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.

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.

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

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2267-2267
Author(s):  
Christina Koehler ◽  
Sebastian Werth ◽  
Vera Gelbricht ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Oral Anticoagulants ◽  
Safety Data ◽  
Real Life ◽  
Prolonged Treatment ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Vascular Events ◽  
Daily Care ◽  
Short Period

Abstract Abstract 2267 Background: In the EINSTEIN-EXT trial, rivaroxaban (RX) has been found to be at least as effective and safe as warfarin in extended venous thromboembolism (VTE) treatment, which lead to approval 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 for extended VTE treatment in daily care. Patients and methods: In the district of Saxony, Germany, 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, 126 patients received RX for extended VTE treatment (demographic data in table 1). In our registry, the population receiving extended VTE treatment is older than in EINSTEIN-EXT (65.0 vs. 58.2 years). Indication for prolonged treatment is proximal deep vein thrombosis or pulmonary embolism (93.3%). Most patients received 20 mg OD, but a quarter of patients received 15 mg OD due to impaired renal function. Until July 31th, completed FU cumulate to 44.2 patient years. 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 experienced major vascular events (1 ACS, 1 TIA). Bleeding events were frequent (24.6%) but only 2 patients (1.6%) experienced major bleeding events, none of which were fatal. Two patients died due to underlying diseases. At 3 and 6 month, 94% resp. 85% of patients were still taking RX. Conclusion: In unselected patients in daily care, extended VTE treatment with RX is effective and safe with low rates of events or treatment discontinuation in the first 180 days of treatment. Long-term data will be reported. 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.

Prospective 12-Year Follow-up Study of Clinical and Hemodynamic Sequelae After Deep Vein Thrombosis in Low-Risk Patients (Zürich Study)

Circulation ◽  
1996 ◽  
Vol 93 (1) ◽  
pp. 74-79 ◽  
Author(s):  
Ulrich K. Franzeck ◽  
Ilse Schalch ◽  
Kurt A. Jäger ◽  
Ernst Schneider ◽  
Jörg Grimm ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Low Risk ◽  
Vein Thrombosis ◽  
Follow Up Study ◽  
Risk Patients ◽  
Deep Vein

Post-thrombotic syndrome after deep vein thrombosis: The role of follow-up Doppler ultrasound

2021 ◽  
Vol 156 (5) ◽  
pp. 251-252
Author(s):  
Francisco Galeano-Valle ◽  
Jorge del-Toro-Cervera ◽  
Pablo Demelo-Rodríguez
Keyword(s):  
Deep Vein Thrombosis ◽  
Doppler Ultrasound ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Deep Vein

scholarly journals Predictors of long-term post-thrombotic syndrome following high proximal deep vein thrombosis: a cross-sectional study

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Marit Engeseth ◽  
Tone Enden ◽  
Per Morten Sandset ◽  
Hilde Skuterud Wik
Keyword(s):  
Deep Vein Thrombosis ◽  
Proximal Deep Vein Thrombosis ◽  
Cross Sectional ◽  
Clinical Criteria ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Younger Age ◽  
Deep Vein

Abstract Background Post-thrombotic syndrome (PTS) is a frequent chronic complication of proximal deep vein thrombosis (DVT) of the lower limb, but predictors of PTS are not well established. We aimed to examine predictors of PTS in patients with long-term PTS following proximal DVT. Methods During 2006–09, 209 patients with a first time acute upper femoral or iliofemoral DVT were randomized to receive either additional catheter-directed thrombolysis or conventional therapy alone. In 2017, the 170 still-living participants were invited to participate in a cross-sectional follow-up study. In the absence of a gold standard diagnostic test, PTS was defined in line with clinical practice by four mandatory, predefined clinical criteria: 1. An objectively verified DVT; 2. Chronic complaints (> 1 month) in the DVT leg; 3. Complaints appeared after the DVT; and 4. An alternative diagnosis was unlikely. Possible predictors of PTS were identified with multivariate logistic regression. Results Eighty-eight patients (52%) were included 8–10 years following the index DVT, and 44 patients (50%) were diagnosed with PTS by the predefined clinical criteria. Younger age and higher baseline Villalta score were found to be independent predictors of PTS, i.e., OR 0.96 (95% CI, 0.93–0.99), and 1.23 (95% CI, 1.02–1.49), respectively. Lack of iliofemoral patency at six months follow-up was significant in the bivariate analysis, but did not prove to be significant after the multivariate adjustments. Conclusions In long-term follow up after high proximal DVT, younger age and higher Villalta score at DVT diagnosis were independent predictors of PTS.

The development of valvular incompetence after deep vein thrombosis: A follow-up study with duplex scanning

1994 ◽  
Vol 19 (6) ◽  
pp. 1059-1066 ◽  
Author(s):  
Bert van Ramshorst ◽  
Paul S. van Bemmelen ◽  
Hans Hoeneveld ◽  
Bert C. Eikelboom
Keyword(s):  
Deep Vein Thrombosis ◽  
Duplex Scanning ◽  
Vein Thrombosis ◽  
Follow Up Study ◽  
Deep Vein

scholarly journals Rheolytic Thrombectomy Using AngioJet ZelanteDVT Catheter or Solent Omni Catheter for Treatment of Patients with Proximal Vein Thrombosis

2021 ◽  
Author(s):  
Maofeng Gong ◽  
Guanqi Fu ◽  
Zhengli Liu ◽  
Yangyi Zhou ◽  
Jie Kong ◽  
...  
Keyword(s):  
Clinical Success ◽  
Successful Outcome ◽  
Success Rates ◽  
Technical Success ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
Rheolytic Thrombectomy ◽  
Deep Vein ◽  
Clinical Characteristic

Abstract Purpose The present study aimed to investigate the preliminary safety and efficacy of rheolytic thrombectomy (RT) using AngioJet ZelanteDVT catheter or Solent Omni catheter for acute proximal deep vein thrombosis (DVT).Material and Methods We conducted a retrospective review of 40 patients who treated by AngioJet RT divided into ZelanteDVT group (n=17) and Solent group (n=23) from January 2019 to January 2021. Data of demographics, clinical characteristic, technical success, clinical success, complications, and early follow-up were analysed.Results No significant differences regarding demographics were detected (all p >.05). The technical success rates were both 100%. ZelanteDVT group had a shorter duration time of RT and a higher primary RT success than those of Solent group (all p <.05), and percentage of adjunctive CDT was 29.4% in ZelanteDVT group, significantly lower than that was 79.3% in Solent group (p =.010). The successful outcome for ZelanteDVT group and Solent group were 100% (17/17) and 95.7% (22/23), both high in the two groups (p >.05). Except for transient macroscopic hemoglobinuria occurred in all patients at the first 24 hours post-RT, none suffered other procedure-related adverse events or major complications in both groups. Minor complications presented as bleeding events occurred in 21.7% (5/23) patients of Solent group, and one (5.9%) patient in Zelante DVT group (p >.05). At 6-month, the frequency of PTS was 5.9% (1/17) in ZelanteDVT group compared with 17.4% (4/ 23) in Solent group (p >.05).Conclusion Both catheters are safe and effective for the management of patients with proximal DVT, leading to improved clinical outcomes with low complication. Zelante-DVT catheter offered more powerful thrombectomy over Solent catheter, allowing for faster extraction of the DVT with shorter run time and lower adjunctive CDT.

scholarly journals Safety of a strategy combining D-dimer testing and whole-leg ultrasonography to rule out deep vein thrombosis

2020 ◽  
Vol 4 (20) ◽  
pp. 5002-5010
Author(s):  
Synne G. Fronas ◽  
Camilla T. Jørgensen ◽  
Anders E. A. Dahm ◽  
Hilde S. Wik ◽  
Jostein Gleditsch ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Pretest Probability ◽  
Vein Thrombosis ◽  
Venous Thromboembolic ◽  
Deep Vein ◽  
D Dimer ◽  
Rule Out ◽  
Compression Ultrasonography ◽  
High Pretest Probability

Abstract Guidelines for the diagnostic workup of deep vein thrombosis (DVT) recommend assessing the clinical pretest probability before proceeding to D-dimer testing and/or compression ultrasonography (CUS) if the patient has high pretest probability or positive D-dimer. Referring only patients with positive D-dimer for whole-leg CUS irrespective of pretest probability may simplify the workup of DVT. In this prospective management outcome study, we assessed the safety of such a strategy. We included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected DVT between February 2015 and November 2018. STA-Liatest D-Di Plus D-dimer was analyzed for all patients, and only patients with levels ≥0.5 µg/mL were referred for CUS. All patients with negative D-dimer or negative CUS were followed for 3 months to assess the venous thromboembolic rate. One thousand three hundred ninety-seven patients were included. Median age was 64 years (interquartile range, 52-73 years), and 770 patients (55%) were female. D-dimer was negative in 415 patients (29.7%) and positive in 982 patients (70.3%). DVT was diagnosed in 277 patients (19.8%). Six patients in whom DVT was ruled out at baseline were diagnosed with DVT within 3 months of follow-up for a thromboembolic rate of 0.5% (95% confidence interval, 0.2-1.2). A simple diagnostic approach with initial stand-alone D-dimer followed by a single whole-leg CUS in patients with positive D-dimer safely ruled out DVT. We consider this strategy to be a valuable alternative to the conventional workup of DVT in outpatients. This trial was registered at www.clinicaltrials.gov as #NCT02486445.

Die vollständige Kompressionssonographie zur Diagnose der proximalen und distalen Venenthrombose – eine retrospektive Untersuchung

VASA ◽  
2001 ◽  
Vol 30 (4) ◽  
pp. 253-257 ◽  
Author(s):  
Sebastian M. Schellong ◽  
T. Schwarz ◽  
T. Pudollek ◽  
B. Schmidt ◽  
H. E. Schroeder
Keyword(s):  
Deep Vein Thrombosis ◽  
Outcome Study ◽  
Repeated Testing ◽  
Clinical Safety ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Compression Ultrasound ◽  
Low Incidence ◽  
Deep Vein

Background: Compression ultrasound is considered the preferred test for the diagnosis of deep vein thrombosis of the leg (DVT). Since sensitivity for distal thrombosis is low additional tests are required. We developed a protocol of complete compression ultrasound of all venous segments of the leg (CCUS). A retrospective outcome study was performed to get an estimate of the rate of indeterminate results necessitating repeated testing as well as for the clinical safety of CCUS in a cohort of consecutive, unselected patients. Patients and methods: Case records of all patients referred for clinical suspicion of deep vein thrombosis within a three months period were reviewed. Patients with negative CCUS were followed directly or via the general practitioner in order to know whether an episode of venous thromboembolism had been documented since the initial CCUS. Results: 132 inpatients and 154 outpatients were identified. Clinical probability was high in 50 patients, medium in 142, and low in 94. The first CCUS was negative in 209 cases. Five patients (1,8%) had repeated CCUS within the next 7 days because of incomplete visualisation of the distal veins and turned out to be negative as well. Of all 214 patients with negative CCUS a clinical follow-up information was obtained after 168 ± 25 days. Five patients had died, none due to pulmonary embolism. In two patients deep vein thrombosis had been documented (0,9% [95% CI: 0,1–3,3%]) 148 and 172 days after CCUS, respectively. Conclusion: CCUS for diagnosis of DVT needs to be repeated in very few cases only. Clinical safety seems to fall into the same range as with combined algorithms and should be tested in a prospective design. Patients with medium and high probability showed a very low incidence of DVT within three months following CCUS; therefore, they may be included in a prospective outcome study.

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