Comparative Efficacy and Safety Of Dabigatran Etexilate and Rivaroxaban For The Treatment Of Deep Vein Thrombosis and Pulmonary Embolism

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4807-4807
Author(s):  
Andreas Clemens ◽  
Shaun Abeysinghe ◽  
Ann-Katrin Gonschior ◽  
Volker Hösel ◽  
Sarah Lock ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Lower Risk ◽  
Dabigatran Etexilate ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Meta Analyses ◽  
Deep Vein

Objective Two novel oral anticoagulants recently have been investigated for the treatment of deep vein thrombosis and/or pulmonary embolism: dabigatran etexilate (dabigatran) and rivaroxaban. The aim of this analysis was to compare their efficacy and safety. Methods Randomized, controlled trials investigating dabigatran or rivaroxaban were identified by a systematic review. Direct meta-analyses and anchored (adjusted) indirect comparisons (AICs) were performed using aggregated results for the following endpoints for the overall treatment duration: first recurrent symptomatic venous thromboembolism (VTE) or VTE-related death, major bleeding events (MBEs), MBEs or clinically relevant bleeding events (CRBEs), and all-cause mortality. Results Four trials were identified; two compared dabigatran with warfarin and two compared rivaroxaban with vitamin K antagonists. The results of the trials, and the direct meta-analyses of the two dabigatran trials and the two rivaroxaban trials, are presented in Table 1. Overall, there was little evidence of heterogeneity in treatment effects among the RE-COVER trials (VTE or VTE-related death, MBEs, MBEs or CRBEs, all-cause mortality: P= 0.82, 0.67, 0.97, 0.97, respectively; I2= 0%). There was some evidence of heterogeneity among the EINSTEIN trials for VTE or VTE-related death (P=0.11; I2=61.9%) and all-cause mortality (P=0.16; I2=50%), but none for MBEs and MBEs/CRBEs with I2= 0% (P= 0.43, 0.47). In the AICs, sensitivity analyses were performed to explore potential trial heterogeneity arising from differences in the type of index VTE and time with an international normalized ratio between 2.0 and 3.0. AIC results suggested that dabigatran was associated with a lower risk of MBEs/CRBEs than rivaroxaban (upper 95% confidence limits for relative risks were less than 1.00). There was no evidence to suggest a difference between dabigatran and rivaroxaban with respect to prevention of recurrent symptomatic VTE or VTE-related death, MBEs, or all-cause mortality. Conclusions Dabigatran may be associated with a lower risk of major or clinically relevant bleeding; there was no evidence to suggest a difference among drugs in prevention of recurrent VTE, MBEs, or overall mortality. Disclosures: Clemens: Boehringer Ingelheim Pharma GmbH & Co. KG: Employment. Off Label Use: Dabigatran etexilate, direct oral thrombin inhibitor, anticoagulant effect; indications for stroke prevention in atrial fibrillation patients in about 90 countries including US; indication for primary VTE prevention in total hip or knee replacement patients in about 100 countries excluding US. Abeysinghe:Boehringer Ingelheim International GmbH: Consultancy. Gonschior:Boehringer Ingelheim GmbH: Employment. Hösel:Boehringer Ingelheim GmbH: Consultancy. Lock:Boehringer Ingelheim International GmbH: Consultancy. Wolowacz:Boehringer Ingelheim International GmbH: Consultancy. Woods:Boehringer Ingelheim International GmbH: Consultancy. Zimovetz:Boehringer Ingelheim International GmbH: Consultancy.

Tinzaparin in Outpatients with Pulmonary Embolism or Deep Vein Thrombosis

2005 ◽  
Vol 39 (7-8) ◽  
pp. 1182-1187 ◽  
Author(s):  
William E Dager ◽  
Jeff H King ◽  
Jennifer M Branch ◽  
Stacey L Chow ◽  
Ruby E Ferrer ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Warfarin Therapy ◽  
Outpatient Setting ◽  
Minor Bleeding ◽  
Low Molecular Weight Heparins ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
The University ◽  
Deep Vein

BACKGROUND The low-molecular-weight heparins (LMWHs) have been shown to be effective in the outpatient treatment of deep vein thrombosis (DVT). Data regarding outpatient use of any LMWH in pulmonary embolism (PE) or tinzaparin in DVT while transitioning therapy to a vitamin K antagonist are limited. OBJECTIVE To determine the safety and efficacy of tinzaparin in patients with either DVT or PE being transitioned to warfarin during LMWH therapy in the outpatient setting. METHODS All patients who were treated with at least one outpatient dose of tinzaparin for venous thromboembolism (VTE) were identified. Charts of all patients followed within the University of California Davis healthcare system were reviewed. The incidence of bleeding and recurrent thromboembolism over a minimum of the first 4 weeks to a maximum of 12 weeks after initiating anticoagulation was assessed. RESULTS A total of 178 patients with acute VTE were treated with tinzaparin, and outcomes could be determined in 140 cases. Forty-seven percent of these patients had objectively documented PE. Only one (0.7%) case of recurrent VTE was observed. Major bleeding was documented in 5 (3.6%) and minor bleeding in 8 (5.8%) patients. Two bleeding events, both major, occurred during tinzaparin therapy. CONCLUSIONS Outpatient use of tinzaparin during transition to warfarin therapy in the treatment of VTE, including PE, appears to be feasible in patients who are judged candidates for home therapy.

Real Life Efficacy and Safety of Rivaroxaban for Acute VTE Treatment – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1159-1159
Author(s):  
Vera Gelbricht ◽  
Christina Koehler ◽  
Sebastian Werth ◽  
Ulrike Haensel ◽  
Thomas Schreier ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Vascular Event ◽  
Acute Limb Ischemia ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
Daily Care ◽  
Short Period ◽  
Deep Vein

Abstract Abstract 1159 Background: In the EINSTEIN study rivaroxaban (RX) has been found to be at least as effective and safe as warfarin in treatment of acute deep vein thrombosis (DVT), which lead to approval of RX in many countries. However, patients in RCT‘s present a selected population treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives: To evaluate the efficacy, safety and management issues of rivaroxaban anticoagulation in acute VTE in daily care. Patients and methods: A network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July 31th 2012, 938 patients were registered. Of these, 105 patients received RX for acute VTE treatment (demographic data in table 1). In our registry, the population receiving acute VTE treatment is older than the EINSTEIN population (62.2 vs. 55.8 years). Most patients are treated for major VTE (proximal deep vein thrombosis (DVT) pulmonary embolism (PE)), but about 20% are treated for isolated distal DVT. The results of 1-, 3- and 6-months FU are shown in table 2. Until now, no recurrent VTE or VTE-related death occurred. Two patients (1.9%) experienced a major vascular event (acute limb ischemia) at the beginning of NOAC therapy and one patient experienced a minor vascular event (tachyarrhythmia). Bleeding events were frequent (22.3%) but only five patients (4.8%) experienced major bleeding events, one of which was a fatal intracranial bleeding. Three patients (2.9%) died during FU (1 intracranial bleed, 2 of underlying diseases). At 6 month, only eight patients (7.8%) were switched to other anticoagulants and one patient (1.0%) had an unscheduled discontinuation of anticoagulant therapy. Conclusion: In unselected patients in daily care, acute VTE treatment with RX is effective and safe with low rates of cardiovascular or bleeding events during the first 180 days of treatment. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

scholarly journals Prognostic Significance of Incidental Deep Vein Thrombosis in Patients with Cancer Presenting with Incidental Pulmonary Embolism

Cancers ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2267 ◽  
Author(s):  
Maria Barca-Hernando ◽  
Rocio Ortega-Rivera ◽  
Sergio Lopez-Ruz ◽  
Teresa Elias-Hernandez ◽  
Maria Isabel Asensio-Cruz ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Prognostic Significance ◽  
Multivariate Regression Analysis ◽  
Prognostic Effect ◽  
Vein Thrombosis ◽  
Patients With Cancer ◽  
Incidental Pulmonary Embolism ◽  
All Cause Mortality ◽  
Deep Vein

In symptomatic acute pulmonary embolism (PE), the presence of deep vein thrombosis (DVT) is a risk factor for 30- and 90-day mortality. In patients with cancer and incidental PE, the prognostic effect of concomitant incidental DVT is unknown. In this retrospective study, we examined the effect of incidental DVT on all-cause mortality in such patients. Adjusted Cox multivariate regression analysis was used for relevant covariates. From January 2010 to March 2018, we included 200 patients (mean age, 65.3 ± 12.4 years) who were followed up for 12.5 months (interquartile range 7.4–19.4 months). Of these patients, 62% had metastases, 31% had concomitant incidental DVT, and 40.1% (n = 81) died during follow-up. All-cause mortality did not increase in patients with DVT (hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.43–2.75, p = 0.855). On multivariate analysis, weight (adjusted HR 0.96, 95% CI 0.92–0.99, p = 0.032), and metastasis (adjusted HR 10.26, 95% CI 2.35–44.9, p = 0.002) were predictors of all-cause mortality. In conclusion, low weight and presence of metastases were associated with all-cause mortality, while presence of concomitant DVT was unrelated to poorer survival.

scholarly journals Pulmonary Embolism and Coexisting Deep Vein Thrombosis: A Detrimental Association?

2019 ◽  
Vol 8 (6) ◽  
pp. 899 ◽  
Author(s):  
Elena-Mihaela Cordeanu ◽  
Hélène Lambach ◽  
Marie Heitz ◽  
Julie Di Cesare ◽  
Corina Mirea ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Prognostic Significance ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Deep Vein ◽  
The Impact

Background: The prognostic significance of coexisting deep vein thrombosis (DVT) in acute pulmonary embolism (PE) is controversial. This study aimed to provide routine patient care data on the impact of this association on PE severity and 3-month outcomes in a population presenting with symptomatic venous thromboembolism (VTE) from the REMOTEV registry. Methods and Results: REMOTEV is a prospective, non-interventional study of patients with acute symptomatic VTE, treated with direct oral anticoagulants (DOACs) or standard anticoagulation (vitamin K antagonists (VKA) or parenteral heparin/fondaparinux alone) for at least 3 months. From 1 November 2013 to 28 February 2018, among 1241 consecutive patients included, 1192 had a follow-up of at least 3 months and, among them, 1037 had PE with (727) or without DVT (310). The median age was 69 (55–80, 25th–75th percentiles). Patients with PE-associated DVT had more severe forms of PE (p < 0.0001) and, when DVT was present, proximal location was significantly correlated to PE severity (p < 0.01). However, no difference in all-cause mortality rate (hazard ratio (HR) 1.36 (CI 95% 0.69–2.92)), nor in the composite criterion of all-cause mortality and recurrence rate (HR 1.56 (CI 95% 0.83–3.10)) was noted at 3 months of follow-up. Conclusion: In REMOTEV, coexisting DVT was associated with a higher severity of PE, with no impact on short-term prognosis.

Evaluation of Once Weekly Subcutaneous Idraparinux Versus Standard Therapy with Heparin and Vitamin K Antagonists in the Treatment of Deep-Vein Thrombosis or Pulmonary Embolism - The Van Gogh Investigators.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 6-6 ◽  
Author(s):  
Harry R. Buller ◽  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Vitamin K ◽  
Odds Ratio ◽  
Vitamin K Antagonists ◽  
Percent Confidence Interval ◽  
Efficacy And Safety ◽  
Vein Thrombosis ◽  
Deep Vein

Abstract Background Venous thromboembolism is treated with heparins, followed by a vitamin K antagonist. It would be desirable to replace this complex approach with one simple anticoagulant regimen. Methods We conducted two randomized, open-label trials involving 2904 patients with deep-vein thrombosis and 2215 patients with pulmonary embolism to compare efficacy and safety of idraparinux alone versus standard therapy, and document non-inferiority for efficacy. Patients received either idraparinux (2.5 mg once-weekly, subcutaneously), or low-molecular-weight heparin/unfractionated heparin with adjusted-dose vitamin K antagonists, for three or six months. The primary efficacy outcome was the three-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal). Results In the deep-vein thrombosis study the incidence of recurrence at day 92 was 2.9 percent with idraparinux and 3.0 percent in controls (odds ratio 0.98, 95 percent confidence interval 0.63 to 1.50), satisfying the pre-specified non-inferiority requirement. The six-month hazard ratio was 1.01. The incidence of clinically relevant bleeding at day 92 was 4.5 percent and 7.0 percent , respectively (P<0.01). By six months bleeding rates were similar. In the pulmonary embolism study the incidence of recurrence at day 92 was 3.4 percent with idraparinux and 1.6 percent in controls (odds ratio 2.14, 95 percent confidence interval 1.21 to 3.78), excluding non-inferiority. Conclusion In patients with deep-vein thrombosis, once-weekly subcutaneous idraparinux for three or six months had similar efficacy and safety as heparins and vitamin K antagonists, while, in pulmonary embolism, this regimen was less efficacious than standard anticoagulant therapy which had an unexpectedly low recurrence rate.

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