Ximelagatran Versus Warfarin: A Comparison of Bleeding Outcomes in Patients with Nonvalvular Atrial Fibrillation.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1765-1765
Author(s):  
James D. Douketis ◽  
Karin Arneklev ◽  
Samuel Goldhaber ◽  
John Spandorfer ◽  
Frank Halperin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Lower Risk ◽  
Case Fatality Rate ◽  
Time Course ◽  
Case Fatality ◽  
Annual Incidence ◽  
Bleeding Complications ◽  
Fatality Rate ◽  
Nonvalvular Atrial Fibrillation

Abstract Background: The conventional anticoagulant management of patients with nonvalvular atrial fibrillation (AF) involves warfarin, administered to achieve a target international normalized ratio (INR) of 2.0–3.0. Ximelagatran is a novel oral direct thrombin inhibitor that, unlike warfarin, has a predictable anticoagulant effect and does not require dose adjustments based on the INR. In the SPORTIF III and V trials, ximelagatran was as effective as warfarin in preventing stroke and other thromboembolic complications in patients with nonvalvular AF. However, these studies were not designed to determine if ximelagatran was associated with a lower risk of major bleeding. Furthermore, these studies did not compare the case-fatality rate, time course, and anatomic sites of bleeding in ximelagatran- and warfarin-treated patients. Methods: We undertook a pooled analysis of the SPORTIF III and V trials that involved 7329 patients with AF who received oral ximelagatran, 36 mg twice daily, or warfarin, administered to achieve a target INR of 2.0–3.0. Patients had nonvalvular AF and 1 or more risk factors for stroke: hypertension; age ≥75 yrs; previous stroke, transient ischemic attack or systemic embolism; left ventricular dysfunction; age ≥65 yrs and coronary artery disease; or age ≥65 yrs and diabetes. Major exclusion criteria were: mitral stenosis; previous heart valve surgery; transient AF; and increased risk for bleeding. Bleeding event rates were compared using Fisher’s exact test and the log-rank test and were expressed as the number of bleeds per year. The case-fatality rate of major bleeding was defined as the number of fatal bleeds divided by fatal plus nonfatal bleeds. Results: The annual incidence of major bleeding was 2.0% in ximelagatran-treated patients and 2.7% in warfarin-treated patients (P = 0.029). The annual incidence of any (major or minor) bleeding was 31.7% in ximelagatran-treated patients and 38.8% in warfarin-treated patients (P < 0.0001). If episodes of intracranial hemorrhage were excluded, the annual incidence of major bleeding was 1.9% in ximelagatran-treated patients and 2.4% in warfarin-treated patients (P = 0.054). The case-fatality rate of major bleeding was 8.2% in ximelagatran-treated and 8.1% in warfarin-treated patients (P = 0.98). The time course and anatomic sites of major bleeding were not significantly different in ximelagatran-treated and warfarin-treated patients. Most bleeds involved the gastrointestinal tract, urinary tract or soft tissues. Conclusion: In patients with nonvalvular AF who require long-term anticoagulation, treatment with oral ximelagatran, 36 mg twice daily, is associated with a lower risk of bleeding complications than warfarin.

scholarly journals Direct Oral Anticoagulants in Atrial Fibrillation Patients With Concomitant Hyperthyroidism

2020 ◽  
Vol 105 (9) ◽  
pp. 2893-2904
Author(s):  
Yi-Hsin Chan ◽  
Lung-Sheng Wu ◽  
Lai-Chu See ◽  
Jia-Rou Liu ◽  
Shang-Hung Chang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Lower Risk ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Study Groups ◽  
Research Database ◽  
Nonvalvular Atrial Fibrillation ◽  
Asian Patients

Abstract Objective Patients with hyperthyroidism were excluded from the randomized clinical trials of direct oral anticoagulants (DOACs) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Methods We performed a nationwide retrospective cohort study using data from the Taiwan National Health Insurance Research Database. We enrolled 3213 and 1181 NVAF patients with hyperthyroidism who were taking DOACs and warfarin, respectively, from June 1, 2012 to December 31, 2017. We also enrolled 53 591 and 16 564 NVAF patients without hyperthyroidism, taking DOACs and warfarin, respectively. We used propensity score stabilized weights (PSSWs) to balance covariates across the study groups. We also used 1:4 matching on both taking DOACs, with (n = 3213) and without hyperthyroidism (n = 12 852); and both taking warfarin, with (n = 1181) and without hyperthyroidism (n = 4724). Results After PSSW, DOAC had a comparable risk of ischemic stroke/systemic embolism (IS/SE) and a lower risk of major bleeding (hazard ratio [HR] 0.65; 95% confidential interval [CI], 0.44–0.96; P = 0.0295) than warfarin among patients with hyperthyroidism. There were comparable risks of IS/SE and major bleeding between those patients with and without hyperthyroidism. However, among patients taking warfarin, those with hyperthyroidism had a lower risk of IS/SE than those without hyperthyroidism (HR 0.61; 95% CI, 0.43–0.86; P = 0.0050). Conclusion Among NVAF Asian patients with concomitant hyperthyroidism, DOACs may be an effective and safer alternative to warfarin. Thromboprophylaxis with DOACs may be considered for such patients, and it is important to validate this finding in further prospective study.

Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants

2015 ◽  
Vol 114 (11) ◽  
pp. 1076-1084 ◽  
Author(s):  
Franziska Michalski ◽  
Luise Tittl ◽  
Sebastian Werth ◽  
Ulrike Hänsel ◽  
Sven Pannach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Case Fatality ◽  
Bleeding Risk ◽  
Vitamin K Antagonist ◽  
Bleeding Complications ◽  
Treatment Rate

SummaryAtrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such “stable” VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71% and increased to 75% during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95% CI 2.60–6.29) with a case-fatality rate of 16.3% (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

scholarly journals Implementation of MenACWY vaccination because of ongoing increase in serogroup W invasive meningococcal disease, the Netherlands, 2018

2018 ◽  
Vol 23 (16) ◽  
Author(s):  
Mirjam J Knol ◽  
Wilhelmina LM Ruijs ◽  
Laura Antonise-Kamp ◽  
Hester E de Melker ◽  
Arie van der Ende
Keyword(s):  
The Netherlands ◽  
Incidence Rate ◽  
Meningococcal Disease ◽  
Case Fatality Rate ◽  
Clonal Complex ◽  
Case Fatality ◽  
Annual Incidence ◽  
Invasive Meningococcal Disease ◽  
Fatality Rate ◽  
Annual Incidence Rate

The annual incidence rate of serogroup W invasive meningococcal disease in the Netherlands increased from < 0.05/100,000 (n < 10) before 2015 to 0.5/100,000 (n = 80) in 2017. Most isolates (94%) belong to clonal complex 11. The incidence rate is highest among  < 5 year-olds and 15–24 year-olds. The case fatality rate was 12% (17/138) in 2015–2017. From May 2018, MenACWY vaccination replaces MenC vaccination at age 14 months and from October 2018, 13–14 year-olds are offered MenACWY vaccination.

Case Fatality Rates of Recurrent Venous Thromboembolism during and Following Anticoagulation Therapy

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3032-3032
Author(s):  
Marc Carrier ◽  
Gregoire Le Gal ◽  
Philip Wells ◽  
Marc Rodger
Keyword(s):  
Major Bleeding ◽  
Case Fatality Rate ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Case Fatality ◽  
Fatality Rate ◽  
Weighted Estimates ◽  
Vein Thrombosis ◽  
Anticoagulation Treatment ◽  
Recurrent Vte

Abstract Background: The optimal duration of anticoagulation treatment in patients with unprovoked VTE is unknown. In order to counsel VTE patients on the risks and benefits of discontinuing anticoagulants, clinicians need to balance the long-term risk of recurrent VTE with major bleeding on anticoagulants. For all VTE patients on oral anticoagulant, the case-fatality rate of major bleeding was previously reported to be 13.4% (95% confidence intervals (CI): 9.4% to 17.4%). A major knowledge gap exists regarding the case-fatality rate of recurrent pulmonary embolism (PE) during and following anticoagulation therapy for VTE. Purpose: To summarize the case fatality rate of recurrent VTE during and following anticoagulation therapy. Data Source: A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Study Outcome: We selected 62 studies that reported the rates of fatal PE in patients with recurrent VTE. Fatal PE was defined as confirmed autopsy report; death preceding with confirmed deep vein thrombosis (DVT) or non-fatal PE; sudden death not explained by a condition other than PE. Measurements: Pooled case fatality rates were generated. Ninety-five percent CI were calculated for each case fatality rate using averaged, inverse variance-weighted estimates from each study. Data Synthesis: 30,885 VTE patients were included (17,650 DVT, 8801 PE and 4434 DVT or PE Limitations: Unable to determine the case fatality rate by etiology of VTE (i.e. provoked, unprovoked). Conclusion: Case fatality rates for recurrent VTE are elevated during and following anticoagulation treatment for VTE but appear lower than the case-fatality rate for major bleeding with oral anticoagulants. This information must be considered by clinicians when counseling patients on whether to continue or discontinue anticoagulant therapy following VTE. Not only must absolute recurrent VTE and major bleeding rates be compared between groups that continue and discontinue anticoagulants but the relative consequences (i.e. case fatality rates) must be also considered with more weight placed on major bleeding episodes. Initial event During anticoagulation Treatment (%, 95% CI) Following anticoagulation Treatment (%, 95% CI) DVT 10.6 (8.3–13.0) 7.3 (5.0–9.7) PE 12.3 (5.9–18.7) 12.5 (6.4–28.7) Any event 10.2 (7.9–12.5) 9.0 (7.3–10.8)

National trends in hospital admission, case fatality, and sex differences in atrial fibrillation-related strokes

2019 ◽  
Vol 15 (5) ◽  
pp. 521-527
Author(s):  
Gordon AE Jewett ◽  
M Patrice Lindsay ◽  
Cristina Goia ◽  
Brandon Zagorski ◽  
Noreen Kamal ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Sex Differences ◽  
Ischemic Stroke ◽  
Case Fatality Rate ◽  
Hospital Admissions ◽  
Temporal Trends ◽  
Case Fatality ◽  
Fatality Rate ◽  
Younger Women ◽  
Increased Risk

Background and aim Atrial fibrillation is associated with increased risk of ischemic stroke and its global prevalence is increasing. We aimed to describe the contemporary temporal trends in hospital admissions, case fatality rate, as well as sex differences in atrial fibrillation-related stroke in Canada. Methods We conducted a retrospective cohort study using Canadian national administrative data to identify admissions to hospital for stroke with comorbid atrial fibrillation between 1 April 2007 and 31 March 2016. We determined temporal trends in the crude and the age- and sex-standardized admission and case fatality rates. We also evaluated for any sex differences in these outcomes. Results There were 222,100 admissions to hospital for ischemic (n = 182,990) or hemorrhagic (n = 39,110) stroke. Comorbid atrial fibrillation was present in 20.2% of admissions for ischemic strokes and 10.1% for hemorrhagic strokes. Over the study period, the age–sex adjusted proportion of admissions with atrial fibrillation increased from 16.3% to 20.5% (p = 0.02) for ischemic stroke and was stable for hemorrhagic stroke. In-hospital case fatality rate decreased for ischemic stroke with and without comorbid atrial fibrillation. Women aged 65 years and older with ischemic stroke were more likely to have comorbid atrial fibrillation compared to men, while this association was reversed in younger women. There were no sex differences in the case fatality rate for people with atrial fibrillation-related ischemic stroke. Conclusion Atrial fibrillation is present in an increasing proportion of people hospitalized in Canada with ischemic stroke and disproportionately affects older women. Renewed focus is needed on atrial fibrillation-related stroke prevention with particular attention to sex disparities.

Dynamics of case-fatalilty rates of recurrent thromboembolism and major bleeding in patients treated for venous thromboembolism

2013 ◽  
Vol 110 (10) ◽  
pp. 834-843 ◽  
Author(s):  
Ana Alfonso ◽  
David Jiménez ◽  
Carmen Fernández Capitán ◽  
Paolo Prandoni ◽  
Philip S. Wells ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Case Fatality Rate ◽  
Real Life ◽  
Case Fatality ◽  
Fatality Rate ◽  
Duration Of Therapy ◽  
Fatal Bleeding ◽  
Recurrent Vte ◽  
Over Time

SummaryIn patients with venous thromboembolism (VTE), assessment of the risk of fatal recurrent VTE and fatal bleeding during anticoagulation may help to guide intensity and duration of therapy. We aimed to provide estimates of the case-fatality rate (CFR) of recurrent VTE and major bleeding during anticoagulation in a ‘real life’ population, and to assess these outcomes according to the initial presentation of VTE and its etiology. The study included 41,826 patients with confirmed VTE from the RIETE registry who received different durations of anticoagulation (mean 7.8 ± 0.6 months). During 27,110 patient-years, the CFR was 12.1% (95% CI, 10.2–14.2) for recurrent VTE, and 19.7% (95% CI, 17.4–22.1) for major bleeding. During the first three months of anticoagulant therapy, the CFR of recurrent VTE was 16.1% (95% CI, 13.6–18.9), compared to 2.0% (95% CI, 0–4.2) beyond this period. The CFR of bleeding was 20.2% (95% CI, 17.5–23.1) during the first three months, compared to 18.2% (95% CI, 14.0–23.2) beyond this period. The CFR of recurrent VTE was higher in patients initially presenting with PE (18.5%; 95% CI, 15.3–22.1) than in those with DVT (6.3%; 95% CI, 4.5–8.6), and in patients with provoked VTE (16.3%; 95% CI, 13.6–19.4) than in those with unprovoked VTE (5.5%; 95% CI, 3.5–8.0). In conclusion, the CFR of recurrent VTE decreased over time during anticoagulation, while the CFR of major bleeding remained stable. The CFR of recurrent VTE was higher in patients initially presenting with PE and in those with provoked VTE.

A Meta-Analysis of Case Fatality Rates of Recurrent Venous Thromboembolism and Major Bleeding in Patients with Cancer

2020 ◽  
Vol 120 (04) ◽  
pp. 702-713 ◽  
Author(s):  
Alym Abdulla ◽  
Wendy M. Davis ◽  
Namali Ratnaweera ◽  
Elena Szefer ◽  
Brooke Ballantyne Scott ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Case Fatality Rate ◽  
Meta Analysis ◽  
Case Fatality ◽  
Fatality Rate ◽  
Patients With Cancer ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte

Abstract Background Knowing the case fatality rates of recurrent venous thromboembolism (VTE) and major bleeding is important for weighing the relative risks and benefits of anticoagulation and deciding on the duration of anticoagulant therapy, but these rates are uncertain in patients with cancer-associated thrombosis. Methods We performed a systematic review and a meta-analysis to determine the incidence of recurrent VTE and major bleeding and their respective case fatality rates in patients with cancer-associated VTE. Results Our analysis included 29 studies (15 prospective cohort studies and 14 randomized controlled trials) from 1980 to January 2019. Data from 8,000 cancer patients with 4,786 patient-years of follow-up were summarized. Rates of recurrent VTE and fatal recurrent VTE were 23.7 (95% confidence interval [CI]: 20.1–27.8) and 1.9 (95% CI: 0.8–4.0) per 100 patient-years of follow-up, respectively, with a case fatality rate of 14.8% (95% CI: 6.6–30.1%). The rates of major bleeding and fatal major bleeding events were 13.1 (95% CI: 10.3–16.7) and 0.8 (95% CI: 0.3–2.1) per 100 patient-years of follow-up, respectively, with a case fatality rate of 8.9% (95% CI: 3.5–21.1%). While the estimates of case fatality vary by anticoagulation regimen and study design, the differences between them were not statistically significant. Conclusion In cancer patients receiving anticoagulation, the case fatality rate of recurrent VTE is higher than the case fatality rate of major bleeding. These findings may help to inform decisions regarding the management of anticoagulation in patients with active cancer and VTE.

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