Acute Treatment Of Pulmonary Embolism With Rivaroxaban - Real Life Data From The Prospective Dresden Noac Registry (NCT01588119)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2380-2380
Author(s):  
Christina Köhler ◽  
Sebastian Werth ◽  
Luise Tittl ◽  
Jan Beyer-Westendorf
Keyword(s):  
Pulmonary Embolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Complications ◽  
Daily Care ◽  
Study Results ◽  
Bayer Healthcare ◽  
Recurrent Vte ◽  
Acute Pe

Abstract Background and Objectives In the EINSTEIN PE study rivaroxaban (RX) was found to be as effective as warfarin in the treatment of acute pulmonary embolism (PE) with superior safety. However, study results need to be confirmed in unselected PE patients in daily care. Patients and Methods Using prospectively collected data from a large regional registry of patients treated with novel direct oral anticoagulants (NOAC) in the district of Saxony, Germany, we evaluated the rate of recurrent VTE, other cardiovascular complications and bleeding events in patients receiving rivaroxaban for acute PE. In this ongoing registry, a network of 239 physicians enrols up to 2500 daily care NOAC patients who receive central prospective follow up (FU) by the registry office at day 30 day and quarterly thereafter to collect efficacy and safety data. All outcome events are centrally adjudicated using standard scientific definitions. Results Until July 31th 2013, 2249 patients were enrolled. Of these, 72 patients received RX for acute PE treatment (demographic data in table 1). Registry patients were older than the EINSTEIN PE population (67.3 vs. 55.8 years), 55.6% were female and 23.6% were treated for a recurrent VTE. During follow-up, unplanned rivaroxaban discontinuation rates were low (around 5%; table 1). So far, only one recurrent VTE event occurred (1.7 events per 100 patient years). One patient experienced non-fatal ischaemic stroke within 4 weeks after PE diagnosis (1.7 events per 100 patient years). Bleeding complications were frequent but only 2 major bleeding (non-fatal vaginal bleeds) occurred (3.3 events per 100 patient years). During follow-up three patients died of underlying diseases but none of these deaths were related to VTE or bleeding complications. Conclusion Acute PE treatment with rivaroxaban in daily care is effective, safe and well tolerated with low rates of unplanned treatment discontinuation. Thromboembolic and major bleeding complications are rare and seem to occur predominantly in the early phase of PE treatment. At ASH, updated results from our registry will be presented Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Pfizer: Research Funding, Speakers Bureau; Boehringer Ingelheim: Research Funding, Speakers Bureau; Bayer Healthcare: Research Funding, Speakers Bureau.

Outpatient Treatment In Patients with Acute Pulmonary Embolism: The Hestia Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. LBA-1-LBA-1
Author(s):  
Wendy Zondag ◽  
Inge Mos ◽  
Dina Creemers ◽  
Lidia Hoogerbrugge ◽  
Olaf Dekkers ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Confidence Interval ◽  
Outpatient Treatment ◽  
Research Funding ◽  
Acute Pulmonary Embolism ◽  
Bleeding Event ◽  
Total Mortality ◽  
Recurrent Vte ◽  
Acute Pe

Abstract Abstract LBA-1 Introduction: Patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The most recent guideline of the American College of Chest Physicians on Antithrombotic therapy 2008 reports some small studies on outpatient treatment in patients with pulmonary embolism, which suggest outpatient treatment in selected patients with PE is potentially effective and safe but firm recommendations for clinical practice are lacking. Clinicians urgently need reliable, easy-to-use selection criteria for selection of patients with pulmonary embolism eligible for outpatient treatment. Objective: To evaluate the efficacy and safety of outpatient treatment according to predefined criteria (Hestia criteria) in patients with acute PE. Patients and Methods: Open-label, single-arm, multicenter clinical trial of patients with objectively proven acute pulmonary embolism, conducted in twelve hospitals in the Netherlands from 2008 to 2010. Follow-up was completed in September 2010. Patients with acute PE were triaged with the predefined Hestia criteria for eligibility for outpatient treatment starting with therapeutic weight adjusted doses of LMWH (Nadroparin), followed by vitamin K antagonists. All patients eligible for outpatient treatment according to the Hestia criteria, were sent home either immediately or within 24 hours after PE was objectively diagnosed. Outcome: Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep venous thrombosis (DVT), major haemorrhage and total mortality during initial LMWH treatment and 3 months follow up. We considered outpatient treatment to be effective if the upper limit of the 95% confidence interval of the incidence of recurrent VTE would not exceed 7%. Results: Of 297 included patients, who all completed follow-up, 6 patients (2.0%; 95% confidence interval [CI], 0.8–4.3) had recurrent VTE (5 PE (1.7%), 1 DVT (0.3 %)). Three patients (1.0%, 95% CI 0.2–2.9) died during three months follow-up, but none as a result of fatal PE. One patient died of fatal intracerebral haemorrhage, the other two patients died of progressive malignancy. In addition to the patient with intracranial bleeding, one other patient had a major bleeding event (0.7 %, 95% CI 0.08%-2.4%). Conclusion: Outpatient anticoagulant treatment is effective and safe for patients with pulmonary embolism who have been selected with the Hestia criteria. (Dutch Trial Register NTR1319). Disclosures: Huisman: GSK: Research Funding; Actelion: Research Funding; Bayer: Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Pfizer: Speakers Bureau.

scholarly journals Treatment of Acute VTE with Rivaroxaban - Results of the Prospective Dresden Noac Registry (NCT01588119)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2618-2618
Author(s):  
Loretta Keller ◽  
Sandra Marten ◽  
Judith Hecker ◽  
Sebastian Werth ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Research Funding ◽  
Phase Iii ◽  
Bleeding Complications ◽  
Daily Care ◽  
Age Related ◽  
Fatal Bleeding ◽  
End Of Treatment ◽  
Recurrent Vte ◽  
Mean Time

Abstract Background: The effectiveness and safety of acute venous thromboembolism (VTE) treatment with rivaroxaban, demonstrated in phase-III trials, needs to be evaluated in unselected patients treated under daily care conditions. Patients and methods: The Dresden NOAC registry is a prospective regional registry in which patients with oral anticoagulation undergo prospective follow- up (FU). So far, more than 3200 patients have been enrolled, including 772 VTE patients with rivaroxaban treatment. For this analysis, only patients with acute VTE who started rivaroxaban within 14 days after diagnosis of VTE and who were enrolled within these 14 days were evaluated with regard to patient characteristics, treatment persistence and clinical outcomes. All reported outcome events were centrally adjudicated based on source documentation and standard definitions. Results: Between December 1st 2011 and March 31st 2016, 407 patients received rivaroxaban for acute VTE treatment (51.6% female, 80.8% DVT; 19.2% PE±DVT, mean age 61.4 years). Mean time between VTE diagnosis and initiation of rivaroxaban was 1.7±3.3 days (median 0d; 25th/75th percentile 0; 1d). At baseline, rivaroxaban doses consisted of 15 mg BID in 93.1%, 20 mg OD in 3.4%, 15 mg OD in 3.2% and 10 mg OD in 0.2% of patients. Reasons for not using 2x15 mg rivaroxaban BID were pre-treatment with therapeutic parenteral anticoagulants for ≥7 d in 14 cases, comorbidities (e.g. bleeding history, renal impairment) in 4 cases and unknown in 10 cases. During FU (mean 762.4±462.7d), the mean rivaroxaban exposure was 357.7±385.9 days. During treatment with rivaroxaban, 4/407 patients (1.0%) experienced a recurrent VTE, which translated into a recurrence rate of 1.0/ 100 pt. years. During treatment, 172/407 (42.3%) patients reported bleeding complications, which in 13 cases (3.2%; 3.3/100 pt. years) were major bleeding according to ISTH definition, including one fatal intracranial bleeding. Patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) had similar rates of recurrent VTE during rivaroxaban treatment (1.01 and 1.01/100 pt. years) but PE patients had numerically higher rates of major bleeding (3.99/100 pt. years compared to 3.09/100 pt.years in the DVT group). Effectiveness and safety profiles were consistent across relevant subgroups (table 1). 18 patients died during FU (2.12/100 pt.years), of which 8 deaths occurred during or within 3 days after last intake of rivaroxaban. Most common causes of death were fatal cardiovascular event (n=7) and terminal malignant disease (n=4), followed by sepsis/infection (n=3), age related death (n=1), fatal bleeding (n=1) and other reasons (n=2). At 6 months (FU completed in 365 pts.), 61.4% of patients were still taking rivaroxaban. The remaining patients had a scheduled end of treatment (28.8%) or were switched to other anticoagulants (7.1%). Therefore, the rate of unplanned complete discontinuation at 6 months was 2.7%. At 12 months (FU completed in 289 pts.), 41.5% of patients were still taking rivaroxaban. The remaining patients had a scheduled end of treatment (45.0%) or were switched to other anticoagulants (8.3%). Therefore, the rate of unplanned complete discontinuation at 12 months was 5.2%. After rivaroxaban interruption for more than 3 days or permanent discontinuation, 21 patients experienced a recurrent VTE (9 PE±DVT, 12 DVT) with a mean time between last intake of rivaroxaban and VTE recurrence of 351.2±282.6 days (range 7-926d). PE was a common manifestation of VTE recurrence and, despite numerically lower bleeding rates after discontinuation, 2 cases of intracranial haemorrhage occurred (table 2). Conclusions: In unselected patients in daily care, rivaroxaban treatment for acute VTE has high effectiveness and acceptable rates major bleeding. Initial dosing was according to label in over 90% of patients and, at 6 and 12 months, persistence to rivaroxaban therapy was excellent with low rates of unplanned complete discontinuation. Fatal VTE and fatal bleeding are rare events during rivaroxaban therapy and all-cause mortality is mostly related to underlying diseases, age or acute co-morbidities. Treatment discontinuation resulted in a relevant increase in VTE recurrence, of which more than 40% manifested as PE. In contrast, major bleeding rates declined after discontinuation but with 1%/year remained at a clinically relevant level, probably due to co-morbidities. Disclosures Marten: Bayer: Honoraria; Daichii Sankyo: Honoraria. Werth:Pfizer: Honoraria; Bayer: Honoraria; Boehringer Ingelheim: Honoraria; Daiichi Sankyo: Honoraria; OmniaMed: Honoraria; LEO-Pharma: Honoraria. Beyer-Westendorf:Pfizer: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Daichii Sankyo: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; LEO: Consultancy, Honoraria, Research Funding.

Pattern and Management Of Bleeding Complications With Novel Oral Anticoagulants – Results Of The Prospective Dresden Noac Registry (NCT01588119)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 214-214
Author(s):  
Kati Förster ◽  
Franziska Ebertz ◽  
Vera Gelbricht ◽  
Denise Röllig ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Major Bleeding ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Safety Data ◽  
Factor Vii ◽  
Bleeding Complications ◽  
Daily Care

Abstract Background The most common side effect of oral anticoagulants are bleeding complications. In large trials, novel direct oral anticoagulants (NOAC) have been shown to reduce the risk of major bleeding compared to warfarin. However, little is known about the distribution pattern, management and outcome of NOAC-related bleeding complications in daily care. Patients and methods Using data from a large regional registry of patients treated with novel direct oral anticoagulants (NOAC) in the district of Saxony, Germany, we evaluated pattern and management of NOAC-related bleeding complications in daily care. In this ongoing registry, a network of 239 physicians enrols up to 2500 daily care NOAC patients who receive central prospective follow up (FU) by the registry office at day 30 day and quarterly thereafter to collect efficacy and safety data. All outcome events are centrally adjudicated using standard scientific definitions. Results Until July 31th 2013, 2249 patients were enrolled into the registry. Of these, 1738 (77.3%) patients received rivaroxaban, 356 (15.8%) received dabigatran and 155 (6.9%) received apixaban. During follow-up (2674.0 patient years), a total of 825 patients reported 1137 bleeding complications (59.1% minor, 33.9% non-major, clinically relevant (NMCR) and 6.9% major bleeding according to ISTH definition). For non-major bleedings, mucosal and skin bleeding were the most common bleeding sites (67.9% of all bleedings), followed by genitourinary (10.9%) and gastrointestinal bleeding (10.9%). For major bleeding, gastrointestinal bleeding was the most common manifestation (2.8%), followed by genito-urinary (0.6%) bleeding. In 93% of all bleeding events, treatment was not necessary or consisted of conservative treatment with compression, tamponade or red blood transfusion. Surgical or interventional treatment was reqired in 7.0% of all bleedings (0.0% of minor, 13.0% of NMCR and 38.0% of major bleedings). Prothrombin complex concentrate was used in 1.3% (24% of all major bleedings). No patient received recombinant factor VII. Bleeding-associated mortality was 0.5% for all and 7.5% for major bleeding. Of the six fatal bleedings observed, three were intracranial bleedings. Conclusion Bleeding complications are common in daily care NOAC patients and are usually managed conservatively. Only 7% of all observed bleedings fulfil the ISTH criteria of major bleeding (mainly for RBC transfusion criterion) and are managed using interventions, FFP or PCC. Overall, only few NOAC-associated bleeding complications in daily care are fatal, indicating that available management strategies are sufficient. For presentation at ASH, updated results including risk assessments will be reported. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Research Funding, Speakers Bureau; Boehringer Ingelheim: Research Funding, Speakers Bureau; Pfizer: Research Funding, Speakers Bureau.

Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

2020 ◽  
pp. 1358863X2096741
Author(s):  
Matthew C Bunte ◽  
Kensey Gosch ◽  
Ahmed Elkaryoni ◽  
Anas Noman ◽  
Erin Johnson ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Major Bleeding ◽  
Hospital Readmission ◽  
Common Adverse Event ◽  
Hospital Length Of Stay ◽  
Hospital Death ◽  
Systemic Thrombolysis ◽  
Catheter Directed Thrombolysis ◽  
Acute Pe

Limited data exist that comprehensively describe the practical management, in-hospital outcomes, healthcare resource utilization, and rates of post-hospital readmission among patients with submassive and massive pulmonary embolism (PE). Consecutive discharges for acute PE were identified from a single health system over 3 years. Records were audited to confirm presence of acute PE, patient characteristics, disease severity, medical treatment, and PE-related invasive therapies. Rates of in-hospital major bleeding and death, hospital length of stay (LOS), direct costs, and hospital readmission are reported. From January 2016 to December 2018, 371 patients were hospitalized for acute massive or submassive PE. In-hospital major bleeding (12.1%) was common, despite low utilization of systemic thrombolysis (1.8%) or catheter-directed thrombolysis (3.0%). In-hospital death was 10-fold higher among massive PE compared to submassive PE (36.6% vs 3.3%, p < 0.001). Massive PE was more common during hospitalizations not primarily related to venous thromboembolism, including hospitalizations primarily for sepsis or infection (26.8% vs 8.2%, p = 0.001). Overall, the median LOS was 6.0 days (IQR, 3.0–11.0) and the median standardized direct cost of admissions was $10,032 (IQR, $4467–$20,330). Rates of all-cause readmission were relatively high throughout late follow-up but did not differ between PE subgroups. Despite low utilization of thrombolysis, in-hospital bleeding remains a common adverse event during hospitalizations for acute PE. Although massive PE is associated with high risk for in-hospital bleeding and death, those successfully discharged after a massive PE demonstrate similar rates of readmission compared to submassive PE into late follow-up.

Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 502-502
Author(s):  
Vera Gelbricht ◽  
Sebastian Werth ◽  
Christina Koehler ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Safety Data ◽  
Real Life ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Daily Care ◽  
Short Period

Abstract Abstract 502 Background: In the RE-LY trial, dabigatran (DB) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF), 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 dabigatran anticoagulation in AF 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 July31th 2012, 938 patients were registered. Of these, 201 received DB for AF (table 1). The population in our registry is older than in RELY (74.2 vs. 71.5 years) and has a higher CHADS2-Score (2.7 vs. 2.1). Interestingly, 110 mg BID was the preferred dosage in DB patients (55.7%) despite the fact that these patients had higher CHADS2-scores than patients receiving 150 mg BID (2.3 vs. 2.9). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications. Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 86.8 patient years. During FU, Three patients (1.5%) experienced major cardiovascular events (xyz) and another two patients (1.0%) minor cardiovascular events (syncope). Until now, no deaths occurred. Bleeding complications were frequent (14.9%) but major bleeding was rare (n=3; 1.5%) none of which was fatal. At 3 month, 93% of patients were still taking DB but switch to other anticoagulants increased between 3 and 6 month, mainly due to side effects or incompliance. Conclusion: In unselected patients in daily care, DB is effective and safe with low rates of cardiovascular or major bleeding events. However, within 6 month, about 20% of patients are switched to other anticoagulants. 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.

Two Years Versus Six Months of Oral Anticoagulation after a First Episode of Unprovoked Pulmonary Embolism: The Padis PE Multicenter, Double-Blind, Randomized Trial

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. LBA-3-LBA-3
Author(s):  
Francis Couturaud ◽  
Olivier Sanchez ◽  
Gilles Pernod ◽  
Patrick Mismetti ◽  
Patrick Jego ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Placebo Group ◽  
Board Of Directors ◽  
Major Bleeding ◽  
Research Funding ◽  
Composite Outcome ◽  
Advisory Committees ◽  
Entire Study ◽  
Warfarin Group ◽  
Recurrent Vte

Abstract Background: Patients with a first episode of unprovoked pulmonary embolism have a high risk of recurrent venous thromboembolism (VTE) after anticoagulation is discontinued. Prolongation of anticoagulant therapy beyond the initial period of 3 to 6 months is associated with a significant reduction of recurrent VTE, but an excess of bleeding events. In addition, most studies assessing prolonged treatment did not follow the patients after treatment had been stopped. Thus, the optimal duration of anticoagulation in patients with a first unprovoked pulmonary embolism remains uncertain. Method: In a multicenter, randomized, double-blind, controlled trial, we compared an additional 18 months of warfarin (target International Normalized Ratio, 2 to 3) with placebo in patients with a first episode of unprovoked pulmonary embolism that had been initially treated with a vitamin K antagonist for 6 uninterrupted months. In both groups, all patients were followed up for an additional median period of 2 years after treatment had been stopped. Primary outcome was the composite of recurrent VTE or major bleeding during the 18-month treatment period. Secondary outcomes included the composite outcome during the entire study period (i.e. 18 months plus a median follow-up of 2 years), deaths not caused by pulmonary embolism or major bleeding and the components of the composite outcome during the treatment period and during the entire study period. All outcomes were centrally adjudicated. Results: A total of 371 patients were included in the study and analyzed on an intention-to-treat basis. During the treatment period, the composite outcome occurred in 6 of 184 patients (3.3%) in the warfarin group and in 25 of 187 patients (13.5%) in the placebo group (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.09-0.55; p=0.0004). Recurrent VTE occurred in 3 (1.7%) patients in the warfarin group and in 25 (13.5%) in the placebo group (HR, 0.11; 95%CI, 0.03-0.37); major bleeding occurred in 4 (2.2%) patients in the warfarin group and in 1 (0.5%) in the placebo group (HR, 4.07; 95%CI, 0.45-36.38). Two deaths not related to the study outcome occurred in each group. During the entire median study period of 41 months, the composite outcome occurred in 33 (20.8%) patients in the warfarin group and in 41 (23.5%) in the placebo group (HR, 0.76; 95%CI, 0.48-1.20; p=0.24) (Figure 1). Recurrent VTE occurred in 28 (17.9%) patients in the warfarin group and in 39 (22.1%) in the placebo group (HR, 0.67; 95%CI, 0.41-1.08); major bleeding occurred in 6 (3.5%) patients in the warfarin group and in 4 (2.5%) in the placebo group (HR, 1.57; 95%CI, 0.44-5.55). Thirteen (11.9%) patients died in the warfarin group, four deaths being related to recurrent VTE and one to major bleeding; six (3.6%) patients died in the placebo group from a cause unrelated to recurrent VTE or bleeding (p=0.08). Of the 67 episodes of recurrent VTE, 52 (77.6%) were pulmonary embolism and 58 (86.6%) were unprovoked. Conclusion: After 6 months of anticoagulation for a first episode of unprovoked pulmonary embolism, extending anticoagulation for an additional 18 months was associated with a major reduction in the risk of recurrent VTE or major bleeding during the treatment period. However, this benefit was not maintained after discontinuation of anticoagulation. (ClinicalTrials.gov number NCT00740883). Figure 1. Cumulative risk of the composite outcome (recurrent VTE or major bleeding) over the entire study period Figure 1. Cumulative risk of the composite outcome (recurrent VTE or major bleeding) over the entire study period Disclosures Couturaud: Astra Zeneka: Co-investigator in clinical trial, Co-investigator in clinical trial Other, Membership on an entity's Board of Directors or advisory committees; Bayer: Co-investigator in clinical trial Other, Membership on an entity's Board of Directors or advisory committees. Sanchez:Bayer: Membership on an entity's Board of Directors or advisory committees. Mismetti:Bayer: Membership on an entity's Board of Directors or advisory committees; pfizer: Membership on an entity's Board of Directors or advisory committees; boerhinger ingelheim: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees. Jego:Bayer: Membership on an entity's Board of Directors or advisory committees; actelion: Research Funding; GlaxoSmithKline: Research Funding. Parent:Bayer: Membership on an entity's Board of Directors or advisory committees. Lorillon:Astra Zeneka: Membership on an entity's Board of Directors or advisory committees, symposium invitation Other; Sanofi: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees. Girard:Leo Pharma: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees. Lacut:Bayer-Healthcare: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding; Boehringer Ingelheim: Research Funding. Leroyer:Novartis: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Investigator in COPD clinical trials, Investigator in COPD clinical trials Other, Membership on an entity's Board of Directors or advisory committees; Astra Zeneka: Investigator in asthma clinical trials Other, Membership on an entity's Board of Directors or advisory committees. Decousus:Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees. Meyer:Sanofi-Aventis: Research Funding; LEO Pharma: Research Funding; Bayer: Research Funding; Boehringer Ingelheim: Research Funding. Mottier:Pfizer: Membership on an entity's Board of Directors or advisory committees; bayer: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Sanofi: Research Funding.

scholarly journals Drug Persistence with Rivaroxaban Therapy in Atrial Fibrillation Patients Results from the Dresden NOAC registry

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4264-4264
Author(s):  
Jan Beyer-Westendorf ◽  
Kati Förster ◽  
Franziska Ebertz ◽  
Vera Gelbricht ◽  
Franziska Michalski ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Research Funding ◽  
Treatment Discontinuation ◽  
Baseline Risk ◽  
Bleeding Complications ◽  
Event Analysis ◽  
Daily Care ◽  
Kaplan Meier

Abstract Aims: Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation (SPAF) but little is known about the rates of or reasons for rivaroxaban discontinuation in daily care. Using data from a prospective, non-interventional oral anticoagulation (NOAC) registry, we analysed rivaroxaban treatment persistence. Methods and results: Persistence with rivaroxaban in SPAF was assessed in an ongoing, prospective, non-interventional registry of >2600 NOAC patients from daily care using Kaplan-Meier time-to-first-event analysis. Reasons for and management of rivaroxaban discontinuation were assessed. Potential baseline risk factors for treatment discontinuation were evaluated using Cox regression analysis. Between October 2011 and April 2014, 2603 patients were enrolled in the registry. Of these, 1204 (46.3%) received rivaroxaban for SPAF, with 473 (39.3%) switched from VKA pretreatment to rivaroxaban and 731 (60.7%) newly anticoagulated rivaroxaban patients. As of 30 April 2014, follow-up information was available for all 1204 patients (100%). By that date, the median treatment duration with rivaroxaban was 544 days (25th and 75th percentile 444/639d) for all patients. During follow-up, the overall persistence with rivaroxaban therapy was 81.5% (223/1204 patients discontinued rivaroxaban) and similar for patients switched from VKA to rivaroxaban or newly treated rivaroxaban patients (82.0% vs 81.1%). In the intention-to-treat analysis, rates of treatment discontinuation per 100 patient-years were assessed as a Kaplan–Meier time-to-first-event analysis and found to be 13.6 [95% CI 11.8–15.4] for all patients and similar for newly treated rivaroxaban patients (14.1 [95% CI 11.9–16.7]) and patients switched from VKA to rivaroxaban (12.7 [95% CI 10.1–15.7]; p = 0.35; Figure 1a). This finding did not change if only patients with a completed 12-month follow-up were assessed (Figure 1b). Discontinuation rates were highest in the first 6 months of treatment (9.9% [95% CI 7.7–12.1%] for patients newly treated with rivaroxaban and 10% [95% CI 7.3–12.7%] for patients switched from VKA pretreatment to rivaroxaban) and declined similarly in both subgroups over time (for 6–12 months: 6% [95% CI 5.5–6.4%] and 3.9% [95% CI 3.5–4.4%], respectively; after 12 months: 4.4% [95% CI 3.9–5%) and 7.7% [95% CI 6.0–9.2%], respectively). Most common reasons for treatment discontinuations were bleeding complications (30% of all discontinuations), followed by other side-effects (24.2%) and diagnosis of stable sinus rhythm (9.9%). Within the group of 67 bleeding complications, according to the International Society on Thrombosis and Haemostasis bleeding definition, 14 were major and 53 were non-major clinically relevant bleeding events that led to treatment discontinuation. A history of chronic heart failure (HR 1.43; 95% CI 1.09-1.87; p=0.009) or diabetes (HR 1.39; 95% CI 1.06-1.82; p=0.018) were the only statistically significant baseline risk factors for rivaroxaban discontinuation. After discontinuation of rivaroxaban, patients received antiplatelet therapy (31.8%), VKA (24.2%), another NOAC (18.4%), heparin (9.9%) or nothing (15.7%). Conclusion: Our data indicate that overall persistence with rivaroxaban therapy is high, with a discontinuation rate of approximately 15% in the first year of treatment and few additional discontinuations thereafter. Non-major bleeding is the most common reason for riaroxaban discontinuation and nearly 50% of all discontinuing patients receive only antiplatelet or no antithrombotic treatment. Figure 1: Kaplan–Meier analysis of persistence to rivaroxaban treatment for all patients (left diagram) and for all patients who were observed for at least 12 months (right diagram), according to VKA pretreatment Figure 1:. Kaplan–Meier analysis of persistence to rivaroxaban treatment for all patients (left diagram) and for all patients who were observed for at least 12 months (right diagram), according to VKA pretreatment Disclosures Beyer-Westendorf: Bayer: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding. Weiss:Boehringer Ingelheim: Honoraria; Bayer: Honoraria.

scholarly journals Risk of Recurrent Venous Thromboembolism and Bleeding in Patients with Cancer Associated Thrombosis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 18-18
Author(s):  
Doaa Attia ◽  
Xuefei Jia ◽  
Mailey L Wilks ◽  
Barbara Tripp ◽  
Christopher D'Andrea ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Research Funding ◽  
Cleveland Clinic ◽  
Treatment Groups ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis

Background: The treatment paradigm for cancer associated thrombosis (CAT) has evolved over recent years from using low molecular weight heparin (LMWH) to direct oral anticoagulants (DOACs). Some randomized trials suggest decreased rates of recurrent venous thromboembolism (VTE) in CAT patients treated with DOACs compared to LMWH but also reported increased rates of bleeding. The Cleveland Clinic Taussig Cancer Center has been treating cancer thrombosis in a centralized CAT clinic since 2014. Here we report our rates of bleeding and recurrent VTE in cancer patients treated with anticoagulation. Methods: We prospectively followed cancer patients referred to our clinic from 8/2014-10/2019. A total of 1548 patients were referred to the clinic, of whom 462 were diagnosed with an acute VTE. VTE events, including deep venous thrombosis, pulmonary embolism, and visceral thrombosis, were noted. The comparison of bleeding rates (defined using ISTH criteria for major and clinically relevant non major bleeding, CRNMB) among treatment groups (LMWH vs DOACs) was examined using chi-square test. Rate of recurrent VTE was analyzed using a competing model in which death was treated as a competing risk. Results: The study population comprised 462 patients with acute VTE with a mean age of 62.67±12.23 and 51.8 % males. Of these, 234 (52.9%) received LMWH, 161(36.4%) received DOACs, and 47 (10.6%) received other agents including warfarin for initial anticoagulation. Overall, the 6-month, 1 year, and 2-year VTE recurrence rate was 5.9%, 6.6%, 7.9%, respectively. Recurrent VTE rates were similar for LMWHs, DOACs and other agents (P&gt;0.05). Of 368 patients for whom follow-up data was available, 74 (16.7%) had bleeding event , of which 25 (33.8%) had major bleeding and 49 (66.4%) had CRNMB at 6 month follow-up with no difference across three treatment groups (p=0.56). Conclusion: In this real-world practice setting, rates of recurrent VTE and bleeding were similar for DOACs and LMWH suggesting that with careful patient selection the concern for higher bleeding with DOACs in cancer patients can be safely overcome. Disclosures McCrae: Momenta Pharmaceuticals: Consultancy; Novartis: Honoraria; Rigel: Consultancy; Dova: Consultancy. Khorana:Merck: Research Funding; Medscape: Honoraria; Leo Pharma: Honoraria; Seattle Genetics: Honoraria; Pharmacyte: Honoraria; Pharmacyclics: Honoraria; Array: Other: Research funding (to institution); Janssen: Honoraria; Bayer: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria; BMS: Honoraria, Research Funding; Leap: Research Funding.

Pulmonary Embolism in Patients with COVID-19: Comparison between Different Care Settings

2021 ◽  
Author(s):  
Giacomo Buso ◽  
Lucia Mazzolai ◽  
José Antonio Rueda-Camino ◽  
Carmen Fernández-Capitán ◽  
David Jiménez ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Clinical Characteristics ◽  
Multivariable Analysis ◽  
Outpatient Setting ◽  
Full Spectrum ◽  
First 90 Days ◽  
Acute Pe

AbstractThe clinical characteristics and outcomes of patients with coronavirus disease 2019 (COVID-19) who develop pulmonary embolism (PE) in the full spectrum of patient care settings need to be elucidated. The aim of this study was to compare the clinical characteristics, treatment, and 90-day outcomes in patients diagnosed with PE while recovering from COVID-19 in the outpatient setting versus those who were diagnosed with PE while being hospitalized with COVID-19. Data from the international Registro Informatizado de Enfermedad TromboEmbólica (RIETE) registry were used. The major study outcomes were all-cause death, major bleeding, and venous thromboembolism (VTE) recurrences during the first 90 days after PE. From March 2020 to March 2021, 737 patients with COVID-19 experienced acute PE. Of these, 340 (46%) were recovering from COVID-19 as outpatients (267 patients who had been treated at home for COVID-19 and 73 discharged after being hospitalized with COVID-19). Compared with inpatients with COVID-19, those recovering in the outpatient setting upon PE were less likely to be men (odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.40–0.72) and less likely to have hypertension (OR: 0.55; 95% CI: 0.41–0.74) or diabetes (OR: 0.51; 95% CI: 0.33–0.76). At 90-day follow-up, eight patients (none recovering from COVID-19 as outpatient vs. 2.4% of inpatients with COVID-19) developed recurrent VTE, 34 (1.9 vs. 7.9%) had major bleeding, and 128 (10 vs. 24%) died. On multivariable analysis, inpatients with COVID-19 were at a higher risk of major bleeding (adjusted hazard ratio [HR]: 6.80; 95% CI: 1.52–30.4) or death (adjusted HR: 2.24; 95% CI: 1.40–3.58). In conclusion, using a large multinational registry of patients with COVID-19 who experienced PE, thromboembolic episodes occurring in those recovering from COVID-19 as outpatients were associated with less ominous outcomes than inpatients with COVID-19.

Pattern and Management of Vaginal Bleeding Complications, Especially Hypermenorrhea, with Direct Oral Anticoagulants - Results of the Prospective Dresden Noac Registry (NCT01588119)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1131-1131
Author(s):  
Sandra Marten ◽  
Luise Tittl ◽  
Katharina Daschkow ◽  
Jan Beyer-Westendorf
Keyword(s):  
Treatment Satisfaction ◽  
Research Funding ◽  
Vaginal Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Complications ◽  
Common Complication ◽  
Bleeding Events ◽  
Bayer Healthcare

Abstract Background : Bleeding is a common complication of oral anticoagulation (OAC). In anticoagulated women of child-bearing potential (WOCBP), increase of menstrual bleeding may be discomforting and severe cases of menorrhagia may require dedicated treatment or even discontinuation of OAC. Since hypermenorrhea seems to be more frequent in patients receiving direct oral anticoagulants (DOAC) compared to classic OAC with vitamin-K antagonists, patterns of menorrhagia need to be studied in daily care cohorts. Patients and methods: Using data from the prospective, non-interventional Dresden NOAC registry and phase-III DOAC trial patients at our site, we evaluated rates, severity and management of vaginal bleeding complications in WOCBP (defined as age ≤55 years and without sterilizing procedures or age >55 years with documented menstrual bleeding). All bleeding complications were centrally adjudicated and classified according to ISTH definition. Annualized rates of vaginal bleeding and hypermenorrhea were calculated as number of bleeding events divided by cumulative days of DOAC exposure divided by 365 days. OAC treatment satisfaction was assessed in all registry patients at every follow-up visit by a simple six-graded scale (ranging from 1=very satisfied to 6=very unsatisfied). To assess impact of vaginal bleeding on quality of live, the first available score after a vaginal bleeding was compared with the last available score of WOCBPs without vaginal bleeding. Results: Until March 31th 2015, 1343 women were enrolled, of which 154 were WOCBPs (mean age 39±12 years; range 14-56). In these patients, OAC consisted of dabigatran (1.3%), rivaroxaban (92.2%), apixaban (5.8%) or edoxaban (0.6%). During follow-up (mean FU duration 24.6 months), 85 female patients reported 107 vaginal bleeding complications, of which 68 occurred in 53 WOCBPs (53 cases of hypermenorrhea and 15 bleedings unrelated to cycle). Table 1 indicates severity of hypermenorrhea and vaginal bleedings unrelated to cycle. According to ISTH definition, 37/68 (54.4%) of the vaginal bleeding in WOCBPs were minor, 25/68 (36.8%) were non-major, clinically relevant (NMCR) and 6/68 (8.8%) major bleeding (classified as "major" due to drop of hemoglobin ≥2g/l in 5 cases and/or transfusion of ≥2 units of red blood cells in 5 cases). In relation to all exposed WOCBPs, the rate of vaginal bleeding events was found to be 0.41 events per exposure year and the rate of hypermenorrhea was found to be 0.32 events per exposure year (median exposure time 243d; 25th/75th percentile 105/674d and median time to first hypermenorrhea 26d; 25th/75th percentile 10/46d). Of the 53 WOCBPs that described vaginal bleeding complications (including hypermenorrhea and cycle-unrelated bleeding), 12/53 (22.6%) experienced a 2nd and 3/53 (5.7%) a 3rd event (figure 1). While bleeding intensity remained stable in most recurrent events, bleeding intensity increased in 6 cases with a 2nd bleeding episode while bleeding intensity remained stable or decreased in all 3 cases with a third episode. In only 16 of the 53 hypermenorrhea events, anatomical causes could be established and 3 of these cases progressed to major bleeding (necessity of at ≥2 units of red blood cells). In contrast, in the 34 hypermenorrhea events without anatomical causes, bleeding intensity was less severe (table 1). Surgical or interventional treatment was necessary in 6/68 (8.8%) vaginal bleeding events. The remaining 62 (91.2%) events were treated conservatively (start or change of hormone therapy, tranexamic acid, OAC dose reduction or temporary interruption). Overall, OAC treatment satisfaction in WOCBP was good (mean score 1.6; 25th/75th percentile 1/2 with data available for 98/154 WOCBPs) and not different in patients with and without vaginal bleeding complications (1.6; 25th/75th percentile 1/2 vs. 1.5; 1/2; p=0.548). Conclusion : Vaginal bleeding and especially hypermenorrhea is a common complication in WOCBPs receiving oral anticoagulation. Only a small proportion of affected patients have underlying anatomical causes for bleeding but these patients often develop more severe bleeding. The majority of cases can be conservatively managed and bleeding intensity rarely increases over time. Overall, the impact of vaginal bleeding complications on treatment satisfaction seems small. Disclosures Marten: Bayer HealthCare: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding.

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