Prevention Of Thromboembolism Research Articles

Effect of different application duration of a venous foot pump on prevention of venous thromboembolism after hip and knee arthroplasty: a multicenter prospective clinical trial

ObjectiveTo investigate the optimal duration of applying a venous foot pump (VFP) in the prevention of venous thromboembolism (VTE) following hip and knee arthroplasty.MethodsA total of 230 patients undergoing hip and knee arthroplasty between March 2021 and March 2022 in orthopaedic departments of four major teaching hospitals were prospectively enrolled. Patients were randomly divided into five groups based on the duration of the VFP application. Postoperative deep vein thromboses (DVT), including proximal, distal, and intermuscular DVT, were recorded for analysis. Postoperative blood coagulation examinations, such as D-dimer and active partial thromboplastin time (APTT), pain outcome, and degree of comfort were also collected.ResultsTwo of the 230 patients withdrew due to early discharge from the hospital, and 228 patients were included in the final analysis. The mean age was 60.38 ± 13.33 years. The baseline characteristics were comparable among the five groups. Compared with the other groups, patients treated with 6-hour VFP had the lowest incidence of DVT (8.7%, 4/46), followed by those treated with 1-hour VFP (15.2%, 7/46), 12-hour VFP (15.6%, 7/45), 18-hour VFP(17.8%, 8/45) and 20-hour VFP(21.7%, 10/46), but with no significant difference (P = 0.539). Regarding postoperative blood coagulation examinations, patients treated with 6-hour VFP had the lowest D-dimer (P = 0.658) and the highest APTT (P = 0.262) compared with the other four groups. 6-hour VFP also had the lowest pain score (P = 0.206) and the highest comfort score (P = 0.288) compared with the other four groups.ConclusionsSix hours may be the optimal duration of applying VFP for the prevention of VTE in patients undergoing hip and knee arthroplasty in terms of VTE incidence, postoperative blood coagulation examinations, pain outcomes, and comfort scores.

Oral Anticoagulant Therapy in Patients with Philadelphia-Negative Myeloproliferative Neoplasms: A Real-Life Comparison between Vitamin K Antagonists and Direct Oral Anticoagulants

BACKGROUND Chronic myeloproliferative neoplasms (MPN) are characterized by an high risk of thrombosis and bleeding. Historically, vitamin K inhibitors (VKAs) have been the preferred oral anticoagulant therapy (OAT) for these patients (pts). However, nowadays, VKAs are being used less frequently, and direct oral anticoagulants (DOACs) are becoming more popular. Despite this trend, there is still limited evidence in the literature regarding the efficacy and safety of these drugs in the context of MPN. Specifically, there is a lack of data directly comparing VKAs and DOACs in a real-world clinical setting. AIMS The study aimed to conduct a real-world analysis comparing the efficacy and safety of DOACs and VKAs in patients with MPN. Both medications were prescribed for the treatment and secondary prevention of venous thromboembolism (VTE) or for the prevention of thrombosis in pts with atrial fibrillation (AF). The secondary endpoints were to assess the influence of common demographic, clinical, and hematological variables on the incidence of thrombotic events (TE) and bleeding events (BE) METHODS We conducted an observational retrospective monocentric study that enrolled all consecutive pts with MPN, followed at the MPN Clinic of the IRCCS Foundation S. Gerardo dei Tintori - Monza between 1993 and 2022, who received OAT with VKAs or DOACs for VTE or AF. For each pts, we collected demographic, clinical, biological, therapeutic, and hematological data. TE were categorized based on their type (arterial or venous) and location. BE were classified as minor, major, or clinically relevant non-major bleeding, according to the ISTH classification. Thrombosis-free survival (TFS) and bleeding-free survival (BFS) were assessed from the initiation of OAT until the occurrence of the first TE or BE, respectively, and estimated using Kaplan-Meier analysis. The other analyses were conducted using common statistical methods. Multivariable analyses included previously established risk factors for BE and TE. RESULTS A total of 156 pts were enrolled: 89 were women (57%). The median age was 69 years (range 25-92); 61 were affected by myelofibrosis, 35 by polycythemia vera, and 48 by essential thrombocythemia. 64 pts received OAT with VKAs (41%), and 92 with DOACs (59%). For 82 pts OAT was prescribed for AF (52.6%), and for 74 for VTE (47.4%). 17 pts treated with DOACs for VTE received a reduced-dose extended treatment (45.9%). The median exposure time to OAT was 5.8 years in the VKAs group (range 0.2-20 years) and 1.77 years in the DOACs group (range 0.2-10 years). After a median follow-up of 3,2 years, 14 TE were reported: 5 (35.7%) in the DOAC-treated group, of which 4 were arterial (80%), and 9 (64.3%) in the VKA-treated group (7 arterial - 77.8%). The incidence rate of TE was 2.11 thrombosis/pts/year in the VKAs group and 2.14 thrombosis/pts/year in the DOACs group. There were no significant differences in terms of TFS between the two groups, whether considering the entire population or analyzing the therapeutic indications separately (respectively p=0.72, p=0.53, p=0.55). Overall, there were 27 BE: 13 in the DOACs group (51.9%), 14 in the VKAs group (48.1%). Among these, we report 8 major BE, 4 in both groups. The incidence rate of BE was 5.6/pts/year in the DOACs group and 3.3/pts/year in the VKAs group. We did not observe significant differences in terms of BFS analyzing the whole population and the VTE group (respectively p=0.13 and p=0.75), while we found a trend for lower BFS in pts treated with DOACs for AF (p=0.08, Fig. 1). In a multivariate model, adjusted for time of exposition to OAT, age, gender and antiplatelet treatment, the risk of BE was associated solely with DOACs administration (hazard ratio 3.7, p=0.01) We found no significant differences in the risk of TE and BE when considering the various types of DOACs used. Moreover, 45 (28.8%) patients received concomitant antiplatelet therapy, and we found no significant differences in the risk of BE or TE compared to the other group (p=0.39 and p=0.41, respectively). CONCLUSIONS To our knowledge, this is the largest study investigating the safety and efficacy of DOACs compared to VKAs for the treatment and prevention of TE in pts with MPN and VTE or AF. Our findings suggest that DOACs are as effective as VKAs, but they appear to exhibit a trend towards a higher overall risk of BE, especially in the AF group. More data from prospective multicentric studies are necessary to validate our results.

Evaluation of Venous Thromboembolism Prevention Practices in US Hospitals

Background Hospital-associated venous thromboembolism (HA-VTE) is a significant, deadly, costly, and growing public health problem. While as many as 70% of cases of HA-VTE in patients could be prevented, proven VTE prevention strategies are not applied systematically across U.S. hospitals systems. There is a need to assess and better understand the landscape around VTE prevention practices in U.S. hospitals. Methods The Joint Commission and the Centers for Disease Control and Prevention (CDC) collaborated in the development of a probability-based hospital survey collected in accordance with the American Association for Public Opinion Research guidelines. The population comprised all U.S. and territorial general medical, general surgical, and critical-access hospitals in the 2019 American Hospital Association database. Hospitals were stratified by bed size (small ≤100 beds; medium 100-399 beds; and large ≥400 beds), then randomly sampled an equal number of hospitals in each group. The intended respondent was the chief medical officer, director of quality or safety, or person of a similar title. The questionnaire comprised 44 items, including topics on hospital policies and protocols, barriers to implementation of VTE prevention practice, quality monitoring and improvement efforts, and risk assessment activities. The χ2 test was used to examine differences in response rates by hospital characteristics. This project was deemed non-research in accordance with federal regulation for the protection of human subjects in research. Results There were 4605 eligible hospitals, of which 1290 were randomly selected for the sample, and 1212 had available contact information and were presumed reached. Of these, 311 submitted sufficient data for inclusion, a response rate of 25.7%. Response rates did not differ significantly by location (urban vs rural) or bed size, however major teaching hospitals were more likely to respond than minor or non-teaching hospitals (p<.001). (Table 1) More than half of hospitals reported having a VTE prevention policy (58.0%) (Table 2). Most had a hospital-wide VTE prevention protocol (81.5%) and/or unit-specific protocols (59.9%). Less than half had a VTE prevention team, committee, or workgroup and only 21.8% had a designated VTE prevention team and 19.2% reported VTE prevention activities were addressed by another committee. Large hospitals were more likely to have a designated team (p<.001). When a team or committee exists, there is representation from at least 2 departments (96.7%). Almost 80% reported they have clinical decision support (CDS) tools to help guide the selection of appropriate VTE prophylaxis for medical and surgical patients. The availability of CDS was greater in large and medium hospitals for both medical and surgical units (p<.002). Approximately 60% reported that their admission order sets addressed VTE prophylaxis and completion is mandatory. Reminders or alerts are provided for patients by about 60% of hospitals. Missed anticoagulant doses are routinely documented at 80.1% of hospitals. Around 50% of hospitals reported they conduct audits and provide feedback related to VTE prophylaxis for patients. Over 70% of hospitals educate patients about VTE prevention, including the importance of VTE prophylaxis, during the hospitalization; a little more than a third of hospitals provide annual VTE prevention education to clinicians. About half reported they have an ambulation protocol for patients. There were no variations by hospital bed size for education or ambulation protocols. Data on the number of newly diagnosed HA-VTE is collected in 75.6% of hospitals. This was lower in small hospitals (p=.004). Whereas just 44.7% track the number of patients with bleeding events and/or complications related to anticoagulant prophylaxis. Only 43.7% collect data on the patients receiving appropriate VTE prophylaxis and even fewer collect data on of patients receiving risk assessment (29.3%). Conclusion This survey of hospital VTE prevention practices identified numerous areas for improvement in the establishment and implementation of HA-VTE prevention policies and procedures. Overall, there were limited differences in prevention practices based on hospital bed size. Improving the awareness and application of evidence-based guidelines and interventions may reduce the incidence of HA-VTE.

Bleeding Associated with Prophylactic Anticoagulation for Hospital Related Venous Thromboembolism Prevention: A Case Series

The use of heparin products for prophylaxis of venous thromboembolism (VTE) have decreased the prevalence of VTE in all hospitalized patients, however the possibility of bleeding from prophylactic heparin cannot be disregarded. While life-threatening bleeding is less common with prophylactic doses, it can occur in the presence of other risk factors for bleeding. We aim to describe characteristics that may increase bleeding risk from prophylactic use of heparin. We present a single-center, retrospective case series of patients who received protamine for bleeding complications from prophylactic heparin administration at our facility between 2016-2020. We assessed patient demographics, medical history, types of heparin formulations administered, and patient outcomes. We observed that all patients were female. Patients who developed bleeding events from VTE prophylaxis had at least two of these attributes; BMI <18.5 kg/m2, weight <50kg, trauma within 1-month, surgery within 1-month or were taking anti-platelet agents. We suggest that the collective presence of two or more of these characteristics should lend consideration to dose adjustment and/or closer monitoring. In the absence of rigorous research comparing alternative doses to standard doses for prophylaxis in these patients, these decisions fall largely to the discretion of individual physicians. Designing larger studies following patients over long periods of time can help conclusively identify risk factors that predispose patients to bleeding.

Warfarin and bisphosphontes interaction in patients undergoing total knee arthroplasty

BackgroundPatients undergoing knee arthroplasty (TKA) surgery need anticoagulant therapy, mainly warfarin for prevention of venous thromboembolism (VTE). Warfarin is mainly eliminated by renal glomerular filtration where 92 % of warfarin is excreted in urine. Warfarin overdose may lead to significant bleeding and warfarin underdosing may cause VTE and other complications. Thus, international normalized ratio (INR) monitoring is crucial in TKA patients taking warfarin. Great interest has been expressed in bisphosphonate to reduce periprosthetic osteoporosis in patients undergoing total joint arthroplasty. Many human case reports and cohort studies proved bisphosphonates induced impaired renal function. ObjectivesThe main goal of the current study is to examine the pharmacodynamin effect of bisphosphonates on warfarin excretion and clinical effects in patients undergoing TKA surgery. MethodsFifty patients undergoing TKA were recruited in the current study. Twenty five patients were given warfarin and twenty five patients were given warfarin and bisphosphonates starting three days after surgery. INR, major bleeding events and minor bleeding events were followed up in all recruited patients for one month after surgery. Resultswarfarin plus zoledronic acid group had significantly higher percent of post INR greater than 4 (p = 0.022) and significantly higher percent of minor bleeding events (p = 0.041) than warfarin only group. ConclusionConcomitant administration of bisphosphonates may increase warfarin bleeding adverse effects in elderly patient undergoing TKA.

The trends in venous thromboembolism occurrence and prevention after minimally invasive varicose vein surgery.

To assess the trends of VTE occurrence and prevention in varicose vein surgery. The registry-based CAPSIVS trial (NCT03041805) analysis includes results in 1878 lower limbs. The primary outcome is a 28-day symptomatic or asymptomatic DVT revealed with duplex ultrasound. Any DVT, including EHIT, was observed in 3.4%, while symptomatic in 0.5%. Prophylactic anticoagulation was administrated in 20.4% with LMWH (13.2%) or DOAC (7.1%) for patients with higher VTE risk but did not reduce the events rate. With propensity score matching DOACs were superior to LMWHs (1.5% vs 9.8%). Duration of anticoagulation was essential: the lowest incidence (4.2%) was associated with prophylaxis for up to 7days, while a single LMWH injection resulted in a DVT rate of 8.8%. With individual VTE history, any anticoagulation duration appeared insufficient. Prophylactic anticoagulation after varicose vein surgery should be based on the individual VTE risk and provided for ≥7-30days.

Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial

Paediatric patients with acute lymphoblastic leukaemia or lymphoma are at increased risk of venous thromboembolism resulting in increased mortality and morbidity. We hypothesised that apixaban, a direct oral anticoagulant, would safely reduce venous thromboembolism in this patient population. PREVAPIX-ALL was a phase 3, open-label, randomised, controlled trial conducted in 74 paediatric hospitals in 9 countries. Participants aged 1 year or older to younger than 18 years with newly diagnosed acute lymphoblastic leukaemia (pre-B cell or T cell) or lymphoblastic lymphoma (B cell or T cell immunophenotype) and a central venous line in place throughout induction were randomly assigned 1:1 to standard of care (SOC, ie, no systemic anticoagulation) or weight-adjusted twice-daily apixaban during induction. Randomisation was performed centrally and stratified by age (those <10 years or those ≥10 years). Participants weighing 35 kg or less were administered 2·5 mg twice daily of apixaban as a 2·5 mg tablet, 0·5 mg tablets, or 0·4 mg/mL oral solution, while those weighing more than 35 kg were administered weight-adjusted prophylactic doses using 0·5 mg tablets or the 0·4 mg/mL oral solution twice daily. Primary outcomes were assessed by a blinded central adjudication committee. The primary efficacy outcome for the intention to treat population was the composite of symptomatic or clinically unsuspected venous thromboembolism, the primary safety outcome was major bleeding, and secondary safety outcomes included clinically relevant non-major (CRNM) bleeding. Patients were screened for venous thromboembolism by ultrasound and echocardiogram at the end of induction. The trial was registered with ClinicalTrials.gov (NCT02369653) and is now complete. Between Oct 22, 2015, and June 4, 2021, 512 participants were randomly assigned and included in analyses (222 [43%] female and 290 [57%] male; 388 [76%] White, 52 [10%] Asian, 24 [5%] Black or African American, and 48 [9%] other races; and 122 [24%] Hispanic or Latino ethnicity). During a median follow-up period of 27 days (IQR 26-28), 31 (12%) of 256 patients on apixaban had a composite venous thromboembolism compared with 45 (18%) of 256 participants receiving SOC (relative risk [RR] 0·69, 95% CI 0·45-1·05; p=0·080). Two major bleeding events occurred in each group (RR 1·0, 95% CI 0·14-7·01; p=1·0). A higher incidence of CRNM bleeding, primarily grade 1 or 2 epistaxis, occurred in the apixaban group (11 [4%] of 256 participants) compared with the SOC group (3 [1%] of 256; RR 3·67, 95% CI 1·04-12·97, p=0·030). The most frequent grade 3-5 adverse events in both groups were thrombocytopenia (n=28 for the apixaban group and n=20 for the SOC group) or platelet count decreased (n=49 and n=45), anaemia (n=77 and n=74), febrile neutropenia (n=27 and n=20), and neutropenia (n=16 and n=17) or neutrophil count decreased (n=22 and n=25). Five deaths occurred, which were due to infection (n=3 in the SOC group), cardiac arrest (n=1 in apixaban group), and haemorrhagic cerebral sinus vein thrombosis (n=1 in the SOC group). There was one apixaban-related death (coagulopathy and haemorrhage after cardiac arrest of unknown cause). PREVAPIX-ALL is, to our knowledge, the first trial assessing primary thromboprophylaxis using a direct oral anticoagulant in paediatric patients with acute lymphoblastic leukaemia or lymphoma. No statistically significant treatment benefit was identified in participants receiving apixaban. Major and CRNM bleeding were infrequent overall, but a higher incidence of CRNM bleeding (primarily epistaxis in younger children) occurred in participants receiving apixaban. For patients deemed to be at particularly high risk of thrombosis, PREVAPIX-ALL provides encouraging safety data for the use of apixaban in clinical settings in which the potential benefits are thought to outweigh the risk of bleeding. Bristol Myers Squibb-Pfizer Alliance.

Factor XI/XIa inhibitors for the prevention and treatment of venous and arterial thromboembolism: A narrative review.

During the past decade, direct oral anticoagulants (DOACs) have advanced and simplified the prevention and treatment of venous thromboembolism (VTE). However, there remains a high incidence of bleeds, which calls for agents that have a reduced risk of bleeding. Factor XI (FXI) deficiency is associated with lower rates of venous thrombosis and stroke compared to the general population with a lower risk of bleeding. In conjunction with this, phase 2 studies have demonstrated safety and the potential for reduced thrombotic events with FXI inhibitors as compared to currently available medications. The aim of this review is to summarize key data on the clinical pharmacology of FXI, the latest developments in clinical trials of FXI inhibitors, and to describe the efficacy and safety profiles of FXI inhibitors for the prevention of venous and arterial thromboembolism.

Safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: a prospective cohort study with historical control comparison

Abstract Introduction In adults with congenital heart disease (ACHD), atrial arrhythmias (AA) confer an increased risk of thromboembolic events. Data regarding treatment with non-vitamin K oral anticoagulants (NOACs) of patients with ACHD and AA are limited. Methods A prospective, multicenter, observational study of ACHD patients with AA (atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia) treated with apixaban from 2019 to 2022 was performed (PROTECT-AR, NCT03854149). Comparisons were made with a historical vitamin-K antagonist (VKA) treatment cohort from 2002 to 2014. The primary efficacy endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. Results The apixaban-treated cohort consisted of 215 patients (median follow-up 28 months) and the historical VKA-treated ­cohort consisted of 229 patients with ACHD and AA (median follow-up 48 months). The burden of age and comorbidities was higher in the apixaban versus the VKA treatment group (Table). Comparing the apixaban with the VKA treatment group yielded no significant differences in the annualized rate of stroke or thromboembolism (1.2% vs. 1.4%, respectively; p=0.24) and major bleeding (1.2% vs. 4.4%, respectively; p=0.08) (Figure). Conclusion In ACHD patients with AA treated with apixaban as part of routine care, the risk of major thromboembolic and bleeding events was low. This risk was comparable with historical cohort data on VKA. Prospective studies directly comparing NOAC and VKA-treated patients are needed.

Clinical effectiveness and safety of aspirin versus anticoagulation for venous thromboembolism prevention following orthopedic trauma and surgery: a meta-analysis of randomized controlled trials

Abstract Background The risk for venous thromboembolism (VTE) following orthopedic trauma and surgery is high. When preventive measures are not used, the odds of DVT can reach 60% within 90 days from surgery and 1.5% for fatal pulmonary embolism. Until now, consensus is not yet reached for the best pharmacologic prevention given the clinical situation. Guidelines on VTE prophylaxis vary across expert societies. Objective To compare the clinical effectiveness and safety between aspirin and anticoagulation in preventing venous thromboembolism (VTE) following an orthopedic trauma or surgery Study Selection Only randomized controlled trials (RCT) comparing aspirin and any anticoagulants as VTE prophylaxis following an orthopedic trauma or surgery were selected for review. Methods Pubmed, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) reporting clinical outcomes of aspirin versus any anticoagulants for VTE prevention. Primary endpoint was composite of venous thromboembolism (VTE) events. Secondary endpoints were mortality, bleeding events, and wound complications. Results Eleven RCTs with 17,963 patients were included in the analysis. Patients receiving aspirin as VTE prophylaxis have no significant difference in terms of reducing venous thromboembolism (VTE) events (RR 1.03; 95% CI, 0.71-1.48; p = 0.88), mortality (RR 1.01; 95% CI, 0.68-1.49; p = 0.97), bleeding events (RR 0.97; 95% CI, 0.80-1.05; p = 0.38), and wound complications (RR 0.76; 95% CI, 0.50-1.16; p = 0.21), as compared to anticoagulation after orthopedic trauma or surgery. Conclusion There are no significant differences between aspirin and anticoagulation in terms of reducing venous thromboembolism events, mortality, bleeding events, and wound complications following orthopedic trauma or surgery.

Abstract 13691: New Model for Prevention and Management of Venous Thromboembolism After Heart Valve Surgery

Introduction: Venous thromboembolism (VTE) is one of the possible complications that can occur after heart valve surgery. Exploring effective VTE prevention and management models for post-cardiac surgery is an important issue in perioperative management. Hypothesis: We hypothesized that a new model for VTE prevention and management can effectively reduce the incidence of VTE in patients undergoing heart valve surgery. Methods: A total of 1200 patients who underwent heart valve surgery were included in this study and randomized in a 1:1 ratio into the control group and new management group. The control group received basic VTE prevention measures, while the intervention group implemented a newly designed VTE prevention and management protocol in addition to the basic preventive measures. The protocol included multidisciplinary team training and assessment, a comprehensive VTE evaluation mechanism, proper execution of preventive measures, physical and mechanical prophylaxis, patient rehabilitation training, and education. The primary outcome measure was the incidence of perioperative VTE, and secondary outcome measures included the occurrence of postoperative pulmonary embolism and all-cause mortality after heart valve surgery. Results: The intervention group included a total of 600 patients, with 57.6% being male and an average age of 56.7 ± 13.4 years. The control group also included 600 patients, with 55.5% being male and an average age of 57.5 ± 12.8 years. There were no significant differences in general clinical data between the two groups. The incidence of in-hospital deep vein thrombosis (DVT) in the intervention group was significantly lower than that in the control group (0.3% vs 1.5%, P&lt;0.05). However, there were no significant differences between the two groups in terms of in-hospital pulmonary embolism and early postoperative all-cause mortality. The intervention group showed a significantly higher accuracy rate in VTE risk assessment compared to the control group (91.3% vs 87.9%, P&lt;0.05). Conclusions: The new model for VTE prevention and management can effectively reduce the incidence of VTE in patients undergoing heart valve surgery, providing important evidence for the prevention and management of VTE in cardiac surgery.

Abstract 15341: A Prospective Study on the Safety and Effectiveness of Apixaban for the Prevention of Thromboembolism in Adults With Congenital Heart Disease and Atrial Arrhythmias: The PROTECT-AR Study

Introduction: In adults with congenital heart disease (ACHD), atrial arrhythmias (AA) confer an increased risk of thromboembolic events. Limited data exist on non-vitamin K oral anticoagulant (NOAC) treatment for ACHD. We aimed to assess the effectiveness and safety of apixaban in ACHD patients with AA. Methods: PROTECT-AR (NCT03854149) was a prospective, multicenter, observational study conducted from 2019 to 2023. ACHD patients with atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia, who were routinely treated with apixaban, were included. The primary efficacy endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. Patients who were previously on vitamin K antagonists (VKAs) before transitioning to apixaban served as a historical control group. Results: In total, 218 patients with ACHD and AA on apixaban (previous VKA users 34.9%) were included (mean age 51±17 years; 45.9% male; predominantly moderate complexity). Over a mean follow-up of 2.4±1.3 years, the rate of stroke or thromboembolism was 0.57% [95% confidence interval (CI): 0.15-1.55] and the rate of major bleeding was 1.52% [95%CI: 0.71-2.88] per patient-year, respectively. In the subset of patients who were previously on VKA, the risk of the primary endpoints did not differ significantly between apixaban and VKA-treatment periods (Figure). Conclusion In ACHD patients with AA on routine apixaban treatment, the risk of major thromboembolic and bleeding events was low. Among prior VKA users, the risk of adverse events during the apixaban-treatment period was comparable to that during the VKA-treatment period. Prospective studies directly comparing NOAC and VKA-treated patients are needed.

Abstract 14451: Switching From Warfarin to Direct Oral Anticoagulants (DOACs) in Medicine Clinic at a Safety Net Hospital in New York City: A Quality Improvement Project

Introduction: Many patients are still using warfarin for thromboembolic prevention, even though Direct-Acting Oral Anticoagulants (DOACs) have replaced it in most indications to decrease the need for frequent dose adjustments and minimize drug interactions. Methods: This study is a clinic patient-based observational quality improvement project to review warfarin use in adult patients following at the anticoagulation clinic at Metropolitan Hospital. Electronic medical records were screened, and TTR was calculated over 3 months. STATA was used for statistical analysis, including Histograms, Skewness-Kurtosis tests for normality, student-T tests for continuous variables, and χ2 tests for categorical variables. The P-value of less than 0.05 was considered statically significant. Results: A total of 45 patients were included; the mean age was 61, of whom 23 (51.1%) were males. The comorbidities observed were hypertension (HTN), diabetes mellitus (DM), chronic obstructive pulmonary disease (COPD), and obesity. The time in therapeutic range (TTR) was less than 65% in 22 patients (48.9%). Warfarin was indicated in 28 patients (62.2%) and not indicated in 17 patients (37.8%), out of which 6 patients (36.3%) agreed to switch to direct oral anticoagulants (DOACs) (Figure 1). Conclusions: Our project revealed a significant number of patients are still using warfarin despite being suitable for DOACs. 60% prefer warfarin due to perceived safety with frequent clinic visits. Socioeconomic status affects the transition. The PINNACLE Study identified practice and provider variations, Practices with high-volume clinics, more electrophysiologists, and those located in the western region are more likely to switch to DOACs. Based on our findings, we recommend the following: - Physicians should engage in shared decision-making with patients on warfarin use. - Physicians may need to discuss the available DOACs options with insurance companies due to coverage limitations.

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial

Background and objectivesLong-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI).MethodsThis prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE).ResultsBetween 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ.ConclusionDiscontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.Graphical abstract

Extended Full Dose Versus Low Dose Direct Oral Anticoagulants in Cancer and Overweight Patients

Background: Reduced or low-dose direct oral anticoagulants (DOACs) have been studied in randomized control trials for the extended prevention of venous thromboembolism (VTE) after 6 months of treatment at full, therapeutic doses. The real-world effectiveness as well as utilization of this approach in clinical practice compared to continuing at therapeutic doses is unclear. Aims: Examine the effectiveness, safety and utilization of reduced-dose DOACs in cancer patients and overweight patients. Methods: Consecutive patients with VTE were identified using the Mayo Clinic VTE Registry from March 1st, 2013 to December 31st, 2021. Patients were followed prospectively for outcomes of VTE recurrence, death, major bleeding and clinically relevant non major bleeding (CRNMB) either in person or by survey. Patients with recurrent VTE or bleeding during the first 3 months were excluded from further analysis. After completion of anticoagulation treatment for 3 months with either rivaroxaban or apixaban, patients continuing anticoagulation were evaluated in a nested case-control study. Results: A total of 404 patients (283 (70%) on apixaban and 121 (30%) on rivaroxaban) were identified in the low dose DOAC and 3060 in the full dose anticoagulation group. Overall, the mean age was 60.7 years (SD 14.4), mean weight was 89.9 kg (SD 23.8) and 55.1% were males. Within the full cohort, patients with active cancer were less likely to be prescribed low dose DOACs (HR 0.56; 95%CI 0.42-0.73; p&amp;lt;0.001). However, low dose DOAC prescription was more likely in patients with pulmonary embolism alone (HR 1.48; 95%CI 1.21-1.80; p&amp;lt;0.001) or in combination with DVT (HR 1.54; 95%CI 1.25,1.90; p&amp;lt;0.001). Patients transitioned to low dose DOACs had similar age, sex and weight compared to the full dose anticoagulation group, however, fewer patients with weight ≥120 kg had reduced dosing (HR 0.68; 95%CI 0.46,0.99; p=0.046). The mean time to start of a low dose DOAC was 5.1 months overall, 5.4 months in cancer patients, and 3.6-4.9 months in non-cancer patients (Table 1). Non-cancer patients had significantly lower transition numbers in those ≥120kg (HR 0.62; 95%CI 0.40,0.97; p=0.038). In non-cancer patients In comparing weight, ≥120kg to &amp;lt;120kg, in the low dose group, only death was statistically different with higher risk in those ≥120kg (HR 6.44; 95%CI1.27,32.81; p=0.025). Cancer patients transitioned to low dose DOACs around 5 months on average with a median of 3.3 months. Apixaban continued to be the dominant DOAC used (78%) in the low dose group. The cancers with the most patients on low dose DOACs include lymphoma, prostate, melanoma, ovarian, and breast. There was no significant difference in VTE recurrence or death in the cancer group on different DOAC doses. Conclusion: Our results show that anticoagulant prescribers are not always waiting until 6 months to transition to low doses and low doses are being utilized in cancer patients despite lack of cancer-specific studies during the analyzed time period. Although the sample size limits the precision of this analysis, we did not find statistically significant increases in VTE recurrence with low dose DOACs in either cancer patients or with elevated body weight. We did find CRNMB but not MB was observed more frequently in weights above 120kg, possibly from unadjusted confounding in this unadjusted analysis.

Multisystem inflammatory syndrome complicated by pulmonary embolism in a child

Purpose - to present a clinical case of a particular complication of post-COVID multisystem inflammatory syndrome (MIS) - pulmonary embolism (PE) which developed due to primary hereditary thrombophilia in a child for better understanding of the MIS evolution and prognosis in children (MIS-C). Case report. In an 11-year-old boy who previously had no hemorrhagic manifestations, the first symptoms of the disease occurred in the form of fever and a hemorrhagic rash on the lower extremities. Later, he developed signs of respiratory failure, his condition worsened, and bilateral community-acquired viral pneumonia caused by COVID-19 was diagnosed. The child presented with post-COVID MIS manifested as PE, which caused further genetic examinations for hereditary thrombophilia. Primary thrombophilia was detected (F2 gene - prothrombin (20210 G&gt;A) D68.5). Concomitant hereditary pathology was probably the reason for a severe course of the infection and the development of a complication in the form of PE requiring intensive and long-term anticoagulant therapy. Conclusions. In case of PE detection, especially in young patients, examinations to confirm or rule out hereditary or acquired thrombophilia are required, that defines recurrent venous thromboembolism prevention programs. This clinical case report is a contribution to the study on the issues of MIS-C, defining links between pulmonary complications (transient or persistent) and serious sequelae in the future. The research was carried out in accordance with the principles of the Helsinki Declaration. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Guidelines in Practice: Prevention of Venous Thromboembolism.

Venous thromboembolism (VTE), a condition involving deep vein thrombosis and embolism, can cause death when left untreated. Hospitalized patients and those who have recently undergone surgery or have a cancer diagnosis are at increased risk for VTE development. The updated AORN "Guideline for prevention of venous thromboembolism" provides perioperative nurses with a variety of evidence-based recommendations associated with the topic. This article provides an overview of the guideline and discusses recommendations for a VTE protocol, VTE and bleeding risk assessments, pharmacologic and mechanical VTE prophylaxis, postoperative ambulation, and patient and family education. It also includes a scenario that illustrates the importance of the VTE assessment and the use of mechanical prophylaxis for high-risk patients undergoing operative or other invasive procedures. Perioperative nurses should review the guideline in its entirety and implement recommendations in operative and procedural settings.

Prevention of venous thromboembolism in acute spontaneous intracerebral haemorrhage: A survey of opinion

IntroductionPeople immobilized following acute spontaneous intracerebral haemorrhage (ICH) are at risk of venous thromboembolism (VTE) but the role of short-term prophylactic anticoagulation remains uncertain. We surveyed UK clinical practice and opinion regarding preventing VTE after ICH. Patients and methodsAn online survey was sent to stroke healthcare professionals within the United Kingdom and Ireland via a professional society (British and Irish Association of Stroke Physicians (BIASP)). ResultsOne hundred and twenty-three staff members responded to the survey, of whom 80% were consultant stroke physicians. All responders except one considered the issue to be important or extremely important, but only 5 (4%) were “extremely certain” and 51 (41%) “fairly certain” regarding the optimal treatment approach. Intermittent pneumatic compression (IPC) devices alone were the most used method (in 60%) followed by IPC devices and switching to low molecular weight heparin (LMWH) (in 30%). We identified high levels of uncertainty regarding the role of anticoagulation, and its optimal timing; uncertainty was greater in lobar compared to deep ICH. Most respondents (93%) consider a randomised controlled trial investigating the role of pharmacological VTE prophylaxis after acute ICH as important and would consider participation. Discussion and conclusionThe optimal method for the prevention of VTE in non-traumatic ICH patients remains an area of clinical uncertainty. Clinical trials assessing short-term anticoagulation in patients after acute ICH would be beneficial in providing evidence to resolve this clinical dilemma.

What should a general practitioner know about the management of patients with venous thromboembolism?

The era of the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus has shown that non-core specialists can be involved in the treatment of epidemic diseases. However, the entire burden for the prevention and treatment of venous thromboembolism (VTE) falls on doctors – cardiovascular surgeons, phlebologists. It should be borne in mind that most of the thromboses – more than 2 million cases per year – are asymptomatic, and only a small part has pulmonary embolism, pulmonary hypertension, and death. The survival rate of patients with deep vein thrombosis (DVT) for 8 years is 65 %, with a combination of DVT with pulmonary embolism; the survival rate does not exceed 34 %, so a doctor of any specialty should know how to suspect VTE. The clinical picture of DVT is not always pronounced. Most often, with DVT, patients complain of swelling and pain in the affected lower limb, a decrease in the volume of active movements, and skin cyanosis. Diagnosis of DVT and thromboembolic complications at the non-specialized level should initially consist of assessing the risk of VTE using special scales, among which the Wales scale is of the greatest importance. The gold standard for diagnosing DVT is duplex ultrasound. Among the main indicators for hospitalization is not the fact of the established diagnosis of DVT, but the presence of comorbid pathology, chronic lung diseases, and old age. Additional risk factors include extended DVT, suspected pulmonary embolism, and pregnancy. The goal of anticoagulant therapy is to stop the process of pathological hypercoagulability, the progression of thrombus formation and create conditions for restoring vascular patency, while the pathological idea is that anticoagulants “dissolve the thrombus”. In this regard, anticoagulant therapy is the mainstay of treatment for DVT. To determine the duration of anticoagulant therapy, the etiology of thrombosis is of particular importance – the trigger that led to the formation of thrombotic masses.

Review of Topical Sodium Heparin 1000 IU/g Gel in Symptomatic Uncomplicated Superficial Thrombophlebitis.

Heparin, a mixture of sulfated polymorphic polysaccharides (glycosaminoglycan) chains of variable lengths and weights and a natural anticoagulant, is widely used in medical practice to prevent intravascular blood coagulation. Heparin has demonstrated antithrombotic and anti-inflammatory activity, and it is mostly administered systemically (intravenously or subcutaneously) for primary or secondary prevention of venous thromboembolism after surgical interventions, or immobilized patients, or on short-term antithrombotic therapy of patients with atrial fibrillation who must undergo treatment. However, since systemic administration of heparin could be, in certain cases, linked to an increased risk of bleeding, topical heparin is widely used for the prevention and treatment of local symptoms of peripheral vascular disorders, such as venous insufficiency, varicose veins, or superficial thrombophlebitis. This review summarizes the main safety and efficacy characteristics of the topical formulation of Heparin in Gel form (1000 International Units of Heparin/g Gel) currently in use, which has demonstrated an excellent efficacy and tolerability profile in reducing signs and symptoms of peripheral vascular disease, e.g., varicose syndromes and their complications, phlebothrombosis, thrombophlebitis, superficial periphlebitis, varicose ulcers, for post-operative varicophlebitis, sequelae of saphenectomy, for traumas and contusions, local edemas and infiltrates, subcutaneous hematoma and for traumatic affections of musculotendinous and capsuloligamentous apparatuses.