bleeding Events

Lutsey et al (2019)¹⁴ characterized the rate of major hospitalized bleeding events associated with the use of apixaban (n=6,786), XARELTO (n=30,982), and warfarin (n=46,217) in a retrospective, cohort study. VTE patient health claims data obtained from the MarketScan data warehouse from January 1^st, 2011, to December 31^st, 2016, were utilized.

• Of the 83,985 VTE patients, a total of 1944 hospitalized bleeding events occurred during the first 180 days after oral anticoagulation initiation. The cumulative incidence of hospitalized bleeding was lower among new users of apixaban (1.1%) when compared to new users of XARELTO (2.0%) or warfarin (2.7%).
• The rate of hospitalized bleeding was lower among apixaban users, as compared to XARELTO [HR 95% CI: 0.58 (0.41, 0.80)] or warfarin users [0.68 (0.50, 0.92)].
• Apixaban was associated with lower hospitalized bleeding risk than XARELTO in several sensitivity analyses.

Howe et al (2019)¹⁵ studied overall bleeding rates between apixaban (n=716) and XARELTO (n=452) using a retrospective chart review of Veterans between March 15, 2016 to March 15, 2017 from the Richard L. Roudebush VA Medical Center.

• The rates of bleeding for Veterans taking XARELTO or apixaban did not differ significantly (1.95% vs 1.05%, P>0.05). No differences were seen in Veterans receiving XARELTO or apixaban for long term VTE treatment (2.68% vs. 0.32%, P>0.05) when further stratified by indication.
• The analysis did not detect any statistically significant differences between apixaban and XARELTO in terms of overall, (ARR 0.90% per 100 patient-years, 95% CI, 0.58 to 2.38%, P>0.05) major, (ARR, 0.22% per 100 patient-years; 95% CI, 0.74 to 1.17%, P>0.05) or non-major clinically relevant (ARR, 0.35% per 100 patient-years, 95% CI, 0.57 to 1.27%, P>0.05) bleeding.
• Rates of bleeding in Veterans taking XARELTO or apixaban for long term VTE treatment (3.97% vs. 8.03%, P< 0.0001; 0.14% vs. 15.51%, P<0.0001) were significantly lower than those reported by the primary literature. GI bleeds were the most common type of clinically relevant bleed in this patient population for both XARELTO (58%) and apixaban (70%).

Healthcare Utilization

Lutsey et al (2020)¹⁶ evaluated whether in the first 6 months post-VTE diagnosis, healthcare utilization differed whether the patient was prescribed apixaban (n=7,673), XARELTO (n=10,414), or warfarin (n=5,777) for primary treatment of their VTE event. IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases between 2016 and 2017 were utilized.

• The mean number of hospitalization rates were 24% lower (IRR), 0.76; 95% CI, 0.69, 0.83) for patients prescribed XARELTO and 22% lower (IRR, 0.78; 95% CI, 0.71, 0.87) for patients prescribed apixaban, as compared to those prescribed warfarin (IRR, 1.00 (reference)).
• Healthcare utilization was similar between apixaban and XARELTO users. When comparing apixaban to XARELTO, there were no differences in the number of hospitalizations, days hospitalized, or emergency department visits.
• In a secondary analysis, the IRRs for hospitalized bleeding associated with XARELTO and apixaban were 0.79 (95% CI, 0.54, 1.15) and 0.57 (95% CI, 0.38, 0.87) as compared to warfarin, respectively. The IRR for hospitalized bleeding days was lower for both apixaban (0.73; 95% CI, 0.36, 1.49) and XARELTO (0.58; 95% CI, 0.30, 1.14), compared to warfarin.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 October 2024.