Thromboembolic and Major Bleeding Events With Rivaroxaban Versus Warfarin Use in a Real-World Setting

2017 ◽  
Vol 52 (1) ◽  
pp. 19-25 ◽  
Author(s):  
Giavanna Russo-Alvarez ◽  
Kathryn A. Martinez ◽  
Megan Valente ◽  
James Bena ◽  
Bo Hu ◽  
...  
Keyword(s):  
Health System ◽  
Major Bleeding ◽  
Real World ◽  
Relative Effectiveness ◽  
Cleveland Clinic ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Significant Difference ◽  
The Mean ◽  
Major Bleeding Events

Background: Although randomized trials demonstrate the noninferiority of rivaroxaban compared with warfarin in the context of nonvalvular atrial fibrillation (AF), little is known about how these drugs compare in practice. Objective: To assess the relative effectiveness and safety of rivaroxaban versus warfarin in a large health system and to evaluate this association by time in therapeutic range (TTR). Methods: We conducted a retrospective cohort study with propensity matching in the Cleveland Clinic Health System. The study included patients initiated on warfarin or rivaroxaban for thromboembolic prevention in nonvalvular AF between January 2012 and July 2016. The main outcomes were thromboembolic events and major bleeds. Analyses were stratified by warfarin patients’ TTR. Results: The cohort consisted of 472 propensity-matched pairs. The mean age was 73.6 years (SD = 11.7), and the mean CHADS2 score was 1.8. The median TTR for warfarin patients was 64%. In the propensity-matched analysis, there was no significant difference in thromboembolic or major bleeding events between groups. Among warfarin patients with a TTR <64% and their matched rivaroxaban pairs, there was also no significant difference in thromboembolic or major bleeding events. Conclusions: Under real-world conditions, warfarin and rivaroxaban were associated with similar safety and effectiveness, even among those with suboptimal therapeutic control. Individualized decision making, taking into account the nontherapeutic tradeoffs associated with these medications (eg, monitoring, half-life, cost) is warranted.

scholarly journals A Systematic Review of Network Meta-Analyses and Real-World Evidence Comparing Apixaban and Rivaroxaban in Nonvalvular Atrial Fibrillation

2020 ◽  
Vol 26 ◽  
pp. 107602961989876 ◽  
Author(s):  
Nathan R. Hill ◽  
Belinda Sandler ◽  
Evelien Bergrath ◽  
Dušan Milenković ◽  
Ajibade O. Ashaye ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Health Care Expenditure ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Real World Evidence ◽  
Evidence Review ◽  
Major Bleeding Events ◽  
Meta Analyses

There is no direct evidence comparing the 2 most commonly prescribed direct oral anticoagulants, apixaban and rivaroxaban, used for stroke prevention in nonvalvular atrial fibrillation (NVAF). A number of network meta-analyses (NMAs) of randomized control trials and real-world evidence (RWE) studies comparing the efficacy, effectiveness, and safety of apixaban and rivaroxaban have been published; however, a comprehensive evidence review across the available body of evidence is lacking. In this study, we aimed to systematically review and evaluate the clinical outcomes of apixaban and rivaroxaban using a combination of data gleaned from both NMAs and RWE studies. The review identified 21 NMAs and 5 RWE studies. The data demonstrated that apixaban was associated with fewer major bleeding events compared to rivaroxaban. There was no difference in the efficacy/effectiveness profiles between these treatments. Bleeding is a serious complication of anticoagulation therapy for the management of NVAF, and is associated with increased rates of hospitalization, morbidity, mortality, and health-care expenditure. The majority of studies in this comprehensive evidence review suggests that apixaban has a lower risk of major bleeding events compared to rivaroxaban in patients with NVAF.

scholarly journals Anticoagulation and bleeding events in Patients with Post- Operative Atrial Fibrillation After Cardiac Surgery

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
Z Alam ◽  
R Porudominsky ◽  
S Lo Presti ◽  
V Li ◽  
C Rodriguez-Correa ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Major Bleeding ◽  
Hospital Length Of Stay ◽  
Bleeding Events ◽  
Dose Heparin ◽  
Post Operative Atrial Fibrillation ◽  
History Of ◽  
The Mean ◽  
Major Bleeding Events

Abstract Background Post-operative atrial fibrillation (POPAF) following cardiac surgery is a common arrhythmia associated with an increased morbidity and mortality. There is little data evaluating the safety and effectiveness of anticoagulation (AC) in POPAF patients. We investigated the occurrence of 30-days POP major bleeding or embolic events and their timing in relation to the index cardiac surgery, the initiation of the arrhythmia and of anticoagulation in patients who developed new onset POPAF. Methods 4,073 consecutive patients undergoing cardiac surgery from September 2010- December 2016 were evaluated. Patients with history of AF/Aflutter were excluded. POPAF was confirmed by ECG or telemetry. Major post-operative bleeding that occurred after AF was defined using PLATO criteria or the BARC scale (any ≥3). Results 3,230 patients were included (37% CABG, 69% valve surgery). The incidence of POAF was 24%. The median time (IQR) of POPAF was 3 (2) days after the index surgery. 64% of POAF patients were male and 14% had a history of stroke. The mean (SD) age was 72 (9) years old. The average (SD) CHA2DS2-VASc score was 3.9 (1.5). The initial postoperative AC was full dose heparin, lovenox or argatroban in 58% of patients. The rest of patients had low dose heparin/lovenox for DVT prophylaxis and/or were started on oral anticoagulation without a bridge. The median (IR) time of POPAF to anticoagulation was 1 (2) days. There were 15 (1.9%) major bleeding events; 88% of which occurred in patients receiving full anticoagulation. Major bleeding events occurred a median of 15 (9) days after the index surgery and 9 (6) days after anticoagulation. Independent predictors of major bleed were history of PAD (P&lt;0.01) and pre-operative use of b-blockers (P=0.04). There were 11 (1.4%) POP strokes which occurred a median of 5 (16) days after the index surgery, and 2 (13) days after POPAF. 63% of strokes happened in patients that received anticoagulation. The mean CHA2DS2-VASc score were 3.9 (1.5) and 4.7 (1.7), P=0.1 for patients without and with strokes, respectively. Stroke history (P&lt;0.01) was the only independent stroke predictor. Both strokes and bleeding events were associated with significantly longer ICU and hospital length of stay. 86% of POPAF patients received amiodarone during hospitalization and 2.1% electric cardioversion. Upon discharge, 2.3% of patients were in in atrial fibrillation and 0.8% in atrial flutter. Conclusion The post-operative course of major bleeds and stroke in patients with POPAF after cardiac surgery is different. Bleeding events are delayed and appear related to anticoagulation. The relative benefit of perioperative anticoagulation remains unclear. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Rivaroxaban for cancer-associated venous thromboembolism

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110121
Author(s):  
Bo Liang ◽  
Yi Liang ◽  
Li-Zhi Zhao ◽  
Yu-Xiu Zhao ◽  
Ning Gu
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure ◽  
Bleeding Events ◽  
Significant Difference ◽  
Major Bleeding Events

All cancers can increase the risk of developing venous thromboembolism (VTE), and anticoagulants should be considered as an optimal treatment for patients suffering from cancer-associated VTE. However, there is still a debate about whether the new oral anticoagulant, rivaroxaban, can bring better efficacy and safety outcomes globally. Thus, this systematic review and meta-analysis was conducted to evaluate the efficacy and safety of rivaroxaban. We searched PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and China National Knowledge Infrastructure for relevant published papers before 1 September 2019, with no language restrictions. The primary outcomes are defined as the recurrence of VTE. The secondary outcomes are defined as clinically relevant non-major bleeding, adverse major bleeding events, and all-cause of death. The data were analyzed by Stata with risk ratio (RR) and 95% confidence interval (CI). Four trials encompassing 1996 patients were included. Rivaroxaban reduced recurrent VTE with no significant difference (RR = 0.68, 95% CI = 0.43–1.07). Similarly, there were no significant differences in adverse major bleeding events (RR = 0.86, 95% CI = 0.37–2.00), clinically relevant non-major bleeding (RR = 1.24, 95% CI = 0.73–2.12) and all-cause mortality (RR = 0.76, 95% CI = 0.40–1.44). In a selected study population of cancer patients with VTE, rivaroxaban is as good as other anticoagulants. Further, carefully designed randomized controlled trials should be performed to confirm these results.

Abstract 2: Comparative Effectiveness and Safety of Anticoagulant Therapy With Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients With Nonvalvular Atrial Fibrillation

2016 ◽  
Vol 9 (suppl_2) ◽  
Author(s):  
Gboyega Adeboyeje ◽  
Gosia Sylwestrzak ◽  
Jeff White ◽  
Alan Rosenberg ◽  
Jacob Abarca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Thromboembolic Event ◽  
Relative Effectiveness ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
The United States ◽  
Baseline Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Significant Difference

Background: The efficacy and safety of novel oral anticoagulants (NOACs) as alternatives to warfarin therapy in nonvalvular atrial fibrillation (NVAF) patients have been studied in randomized trials. Given the increasing use of NOACs, additional data is required to assess the relative effectiveness and safety of anticoagulation with warfarin, dabigatran, apixaban, or rivaroxaban therapy in real-world settings in the United States (U.S). Methods: A retrospective cohort study design was used to analyze data from a U.S. commercial claims database of > 38 million members. Study population included new users of warfarin, dabigatran, apixaban, or rivaroxaban aged ≥ 18 years with ≥ 2 diagnoses of NVAF from November 2010 to February 2015. The primary effectiveness outcome was a composite of thromboembolic event or stroke; the primary safety outcome was major bleeding event requiring hospitalization. Cox proportional hazards models with inverse probability of treatment weighting (IPTW) were used to compare event rates between NOAC and warfarin users, and among NOAC users. Results: In the final NVAF cohort studied, there were 23,431 warfarin, 8,539 dabigatran, 3,689 apixaban, and 8,398 rivaroxaban users. A total of 7,022 primary outcome events and 3,264 safety events were identified. Warfarin users were older than dabigatran, apixaban, or rivaroxaban users (mean: 73 vs 66 vs 69 vs 67 years). After IPTW, all treatment groups were balanced on all baseline risk factors including stroke and bleeding risk. Compared to warfarin, NOAC users had fewer thromboembolic events or strokes: dabigatran (hazard ratio HR, 0.77 [95% CI: 0.72 - 0.82]), apixaban (HR, 0.73 [CI: 0.65 - 0.82]), and rivaroxaban (HR, 0.80 [CI: 0.75 - 0.86]). Additionally, dabigatran ([HR], 0.67 [CI: 0.60 - 0.76]), and apixaban users (HR, 0.52 [CI: 0.41 - 0.67) experienced fewer major bleeding events compared to warfarin users. No significant difference was found in major bleeding risk between rivaroxaban (HR, 1.00 [CI: 0.89 - 1.12]) and warfarin users. All three NOAC groups had similar risks for thromboembolic event or stroke: dabigatran vs rivaroxaban (HR, 0.96 [CI: 0.88 - 1.05]); apixaban vs rivaroxaban (HR, 0.91 [CI: 0.80 - 1.04]); dabigatran vs apixaban (HR, 1.05 [CI: 0.93 - 1.19]). However, compared to rivaroxaban users, major bleeding risk was 33% and 48% lower in dabigatran and apixaban users respectively (HR, 0.67[CI: 0.58 - 0.78]) and HR, 0.52 [CI: 0.40 - 0.68]). Conclusions: Our results demonstrated a lower risk of a thromboembolic event or stroke among dabigatran, apixaban, or rivaroxaban users compared to warfarin users. Among NOACs, risks of a thromboembolic event or stroke were similar. Further studies are needed to clarify the finding of a higher major bleeding risk in warfarin and rivaroxaban users.

scholarly journals Management of Major Bleeding Events in Patients Treated With Dabigatran for Nonvalvular Atrial Fibrillation: A Retrospective, Multicenter Review

2017 ◽  
Vol 69 (5) ◽  
pp. 531-540 ◽  
Author(s):  
Truman J. Milling ◽  
Christian Fromm ◽  
Michael Ganetsky ◽  
Daniel J. Pallin ◽  
Julie Cong ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Major Bleeding Events

scholarly journals Differences in Major Bleeding Events Between Patients With Severe Hemophilia A and Hemophilia B: A Nationwide, Population-Based Cohort Study

2019 ◽  
Vol 25 ◽  
pp. 107602961988802
Author(s):  
Ming-Yang Shih ◽  
Jiaan-Der Wang ◽  
Jia-De Yin ◽  
Yu-Tse Tsan ◽  
Wei-Cheng Chan
Keyword(s):  
Cohort Study ◽  
Incidence Rate ◽  
Major Bleeding ◽  
Hemophilia A ◽  
Population Based ◽  
Hemophilia B ◽  
Bleeding Events ◽  
On Demand ◽  
Significant Difference ◽  
Major Bleeding Events

There has been an ongoing debate as to whether hemophilia A (HA) is more severe than hemophilia B (HB), and there are studies supporting each side of the argument. The study aimed to investigate whether any differences in major bleeding events exist between patients with severe HA and HB. A nationwide, population-based retrospective cohort study using the National Health Insurance Research Database was conducted. We compared 658 patients with severe HA and 137 patients with severe HB without inhibitors from 1997 to 2013, during the period when adult patients older than 18 years old were treated with the on-demand therapy since birth. There was no significant difference between patients with severe HA and HB in the rate of major bleeding events, with an adjusted relative ratio of 0.79 (95% confidence interval [CI]: 0.36-1.71, P = .548). There was also no significant difference in the incidence rate of major bleeding events between adult patients with HA and HB with the on-demand therapy, and an adjusted hazard ratio (HR) of 0.82 (95% CI: 0.65-1.02). However, patients with HA had a lower incidence rate of intracranial hemorrhage, with an adjusted HR of 0.44 (95% CI: 0.25-0.79). In addition, no significant difference in the frequency of major bleeding events requiring hospitalization between patients with HA and HB was found, P > .05. In conclusion, the study demonstrated that patients with severe HB encountered a similar rate of major bleeding events to those with severe HA.

Comparative effectiveness and safety of apixaban versus warfarin in patients with venous thromboembolism

2020 ◽  
Vol 77 (3) ◽  
pp. 188-195 ◽  
Author(s):  
Ghadeer K Dawwas ◽  
Steven M Smith ◽  
Eric Dietrich ◽  
Wei-Hsuan Lo-Ciganic ◽  
Haesuk Park
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Real World ◽  
Treatment Effect ◽  
Randomized Clinical Trials ◽  
Cohort Analysis ◽  
Bleeding Events ◽  
Heterogeneity Of Treatment Effect ◽  
Recurrent Vte ◽  
Major Bleeding Events

Abstract Purpose Compared with conventional therapy (enoxaparin followed by warfarin), the direct-acting oral anticoagulant apixaban is thought to offer similar protection against recurrent venous thromboembolism (VTE) with lower bleeding risk. However, evidence regarding the heterogeneity of treatment effect from real-world data is lacking. The study described here aimed to compare the effectiveness and safety of use of apixaban versus warfarin in patients with VTE. Methods We conducted a retrospective cohort analysis of commercial and Medicare supplemental databases (data coverage period, 2014-2017) among patients with a diagnosis of VTE who were new users of apixaban or warfarin. We controlled for confounding using propensity score [PS] 1:4 matching. Cox proportional hazard models were used to obtain hazard ratios (HRs) and 95% confidence intervals (CIs). Heterogeneity of treatment effect was assessed among patients with provoked VTE versus unprovoked VTE. Results After PS matching, a total of 36,907 patients were included in the cohort (n = 8,094 apixaban users and n = 28,813 warfarin users). In Cox regression models, the use of apixaban versus warfarin was associated with lower risks of recurrent VTE (HR, 0.54; 95% CI, 0.45-0.65) and major bleeding events (HR, 0.67; 95% CI, 0.54-0.84); these results remained consistent in patients with provoked VTE and those with unprovoked VTE. Conclusion This population-based analysis of patients with VTE extends results of randomized clinical trials indicating lower risks of development of recurrent VTE and major bleeding events with use of apixaban versus warfarin in real-world settings. The observed benefits of apixaban extended to selected subgroups of the VTE population, including patients with provoked VTE.

scholarly journals Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial

2021 ◽  
Author(s):  
Behnood Bikdeli ◽  
Azita H Talasaz ◽  
Farid Rashidi ◽  
Hooman Bakhshandeh ◽  
Farnaz Rafiee ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Major Bleeding ◽  
Arterial Thrombosis ◽  
Dose Group ◽  
Standard Dose ◽  
Controlled Trial ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Prophylactic Anticoagulation ◽  
Intermediate Dose

Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

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