Thromboembolic risk of carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for newly diagnosed multiple myeloma: A comparative systematic review and meta-analysis.

Thrombosis represents a frequent and potentially severe complication in individuals diagnosed with multiple myeloma (MM). These events can be driven by both the disease as well as the therapies themselves. Overall, available evidence is inconclusive about the differential thrombogenicity of carfilzomib/lenalidomide/dexamethasone (KRd) and bortezomib/lenalidomide/dexamethasone (VRd). This meta-analysis compares the risk for venous thromboembolism (VTE; including deep venous thrombosis and pulmonary embolism) and arterial thromboembolism (ATE; including myocardial infarction and ischemic stroke) with KRd versus VRd as primary therapy for newly diagnosed MM (NDMM). Out of 510 studies identified after deduplication, one randomized controlled trial and five retrospective cohort studies were included. We analyzed 2304 patients (VRd: 1380; KRd: 924) for VTE events and 2179 patients (VRd: 1316; KRd: 863) for ATE events. Lower rates of VTE were observed in the VRd group when compared with the KRd group (6.16% vs. 8.87%; odds ratio [OR], 0.53; 95% confidence interval [CI], 0.32-0.88; p = .01). Both treatment groups exhibited minimal ATE incidence, with no significant difference between them (0.91% vs. 1.16%; OR, 1.01; 95% CI, 0.24-4.20; p = .99). In view of potential biases from retrospective studies, heterogeneity of baseline population characteristics, and limited access to patient-level data (e.g., VTE risk stratification and type of thromboprophylaxis regimen used) inherent to this meta-analysis, additional research is warranted to further validate our findings and refine strategies for thrombosis prevention in MM.

Left atrial appendage occlusion: Percutaneous and surgical approaches in everyday practice.

Prophylactic left atrial appendage occlusion has been suggested as a means of reducing cardioembolism risk in patients with atrial fibrillation. Its clinical benefits have been discussed together with potential endocrine or hemodynamic adverse effects, with conflicting conclusions. We aimed to provide a thorough overview of the current literature and a recommendation for daily clinical decision-making. A comprehensive Medline search through PubMed was conducted to search for relevant articles, which were further filtered using the title and abstract. Sixty-five articles were selected as relevant to the topic. Concomitant left atrial appendage occlusion during cardiac surgery for other reasons is effective in terms of thromboembolism risk reduction in patients with a history of atrial fibrillation and higher CHA2DS2-VASc scores. Surgical occlusion is safe, and epicardial closure techniques are preferred. Thoracoscopic and transcatheter techniques are also feasible, and the individual treatment choice must be tailored to the patient. The concerns about endocrine imbalance or risk of heart failure after occlusion are not supported by evidence. Current evidence is conflicting with regard to hemodynamic consequences of appendage occlusion.

Direct oral anticoagulants in trauma patients.

PURPOSE OF REVIEW: Direct oral anticoagulants (DOACs) are increasingly prescribed for prevention of thromboembolic events. Thus, trauma care providers are facing a steadily raising number of injured patients on DOACs. RECENT FINDINGS: Despite a predictable pharmacokinetic profile, the resulting plasma levels of trauma patients upon admission and bleeding risks remain uncertain. Therefore, recent guidelines recommend the measurement of DOAC plasma concentrations in injured patients. Alternatively, DOAC specific visco-elastic tests assays can be applied to identify DOAC patients at bleeding risk.Bleeding complications in trauma patients on DOACs are generally higher compared to nonanticoagulated subjects, but comparable to vitamin K antagonists (VKAs). In particular, a traumatic brain injury does not carry an increased risk of intracranial bleeding due to a DOAK intake compared to VKAs. Current studies demonstrated that up to 14% of patients with a hip fracture are on DOACs prior to surgery. However, the majority can be operated safely within a 24h time window without an increased bleeding rate.Specific antagonists facilitate rapid reversal of patients on DOACs. Idarucizumab for dabigatran, and andexanet alfa for apixaban and rivaroxaban have been approved for life threatening bleeding. Alternatively, prothrombin complex concentrate can be used. Dialysis is a potential treatment option for dabigatran and haemoabsorption with special filters can be applied in patients on FXa-inhibitors. SUMMARY: Current guidelines recommend the measurement of DOAC plasma levels in trauma patients. Compared to VKAs, DOACs do not carry a higher bleeding risk. DOAC specific antagonists facilitate the individual bleeding management.

Current Gaps in the Provision of Safe and Effective Anticoagulation in Atrial Fibrillation and the Potential for Factor XI-Directed Therapeutics.

The global prevalence of atrial fibrillation is rapidly increasing, in large part due to the aging of the population. Atrial fibrillation is known to increase the risk of thromboembolic stroke by 5 times, but it has been evident for decades that well-managed anticoagulation therapy can greatly attenuate this risk. Despite advances in pharmacology (such as the shift from vitamin K antagonists to direct oral anticoagulants) that have increased the safety and convenience of chronic oral anticoagulation in atrial fibrillation, a preponderance of recent observational data indicates that protection from stroke is poorly achieved on a population basis. This outcomes deficit is multifactorial in origin, stemming from a combination of underprescribing of anticoagulants (often as a result of bleeding concerns by prescribers), limitations of the drugs themselves (drug-drug interactions, bioaccumulation in renal insufficiency, short half-lives that result in lapses in therapeutic effect, etc), and suboptimal patient adherence that results from lack of understanding/education, polypharmacy, fear of bleeding, forgetfulness, and socioeconomic barriers, among other obstacles. Often this adherence is not reported to treating clinicians, further subverting efforts to optimize care. A multidisciplinary, interprofessional panel of clinicians met during the 2023 International Society of Thrombosis and Haemostasis Congress to discuss these gaps in therapy, how they can be more readily recognized, and the potential for factor XI-directed anticoagulants to improve the safety and efficacy of stroke prevention. A full appreciation of this potential requires a reevaluation of traditional teaching about the "coagulation cascade" and decoupling the processes that result in (physiologic) hemostasis and (pathologic) thrombosis. The panel discussion is summarized and presented here.

Efficacy and safety of oral anticoagulants according to kidney function among patients with atrial fibrillation.

BACKGROUND AND AIMS: Patients with severely reduced kidney function have been excluded from randomized controlled trials and data on the safety and efficacy of direct oral anticoagulants (DOACs) according to kidney function remain sparse. The aim was to evaluate the safety and efficacy of the DOACs across subgroups of kidney function. METHODS: Using multiple Danish nationwide registers and laboratory databases, we included patients initiated on oral anticoagulants (OACs) with atrial fibrillation and available creatinine level and followed patients for 2 years to evaluate occurrence of stroke/thromboembolism (TE) and major bleeding. RESULTS: Among 26 686 included patients, 3667 (13.7%) had an estimated glomerular filtration rate (eGFR) of 30-49 mL/min/1.73 m2 and 596 (2.2%) had an eGFR below 30 mL/min/1.73 m2. We found no evidence of differences regarding the risk of stroke/TE between the OACs (P-value interaction >0.05 for all). Apixaban was associated with a lower 2-year risk of major bleeding compared to vitamin K antagonists (VKA) [hazard ratio 0.79, 95% confidence interval (CI) 0.67-0.93], and the risk difference was significantly larger among patients with reduced kidney function (P-value interaction 0.018). Rivaroxaban was associated with a higher risk of bleeding compared to apixaban (hazard ratio 1.78, 95%CI 1.32-2.39) among patients with eGFR 30-49 mL/min/1.73 m2. CONCLUSIONS: Overall, we found no differences regarding the risk of stroke/TE, but apixaban was associated with a 21% lower relative risk of major bleeding compared to VKA. This risk reduction was even greater when comparing apixaban to VKA among patients with eGFR 15-30 mL/min/1.73 m2, and when comparing apixaban to dabigatran and rivaroxaban among patients with eGFR 30-49 mL/min/1.73 m2.

Thromboembolic and bleeding events after valvular intervention in patients with atrial fibrillation.

AIM: To assess outcomes after cardiac surgery with biological valve replacement, valve repair or transcatheter aortic valve implantation (TAVI) in patients with atrial fibrillation (AF) in accordance with oral anticoagulant (OAC) treatment. METHODS: All patients in Sweden undergoing valvular intervention with AF were included. Associations between OAC exposure and cardiovascular (CV) events (composite of CV death, ischaemic stroke or systemic embolism) and major bleeding were investigated using Cox regression analysis. The analysis was separated in time periods of 0-3 and 3-12 months after discharge. RESULTS: 4730 patients were included in the first time period, 54.0% had received a surgical biological valve prosthesis, 23.8% valve repair and 22.2% TAVI. Exposure to warfarin (comparator) was 62.3%, to non-vitamin K antagonist oral anticoagulants (NOACs) 10.0% and to no OAC 27.7%. NOAC exposure was associated with similar risk of the composite CV outcome and major bleeding from 0 to 3 months. No OAC was associated with increased risk of the composite CV outcome (HR 1.71; 95% CI 1.26 to 2.32) and similar risk of major bleeding. Further analysis of the bioprosthetic valve replacement subgroup indicated increased risk of CV death when exposed to NOAC (HR 2.58; 95% CI 1.15 to 5.78) and no OAC (HR 2.82; 95% CI 1.65 to 4.82) compared with warfarin from 0 to 3 months. No differences were seen between 3 and 12 months. CONCLUSION: In this registry-based cohort study of patients with AF with severe valvular heart disease undergoing various valvular interventions, NOAC appears to be comparable with warfarin regarding efficacy and safety. Patients not receiving OAC had higher risk of CV events. NOAC was associated with increased CV death compared with warfarin in the surgical bioprosthetic valve replacement subgroup, illustrating the importance of being cautious when extrapolating data from one patient group to another. Further studies comparing NOAC and warfarin in the early postoperative phase are warranted, especially following surgical bioprosthetic valve replacement.

Anticoagulant prescribing patterns in patients with primary central nervous system malignancies and secondary metastases.

To evaluate the safety of direct oral anticoagulants (DOACs) versus low-molecular weight heparin (LMWH) in patients with central nervous system (CNS) malignancies and secondary metastases. All adult patients with CNS malignancies and secondary metastases who were treated with a DOAC or LMWH for any indication from 2018 to 2022 were included. The primary outcome was the incidence of any intracranial hemorrhage (ICH) after anticoagulation initiation. Secondary outcomes included non-ICH bleeding events and thromboembolic events. Tolerability was assessed by any changes in anticoagulant therapy during study period. 153 patients were included; 48 patients received enoxaparin and 105 received DOACs, of which apixaban was used most commonly. The population was predominantly White (74%) and male (59%) with a median age of 65. Data was censored for immortal time bias for outcomes evaluated beyond 3 months. ICH occurred in 7.7% of the population, more frequently in the enoxaparin group (DOACs 4, 4% vs. enoxaparin 7, 16%, p = 0.037). Non-ICH bleeds were predominantly minor and more common in the DOAC group (DOACs 13, 13% vs. enoxaparin 1, 2%, p = 0.037). Thromboembolic events were not different between groups (DOACs 9. 9% vs, enoxaparin 2, 4%, p = 0.503). Anticoagulant switches occurred more in the enoxaparin group (DOACs 12, 12.4% vs. enoxaparin, 37.8%, p < 0.001), primarily due to patient or provider preference. Our data supports DOACs to be preferred over LMWH for the treatment of VTE or for stroke prevention with AF to prevent ICH in patients with brain tumors or metastases.

Mitigating the Risk of Tofacitinib-induced Adverse Events in the Elderly Population with Ulcerative Colitis.

BACKGROUND AND AIMS: Older patients with ulcerative colitis treated with tofacitinib are at risk for major cardiovascular events, thromboembolism, herpes zoster, and malignancies and, accordingly, its use is limited by the regulatory authorities. The aim of the present study was to evaluate the occurrence of adverse events and potential preventive measures. METHODS: We retrospectively evaluated patients treated with tofacitinib, divided into two groups according to comorbidities and age. Patient- and disease-related variables were recorded [primary non-response, loss of response, and persistence], together with deviations from the recommended induction regimen, ie, dose reduction, and concomitant treatments with anti-thrombotic therapy. RESULTS: The age-adjusted Charlson comorbidity index of Group 1 [n = 30] was ≥2 and that of Group 2 [n = 37] was ≤ 1. No differences were observed for primary or secondary treatment failures. Both groups achieved comparable steroid-free remission rates at 12 months [53% and 46%, respectively]. Herpes zoster occurred in two patients per group, and no more cases occurred after strict recombinant zoster vaccination. No major cardiovascular event or thromboembolism was registered. Half of patients in Group 1 were treated with a reduced induction dose of 5 mg twice daily and 47% were on concomitant anti-thrombotic therapy. Malignancies were registered in two patients from Group 1 and one patient from Group 2. CONCLUSIONS: Modulation of induction dose and anti-thrombotic therapy may have contributed to prevent cardiological events and thromboembolism. The introduction of zoster vaccine virtually eliminated zoster risk after the first cases. Potential malignancies deserve a careful work-up of older patients before treatment start.

DOACs vs Vitamin K Antagonists During Cardiac Rhythm Device Surgery: A Multicenter Propensity-Matched Study.

BACKGROUND: There is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined. OBJECTIVES: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted). METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring. RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis. CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.

Oral Anticoagulation Versus Antiplatelet Treatment After Mitral Valve Repair: A Systematic Review and Meta-Analysis.

Oral anticoagulation with vitamin K antagonists is currently advised for a period of 3 months after surgical mitral valve repair, regardless of the rhythm status. The evidence supporting this recommendation is weak and recent studies have challenged the safety and efficacy of this recommendation. A systematic review of literature was conducted by searching PubMed, Embase, Web of Science, Emcare, and Cochrane Library databases for original publications comparing the efficacy and safety of oral anticoagulation with vitamin K antagonists to antiplatelet treatment early after mitral valve surgery in patients with no atrial fibrillation. Study end points included thromboembolic complications, bleeding complications and survival. A total of 5 studies, including 5,093 patients, met the inclusion criteria; 2,824 patients were included in the oral anticoagulation and 2,269 in the antiplatelet treatment group. Pooled analyses demonstrated no beneficial effect of oral anticoagulation on the incidence of thromboembolic complications (risk ratio 1.14, 95% confidence interval 0.76 to 1.70, p = 0.53, I2 = 8%). Moreover, oral anticoagulation did not result in a significantly increased risk of bleeding complications (risk ratio 0.89, 95% confidence interval 0.32 to 2.44, p = 0.81, I2 = 87%). When combining the efficacy and safety end points, no difference was observed between groups (risk ratio 1.01, 95% confidence interval 0.51 to 1.97, p = 0.99 I2 = 85%). Likewise, mortality did not differ between groups (risk ratio 0.89, 95% confidence interval 0.15 to 5.23, p = 0.90 I2 = 71%). Our results confirmed the safety but failed to confirm the efficacy of oral anticoagulation in patients who underwent mitral valve surgery. A randomized controlled trial would provide the evidence needed to support treatment recommendations.

Perioperative continuation or ultra-early resumption of antithrombotics in elective neurosurgical cranial procedures.

OBJECTIVE: Discontinuation of antithrombotics (AT) prior to elective cranial procedures is common practice, despite the higher risk of thromboembolic complications in these patients. The aim of this study was to investigate the risks and benefits of a new perioperative management protocol of continuation or ultra-early AT resumption in elective cranial procedures. METHODS: This study was an analysis of a prospectively collected cohort of patients undergoing elective cranial surgery with (AT group) and without (control group) AT. For extraaxial or shunt surgeries, acetylsalicylic acid (ASA) was continued perioperatively. For intraaxial pathologies, ASA was discontinued 2 days before surgery and resumed on postoperative day 3. All other AT were discontinued according to their pharmacokinetics, and resumed on postoperative day 3 after unremarkable postoperative imaging. Additionally, the authors performed a retrospective analysis of patients with AT who underwent surgery before implementation of this new AT management protocol (historical AT group). Primary and secondary outcomes were the incidence of hemorrhagic and thromboembolic complications within 3 months after surgery. RESULTS: Outcomes of 312 patients were analyzed (83 [27%] in the AT group, 106 [34%] in the control group, and 123 [39%] in the historical AT group). For all 3 patient groups, the most common type of surgery was craniotomy for intraaxial tumors (14 [17%] in the AT group, 28 [26%] in the control group, and 60 [49%] in the historical AT group). The most commonly used AT were ASA (38 [46%] in the AT group and 78 [63%] in the historical AT group), followed by non-vitamin K oral anticoagulants (32 [39%] in the AT group and 18 [15%] in the historical AT group). The total perioperative discontinuation time in the AT group was significantly shorter than in the historical AT group (median of 4 vs 16 days; p < 0.001). The rate of hemorrhagic complications was 4% (95% CI 1-10) (n = 3/83) in the AT group, 6% (95% CI 2-12) (n = 6/106) in the control group, and 7% (95% CI 3-13) (n = 9/123) in the historical AT group (p = 0.5). The rate of thromboembolic complications was 5% (95% CI 1-12) (n = 4/82) in the AT group, 8% (95% CI 3-15) (n = 8/104) in the control group, and 7% (95% CI 3-13) (n = 8/120) in the historical AT group (p = 0.7). CONCLUSIONS: The presented perioperative management protocol of continuation or ultra-early resumption of AT in elective cranial procedures does not seem to increase the hemorrhagic risk. Moreover, it appears to potentially protect patients from thromboembolic complications.

Antithrombotic therapy after heart valve intervention: review of mechanisms, evidence and current guidance.

As the population ages and treatment options for heart valve disease increase, the number of patients with intracardiac valve prostheses is growing rapidly. Although all devices have the potential to cause thrombus formation, the propensity depends on the type of prosthesis as well as risk of the individual patient. Mechanical valve prostheses carry the highest (and persistent) risk of thromboembolism, and these patients require anticoagulation with vitamin K antagonists (warfarin). Required international normalised ratio levels are dependent on the location of the valve (mitral>aortic), type of valve (ball and cage vs bilealfet vs On-X bilealfet) and rhythm. The risk of tissue (biological) prosthesis is highest soon after surgery and is dependent on individual patient risk including age, valve location (mitral>aortic), history of thromboembolic events and rhythm. In patients with no other indication for anticoagulation, there is uncertainty on the benefits of anticoagulation versus antiplatelet therapy in patients with tissue prostheses or repaired native valves. Patients with an a priori indication for anticoagulation with a direct oral anticoagulant can continue taking this class of drug. Patients with transcatheter aortic valve implantation devices and no additional evidence-based indication for dual antiplatelet therapy or anticoagulation can be maintained on aspirin monotherapy. Patients undergoing transcatheter instrumentation in the mitral valve position should be anticoagulated, although there is currently no published evidence for antithrombotic management in this group of patients. Patients with thrombosed devices (commonly mitral mechanical) should preferably be treated surgically. Patients at high risk of thromboembolism (with mechanical prostheses) should undergo bridging therapy when undergoing surgery.

Thromboembolic and hemorrhagic complications in patients with prosthetic heart valves cared for in a tertiary care center. What have we learned?

BACKGROUND: Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications. OBJECTIVE: To determine the complications related to complementary anticoagulation therapy and the probability of risk. METHODS: One-hundred and sixty-three patients who underwent heart valve replacement between 2002 and 2016 with either mechanical or biological prostheses, and who received vitamin K antagonists after hospital discharge, were studied. Anticoagulation therapy was categorized into optimal and non-optimal according to INR values prior to the development of complications. Patients with comorbidities and other risk factors for thrombosis and/or bleeding were excluded. RESULTS: In total, 68.7 % of patients received mechanical prostheses, and 31.3 %, biological prostheses (p ≤ 0.001); 25.2 % experienced the complications that motivated the study (p ≤ 0.001), which were hemorrhagic in 48.8 %, thromboembolic in 26.8 %, and of both types in 24.4 % (relative risk = 4.229). Among the patients with complications, 95.1 % received mechanical prostheses, and 4.9 %, biological (p = 0.005); non-optimal INR was identified in 49.7 % (p ≤ 0.001). CONCLUSIONS: Given the high risk of thromboembolic and hemorrhagic complications, valve prostheses must be carefully chosen, and care priorities should include prevention and follow-up, especially in those patients who require anticoagulation therapy.

ANTECEDENTES: El reemplazo valvular por prótesis mecánicas o biológicas implica riesgo de tromboembolismo y complicaciones hemorrágicas. OBJETIVO: Determinar las complicaciones relacionadas con la terapia de anticoagulación complementaria y la probabilidad de riesgo en pacientes portadores de prótesis valvulares del corazón. MÉTODOS: Se estudiaron 163 pacientes entre 2002 y 2016, portadores de prótesis mecánicas y biológicas, quienes recibieron antagonistas de la vitamina K posterior al egreso hospitalario. La terapia de anticoagulación se categorizó en óptima y no óptima conforme a los valores de INR previos a las complicaciones. Fueron excluidos los pacientes con comorbilidades y otros factores de riesgo de trombosis y/o sangrado. RESULTADOS: a 68.7 % de los pacientes se les colocó prótesis mecánica y a 31.3 %, biológica (p ≤ 0.001); 25.2 % presentó las complicaciones motivo de estudio (p ≤ 0.001), hemorrágicas en 48.8 %, tromboembólicas en 26.8 % y de ambos tipos en 24.4 % (riesgo relativo = 4.229); a 95.1 % de los pacientes con complicaciones se les colocó prótesis mecánica y a 4.9 %, biológica (p = 0.005); 49.7 % presentó INR no óptimo (p ≤ 0.001). CONCLUSIONES: Ante riesgo alto de complicaciones tromboembólicas y hemorrágicas, la elección de las prótesis valvulares, la prevención y el seguimiento son prioridades, principalmente en quienes requieren terapia de anticoagulación.

Aspirin is a safe and effective thromboembolic prophylaxis after total knee arthroplasty: a systematic review and meta-analysis.

PURPOSE: Patients undergoing total knee arthroplasty (TKA) are at high risk for thromboembolic events compared to non-surgical patients. Both anticoagulants and antiplatelet agents are used as antithrombotic prophylaxis in TKA. The aim of this review is to understand the role of aspirin in the prevention of thromboembolic events and to compare its efficacy and safety with the main anticoagulants used in antithromboembolic prophylaxis in TKA. METHODS: A systematic review and meta-analysis was performed according to the PRISMA guidelines. An electronic systematic search was conducted using PubMed, Scopus, and the Cochrane Central Registry to evaluate studies that compared aspirin with other anticoagulants, in terms of deep venous thrombosis and pulmonary embolism after TKA. The meta-analysis compared the rate of complications between aspirin and other anticoagulants. RESULTS: Thirteen studies were included in the systematic review for a total of 163,983 patients, and 10 studies were included in the meta-analysis. The meta-analysis demonstrated no statistically significant differences between aspirin and other anticoagulants in terms of the rate of deep venous thrombosis (OR 0.93, 95% CI 0.81-1.08, p = 0.35) and pulmonary embolism (OR 0.89, 95% CI 0.56-1.41, p = 0.61). CONCLUSION: Aspirin is safe, effective, and not inferior to other main anticoagulants in preventing thromboembolic events following TKA.

Optimal activated clotting time during peripheral artery endovascular procedures: cutting the gordian knot.

All endovascular procedures need an effective anticoagulation regimen that avoids thrombo-embolic complications due to the insertion and manipulation of various intravascular devices. Systemic heparinization reduces the risk of thrombosis but there is no conclusive evidence regarding the correct use of anticoagulant medications and accordant monitoring, especially in endovascular peripheral arterial procedures. Anticoagulation must be maintained during the whole vascular procedure, especially during partial or complete blood flow interruption. Reaching and maintaining the correct coagulative status is mandatory to avoid or reduce thromboembolic complications that could limit the procedure's effectiveness or be harmful to the patient. Patients' baseline variables and procedure-related elements can influence the way anticoagulation should be administered and how coagulative status has to be monitored. This review aimed to clarify the critical points of anticoagulation and monitoring management for non-cardiac arterial procedures in order to understand the best way to manage vascular procedures anticoagulation.

Prophylactic intravenous tranexamic acid and thromboembolism in non-cardiac surgery: a systematic review, meta-analysis and trial sequential analysis.

Tranexamic acid is an antifibrinolytic drug that is widely used during surgery, but there are concerns about its thromboembolic effects. We aimed to investigate the effect of prophylactic intravenous tranexamic acid on thromboembolic outcomes in patients undergoing non-cardiac surgery. The MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials were searched. Randomised controlled trials comparing intravenous tranexamic acid with placebo or no treatment in patients undergoing non-cardiac surgery were included. The primary outcome was a composite of peri-operative cardiovascular thromboembolic events, defined as any deep vein thrombosis, pulmonary embolism, myocardial ischaemia/infarction or cerebral ischaemia/infarction. A total of 191 randomised controlled trials (40,621 patients) were included in the review. The primary outcome occurred in 4.5% of patients receiving intravenous tranexamic acid compared with 4.9% of patients in the control group. Our analysis showed that there was no difference between groups for composite cardiovascular thromboembolic events (risk ratio 1.02, 95%CI 0.94-1.11, p = 0.65, I2 0%, n = 37,512). This finding remained robust when sensitivity analysis was performed with continuity correction and in studies with a low risk of bias. However, in trial sequential analysis, our meta-analysis only achieved 64.6% of the required information size. There was no association between intravenous tranexamic acid and seizure rate or mortality rate within 30 days. Intravenous tranexamic acid was associated with a reduced blood transfusion rate compared with control (9.9% vs. 19.4%, risk ratio 0.46, 95%CI 0.41-0.51, p < 0.0001). It was encouraging to see the evidence that the administration of intravenous tranexamic in patients undergoing non-cardiac surgery was not associated with an increased risk of thromboembolic outcomes. However, our trial sequential analysis demonstrated that currently available evidence is not yet sufficient to reach a firm conclusion.

Anticoagulant Treatment in Patients with AF and Very High Thromboembolic Risk in the Era before and after the Introduction of NOAC: Observation at a Polish Reference Centre.

Atrial fibrillation (AF) is associated with an increased risk of stroke. Therefore, patients with AF require appropriate management and anticoagulant therapy. To balance therapy risks and benefits, oral anticoagulants (OAC) treatment should be 'tailored' in patients at a high risk of stroke and bleeding. However, some studies have demonstrated that certain groups of patients do not receive anticoagulants despite the high risk of stroke or thromboembolism. The study aimed to analyse therapeutic methods of stroke prevention in very high-risk patients (CHA2DS2-VASc score of ≥5 in men and ≥6 in women), identify factors predisposing against the use of OACs and assess the administration of anticoagulants before the introduction of non-vitamin K antagonist OAC (NOAC) in 2004-2011 and beyond (years 2012-2019). The analysis covered 2441 patients with AF at a very high thromboembolic risk who were hospitalised in a reference cardiological centre from 2004 to 2019. Data concerning patients' sex, age, comorbidities, type of AF, renal and echocardiographic parameters, reasons for hospitalisation and applied treatment were collected from medical records. HAS-BLED, CHADS2, and CHA2DS2-VASc scores were calculated for all patients. The treatment with oral anticoagulants was compared in the entire population over 2004-2011 and 2012-2019. In this study, a fifth of patients were not treated with OAC. Most patients hospitalised in the years 2012-2019 were treated with OAC. The predictors of not using OAC turned out to be: age of >74 years, heart failure, cancer, paroxysmal AF, and acute coronary syndrome (ACS) or elective coronary angiography/percutaneous coronary intervention (PCI) as a reason for hospitalisation. The introduction of NOAC was associated with a decline in the use of VKA (from 62% to 19.1%) and APT (from 29.1% to 1.3%). This study outlines reasons to initiate OAC treatment in very high-risk patients in clinical practice.

Efficacy and safety of intravenous tranexamic acid in urologic surgery: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: This meta-analysis compared the effects of intravenous Tranexamic acid (TXA) and a placebo on hemostasis, hospital course, and complications in adult patients undergoing various urologic surgeries. METHODS: The literature was extensively searched using various databases. The primary outcomes were standardized mean differences (SMDs) of intraoperative blood loss and odds ratios (ORs) of necessary blood product transfusion. The secondary outcomes included SMDs of operative time, SMDs of decreased hemoglobulin levels at 24 hours after surgery, and ORs of thromboembolic events. RESULTS: The meta-analysis included 13 randomized controlled trials (RCT) comprising 1814 participants in total. The SMD of intraoperative blood loss for TXA versus placebo was -0.705 (95% confidence interval [CI]: -1.113 to -0.297). The pooled ORs of transfusion in the TXA group compared with the placebo group was 0.426 (95% CI: 0.290-0.625). These findings indicated a significantly lower intraoperative blood loss and a reduced need for transfusion following intravenous TXA. The pooled ORs of thromboembolic events in the TXA group compared with the placebo group was 0.664 (95% CI: 0.146-3.024). CONCLUSIONS: Intravenous TXA can reduce intraoperative blood loss, decrease the need for transfusion, and shorten operative time, and it does not increase the risk of thromboembolic events.