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1.
Thromb Res ; 221: 45-50, 2022 Nov 29.
Article in English | MEDLINE | ID: mdl-36470069

ABSTRACT

INTRODUCTION: Evidence suggests that an apixaban-based strategy to treat acute venous thromboembolism (VTE) in patients with End-Stage Kidney Disease (ESKD) may be safer than a warfarin-based strategy. Apixaban has an additional advantage of not requiring bridging with heparin which often necessitates long hospitalizations for patients with ESKD. We sought to determine if an apixaban-based strategy is associated with less healthcare utilization than a warfarin-based strategy. MATERIAL AND METHODS: We employed a new-user, active-comparator retrospective cohort study using inverse probability of treatment weights (IPTW) to adjust for confounding demographic and clinical variables. Patients with ESKD newly initiated on either apixaban or warfarin for an acute VTE between 2014 and 2018 in the United States Renal Data System were included. Outcomes were presence of index hospitalization, length of index hospitalization, total hospital days, total hospital days excluding index hospitalization, total emergency department (ED) visits that did not result in hospitalization, and total skilled nursing facility days. RESULTS: At six months, patients who received apixaban were less likely to have an index hospitalization, had a shorter index hospitalization (median of 4.0 vs 8.0 days, p < 0.001), and had fewer total hospital days. The IPTW and index year-adjusted incidence rate ratios of total hospital days at one, three, and six months were 0.83 (95 % confidence intervals (CI) 0.79-0.86), 0.84 (95 % CI 0.81-0.88), and 0.88 (95 % CI 0.83-0.92) for apixaban compared to warfarin. CONCLUSION: Among patients with ESKD and VTE, resource utilization for an apixaban-based strategy appears to be lower than for a warfarin-based strategy.

3.
Int J Hematol ; 2022 Oct 01.
Article in English | MEDLINE | ID: mdl-36181657

ABSTRACT

Myeloproliferative neoplasms (MPN) are chronic clonal disorders characterized by overproduction of myeloid-lineage blood cells and potential risk of evolution to acute myeloid leukemia (AML). Chronic myeloid leukemia (CML) is distinct from other MPNs in that its pathophysiology stems from the BCR-ABL fusion protein of the Philadelphia chromosome (Ph +). Though there are known cases of Ph- and Ph + MPNs coexisting in a single patient, overall prevalence has never been quantified in a prospective cohort. Here, we review our center's MPN registry, which shows 0.6% of Ph- MPN patients later developed CML. This development occurred no less than 10 and up to 36 years after Ph- MPN diagnosis. This rate of chronic transformation exceeds what is expected, as the incidence of CML in the United States is 2 per 100,000 people-years. The probability of this CML case rate in an average-risk population is less than 0.001%, suggesting there are shared risk factors between Ph- and Ph + MPNs. We speculate that these risk factors may include exposures, genetic predispositions, or be inherent to disease biology. Abrupt-onset leukocytosis heralded post-MPN CML in all cases here and suggests this salient clinical feature should trigger hematologists to consider this diagnosis and perform appropriate testing.

4.
J Am Heart Assoc ; 11(18): e027119, 2022 09 20.
Article in English | MEDLINE | ID: mdl-36047732

ABSTRACT

Background Many hospitalized patients are not administered prescribed doses of pharmacologic venous thromboembolism prophylaxis. Methods and Results In this cluster-randomized controlled trial, all adult non-intensive care units (10 medical, 6 surgical) in 1 academic hospital were randomized to either a real-time, electronic alert-triggered, patient-centered education bundle intervention or nurse feedback intervention to evaluate their effectiveness for reducing nonadministration of venous thromboembolism prophylaxis. Primary outcome was the proportion of nonadministered doses of prescribed pharmacologic prophylaxis. Secondary outcomes were proportions of nonadministered doses stratified by nonadministration reasons (patient refusal, other). To test our primary hypothesis that both interventions would reduce nonadministration, we compared outcomes pre- versus postintervention within each cohort. Secondary hypotheses were tested comparing the effectiveness between cohorts. Of 11 098 patient visits, overall dose nonadministration declined significantly after the interventions (13.4% versus 9.2%; odds ratio [OR], 0.64 [95% CI, 0.57-0.71]). Nonadministration decreased significantly (P<0.001) in both arms: patient-centered education bundle, 12.2% versus 7.4% (OR, 0.56 [95% CI, 0.48-0.66]), and nurse feedback, 14.7% versus 11.2% (OR, 0.72 [95% CI, 0.62-0.84]). Patient refusal decreased significantly in both arms: patient-centered education bundle, 7.3% versus 3.7% (OR, 0.46 [95% CI, 0.37-0.58]), and nurse feedback, 9.5% versus 7.1% (OR, 0.71 [95% CI, 0.59-0.86]). No differential effect occurred on medical versus surgical units. The patient-centered education bundle was significantly more effective in reducing all nonadministered (P=0.03) and refused doses (P=0.003) compared with nurse feedback (OR, 1.28 [95% CI, 1.0-1.61]; P=0.03 for interaction). Conclusions Information technology strategies like the alert-triggered, targeted patient-centered education bundle, and nurse-focused audit and feedback can improve venous thromboembolism prophylaxis administration. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03367364.


Subject(s)
Venous Thromboembolism , Adult , Anticoagulants/adverse effects , Feedback , Hospitalization , Humans , Patient Education as Topic , Venous Thromboembolism/diagnosis , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control
5.
J Surg Res ; 280: 151-162, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35969933

ABSTRACT

INTRODUCTION: Venous thromboembolism (VTE) is a frequent cause of preventable harm among hospitalized patients. Many prescribed prophylaxis doses are not administered despite supporting evidence. We previously demonstrated a patient-centered education bundle improved VTE prophylaxis administration broadly; however, patient-specific factors driving nonadministration are unclear. We examine the effects of the education bundle on missed doses of VTE prophylaxis by sex. METHODS: We performed a post-hoc analysis of a nonrandomized controlled trial to evaluate the differences in missed doses by sex. Pre-intervention and intervention periods for patients admitted to 16 surgical and medical floors between 10/2014-03/2015 (pre-intervention) and 04/2015-12/2015 (intervention) were compared. We examined the conditional odds of (1) overall missed doses, (2) missed doses due to patient refusal, and (3) missed doses for other reasons. RESULTS: Overall, 16,865 patients were included (pre-intervention 6853, intervention 10,012), with 2350 male and 2460 female patients (intervention), and 6373 male and 5682 female patients (control). Any missed dose significantly reduced on the intervention floors among male (odds ratio OR 0.55; 95% confidence interval CI, 0.44-0.70, P < 0.001) and female (OR 0.59; 95% CI, 0.47-0.73, P < 0.001) patients. Similar significant reductions ensued for missed doses due to patient refusal (P < 0.001). Overall, there were no sex-specific differences (P-interaction >0.05). CONCLUSIONS: Our intervention increased VTE prophylaxis administration for both female and male patients, driven by decreased patient refusal. Patient education should be applicable to a wide range of patient demographics representative of the target group. To improve future interventions, quality improvement efforts should be evaluated based on patient demographics and drivers of differences in care.


Subject(s)
Venous Thromboembolism , Humans , Male , Female , Venous Thromboembolism/prevention & control , Patient Education as Topic , Anticoagulants/adverse effects , Hospitalization , Delivery of Health Care
6.
J Hosp Med ; 17(10): 809-818, 2022 10.
Article in English | MEDLINE | ID: mdl-35929542

ABSTRACT

BACKGROUND: Patients with end-stage kidney disease (ESKD) are at significantly increased risk for both thrombosis and bleeding relative to those with normal renal function. The optimal therapy of venous thromboembolism (VTE) in patients with ESKD is unknown. OBJECTIVE: To compare the safety and effectiveness of apixaban relative to warfarin in patients with ESKD and acute VTE. DESIGN, SETTING AND PARTICIPANTS: New-user, active-comparator retrospective United States population-based cohort with inverse probability of treatment weighting, using the United States Renal Data System data from 2014 to 2018. We included adults with ESKD on hemodialysis or peritoneal dialysis who were newly initiated on apixaban or warfarin for an acute VTE. MAIN OUTCOME AND MEASURES: The coprimary outcomes were major bleeding, recurrent VTE, and all-cause mortality within 6 months of anticoagulant initiation. Secondary outcomes were intracranial hemorrhage and gastrointestinal bleeding. The primary analyses were based on intent-to-treat defined by the first drug received and accounted for competing risks of death. Sensitivity analyses included varied follow-up time, as-treated analyses, and dose-specific apixaban subgroups. RESULTS: The apixaban and warfarin cohorts included 2302 and 9263 patients, respectively. Apixaban was associated with a lower risk of major bleeding (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.70-0.94), intracranial bleeding (HR 0.69, 95% CI 0.48-0.98), and gastrointestinal bleeding (HR 0.82, 95% CI 0.69-0.96). Recurrent VTE and all-cause mortality were not significantly different between the groups. CONCLUSION: Apixaban was associated with a lower risk of bleeding relative to warfarin when used to treat acute VTE in patients with ESKD on dialysis.


Subject(s)
Kidney Failure, Chronic , Venous Thromboembolism , Venous Thrombosis , Adult , Anticoagulants/adverse effects , Cohort Studies , Gastrointestinal Hemorrhage/drug therapy , Humans , Kidney Failure, Chronic/chemically induced , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Pyrazoles , Pyridones , Retrospective Studies , United States , Venous Thromboembolism/drug therapy , Venous Thrombosis/drug therapy , Warfarin/adverse effects
7.
Res Pract Thromb Haemost ; 6(5): e12753, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35859579

ABSTRACT

Background and Objectives: Current clinical guidelines recommend thromboprophylaxis for adults hospitalized with coronavirus disease 2019 (COVID-19), yet it is unknown whether higher doses of thromboprophylaxis offer benefits beyond standard doses. Methods: We studied electronic health records from 50 091 adults hospitalized with COVID-19 in the United States between February 2020 and February 2021. We compared standard (enoxaparin 30 or 40 mg/day, fondaparinux 2.5 mg, or heparin 5000 units twice or thrice per day) versus intermediate (enoxaparin 30 or 40 mg twice daily, or up to 1.2 mg/kg of body weight daily, heparin 7500 units thrice per day or heparin 10 000 units twice or thrice per day) thromboprophylaxis. We separately examined risk of escalation to therapeutic anticoagulation, severe disease (first occurrence of high-flow nasal cannula, noninvasive positive pressure ventilation or invasive mechanical ventilation), and death. To summarize risk, we present hazard ratios (HRs) with 95% confidence intervals (CIs) using adjusted time-dependent Cox proportional hazards regression models. Results: People whose first dose was high intensity were younger, more often obese, and had greater oxygen support requirements. Intermediate dose thromboprophylaxis was associated with increased risk of therapeutic anticoagulation (HR, 3.39; 95% CI, 3.22-3.57), severe disease (HR, 1.22; 95% CI, 1.17-1.28), and death (HR, 1.37; 95% CI, 1.21-1.55). Increased risks associated with intermediate-dose thromboprophylaxis persisted in subgroup and sensitivity analyses varying populations and definitions of exposures, outcomes, and covariates. Conclusions: Our findings do not support routine use of intermediate-dose thromboprophylaxis to prevent clinical worsening, severe disease, or death among adults hospitalized with COVID-19.

8.
J Pharm Pract ; : 8971900221116185, 2022 Jul 18.
Article in English | MEDLINE | ID: mdl-35848327

ABSTRACT

BACKGROUND: An antithrombotic stewardship program was implemented to reduce IV DTI use and increase fondaparinux and direct oral anticoagulant (DOAC) use for suspected or confirmed Heparin-induced thrombocytopenia (HIT). OBJECTIVES: This study evaluated the impact of an antithrombotic stewardship program on IV DTI utilization in patients with HIT. METHODS: A retrospective analysis of adults receiving IV DTIs or fondaparinux from July 2016 to July 2017 (pre-stewardship) and October 2017 to July 2019 (post-stewardship) was conducted. RESULTS: The median duration of IV DTI administration was not significantly different in HIT-negative patients between the pre- and post-stewardship cohorts (1.6 days (25th percentile (p25), 75th percentile (p75): .5, 3.3) vs 1.7 days (p25, p75: .9, 3.9), P = .31). The median duration of IV DTI administration in HIT-positive patients was 9.9 days (p25, p75: 7.6, 21.0) pre-stewardship and 7.3 days (p25, p75: 4.8, 16.5) post-stewardship (P = .18). For HIT-positive patients, the time from HIT diagnosis to discharge was 12.8 days (p25, p75: 8.9, 24.9) and 9.2 days (p25, p75: 4.0, 18.1) in the pre- and post-stewardship cohorts, respectively (P = .07). Fondaparinux and DOAC prescribing rates were 40.7% and 62.2% in the pre- and post-stewardship cohorts, respectively (P = .09). The percentage of patients with no contraindications to IV DTI alternatives receiving these agents increased from 31.2% to 78.6% (P = .01) following stewardship implementation. CONCLUSIONS: Intravenous DTI alternative utilization increased significantly after stewardship implementation. Stewardship implementation was associated with a non-statistically significant trend towards decreased IV DTI utilization and decreased length of stay for HIT-positive patients.

9.
J Natl Compr Canc Netw ; : 1-8, 2022 Jun 21.
Article in English | MEDLINE | ID: mdl-35728777

ABSTRACT

Patients with cancer are at high risk of developing arterial and venous thromboembolism (VTE). They constitute 15% to 20% of the patients diagnosed with VTE. Depending on the type of tumor, cancer therapy, and presence of other risk factors, 1% to 25% of patients with cancer will develop thrombosis. The decision to start patients with cancer on primary thromboprophylaxis depends on patient preference, balancing risk of bleeding versus risk of thrombosis, cost, and adequate organ function. Currently, guidelines recommend against the use of routine primary thromboprophylaxis in unselected ambulatory patients with cancer. Validated risk assessment models can accurately identify patients at highest risk for cancer-associated thrombosis (CAT). This review summarizes the recently updated NCCN Guidelines for CAT primary prophylaxis, with a primarily focus on VTE prevention. Two main clinical questions that providers commonly encounter will also be addressed: which patients with cancer should receive primary thromboprophylaxis (both surgical and medical oncology patients) and how to safely choose between different anticoagulation agents.

10.
Pediatrics ; 150(1)2022 07 01.
Article in English | MEDLINE | ID: mdl-35484817

ABSTRACT

BACKGROUND: Evidence regarding the safety and efficacy of anticoagulant thromboprophylaxis among pediatric patients hospitalized for coronavirus disease 2019 (COVID-19) is limited. We sought to evaluate safety, dose-finding, and preliminary efficacy of twice-daily enoxaparin as primary thromboprophylaxis among children hospitalized for symptomatic COVID-19, including primary respiratory infection and multisystem inflammatory syndrome in children (MISC). METHODS: We performed a phase 2, multicenter, prospective, open-label, single-arm clinical trial of twice-daily enoxaparin (initial dose: 0.5mg/kg per dose; max: 60mg; target anti-Xa activity: 0.20-0.49IU/mL) as primary thromboprophylaxis for children <18 years of age hospitalized for symptomatic COVID-19. Study endpoints included: cumulative incidence of International Society of Thrombosis and Haemostasis-defined clinically relevant bleeding; enoxaparin dose-requirements; and cumulative incidence of venous thromboembolism within 30-days of hospital discharge. Descriptive statistics summarized endpoint estimates that were further evaluated by participant age (±12 years) and clinical presentation. RESULTS: Forty children were enrolled and 38 met analyses criteria. None experienced clinically relevant bleeding. Median (interquartile range) dose to achieve target anti-Xa levels was 0.5 mg/kg (0.48-0.54). Dose-requirement did not differ by age (0.5 [0.46-0.52] mg/kg for age ≥12 years versus 0.52 [0.49-0.55] mg/kg for age <12 years, P = .51) but was greater for participants with MISC (0.52 [0.5-0.61] mg/kg) as compared with primary COVID-19 (0.48 [0.39-0.51] mg/kg, P = .010). Two children (5.3%) developed central-venous catheter-related venous thromboembolism. No serious adverse events were related to trial intervention. CONCLUSIONS: Among children hospitalized for COVID-19, thromboprophylaxis with twice-daily enoxaparin appears safe and warrants further investigation to assess efficacy.


Subject(s)
COVID-19 , Venous Thromboembolism , Anticoagulants/adverse effects , COVID-19/complications , Child , Enoxaparin/adverse effects , Hemorrhage , Humans , Prospective Studies , Systemic Inflammatory Response Syndrome , Treatment Outcome , Venous Thromboembolism/prevention & control
11.
Surg Obes Relat Dis ; 18(5): 594-603, 2022 05.
Article in English | MEDLINE | ID: mdl-35093269

ABSTRACT

BACKGROUND: The optimal regimen for prevention and treatment of venous thromboembolism in bariatric surgical patients remains controversial. Direct oral anticoagulants are potentially advantageous over other agents, but inadequate evidence exists regarding their effects in bariatric surgical patients. OBJECTIVES: To investigate single-dose pharmacokinetic (PK) and pharmacodynamic (PD) parameters of apixaban when administered to patients undergoing vertical sleeve gastrectomy (VSG) or Roux-en-Y gastric bypass (RYGB) and to determine whether the PK and PD parameters are affected by type of bariatric surgery and weight loss in the immediate and postoperative period up to 12 months. SETTING: University Hospital and A Bariatric Center of Excellence, Baltimore, Maryland. METHODS: Adults with a body mass index ≥35 kg/m2 approved for bariatric surgery were enrolled in a single-center, open-label, nonrandomized, single-dose clinical study (NCT No. 02406885; www. CLINICALTRIALS: gov). Apixaban PK and PD parameters were measured after a single 5 mg dose of the drug was given preoperatively and at 1, 6, and 12 months postoperatively in patients undergoing VSG and RYGB. Change in PK parameters was assessed as maximum concentration, time to maximum concentration, elimination half-life, and area under the concentration-time curve from 0-72 hours and change in PD parameters were assessed by chromogenic factor X activity. RESULTS: Of 33 patients enrolled, 28 (14 VSG, 14 RYGB) completed all visits and were analyzed. Most patients (89%) were female, with a mean age of 43.8 years and a body mass index of 48.7 kg/m2. Area under the concentration-time curve from 0-72 hours increased from baseline to 1 month (1009.1 to 1232.9 ng/mL/hr, P = .002), returned to baseline at 6 months (1000.9 ng/mL/hr, P = .88), and decreased significantly at 12 months (841.8 ng/mL/hr, P = .001). Maximum concentration did not change significantly. Predose factor X activity dropped significantly from 113% preoperatively to 89.8 % at 12 months postoperatively (P < .0001). Three-hour postdose factor X activity was significantly lower at 1, 6, and 12 months postoperatively versus preoperatively. However, the magnitude of the decrease from predose to 3-hour postdose was not significantly altered by surgery. CONCLUSION: The effect of either VSG or RYGB on apixaban PK and PD parameters is minimal. Factor X activity after 5 mg apixaban was lower in postoperative versus preoperative bariatric patients, but this effect appears to be primarily the result of a decrease in factor X activity from bariatric surgery itself and not a postoperative change in apixaban PK and PD parameters. Future studies should investigate the safety, efficacy, and clinical outcomes of apixaban and other direct oral anticoagulants perioperatively and beyond 12 months following bariatric surgery.


Subject(s)
Gastric Bypass , Obesity, Morbid , Adult , Anticoagulants , Factor X , Female , Gastrectomy/adverse effects , Gastric Bypass/adverse effects , Humans , Male , Obesity, Morbid/etiology , Obesity, Morbid/surgery , Pyrazoles , Pyridones , Retrospective Studies
12.
Ann Intern Med ; 175(4): 513-522, 2022 04.
Article in English | MEDLINE | ID: mdl-35038274

ABSTRACT

BACKGROUND: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described. OBJECTIVE: To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States. DESIGN: Case series. SETTING: United States. PATIENTS: Case patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required. MEASUREMENTS: Reporting rates (cases per million vaccine doses) and descriptive epidemiology. RESULTS: A total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S (n = 54) or a messenger RNA (mRNA)-based COVID-19 vaccine (n = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%). LIMITATIONS: Underreporting and incomplete case follow-up. CONCLUSION: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.


Subject(s)
COVID-19 , Thrombocytopenia , Thrombosis , Vaccines , Ad26COVS1/adverse effects , Adolescent , Adult , Aged , COVID-19/epidemiology , COVID-19 Vaccines/adverse effects , Female , Humans , Male , Middle Aged , RNA, Messenger , Syndrome , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , Thrombosis/chemically induced , Thrombosis/etiology , United States/epidemiology , Vaccination/adverse effects , Vaccines/adverse effects , Young Adult
13.
J Natl Compr Canc Netw ; 20(1): 91-95, 2022 01.
Article in English | MEDLINE | ID: mdl-34991076

ABSTRACT

Venous thromboembolism (VTE) is a major complication in all patients with cancer. Compared with the general population, patients with multiple myeloma (MM) have a 9-fold increase in VTE risk, likely because of their malignancy, its treatments, and other additional patient-related factors. In MM, thromboembolism events tend to occur within 6 months of treatment initiation, regardless of treatment regimen; however, the use of immunomodulatory agents such as thalidomide or lenalidomide, especially in combination with dexamethasone or multiagent chemotherapy, is known to create a significant risk for VTE. Currently, official recommendations for VTE prophylaxis in MM outlined in various national guidelines or multidisciplinary society panels are based on expert opinion, because data from randomized controlled trials are scarce. Large studies which have mainly focused on the efficacy of thromboprophylaxis in patients with cancer at higher risk for VTE either had a very low representation of patients with MM, or excluded them all together, limiting our ability to draw evidence-based conclusions on how to effectively protect MM population from VTE. In this brief perspective, we highlight some of the greatest challenges that have hampered the field concerning the availability of high-quality clinical trial data for the formulation of best VTE prophylaxis strategies in patients with newly diagnosed MM, as well as the rationale for the latest updates in the NCCN Guidelines on this topic.


Subject(s)
Multiple Myeloma , Venous Thromboembolism , Anticoagulants/adverse effects , Humans , Lenalidomide/adverse effects , Multiple Myeloma/complications , Multiple Myeloma/drug therapy , Risk Factors , Thalidomide/adverse effects , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
14.
JACC Basic Transl Sci ; 6(12): 935-945, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34904132

ABSTRACT

COVID-19 is characterized by vascular inflammation and thrombosis, including elevations in P-selectin, a mediator of inflammation released by endothelial cells. We tested the effect of P-selectin inhibition on biomarkers of thrombosis and inflammation in patients with COVID-19. Hospitalized patients with moderate COVID-19 were randomly assigned to receive either placebo or crizanlizumab, a P-selectin inhibitor, in a double-blind fashion. Crizanlizumab reduced P-selectin levels by 89%. Crizanlizumab increased D-dimer levels by 77% and decreased prothrombin fragment. There were no significant differences between crizanlizumab and placebo for clinical endpoints. Crizanlizumab was well tolerated. Crizanlizumab may induce thrombolysis in the setting of COVID-19. (Crizanlizumab for Treating COVID-19 Vasculopathy [CRITICAL]; NCT04435184).

15.
J Natl Compr Canc Netw ; 19(10): 1181-1201, 2021 10 15.
Article in English | MEDLINE | ID: mdl-34666313

ABSTRACT

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Cancer-Associated Venous Thromboembolic Disease focus on the prevention, diagnosis, and treatment of patients with cancer who have developed or who are at risk for developing venous thromboembolism (VTE). VTE is a significant concern among cancer patients, who are at heightened risks for developing as well as dying from the disease. The management of patients with cancer with VTE often requires multidisciplinary efforts at treating institutions. The NCCN panel comprises specialists from various fields: cardiology, hematology/hematologic oncology, internal medicine, interventional radiology, medical oncology, pharmacology/pharmacy, and surgery/surgical oncology. This article focuses on VTE prophylaxis for medical and surgical oncology inpatients and outpatients, and discusses risk factors for VTE development, risk assessment tools, as well as management methods, including pharmacological and mechanical prophylactics. Contraindications to therapeutic interventions and special dosing, when required, are also discussed.


Subject(s)
Neoplasms , Venous Thromboembolism , Venous Thrombosis , Anticoagulants , Humans , Medical Oncology , Neoplasms/complications , Neoplasms/therapy , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Venous Thrombosis/drug therapy
16.
J Natl Compr Canc Netw ; 19(10): 1203-1210, 2021 10 15.
Article in English | MEDLINE | ID: mdl-34666314

ABSTRACT

Venous thromboembolic disease can be a fatal complication of cancer. Despite advances in prevention, thousands of patients require treatment of cancer-associated thrombosis (CAT) each year. Guidelines have advocated low-molecular-weight heparin (LMWH) as the preferred anticoagulant for CAT for years, based on clinical trial data showing LMWH to be associated with a lower risk of recurrent thrombosis when compared with vitamin K antagonists. However, the potentially painful, subcutaneously administered LMWH injections can be expensive, and clinical practice has not been consistent with guideline recommendations. Recently, studies have compared LMWH to the direct oral anticoagulants (DOACs) for the management of CAT. Based on promising trial results outlined in this review, DOACs are now preferred anticoagulants for CAT occurring in patients without gastric or gastroesophageal lesions. For patients with gastrointestinal cancers, who may be at higher risk of hemorrhage with the DOACs, LMWH remains the anticoagulant of choice. Applying the latest data from this rapidly evolving field to care for diverse patient groups can be challenging. This article provides an evidence-based review of outpatient anticoagulant selection for lower-extremity deep vein thrombosis or pulmonary embolism in the setting of cancer, and takes into account special populations with cancer.


Subject(s)
Neoplasms , Thrombosis , Venous Thromboembolism , Venous Thrombosis , Anticoagulants/adverse effects , Heparin, Low-Molecular-Weight , Humans , Neoplasms/complications , Neoplasms/drug therapy , Thrombosis/drug therapy , Thrombosis/etiology , Thrombosis/prevention & control , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Venous Thrombosis/drug therapy , Venous Thrombosis/etiology , Venous Thrombosis/prevention & control
17.
Res Pract Thromb Haemost ; 5(5): e12549, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34308096

ABSTRACT

BACKGROUND: Prophylactic anticoagulation with rivaroxaban significantly reduced the risk of cancer-associated thrombosis during the intervention period in the CASSINI trial. Direct oral anticoagulants may increase the risk of gastrointestinal (GI) tract bleeding in patients with an in situ GI tract cancer or lesion. OBJECTIVE: This post hoc analysis characterized the efficacy and safety of rivaroxaban in patients with and without gastric/gastroesophageal junction (G/GEJ) tumors. METHODS: Primary and secondary efficacy end points and adjudicated bleeding events, including bleeding sites, were analyzed for the intent-to-treat population by cancer type (G/GEJ vs non-G/GEJ) for the 180-day observation period. RESULTS: In patients with G/GEJ tumors, the rates for the primary efficacy end point were 3.4% for rivaroxaban versus 6.9% for placebo (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.11-1.80). In patients with non-G/GEJ tumors, the rivaroxaban group had a lower risk of the primary end point (6.6% vs 9.3%; HR, 0.70; 95% CI, 0.40-1.21). Rates of major bleeding in patients with G/GEJ tumors were 4.6% (4/88) versus 1.2% (1/85) for rivaroxaban and placebo; rates in patients with non-G/GEJ tumors were 1.3% (4/317) versus 0.9% (3/319), respectively. CONCLUSIONS: Excluding patients with G/GEJ tumors resulted in a definable population of cancer patients who achieved an improved benefit-risk balance from rivaroxaban prophylaxis.

18.
Blood Adv ; 5(14): 2813-2816, 2021 07 27.
Article in English | MEDLINE | ID: mdl-34269797

ABSTRACT

Acquired von Willebrand disease (aVWD) is a rare disorder associated with a reduction in von Willebrand factor (VWF) activity, leading to increased bleeding risk. Monoclonal gammopathy of undetermined significance (MGUS) is the most common cause of lymphoproliferative disorder-associated aVWD and is caused by accelerated clearance of circulating VWF. Standard VWF replacement protocols for congenital VWD based on intermittent bolus dosing are typically less effective for aVWD because of antibody-mediated clearance. Intermittent bolus dosing of VWF concentrates often leads to inadequate peak response and profoundly shortened VWF half-life in aVWD. Intravenous immune globulin (IVIG) has demonstrated efficacy in aVWD; however, treatment effect is delayed up to 4 days, limiting its efficacy in acutely bleeding patients. We report the successful use of continuous-infusion VWF concentrate (with or without concomitant IVIG) in 3 patients with MGUS-associated aVWD who had demonstrated an inadequate response to bolus dosing. VWF concentrate doses required in this cohort were higher than typical doses for bleeding treatment in congenital VWD. This report illustrates that continuous-infusion VWF concentrate administration with or without intravenous immunoglobulin rapidly achieves target ristocetin cofactor activity and provides adequate hemostasis in aVWD associated with immunoglobulin G MGUS.


Subject(s)
von Willebrand Diseases , von Willebrand Factor , Hemorrhage/drug therapy , Hemorrhage/etiology , Hemostasis , Humans , Immunoglobulins, Intravenous/therapeutic use , von Willebrand Diseases/drug therapy
19.
Blood Adv ; 5(14): 2807-2812, 2021 07 27.
Article in English | MEDLINE | ID: mdl-34264267

ABSTRACT

Standard treatment of catheter-associated upper extremity deep vein thrombosis (UE-DVT) is anticoagulation, although catheters are often removed for this indication. The optimal time for catheter removal and whether the act and/or timing of catheter removal is associated with pulmonary embolism (PE) remain unknown. A retrospective cohort study was performed at 8 participating institutions through the Venous thromboEmbolism Network US. Patients with hematologic malignancies and central venous catheter (CVC)-associated UE-DVT were included from 1 January 2010 through 31 December 2016. The primary outcome was objectively confirmed PE within 7 days of UE-DVT diagnosis in anticoagulated patients comparing early (≤48 hours) vs delayed (>48 hours) catheter removal. A total of 626 patients were included, among whom 480 were treated with anticoagulation. Among anticoagulated patients, 255 underwent early CVC removal, while 225 had delayed or no CVC removal; 146 patients received no anticoagulation, among whom 116 underwent CVC removal alone. PE within 7 days occurred in 2 patients (0.78%) with early removal compared with 1 patient (0.44%) with delayed or no CVC removal (P > .9). PE or any cause of death within 7 days occurred in 3 patients in both the early removal (1.18%) and delayed/no removal (1.33%) groups (P > .9). In patients treated with CVC removal only (no anticoagulation), there were no PEs but 3 deaths within 7 days. In patients with hematological malignancy and CVC-associated UE-DVT, early removal of CVCs was not associated with an increased risk of PE compared with delayed or no removal.


Subject(s)
Central Venous Catheters , Pulmonary Embolism , Upper Extremity Deep Vein Thrombosis , Central Venous Catheters/adverse effects , Humans , Pulmonary Embolism/etiology , Retrospective Studies , Upper Extremity , Upper Extremity Deep Vein Thrombosis/etiology
20.
Qual Manag Health Care ; 30(4): 226-232, 2021.
Article in English | MEDLINE | ID: mdl-34232138

ABSTRACT

BACKGROUND AND OBJECTIVES: Health services research often relies on readily available data, originally collected for administrative purposes and used for public reporting and pay-for-performance initiatives. We examined the prevalence of underreporting of diagnostic procedures for acute myocardial infarction (AMI), deep venous thrombosis (DVT), and pulmonary embolism (PE), used for public reporting and pay-for-performance initiatives. METHOD: We retrospectively identified procedures for AMI, DVT, and PE in the National Inpatient Sample (NIS) database between 2012 and 2016. From January 1, 2012, through September 30, 2015, the NIS used the International Classification of Diseases, Ninth Revision (ICD-9) coding scheme. From October 1, 2015, through December 31, 2016, the NIS used the International Classification of Diseases, Tenth Revision (ICD-10) coding scheme. We grouped the data by ICD code definitions (ICD-9 or ICD-10) to reflect these code changes and to prevent any confounding or misclassification. In addition, we used survey weighting to examine the utilization of venous duplex ultrasound scan for DVT, electrocardiogram (ECG) for AMI, and chest computed tomography (CT) scan, pulmonary angiography, echocardiography, and nuclear medicine ventilation/perfusion () scan for PE. RESULTS: In the ICD-9 period, by primary diagnosis, only 0.26% (n = 5930) of patients with reported AMI had an ECG. Just 2.13% (n = 7455) of patients with reported DVT had a peripheral vascular ultrasound scan. For patients with PE diagnosis, 1.92% (n = 12 885) had pulmonary angiography, 3.92% (n = 26 325) had CT scan, 5.31% (n = 35 645) had cardiac ultrasound scan, and 0.45% (n = 3025) had scan. In the ICD-10 period, by primary diagnosis, 0.04% (n = 345) of reported AMI events had an ECG and 0.91% (n = 920) of DVT events had a peripheral vascular ultrasound scan. For patients with PE diagnosis, 2.08% (n = 4805) had pulmonary angiography, 0.63% (n = 1460) had CT scan, 1.68% (n = 3890) had cardiac ultrasound scan, and 0.06% (n = 140) had scan. Small proportions of diagnostic procedures were observed for any diagnoses of AMI, DVT, or PE. CONCLUSIONS: Our findings question the validity of using NIS and other administrative databases for health services and outcomes research that rely on certain diagnostic procedures. Unfortunately, the NIS does not provide granular data that can control for differences in diagnostic procedure use, which can lead to surveillance bias. Researchers and policy makers must understand and acknowledge the limitations inherent in these databases, when used for pay-for-performance initiatives and hospital benchmarking.


Subject(s)
Inpatients , Venous Thrombosis , Humans , Reimbursement, Incentive , Retrospective Studies , Tomography, X-Ray Computed , Venous Thrombosis/diagnosis , Venous Thrombosis/epidemiology
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