Improvement of anticoagulant treatment using a dynamic decision support algorithm: A Danish Cohort study

Introduction

Warfarin is the most widely prescribed vitamin K antagonist and in the United States and Europe more than 10 million people are currently in long-term oral anticoagulant treatment. This study aims to retrospectively validate a dynamic statistical model providing dosage suggestions to patients in warfarin treatment.

Materials and methods

The model was validated on a cohort of 553 patients with a mean TTR of 83%. Patients in the cohort were self-monitoring and managed by a highly specialised anticoagulation clinic. The predictive model essentially consists of three parts handling INR history, warfarin dosage and biological noise, which allows for prediction of future INR values and optimal warfarin dose to stay on INR target. Further, the model is based on parameters initially being set to population values and gradually individualised during monitoring of patients.

Primary outcome

Time in therapeutic range was used as surrogate quality measure of the treatment, and model-suggested dosage of warfarin was used to assess the accuracy of the model performance.

Results

The accuracy of the model predictions measured as median absolute error was 0.53 mg/day (interquartile range from 0.25 to 1.0). The model performance was evaluated by the difference between observed and predicted warfarin intake in the preceding week of an INR measurement. In more than 70% of the cases where INR measurements were outside the therapeutic range, the model suggested a more reasonable dose than the observed intake.

Conclusion

Applying the proposed dosing algorithm can potentially further increase the time in INR target range beyond 83%.     

Increased Risk of Deep Vein Thrombosis and Pulmonary Thromboembolism in Patients with Spinal Cord Injury: A Nationwide Cohort Prospective Study

Background

We investigated the effect of spinal cord injury (SCI) on the development of deep vein thrombosis (DVT) and pulmonary thromboembolism (PE) by conducting a nationwide longitudinal cohort study.

Methods

We studied the entire hospitalized population in Taiwan for the 1998–2008 period, with a follow-up period extending to the end of 2010. We identified SCI patients using the Taiwan National Health Insurance Research Database (NHIRD), and selected a cohort that was 1:4 frequency-matched by age (5-y span), sex, and index year from the general population. We analyzed the risks of DVT and PE using Cox proportional-hazards regression models, which included the demographic variables of sex, age, and comorbidities.

Results

A total of 47,916 SCI patients (62.7% men, mean age of 50.0 y) and 191,664 controls were followed for 308,266 and 1,341,169 person-years, respectively. The adjusted hazard ratio (HR) of DVT and PE development was 2.46-fold and 1.57-fold among the SCI patients, respectively. The highest risk of DVT and PE developed within 3 months after an SCI occurred (HR: 16.9 and 3.64, respectively). The adjusted HR of DVT and PE rose markedly with increasing age. The adjusted HR of DVT was highest among C-spine SCI patients, and the adjusted HR of PE was highest among T-spine SCI patients.

Conclusion

This nationwide prospective cohort study demonstrated that the risk of DVT and PE increased significantly in SCI patients compared with that of the general population. The highest risk of DVT and PE developed within 3 months after an SCI occurred.     

Indirect treatment comparison of new oral anticoagulants for the treatment of acute venous thromboembolism

Background

Numerous new oral anticoagulants (NOACs) have been compared to a parenteral anticoagulant/oral vitamin K antagonist (VKA) for the treatment of acute venous thromboembolism (VTE). We aimed to conduct a systematic review and adjusted indirect comparison meta-analysis to compare the efficacy and safety of NOACs for this indication.

Methods

We conducted a systematic literature search through November 2013 for randomized trials that evaluated treatment of acute VTE with a NOAC including rivaroxaban, apixaban, dabigatran and edoxaban. Trials had to report at least one of the following outcomes of interest: mortality, recurrent VTE, recurrent pulmonary embolism (PE), recurrent deep vein thrombosis (DVT), or major bleeding. Included trials were evaluated for quality using the Cochrane Risk of Bias tool. We performed an adjusted indirect comparison meta-analysis to evaluate the comparative efficacy and safety of NOACs, reporting relative risks (RRs) and 95% confidence intervals for each outcome.

Results

Six trials (n = 27,069) met inclusion criteria, one each evaluating apixaban and edoxaban and two trials each evaluating rivaroxaban and dabigatran. Risk of bias was low for all trials. NOACS did not differ significantly in the risk of mortality, recurrent VTE, recurrent PE or recurrent DVT. Dabigatran increased major bleeding risk compared to apixaban [RR 2.69 (1.19 to 6.07)] as did edoxaban compared to apixaban [RR 2.74 (1.40 to 5.39)].

Conclusion

Although NOACs do not appear to differ in the efficacy of treating acute VTE, data suggests apixaban to be the safer than some of its competitors.     

Venous thromboembolism after Diaphragm Pacing in amyotrophic lateral sclerosis

Introduction: Patients with amyotrophic lateral sclerosis (ALS) are prone to venous thromboembolism (VTE) and secondary complications. Because there is an increased incidence of VTE after surgical procedures, placement of a Diaphragm Pacing System (DPS) in ALS patients as treatment for respiratory muscle weakness could potentially increase the incidence of VTE, especially in patients with limited mobility. Methods: We implanted a DPS in 10 ALS patients who met the criteria for this procedure. They underwent a preoperative evaluation as recommended by the guidelines. Results: We report 2 patients with no symptoms of deep vein thrombosis (DVT) before the surgical procedure who then developed perioperative VTE. Conclusions: These patients highlight the need to consider preoperative screening for DVT and postoperative thromboprophylaxis in high‐risk ALS patients who undergo DPS placement. Muscle Nerve 50 : 863–865, 2014     

What Are Drivers of Readmission for Readmission-Requiring Venous Thromboembolic Events After Primary Total Hip Arthroplasty? An Analysis of 544,443 Cases

BackgroundVenous thromboembolism (VTE) is a potential postoperative complication after total hip arthroplasty (THA). These events present with a range of severity, and some require readmission. The present study aimed to identify unexplored risk factors for severe VTE that lead to hospital readmission.MethodsThe Agency of Healthcare Research and Quality’s National Readmissions Database was retrospectively queried for all patients who underwent primary THA (January 2016 to December 2018). Study population included patients who were readmitted for VTE within 90 days after an elective THA. Bivariate and multivariate regression analyses were performed using patient demographics, insurance status, elective nature of the surgery, healthcare institution characteristics, and baseline comorbidities.ResultsHigher risk of readmission for VTE was evident among elderly (71-80 years vs <40 years: odds ratio [OR] 1.7, 95% confidence interval [CI] 1.3-2.2, P = .0002), male patients (OR 1.2, 95% CI 1.2-1.3). Nonelective THAs were associated with markedly higher odds of readmission for VTE (OR 20.5, 95% CI 18.9-22.2), peripheral vascular disease (OR 1.2, 95% CI 1.1-1.4), lymphoma (OR 1.5, 95% CI 1.1-2.1), metastatic cancer (OR 1.8, 95% CI 1.4-2.2), obesity (OR 1.5, 95% CI 1.4-1.6), and fluid-electrolyte imbalance (OR 1.1, 95% CI 1.0-1.2). Home health care (OR 0.8, 95% CI 0.7-0.8) and discharge to skilled nursing facility (OR 0.7, 95% CI 0.7-0.8) had lower odds of readmission for VTE vs unsupervised home discharge, while insurance type was not a significant driver(P > .05).ConclusionOne in 135 THA patients is likely to experience a VTE requiring readmission after THA. Male patients, age >70 years, and specific baseline comorbidities increase such risk. Furthermore, discharge to a supervised setting mitigated the risk of VTE requiring readmission compared to unsupervised discharge. As VTE prophylaxis protocols continue to evolve, these patients may require optimized perioperative care pathways to mitigate VTE complications.     

Extended outpatient chemoprophylaxis reduces venous thromboembolism after radical cystectomy

Purpose

Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism, is a common cause of morbidity and mortality after radical cystectomy. The purpose of our study was to evaluate the utility of extended outpatient chemoprophylaxis against VTE after radical cystectomy—with a focus on any reduction in the incidence of VTE, including DVT and pulmonary embolism.

利伐沙班与低分子肝素预防膝关节翻修术后深静脉血栓的临床疗效分析

目的:比较利伐沙班与低分子肝素预防膝关节翻修术后深静脉血栓（Deep Vein Thrombosis,DVT）的临床疗效。方法:回顾分析2014年1月—2017年1月收治的58例（59膝）膝关节翻修患者的临床资料,按 DVT预防方式分为低分子肝素组33例（33膝）和利伐沙班组25例（26膝）,采用SPSS19.0统计软件进行分析,比较两组患者术后DVT及出血事件的发生率和膝关节疼痛、肿胀、淤血瘀斑、功能以及不良事件发生率的差异。结果:术后患者切口均Ⅰ期愈合,利伐沙班组和低分子肝素组DVT的发生率为分别为4.00%（1/25）和6.06%（2/33）,两组差异无统计学意义（P＞0.05）。利伐沙班组皮下瘀斑的发生率为36.00%（9/25）,显著高于低分子肝素组6.06%（2/33）,差异有统计学意义（P＜0.05）。两组患者术后引流量、出凝血指标、肢体肿胀程度及膝关节HSS（Hospital for Special surgery knee Score）评分、VAS（Visual Analogue Score）疼痛评分、不良事件的发生率均无统计学差异（P＞0.05）。结论:利伐沙班和低分子肝素预防膝关节翻修术后DVT安全有效,二者效果相当,但利伐沙班增加了皮下瘀斑形成的风险。     

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Background

Patients with acute deep vein thrombus (DVT) can safely be treated as outpatients. However the role of outpatient treatment in patients diagnosed with a pulmonary embolism (PE) is controversial. We sought to determine the safety of outpatient management of patients with acute symptomatic PE.

Materials and Methods

A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Pooled proportions for the different outcomes were calculated.

Results

A total of 1258 patients were included in the systematic review. The rate of recurrent venous thromboembolism (VTE) in patients with PE managed as outpatients was 1.47% (95% CI: 0.47 to 3.0%; I²: 65.4%) during the 3 month follow-up period. The rate of fatal PE was 0.47% (95% CI: 0.16 to 1.0%; I²: 0%). The rates of major bleeding and fatal intracranial hemorrhage were 0.81% (95% CI: 0.37 to 1.42%; I²: 0%) and 0.29% (95% CI: 0.06 to 0.68%; I²: 0%), respectively. The overall 3 month mortality rate was 1.58% (95% CI: 0.71 to 2.80%; I²: 45%). The event rates were similar if employing risk stratification models versus using clinical gestalt to select appropriate patients for outpatient management.

Conclusions

Independent of the risk stratification methods used, the rate of adverse events associated with outpatient PE treatment seems low. Based on our systematic review and pooled meta-analysis, low-risk patients with acute PE can safely be treated as outpatients if home circumstances are adequate.     

Thromboprophylaxis patterns,risk factors,and outcomes of care in the medically ill patient population

Introduction

Medically ill, hospitalized patients are at increased risk for venous thromboembolism (VTE) after discharge. This study aimed to examine thromboprophylaxis patterns, risk factors, and post-discharge outcomes.

Methods

This was a retrospective claims analysis involving administrative claims data and in-patient data abstracted from a sample of hospital charts. Patients aged ≥ 40 years hospitalized for ≥ 2 days for nonsurgical reasons between 2005 and 2009 were included. Hospital chart data were abstracted for a random sample of patients without evidence of anticoagulant use at 30 days post-discharge. The combined data determined whether in-patient thromboprophylaxis (anticoagulant or mechanical prophylaxis) reduces risk of VTE at 90 days post-discharge. Hazard ratios (HR) and odds ratios (OR) were calculated using Cox proportional hazard models and logistic regression.

Results

Of 141,628 patients in the claims analysis, 3.9% received anticoagulants (3.6% warfarin). VTE, rehospitalization, and mortality rates were 1.9%, 17.2%, and 6.2%, respectively. The strongest predictors of post-discharge VTE were history of VTE (HR = 4.0, 95% confidence interval [CI]: 3.3-4.8), and rehospitalization (HR = 3.9, 95% CI: 3.6-4.3). Of 504 medical charts, 209 (41.5%) reported in-patient thromboprophylaxis. There was no statistically significant difference in post-discharge VTE rates between patients who did and did not receive in-patient thromboprophylaxis. All-cause mortality was greater among patients without use of VTE prophylaxis.

Conclusion

Utilization rates of in-hospital and post-discharge VTE prophylaxis were low. In-hospital VTE prophylaxis did not reduce the risk of post-discharge VTE in the absence of post-discharge anticoagulation. Combined in-patient and post-discharge thromboprophylaxis lowered the odds of short-term, all-cause post-discharge mortality.