scholarly journals Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial

2017 ◽  
Vol 117 (11) ◽  
pp. 2135-2145 ◽  
Author(s):  
Alok Khorana ◽  
Saroj Vadhan-Raj ◽  
Nicole Kuderer ◽  
Ted Wun ◽  
Howard Liebman ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Factor Xa ◽  
Routine Care ◽  
Bleeding Events ◽  
Double Blind ◽  
Primary Brain Tumours ◽  
Incidental Pulmonary Embolism ◽  
Increased Risk ◽  
Ambulatory Patients

AbstractVenous thromboembolism (VTE) is a frequent complication of cancer associated with morbidity, mortality, increased hospitalizations and higher health care costs. Cancer patients at increased risk for VTE can be identified using a validated risk assessment score, and the incidence of VTE can be reduced in high-risk settings using anticoagulation. Rivaroxaban is a potent, oral, direct, factor Xa inhibitor approved for the prevention and treatment of thromboembolic events, including VTE. CASSINI is a double-blind, randomized, parallel-group, multicentre study comparing rivaroxaban with placebo in adult ambulatory patients with various cancers who are initiating systemic cancer therapy and are at high risk of VTE (Khorana score ≥ 2). Patients with primary brain tumours or those at risk for bleeding are excluded. Approximately 700 patients will be randomized 1:1 to rivaroxaban 10 mg daily or placebo for up to 6 months if there is no evidence of VTE from compression ultrasonography (CU) during screening or from routine care imaging within 30 days prior to randomization. Mandatory CU will also be performed at weeks 8 and 16 (±7 days), and at study end (±3 days). The primary efficacy hypothesis is that anticoagulation with rivaroxaban reduces the composite of objectively confirmed symptomatic or asymptomatic, lower-extremity, proximal deep-vein thrombosis (DVT); symptomatic, upper-extremity DVT; symptomatic or incidental pulmonary embolism; and VTE-related death compared with placebo. The primary safety objective is to assess major bleeding events (Clinical trial information: NCT02555878).

Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism: Pooled Analysis of Coagulation Biomarkers From Stars E-3 and Stars J-V.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2260-2260
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Venous Thromboembolism ◽  
Factor Xa ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Bleeding Events ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Post Operation ◽  
D Dimer

Abstract Abstract 2260 Introduction: Edoxaban is an oral, once-daily, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Two randomized, double-blind, double-dummy, phase III studies (STARS E-3 and STARS J-V) have been conducted to evaluate the efficacy and safety of edoxaban compared to enoxaparin for the prevention of venous thromboembolism (VTE) after total knee arthroplasty (TKA) or total hip arthroplasty (THA). The objective of this pooled analysis was to investigate the effects of edoxaban on key coagulation biomarkers. Methods: Patients (N=1,326) undergoing TKA or THA in Japan and Taiwan were randomized to receive oral edoxaban 30 mg once daily (qd) or subcutaneous enoxaparin 2,000 IU twice daily (bid; equivalent to 20 mg bid) for 11–14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery, which is the standard of care in Japan. Blood samples were collected for coagulation biomarker measurements pre-operation, post-operation (pre-treatment, Day 0), Day 7 (prior to administration of the next dose) and completion day (Day 11–14). The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). The principal safety outcome was the incidence of major and clinically relevant non-major (CRNM) bleeding. Pharmacodynamic endpoints included key coagulation biomarkers such as D-dimer, prothrombin fragment F1+2 (F1+2) and soluble fibrin monomer complex (SFMC). Results: A total of 1,307 patients received at least 1 dose of edoxaban or enoxaparin. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 68 years, mean body weight was 58.8 kg and 83% of patients were female. Overall, edoxaban significantly reduced the incidence of the composite of symptomatic and asymptomatic DVT and PE compared with enoxaparin (5.1% vs 10.7%, P<0.001). The incidence of major and CRNM bleeding events was 4.6% vs 3.7% in the edoxaban and enoxaparin groups, respectively (P=0.427). For both treatment groups, D-dimer and SFMC levels were reduced at Day 7 compared to post-operation/pretreatment levels, then increased slightly by Day 11–14. Levels of F1+2 also decreased by Day 7 in both treatment groups and further decreased by Day 11–14. However, for each coagulation biomarker, levels were significantly lower in the edoxaban group compared to the enoxaparin group at both Day 7 and Day 11–14. (Table, P<0.001). Conclusion: Edoxaban 30 mg qd is superior to enoxaparin 20 mg bid in the prevention of VTE events with significant reduction of D-dimer, F1+2 and SFMC following TKA and THA. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Bayer: Consultancy; Century Medical: Consultancy; Showa Ikakogyo: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Bayer: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Bayer: Consultancy; Toyama Chemical: Consultancy.

Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism: Pooled Analysis of Venous Thromboembolism and Bleeding From STARS E-3 and STARS J-V

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 208-208 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Subgroup Analysis ◽  
Factor Xa ◽  
Pooled Analysis ◽  
Bleeding Events ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Patient Subgroups

Abstract Abstract 208 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Two randomized, double-blind, double-dummy, phase 3 studies (STARS E-3 and STARS J-V) have been conducted to evaluate the efficacy and safety of edoxaban compared with enoxaparin for the prevention of venous thromboembolism (VTE) after total knee (TKA) or hip arthroplasty (THA). The objective of this pooled analysis was to investigate the effects of edoxaban on VTE and bleeding in key subgroups. Methods: Patients (N=1326) undergoing TKA or THA in Japan and Taiwan were randomized to receive oral edoxaban 30 mg once daily (qd) or subcutaneous enoxaparin 2000 IU twice daily (bid, equivalent to 20 mg bid) for 11–14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery, which is the standard of care in Japan. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). The principal safety outcome was the incidence of major and clinically relevant nonmajor (CRNM) bleeding. Results: A total of 1307 patients received at least 1 dose of edoxaban or enoxaparin. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 68 years and mean body weight was 58.8 kg. Over 70% of patients received physiotherapy (intermittent pneumatic compression, elastic stocking). Overall, edoxaban significantly reduced the incidence of the composite of symptomatic and asymptomatic DVT and PE compared with enoxaparin (5.1% vs 10.7%, P<0.001). Subgroup analysis showed that edoxaban numerically reduced the incidence of the composite efficacy endpoint regardless of age or body weight. The effect was statistically significant in patients <75 years of age and in those <70 kg. Edoxaban was also significantly more effective than enoxaparin in the presence or absence of concomitant physiotherapy. The incidence of major and CRNM bleeding events was 4.6% vs 3.7% in the edoxaban and enoxaparin groups, respectively (P=0.427). Subgroup analysis of major and CRNM bleeding indicated no significant difference between edoxaban and enoxaparin in any of the patient subgroups evaluated, based on age, weight, or creatinine clearance. Conclusion: Edoxaban 30 mg qd is superior to enoxaparin 20 mg bid in the prevention of VTE events following TKA and THA without a statistically significant increase in bleeding in important patient subgroups likely to receive this treatment. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Astellas: Consultancy; Showa Ikakogyo: Consultancy; Bayer: Consultancy. Fujita:Astellas: Consultancy; GlaxoSmithKline: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy; Bayer: Consultancy.

External validation of the VTE-BLEED score for predicting major bleeding in stable anticoagulated patients with venous thromboembolism

2017 ◽  
Vol 117 (06) ◽  
pp. 1164-1170 ◽  
Author(s):  
Frederikus A. Klok ◽  
Stefano Barco ◽  
Stavros V. Konstantinides
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Major Bleeding ◽  
External Validation ◽  
Chronic Phase ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Study Population

SummaryOne of the main determinants of establishing the optimal treatment duration of patients with venous thromboembolism (VTE) is the risk of major bleeding during long-term anticoagulant therapy. The 6-variable VTE-BLEED score was recently developed to enable estimation of this bleeding risk. This study aimed at externally validating VTE-BLEED. This was a post-hoc study of the randomised, double-blind, double-dummy, Hokusai-VTE study that compared edoxaban versus warfarin for treatment of VTE. VTE-BLEED was calculated in all 8,240 study patients. The numbers of adjudicated major bleeding events during ‘stable anticoagulation’, i. e. occurring after day 30, in patients with low (total score <2 points) and high risk of bleeding (total score ≥2 points) were compared for the overall study population, patients randomised to edoxaban or warfarin, and for important patient subcategories. During ‘stable’ anticoagulation, major bleeding occurred in 1.02% (40/3,903) and 0.82% (32/3,899) of patients treated with warfarin and edoxaban, respectively. For the overall study population, the risks of bleeding in the low and high risk groups were 0.51% and 2.03%, respectively, for an odds ratio (OR) of 4.04 (95% confidence interval [CI]: 2.51–6.48). ORs were 5.04 (95%CI: 2.62–9.69) and 3.09 (95%CI: 1.54–6.22) for warfarin and edoxaban, respectively. VTE-BLEED was consistently able to identify patients at a 2.5- to 11-fold higher bleeding risk across all the predefined subcategories, as well as for the treatment period between day 30 to day 180, and beyond day 180. In conclusion, patients identified as high risk by VTE-BLEED had a four-fold increased risk of bleeding during the chronic phase of treatment.Supplementary Material to this article is available online at www.thrombosis-online.com.

A Comparative, Double-blind, Randomised Trial of a New Second Generation LMWH (Bemiparin) and UFH in the Prevention of Post-operative Venous Thromboembolism

2000 ◽  
Vol 83 (04) ◽  
pp. 523-529 ◽  
Author(s):  
J. Howes ◽  
V. Sharma ◽  
Z. Kadziola ◽  
V. V. Kakkar ◽  
Keyword(s):  
Venous Thromboembolism ◽  
Hip Arthroplasty ◽  
Randomised Trial ◽  
Factor Xa ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Double Blind ◽  
Subcutaneous Dose ◽  
Number Of Patients ◽  
Risk Patients

SummaryA randomised, prospective, double-blind trial was performed, to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and standard unfractionated heparin (UFH), for the prophylaxis of postoperative venous thromboembolism. 300 patients scheduled to undergo elective hip arthroplasty were included. The principal outcome measures were the incidence of thromboembolic events and bleeding complications. 149 patients received 3,500 anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 5,000 IU of UFH twice a day.The two groups were similar with respect to factors likely to affect the risk of developing post-operative venous thromboembolism (VTE) and risk of bleeding events. During the post-operative period, 34 patients developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 95% CI 1.32-6.62 and p = 0.01).There were no significant differences in the frequency of bleeding complications: major bleeding requiring discontinuation of prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 1.00).A comparison of coagulation parameters on the preoperative day with post-operative day 2 ± 1, day 6 ± 1 and day of discharge showed a significantly higher AT concentration, anti-factor Xa activity and TFPI levels in the bemiparin group when compared with UFH.This study demonstrates that bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk patients undergoing hip arthroplasty is more effective than UFH administered twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both agents are equally safe.List of participants, their affiliations and current addresses are listed in the appendix on p. 528

Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry

2008 ◽  
Vol 100 (07) ◽  
pp. 26-31 ◽  
Author(s):  
Nuria Ruíz-Giménez ◽  
Carmen Suárez ◽  
Rocío González ◽  
José Nieto ◽  
José Todolí ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Low Risk ◽  
Ratio Test ◽  
Validation Sample ◽  
Bleeding Events ◽  
Increased Risk ◽  
Acute Venous Thromboembolism

SummaryA score that can accurately determine the risk of major bleeding during anticoagulant therapy may help to make decisions on anticoagulant use. RIETE is an ongoing registry of consecutive patients with acute venous thromboembolism (VTE). We composed a score to predict the risk for major bleeding within three months of anticoagulant therapy. Of 19,274 patients enrolled, 13,057 (67%) were randomly assigned to the derivation sample, 6,572 to the validation sample. In the derivation sample 314 (2.4%) patients bled (fatal bleeding, 105). On multivariate analysis, age >75 years, recent bleeding, cancer, creatinine levels >1.2 mg/dl, anemia, or pulmonary embolism at baseline were independently associated with an increased risk for major bleeding. A score was composed assigning 2 points to recent bleeding, 1.5 to abnormal creatinine levels or anemia, 1 point to the remaining variables. In the derivation sample 2,654 (20%) patients scored 0 points (low risk); 9,645 (74%) 1–4 points (intermediate); 758 (5.8%) >4 points (high risk). The incidences of major bleeding were: 0.3% (95% confidence interval [CI]: 0.1–0.6), 2.6% (95% CI: 2.3–2.9), and 7.3% (95% CI: 5.6–9.3), respectively. The likelihood ratio test was:0.14 (95% CI:0.07–0.27) for patients at low risk;2.96 (95% CI:2.18–4.02) for those at high risk. In the validation sample the incidence of major bleeding was:0.1%,2.8%,and 6.2%,respectively. In conclusion, a risk score based on six variables documented at entry can identify VTE patients at low, intermediate, or high risk for major bleeding during the first three months of therapy.

scholarly journals Risk Factors and Prediction Models for Venous Thromboembolism in Ambulatory Patients with Lung Cancer

Healthcare ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 778
Author(s):  
Ann-Rong Yan ◽  
Indira Samarawickrema ◽  
Mark Naunton ◽  
Gregory M. Peterson ◽  
Desmond Yip ◽  
...  
Keyword(s):  
Risk Factors ◽  
Lung Cancer ◽  
Venous Thromboembolism ◽  
High Risk ◽  
Prediction Models ◽  
Poor Performance ◽  
Risk Models ◽  
Related Risk ◽  
Wide Range ◽  
Ambulatory Patients

Venous thromboembolism (VTE) is a significant cause of mortality in patients with lung cancer. Despite the availability of a wide range of anticoagulants to help prevent thrombosis, thromboprophylaxis in ambulatory patients is a challenge due to its associated risk of haemorrhage. As a result, anticoagulation is only recommended in patients with a relatively high risk of VTE. Efforts have been made to develop predictive models for VTE risk assessment in cancer patients, but the availability of a reliable predictive model for ambulate patients with lung cancer is unclear. We have analysed the latest information on this topic, with a focus on the lung cancer-related risk factors for VTE, and risk prediction models developed and validated in this group of patients. The existing risk models, such as the Khorana score, the PROTECHT score and the CONKO score, have shown poor performance in external validations, failing to identify many high-risk individuals. Some of the newly developed and updated models may be promising, but their further validation is needed.

The Efficacy of Dextran-40 as a Venous Thromboembolism Prophylaxis Strategy in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

2017 ◽  
Vol 83 (2) ◽  
pp. 134-140 ◽  
Author(s):  
Jason M. Foster ◽  
Richard Sleightholm ◽  
Duncan Watley ◽  
Steven Wahlmeier ◽  
Asish Patel
Keyword(s):  
Venous Thromboembolism ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Medical Center ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Thromboembolism Prophylaxis ◽  
Dextran 40 ◽  
Perioperative Bleeding ◽  
Increased Risk

The incidence of venous thromboembolism (VTE) in peritoneal malignancies can approach 30 to 50 per cent without prophylaxis. Prophylaxis in cytoreductive surgeries (CRS) presents a challenge to preoperative heparin-based therapy because of an increased risk of coagulopathy and potential for bleeding. Herein, we report the large series of CRS and hyperthermic intraperitoneal chemotherapy receiving dextran-40 prophylaxis. Retrospective chart review of peritoneal malignancies patients undergoing CRS at University of Nebraska Medical Center identified 69 individuals who received dextran-40 between 2010 and 2013. The incidences of VTEs, perioperative bleeding, complications, morbidity, and mortality were determined in-hospital and at 90 days. Of the 69 patients treated, the 30-day VTE rate was 8.7 per cent, and no pulmonary embolisms, bleeding, anaphylactoid reaction, or mortality were observed with dextran usage. The specific VTE events included three upper extremity and three lower extremity VTEs. No additional VTE events were identified between 30 and 90 days. In conclusion, dextran-40 prophylaxis was not associated with any perioperative bleeding events, and the observed incidence of VTE was comparable to reported heparin-based prophylaxis in CRS/hyperthermic intraperitoneal chemotherapy patients. This data supports further exploration of dextran-40 as a VTE prophylactic agent in complex surgical oncology cases.

scholarly journals Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis

TH Open ◽  
2020 ◽  
Vol 04 (01) ◽  
pp. e59-e65 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Concetta Lipardi ◽  
Jianfeng Xu ◽  
Colleen Peluso ◽  
Theodore E. Spiro ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Risk Score ◽  
Lower Risk ◽  
Risk Group ◽  
High Risk Group ◽  
Cutoff Score ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
D Dimer

AbstractAn individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51–0.91, p = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, p = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.

Head and Neck Microsurgeon Practice Patterns and Perceptions Regarding Venous Thromboembolism Prophylaxis

2020 ◽  
Vol 36 (08) ◽  
pp. 549-555
Author(s):  
Kaushik P. Venkatesh ◽  
Shoshana W. Ambani ◽  
Aris R.L. Arakelians ◽  
Jonas T. Johnson ◽  
Mario G. Solari
Keyword(s):  
United States ◽  
Venous Thromboembolism ◽  
High Risk ◽  
Head And Neck ◽  
Free Flap ◽  
Practice Patterns ◽  
The United States ◽  
Bleeding Events ◽  
Vte Prophylaxis ◽  
Prophylactic Anticoagulation

Abstract Background Patients undergoing head and neck (H&N) microvascular reconstruction comprise a population at high risk for venous thromboembolism (VTE). Free flap and VTE thromboprophylaxis may coincide but tend to vary from surgeon to surgeon. This study identifies VTE prophylaxis patterns and perceptions among H&N microsurgeons in the United States. Methods An online survey on VTE prophylaxis practice patterns and perceptions was emailed to 172 H&N microsurgeons in the United States using an anonymous link. Results There were 74 respondents (43% response rate). These surgeons completed residencies in otolaryngology (59%), plastic surgery (31%), and oral maxillofacial surgery (7%). Most underwent fellowship training (95%) and have practiced at an academic center (97%) for at least 6 years (58%), performing an average of 42 ± 31 H&N free flap cases per year (range = 1–190). Most adhered to general VTE prophylaxis guidelines (69%) while 11% did not and 20% were unsure. Nearly all surgeons (99%) would provide prophylactic anticoagulation, mostly in the form of subcutaneous heparin (51%) or enoxaparin (44%); 64% additionally used aspirin, while 4% used aspirin alone. The majority of surgeons (68%) reported having postoperative VTE complications, with six surgeons (8%) reporting patient deaths due to pulmonary embolism. A third of the surgeons have encountered VTE prophylaxis-related adverse bleeding events, but most still believe that chemoprophylaxis is important for VTE prevention (92%). While 35% of surgeons were satisfied with their current practice, most would find it helpful to have official prophylactic anticoagulation guidelines specific to H&N free flap cases. Conclusion The majority of microsurgeons experienced postoperative VTE complications after H&N free flap reconstruction despite the routine use of prophylactic anticoagulation. Though bleeding events are a concern, most surgeons believe chemoprophylaxis is important for VTE prevention and would welcome official guidelines specific to this high-risk population.

Calculation of HAS-BLED Score Is Useful for Early Identification of Venous Thromboembolism Patients at High Risk for Major Bleeding Events: A Prospective Outpatients Cohort Study

2017 ◽  
Vol 44 (04) ◽  
pp. 348-352 ◽  
Author(s):  
Reinhard Raggam ◽  
Franz Hafner ◽  
Alexander Avian ◽  
Gerald Hackl ◽  
Gerhard Cvirn ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Bleeding Complications ◽  
Minor Bleeding ◽  
Prospective Evaluation ◽  
Bleeding Events ◽  
Increased Risk ◽  
Major Bleeding Events

AbstractThe aim of this study was prospective evaluation of the performance of the HAS-BLED score in predicting major bleeding complications in a real-world outpatient cohort, during long-term anticoagulation for venous thromboembolism (VTE), treated with a broad spectrum of anticoagulants. We analyzed 111 outpatients objectively diagnosed with VTE and treated long-term with various anticoagulants. Patients were grouped in three cohorts based on the anticoagulant regimen. Calculation of the HAS-BLED score and documentation of bleeding events were performed every 6 months for 1 year. Patients with a HAS-BLED score ≥ 3 had an increased risk for major bleeding events (odds ratio [OR]: 13.05, 95% confidence interval [CI]: 0.96–692.58, p = 0.028) and a trend to higher risk for minor bleeding events as well (OR: 2.25, 95% CI: 0.87–5.85, p = 0.091) when compared with patients with a HAS-BLED score < 3.This indicates that a HAS-BLED score ≥ 3 allows for identification of patients with VTE on long-term anticoagulation at an increased risk for major bleeding events, irrespective of the anticoagulant agent used.

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