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Background: Life-long vitamin K antagonist (VKA) therapy is recommended as a standard of care in antiphospholipid syndrome (APS) patients with thrombosis. Concerns have been raised about the validity of international normalized ratio (INR) measurements in lupus anticoagulant (LA)-positive APS patients because LA may interfere with phospholipid-dependent coagulation tests and could elevate INR measurements. Objectives: Here, we aimed to determine the interference of antigen-specific monoclonal and isolated patient antibodies with LA activity on INR measurements. Methods: Pooled normal plasma and control plasma from patients on VKA (without LA) were incubated with monoclonal and isolated patient immunoglobulin G antiprothrombin and anti-beta-2-glycoprotein I antibodies that express LA activity. INR was determined before and after addition using 3 laboratory assays (Owren STA-Hepato Prest, Quick STA-NeoPTimal, and Quick STA-Neoplastine R) and 1 point-of-care test device (CoaguChek Pro II). Results: Antiprothrombin and anti-beta-2-glycoprotein I antibodies with LA activity interfered with recombinant human thromboplastin reagents (Quick STA-Neoplastine R and CoaguChek Pro II), particularly when added to plasma of VKA-treated controls. This effect was most evident on point-of-care test INR measurements, while the recombinant Quick reagent exhibited a lesser degree of interference. In contrast, tissue-derived thromboplastin reagents (Owren STA-Hepato Prest and Quick STA-NeoPTimal) remained largely unaffected by these antibodies, both in pooled normal plasma and VKA anticoagulated control plasma. Among these reagents, the Owren INR reagent exhibited the lowest sensitivity to the influence of LA antibodies. This observed difference in sensitivity is independent of the plasma dilution factor or the presence of factor V or fibrinogen in Owren reagent. Conclusion: INR reagents that utilize recombinant human thromboplastin are more sensitive to the presence of monoclonal and patient-derived antibodies with LA activity. Consequently, APS patients positive for LA should be monitored using tissue-derived thromboplastin reagents, given its reduced susceptibility to interference by LA-causing antibodies.
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INTRODUCTION: We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients. METHODS: This subgroup analysis compared the safety, especially thromboembolic events (TEEs), and effectiveness of 4F-PCC by stratifying patients into two subgroups according to baseline international normalized ratio (INR) levels with < 2.0 and ≥ 2.0. RESULTS: Of 1271 eligible patients, 215 (17.9%) had INR < 2.0 and 987 (82.1%) had INR ≥ 2.0. Overall baseline characteristics were similar between groups; age (74.0 years vs 74.0 years), body mass index (22.1 kg/m2 vs 21.9 kg/m2), ratio of inpatients (90.2% vs 88.7%), manifested atrial fibrillation (46.0% vs 48.8%). Median INRs at baseline were 1.72 (minimum 0.92, maximum 1.99) in the INR < 2.0 group and 2.95 (2.00, 27.11) in the INR ≥ 2.0 group. The most common reason for 4F-PCC administration was intracranial hemorrhage (67.0% vs 59.5%), and lesser gastrointestinal bleeding (0.9% vs 7.5%). After 4F-PCC administration (average doses 24.5 IU/kg [INR < 2.0 group] and 29.2 IU/kg [INR ≥ 2.0 group]), INRs were significantly reduced to 1.21 (- 28%) and 1.31 (- 68%), respectively, and resulted in hemostasis in a similarly rapid manner. The incidences of adverse drug reactions were 3.7% in each group. TEEs occurred in 4 (1.9%) patients in the INR < 2.0 group and 11 (1.1%) patients in the INR ≥ 2.0 group and were predominantly composed of stroke, while similar rates (67.0% vs 62.9%) of bleeding events post-anticoagulant resumption were observed between groups. CONCLUSION: This study supports the favorable tolerability and efficacy of 4F-PCC regardless of baseline INR (< 2.0 or ≥ 2.0), with a prompt reduction of INR and substantial hemostatic effectiveness in the real-world setting for patients requiring urgent VKA reversal, although no indicated 4F-PCC dose for VKA reversal exists for INR < 2.0 to date.
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PF1 + 2 plasma levels are a crucial indicator for assessing anticoagulant action in individuals receiving anticoagulant treatment. Urine also has PF1 + 2 levels due to its molecular size. Hence, the present study aims to measure urinary prothrombin fragment 1 + 2 (uPF1 + 2) in patients taking anticoagulants in order to divulge a noninvasive surrogate marker of PT-INR of blood coagulopathy. A total of 205 people participated in the study: 104 patients on acenocoumarol (AC) and 101 healthy controls (HC). Clinical parameters, including PT-INR, urinary creatinine, etc., were measured in all subjects. To evaluate uPF1 + 2 in samples, MALDI-TOF-MS, Western blot analysis, and ELISA tests were used. The MALDI-TOF-MS results showed the presence of uPF1 + 2 in both AC and HC urine samples. The Western blot, ELISA experiment, and unpaired t test results displayed that the patients with AC had significantly increased levels of uPF1 + 2 compared to HC. A regression study showed a strong positive relation between blood-based PT-INR and uPF1 + 2. ROC validation also revealed the clinical efficacy of uPF1 + 2. For the goal to monitor anticoagulant medication, the present study highlights PF1 + 2, which describes the overall hemostatic capacity and might be utilized in addition to or instead of PT-INR.
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Objective: To investigate the pivotal determinants contributing to the adverse prognosis in patients afflicted with traumatic lung injury (TLI), with an aim to mitigate the elevated mortality rate associated with this condition. Methods: A retrospective analysis was carried out on 106 TLI patients who were admitted to the intensive care unit of a comprehensive hospital from March 2018 to November 2022. The patients were categorized into two groups based on their 28-day outcome: the survival group (n = 88) and the death group (n = 18). Random forest model, least absolute shrinkage and selection operator (LASSO) regression and support vector machine recursive feature elimination (SVM-RFE) were utilized to pinpoint the primary factors linked to poor prognosis in TLI patients. The Receiver Operating Characteristic (ROC) curve analysis was utilized to ascertain the predictive value of INR in forecasting the prognosis of TLI patients. Based on the cut-off value of INR, patients were categorized into two groups: INR ≥ 1.36 group (n = 35) and INR < 1.36 group (n = 71). The 28-day survival rate was then compared using Kaplan-Meier analysis. Results: Random forest model, LASSO, and SVM-RFE jointly identified International standardization ratio (INR) as a risk factor for TLI patients. The area under the ROC curve for INR in predicting the 28-day mortality of TLI patients was 0.826 (95% CI 0.733-0.938), with a cut-off value of 1.36. The 28-day mortality risk for TLI patients with an INR ≥ 1.36 was 8.5 times higher than those with an INR < 1.36. Conclusion: Traumatic lung injury patients with elevated INR have a poor prognosis. An INR of ≥1.36 can be used as an early warning indicator for patients with traumatic lung injury.
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OBJECTIVES: Our objective was to maintain low interlaboratory variation and bias in international normalized ratio (INR) results following a network change in instrumentation and reagents, using a process of ongoing standardization and harmonization. METHODS: Network-wide standardization to new common instrument and reagent platforms followed by network-wide application of a simple novel process of verification of international sensitive index and mean normal prothrombin time values for each new lot of prothrombin time (PT) reagent that does not require use of World Health Organization reference thromboplastin or INR calibration/certified plasma. RESULTS: The network transitioned from mechanical hemostasis detection instruments with associated PT reagent (Diagnostica Stago; NeoPTimal) to optical detection (ACL TOPs) with associated PT reagent (Werfen; RecombiPlasTin 2G). Comparing 3 years of data for each situation, the network (n = 27 laboratories) maintained low INR variability and bias relative to general mechanical and optical groups and other laboratories. CONCLUSIONS: Harmonized support for patient management of vitamin K antagonists such as warfarin was continuously maintained in our geography, with potentially positive implications for other coagulation laboratories and geographies. For the United States in particular, paucity of US Food and Drug Administration-cleared INR certified plasmas potentially compromises INR test accuracy; our novel approach may provide workable alternatives for other laboratories/networks.
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Background: The 2018 Osaka earthquake caused severe damage to the National Cerebral and Cardiovascular Center, and the interruption to the delivery of hospital food in particular had a significant effect on patients with left ventricular assist devices (LVAD). MethodsâandâResults: We retrospectively assessed 10 patients who had been provided with emergency rations on the day of earthquake and the next day for breakfast. Catered foods were provided thereafter. Vitamin K content was largely reduced due to emergency rations; the prothrombin time-international normalized ratio (PT-INR) on day 2 was significantly higher than on day 1. Conclusions: Close monitoring of PT-INR and assessing vitamin K content may be important for preventing complications in patients with a LVAD during a disaster.
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OBJECTIVES: There is extensive evidence to support the use of FIBTEM to identify hypofibrinogenemia during cardiac surgery, but less to support the use of EXTEM and INTEM clotting times (CTs) to identify other plasmatic coagulation factor deficiencies. The aim of the current study was to assess the diagnostic accuracy of EXTEM, INTEM, and HEPTEM CTs, using laboratory international normalized ratio (INR) and activated partial thromboplastin time (aPTT) as reference standards. DESIGN: This was a retrospective diagnostic accuracy study. SETTING: The work took place at a tertiary referral hospital. PARTICIPANTS: A total of 176 cardiac surgical patients were enrolled. INTERVENTIONS: INR, aPTT, ROTEM EXTEM, INTEM, and HEPTEM were measured post-heparin reversal after cardiopulmonary bypass. MEASUREMENTS AND MAIN RESULTS: Sensitivity, specificity, and positive (PPVs) and negative predictive values (NPVs) for EXTEM CT >80 seconds and HEPTEM CT >280 seconds to detect INR ≥2.0, and INTEM CT >205 seconds to detect aPTT ≥38.5 seconds were calculated for all patients and the subset with normal FIBTEM A5 (>6 mm). The prevalence of INR ≥2.0 was 13%. EXTEM CT >80 seconds had a sensitivity of 1.00, specificity of 0.25, PPV of 0.17, and NPV of 1.00. HEPTEM CT >280 seconds had a sensitivity of 0.91, specificity of 0.38, PPV of 0.18, and NPV of 0.97. INTEM CT >205 seconds had a sensitivity of 0.97, specificity of 0.11, PPV of 0.57, and NPV of 0.75 for aPTT ≥38.5 seconds. These values were similar for the subset of patients with normal FIBTEM A5. CONCLUSIONS: EXTEM CT >80 seconds and HEPTEM CT >280 seconds have high sensitivities and NPVs for INR >2.0, which would effectively "rule out" INR >2.0 as a cause for excessive bleeding. However, the low specificities and PPVs indicate they would be less effective in ruling it in. INTEM CT >205 seconds had low PPV and NPV in identifying aPTT >38.5 seconds.
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Warfarin-related nephropathy (WRN) is defined as acute kidney injury subsequent to excessive anticoagulation with warfarin. Patients with mechanical prosthetic valves require long-term anticoagulant therapy. Nonetheless, warfarin remains the sole available option for anticoagulant therapy. Consequently, patients with mechanical prosthetic valves constitute a special group among the entire anticoagulant population. The present study recorded two cases of patients who had undergone mechanical prosthetic valve surgery and were receiving warfarin therapy. They presented to the hospital with gross hematuria and progressive creatinine levels. Notably, their international normalized ratio (INR) did not exceed three. Subsequent renal biopsies confirmed WRN with IgA nephropathy. The two patients continued to receive warfarin as anticoagulation therapy and were prescribed oral corticosteroids and cyclophosphamide, which resulted in improved renal function during the follow-up. Based on a review of all relevant literature and the present study, we proposed a new challenge: must elevated INR levels be one of the criteria for clinical diagnosis of WRN? Perhaps some inspiration can be drawn from the present article.
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Anticoagulantes , Warfarina , Humanos , Warfarina/efectos adversos , Anticoagulantes/efectos adversos , Masculino , Persona de Mediana Edad , Femenino , Relación Normalizada Internacional , Anciano , Glomerulonefritis por IGA , Biopsia , Lesión Renal Aguda/inducido químicamente , Riñón/patología , Riñón/efectos de los fármacos , Ciclofosfamida/efectos adversos , Corticoesteroides/uso terapéutico , Corticoesteroides/efectos adversos , Corticoesteroides/administración & dosificaciónRESUMEN
BACKGROUND: Warfarin is an effective anticoagulant but requires close International Normalized Ratio (INR) monitoring and may occasionally require correction of excessive anticoagulation. Current guidelines provide limited practical guidance on the administration of vitamin K for the management of supratherapeutic INR levels ≥ 5.0 in non-bleeding outpatients. OBJECTIVE: Based on expert consensus and guidelines, the Atrius Health Anticoagulation Management Services (AMS) has developed internal guidance for oral vitamin K use in highly selected populations. This study will describe the internal guidance for oral vitamin K use and present associated results and clinical outcomes. METHODS: Episodes with INR > 5.0 were included, with vitamin K considered for episodes with INR ≥ 6. Moreover, compelling indications and exclusions to select ideal patients for vitamin K intervention were also defined. RESULTS: Overall, episodes were managed conservatively; of the 246 collected episodes of excessive anticoagulation, in 18 episodes (7%), patients received vitamin K, and in 228 (93%) episodes, patients did not receive vitamin K. The mean index INR was 6.0 (range 5.0 - 10.5, SD 1.07), with nearly 57% of episodes achieving INR correction and 15% of episodes developing INR overcorrection. High thrombotic risk patients, regardless of hemorrhagic risk, were less likely to receive vitamin K. Three episodes (1.2%) resulted in bleeding complications. No thrombotic complications occurred during the 30-day follow-up of the index INR value ≥ 5.0. CONCLUSION: Our internal guidance is a novel, standardized approach that serves as a decision support tool for the management of warfarin-associated coagulopathy and vitamin K intervention using patient-specific characteristics and index INR values. This guidance may assist other anticoagulation management services with practical applications and require validation in a prospective clinical trial.
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Background: Elevated international normalized ratio of prothrombin time (PT-INR) is one of the key characteristics of acute-on-chronic liver failure (ACLF). Whether the staging of PT-INR has the ability to screen out subgroups of ACLF patients who would be more eligible for artificial liver support system (ALSS) treatment has not been studied in detail. Methods: A previous study enrolled patients receiving ALSS treatment with regional citrate anticoagulation from January 2018 to December 2019. Patients with different PT-INR intervals were retrospectively enrolled: 1.3 ≤ PT-INR < 1.5 (Pre-stage), 1.5 ≤ PT-INR < 2.0 (Early-stage), 2.0 ≤ PT-INR < 2.5 (Mid-stage), and PT-INR ≥ 2.5 (End-stage). The Cox proportional hazards models were used to estimate the association between stages of ACLF or sessions of ALSS treatment and 90 day mortality. Results: A total of 301 ACLF patients were enrolled. The 90 day mortality risk of Early-stage ACLF patients (adjusted hazard ratio (aHR) (95% confidence interval (CI)), 3.20 (1.15-8.89), p = 0.026), Mid-stage ACLF patients (3.68 (1.34-10.12), p = 0.011), and End-stage ACLF patients (12.74 (4.52-35.91), p < 0.001) were higher than that of Pre-stage ACLF patients, respectively. The 90 day mortality risk of Mid-stage ACLF patients was similar to that of Early-stage ACLF patients (1.15 (0.69-1.94), p = 0.591). The sessions of ALSS treatment was an independent protective factor (aHR (95% CI), 0.81 (0.73-0.90), p < 0.001). The 90 day mortality risk in ACLF patients received 3-5 sessions of ALSS treatment was lower than that of patients received 1-2 sessions (aHR (95% CI), 0.34 (0.20-0.60), p < 0.001), whereas the risk in patients received ≥6 sessions of ALSS treatment was similar to that of patients received 3-5 sessions (0.69 (0.43-1.11), p = 0.128). Conclusion: ACLF patients in Pre-, Early-, and Mid-stages might be more eligible for ALSS treatment. Application of 3-5 sessions of ALSS treatment might be reasonable.
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Warfarin remains the most prescribed oral anticoagulant of choice in atrial fibrillation (AF) patient in resource-limited settings. Despite evidence linking Time in Therapeutic Range (TTR) to patient outcomes, its use in clinical practice is not widespread. This prospective study explores the impact of a TTR-INR guided Warfarin adjustment protocol on TTR in AF patients. Conducted at the Warfarin clinic of King Chulalongkorn Memorial Hospital. TTR was calculated using the Rosendaal linear interpolation method at baseline, and then at 6 and 12 months post-protocol implementation. The primary outcome was the improvement in TTR following the protocol's implementation. The study analyzed 57 patients, with a mean age of 72 years and an even gender distribution. At baseline, 53% of patients had a TTR of less than 65%. However, TTR significantly improved from 65% at baseline to 80% after 12 months of protocol implementation (p < 0.001). Furthermore, there was a significant increase in the proportion of patients with a TTR of 65% or more, from 47 to 88% (p < 0.001). During the follow-up period in the first 12 months, three patients died, but no ischemic or major bleeding events occurred. The significant improvement in TTR after 12 months of protocol implementation suggests that this strategy could provide additional value in improving TTR and outcomes in AF patients receiving Warfarin.
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Anticoagulantes , Fibrilación Atrial , Relación Normalizada Internacional , Warfarina , Humanos , Warfarina/administración & dosificación , Warfarina/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Masculino , Femenino , Anciano , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Estudios Prospectivos , Persona de Mediana Edad , Anciano de 80 o más Años , Resultado del Tratamiento , Monitoreo de Drogas/métodosRESUMEN
Prothrombin time/international normalized ratio (PT/INR) is related to both antithrombotic effect and risk of bleeding. Its role in the prediction of venous thromboembolism (VTE) recurrence and bleeding for patients with acute VTE who undergo direct oral anticoagulants (DOACs) treatment is unclear, despite previous studies revealed some association between them. The predictive efficiency of INR for VTE recurrence and bleeding were analyzed in a retrospective cohort with VTE patients who underwent DOACs treatment. Then its predictive efficiency for VTE recurrence and bleeding were validated in a prospective cohort with the acquired cutoffs range, and compared with anti-Xa level, DASH and VTE-BLEED scores. In the retrospective cohort (n = 1083), the sensitivity and specificity of INR for the prediction of VTE recurrence were 79.4% and 92.8%, respectively. The area under the curve (AUC) was 0.881 (0.803-0.960)(P = .025). The cutoff value of INR was 0.9. The sensitivity and specificity of INR for the prediction of bleeding were 85.7% and 77.9%, respectively. The AUC was 0.876 (0.786-0.967)(P < .001). The cutoff value of INR was 2.1. In the prospective cohort (n = 202), the calibration showed that there were 4 (50%) patients with VTE recurrence, 156 (97.5%) patients with non-recurrence and bleeding (non-R&B), and 20 (58.8%) patients with bleeding in the low (INR < 0.9)(n = 8), intermediate (0.9 ≤ INR ≤ 2.1)(n = 160), and high (INR > 2.1)(n = 34) groups, respectively. The baseline PT/INR value at the initiation of DOACs treatment is an independent predictor for VTE recurrence and bleeding in patients with acute VTE who undergo DOACs treatment.
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Tromboembolia Venosa , Trombosis de la Vena , Humanos , Anticoagulantes/efectos adversos , Tromboembolia Venosa/tratamiento farmacológico , Relación Normalizada Internacional , Estudios Retrospectivos , Estudios Prospectivos , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Trombosis de la Vena/tratamiento farmacológico , Administración Oral , RecurrenciaRESUMEN
BACKGROUND: The effect of the vitamin K antagonist acenocoumarol on coagulation needs to be reversed when patients undergo an invasive procedure with considerable bleeding risk. A strategy to achieve this is by administering oral vitamin K before a procedure while continuing acenocoumarol. OBJECTIVES: To assess the effect on periprocedural international normalized ratio (INR) values and safety using oral vitamin K as anticoagulant reversal method. METHODS: In this prospective cohort study, consecutive patients using acenocoumarol undergoing elective procedures between 2019 and 2022 were included. According to standard of care in our hospital, patients took 10 mg oral vitamin K 36 to 48 hours before the procedure while continuing their normal use of acenocoumarol. Effectiveness to lower INR to <1.8 preprocedural was assessed. Bleeding and thrombotic complications within 30 days after the procedure were assessed. Periprocedural course of INR was monitored by collecting additional blood samples. RESULTS: Seventy-four patients were included for analysis. On the day of the procedure, an adequate INR of <1.8 was achieved in 99% of patients. One clinically relevant nonmajor bleeding complication and no thrombotic complications were observed during the first 30 days after the procedure. INR gradually restored to therapeutic level during the days after the procedure. CONCLUSION: Using oral vitamin K while patients continue acenocoumarol intake is an effective way to adequately lower INR before an invasive procedure. Low amount of bleeding complications and absence of thromboembolic complications suggest that this is a safe strategy. The INR values returned gradually to therapeutic range after the procedure, probably contributing to the observed low bleeding rate.
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Acenocumarol , Anticoagulantes , Coagulación Sanguínea , Relación Normalizada Internacional , Vitamina K , Humanos , Acenocumarol/administración & dosificación , Acenocumarol/efectos adversos , Vitamina K/antagonistas & inhibidores , Estudios Prospectivos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anciano , Femenino , Masculino , Coagulación Sanguínea/efectos de los fármacos , Persona de Mediana Edad , Administración Oral , Anciano de 80 o más Años , Hemorragia/inducido químicamente , Resultado del Tratamiento , Procedimientos Quirúrgicos Electivos , Factores de Tiempo , Monitoreo de Drogas/métodos , Esquema de MedicaciónRESUMEN
To investigate the effect of reduced early-pregnancy activated partial thrombin time (APTT), prothrombin time (PT), and international standardized ratio (INR) on the risk of preeclampsia. A total of 8549 pregnant women with singleton births were included. Early pregnancy APTT, PT, and INR levels, with age, birth, prepregnancy body mass index, fibrinogen (FBG), thrombin time (TT), D-dimer (DD2), antithrombin III (ATIII), fibrin degradation products (FDP) as confounders, generalized linear model of APTT, the relative risk of PT and INR when INR reduction. After adequate adjustment for confounders, the relative risk of preeclampsia was 0.703 for every 1 s increase in plasma PT results in early pregnancy, and for every 0.1 increase in plasma INR results, the relative risk of preeclampsia was 0.767. With a PT less than the P25 quantile (<11 s), the relative risk of preeclampsia was 1.328. The relative risk of preeclampsia at an INR less than the P25 quantile (<0.92) was 1.24. There was no statistical association between APTT on the risk of preeclampsia. The relative risk of preeclampsia is strongly associated with a decrease in PT and INR in early pregnancy. PT and INR in early pregnancy were a potential marker in the risk stratification of preeclampsia. Focusing on reduced PT and INR levels in early pregnancy can help to identify early pregnancies at risk for preeclampsia.
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Preeclampsia , Humanos , Femenino , Embarazo , Relación Normalizada Internacional , Preeclampsia/epidemiología , Estudios Retrospectivos , Pruebas de Coagulación Sanguínea , Tiempo de Protrombina , Tiempo de Tromboplastina ParcialRESUMEN
Oral anticoagulants are widely used to treat or prevent cardiovascular diseases in millions of patients worldwide. They are the drugs of choice for stroke prevention and systemic embolism in patients with non-valvular atrial fibrillation and prosthetic heart valves, as well as for treatment/prevention of venous thromboembolism. Oral anticoagulants include vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs). The hemostasis laboratory plays a crucial role in the management of treated patients, spanning from dose adjustment based on laboratory testing that applies to VKAs to the measurement of drug concentrations in special situations that apply to DOACs. This article aims to overview how the hemostasis laboratory can help clinicians manage patients on oral anticoagulants. Special interest is devoted to the international normalized ratio, used to manage patients on VKAs and to the measurement of DOAC concentrations, for which the role of the laboratory is still not very well defined, and most interferences of DOACs with some of the most common hemostatic parameters are not widely appreciated.
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PURPOSE: Warfarin is effective therapy to prevent thromboembolic complications of venous thromboembolism, atrial fibrillation, and cardiac thrombus, among valvular heart diseases, including in patients treated with prostheses and/or repair. Its optimum effect is achieved when the international normalized ratio (INR) is in the target therapeutic range, but a subtherapeutic level increases risk of thromboembolism and complications. This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin. METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relationships among variables. FINDINGS: Of 196 patients on warfarin, â¼60% were taking it for atrial fibrillation, followed by deep venous thrombosis, women accounted for 61.7% of patients, and mean (SD) age was 43 (7) years. Most patients (61.7%) lived in rural areas and 44.9% farmed to earn a living. Most of the study participants (51.5%) had a very low monthly income of less than USD50. Most of the patients (n = 107 [54.6%]) were advised on dietary selections while on warfarin and approximately two-thirds (n = 70 [65.4%]) were adherent to the advice. Most participants (n = 118 [60.2%]) were poorly adherent to warfarin therapy and more than two-thirds of them discontinued warfarin for financial reasons. Mean (SD) duration of warfarin therapy was 15.53 (18.92) months (range 1-90 months). Most of the respondents (n = 109 [55.6%]) had subtherapeutic INR and 21 (10.7%) were in the supratherapeutic range. Although the mean (SD) time in therapeutic range was 25.03% (24.17% [range 0-80%]), in most patients (n = 166 [84.7%]), it was <60%. Poor adherence (adjusted odds ratio = 6.13; 95% CI, 3.31-28.10), shorter duration of warfarin (<12 months; adjusted odds ratio = 0.104; 95% CI, 0.012-0.875), and presence of comorbidity (adjusted odds ratio = 0.035; 95% CI, 0.004-0.323) were significantly associated with subtherapeutic INR. IMPLICATIONS: Attainment of therapeutic INR among patients on warfarin therapy is suboptimal. This was evidenced by a significant number of patients with low time in therapeutic range, as well as INR. Poor adherence to warfarin therapy, shorter duration since initiation of warfarin, and presence of comorbid illnesses were significantly associated with subtherapeutic INR. This can lead to complications of atrial fibrillation, including thrombus formation and subsequent cardioembolic stroke, venous thromboembolism, and others, leading to morbidity, increased mortality, and poor quality of life. Therefore, providing health education and treatment for comorbidities may improve adherence, which may also improve attainment of therapeutic INR and reduce complications and improve quality of life.
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Anticoagulantes , Relación Normalizada Internacional , Warfarina , Humanos , Warfarina/uso terapéutico , Warfarina/efectos adversos , Warfarina/administración & dosificación , Etiopía , Femenino , Masculino , Estudios Transversales , Adulto , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Persona de Mediana Edad , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Anciano , Adulto JovenRESUMEN
OBJECTIVES: To determine whether international normalized ratio (INR), bilirubin, and creatinine predict bleeding risk following percutaneous liver biopsy. METHODS: A total of 870 consecutive patients (age 53 ± 14 years; 53% (459/870) male) undergoing non-targeted, ultrasound-guided, percutaneous liver biopsy at a single tertiary center from 01/2016 to 12/2019 were retrospectively reviewed. Results were analyzed using descriptive statistics and logistic regression models to evaluate the relationship between individual and combined laboratory values, and post-biopsy bleeding risk. Receiver operating characteristic (ROC) curves and area under ROC (AUC) curves were constructed to evaluate predictive ability. RESULTS: Post-biopsy bleeding occurred in 2.0% (17/870) of patients, with 0.8% (7/870) requiring intervention. The highest INR within 3 months preceding biopsy demonstrated the best predictive ability for post-biopsy bleeding and was superior to the most recent INR (AUC = 0.79 vs 0.61, p = 0.003). Total bilirubin is an independent predictor of bleeding (AUC = 0.73) and better than the most recent INR (0.61). Multivariate regression analysis of the highest INR and total bilirubin together yielded no improvement in predictive performance compared to INR alone (0.80 vs 0.79). The MELD score calculated using the highest INR (AUC = 0.79) and most recent INR (AUC = 0.74) were similar in their predictive performance. Creatinine is a poor predictor of bleeding (AUC = 0.61). Threshold analyses demonstrate an INR of > 1.8 to have the highest predictive accuracy for bleeding. CONCLUSION: The highest INR in 3 months preceding ultrasound-guided percutaneous liver biopsy is associated with, and a better predictor for, post-procedural bleeding than the most recent INR and should be considered in patient risk stratification. CLINICAL RELEVANCE STATEMENT: Despite correction of coagulopathic indices, the highest international normalized ratio within the 3 months preceding percutaneous liver biopsy is associated with, and a better predictor for, bleeding and should considered in clinical decision-making and determining biopsy approach. KEY POINTS: ⢠Bleeding occurred in 2% of patients following ultrasound-guided liver biopsy, and was non-trivial in 41% of those patients who needed additional intervention and had an associated 23% 30-day mortality rate. ⢠The highest INR within 3 months preceding biopsy (AUC = 0.79) is a better predictor of bleeding than the most recent INR (AUC = 0.61). ⢠The MELD score is associated with post-procedural bleeding, but with variable predictive performance largely driven by its individual laboratory components.
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Biopsia Guiada por Imagen , Relación Normalizada Internacional , Hígado , Ultrasonografía Intervencional , Humanos , Masculino , Persona de Mediana Edad , Femenino , Biopsia Guiada por Imagen/métodos , Biopsia Guiada por Imagen/efectos adversos , Estudios Retrospectivos , Hígado/patología , Hígado/diagnóstico por imagen , Ultrasonografía Intervencional/métodos , Bilirrubina/sangre , Hemorragia/etiología , Creatinina/sangre , Valor Predictivo de las Pruebas , Anciano , AdultoRESUMEN
OBJECTIVE: Spontaneous intracerebral hemorrhage (ICH) poses a public health issue due to its elevated mortality rates. The International Normalized Ratio-platelet index (INR-Plt index) has recently been recognized as a predictive factor for liver disease progression. The potential of applying the INR-Plt index in forecasting ICH prognosis presents an intriguing subject. This study endeavors to examine the correlation between the INR-Plt index and hospital outcomes in patients with spontaneous supratentorial ICH. METHODS: A retrospective examination of 283 adult ICH patients was undertaken. The INR-Plt index was computed using the formula: [INR/platelet counts (1000/µL)] × 100. The clinical outcomes evaluated consisted of mortality rates and the Modified Rankin Scale (mRS) at discharge. An unfavorable outcome was defined as an mRS score from 4 to 6. RESULTS: The study found a significant correlation between the INR-Plt index and hospital mortality (odds ratio: 4.31, 95% CI: 1.07-17.31, P = 0.04). There was a 43% rise in mortality risk for every 0.1 unit increase in the INR-Plt index. Kaplan-Meier survival curves illustrated a considerably lower survival rate at discharge for patients with an INR-Plt index >0.8 (log-rank test: P = 0.047). Regarding unfavorable outcomes, the INR-Plt index was not a significant factor according to logistic regression analyses. CONCLUSIONS: The INR-Plt index is a predictor of hospital mortality in patients with spontaneous supratentorial ICH. A higher INR-Plt index value is associated with an increased risk of mortality, underlining the potential usefulness of this composite index in guiding clinical decision-making and enabling risk stratification.
Asunto(s)
Hemorragia Cerebral , Mortalidad Hospitalaria , Relación Normalizada Internacional , Humanos , Femenino , Masculino , Hemorragia Cerebral/sangre , Hemorragia Cerebral/mortalidad , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Recuento de Plaquetas , Pronóstico , Anciano de 80 o más Años , Adulto , Valor Predictivo de las PruebasRESUMEN
Background: The influence of child characteristics on warfarin dosing has been reported; however, there is no consensus on the nature and extent of this effect. Objectives: To investigate the impacts of the demographic and clinical characteristics of children on the warfarin dose required to achieve a therapeutic international normalization ratio (INR). Methods: This retrospective cohort study included children aged 3 months to 14 years old who were prescribed warfarin for 3 months or longer with a "stable INR." The primary outcome was the total daily dose (TDD) and total weekly dose of warfarin required to achieve a therapeutic INR target. Results: We included 127 patients with a mean age of 7.7 ± 3.7 years and a median weight of 22 (IQR, 16-33) kg. Of the sample, 55 patients (43.3%) required a TDD of ≤0.1 mg/kg. The TDD for children younger than 5 years, 5 to 10 years, and older than 10 years were 0.14 ± 0.06 mg/kg, 0.12 ± 0.05 mg/kg, and 0.096 ± 0.04 mg/kg, respectively (P = .002). Overweight and obese children required a smaller TDD than normal-weight children: 0.09 ± 0.05 vs 0.13 ± 0.05 mg/kg (P = .004), which was similar for underweight children. A lower body surface area (<0.5 m2) required a higher dose. All the other variables did not affect warfarin doses. The incidence of a subtherapeutic or supratherapeutic INR was independent of demographic or clinical variables. Conclusion: The study confirmed that the patient demographics affect the daily warfarin dose required to achieve the INR target. However, they do not have any predictive value for the incidence of out-of-range-INR.
RESUMEN
BACKGROUND: Thrombolytic therapy is effective method in the high-risk acute pulmonary embolism (PE) treatment. Reduced-dose thrombolysis (RDT) plus oral anticoagulation therapy is effective and safe method in the moderate and severe PE treatment. It is leading to good early and intermediate-term outcomes. In the RE-COVER and RE-COVER II studies, dabigatran showed similar effectiveness as warfarin in the treatment of acute PE. Dabigatran leads to fewer hemorrhagic complications and is not inferior in efficacy to warfarin in the prevention of PE after mechanical fragmentation and RDT (catheter-directed treatment [CDT]+RDT) in patients with high and intermediate to high PE risk. We sought to evaluate the efficacy and safety (incidence of clinically significant recurrence of venous thromboembolic complications and deaths) during a 6-month course of treatment with dabigatran or warfarin in patients with high and intermediate to high acute PE risk after endovascular mechanical thrombus fragmentation procedure with RDT (CDT+RDT). METHODS: The RE-SPIRE is a prospective, multicenter randomized double-arm study. Over a 5-year period, 66 consecutive patients with symptomatic high and intermediate to high PE risk after endovascular mechanical thrombus fragmentation procedure with RDT (CDT+RDT) were randomized into two groups within the next 48 hours. The first group continued treatment with dabigatran 150 mg twice a day for 6 months; the second group continued treatment with warfarin under the control of international normalized ratio (2.0-3.0) for 6 months. Both groups received low molecular weight heparins for 2 days after surgery. Then, group 1 continued to receive low molecular-weight-heparin for 5 to 7 days, followed by a switch to dabigatran at a dosage of 150 mg two times a day. Group 2 received both low-molecular-weight heparin and warfarin up to an international normalized ratio of >2.0, followed by heparin withdrawal. The follow-up period was 6 months. RESULTS: There were 63 patients who completed the study (32 in the dabigatran group and 31 in the warfarin group). In both groups, there was a statistically significant decrease in the mean pulmonary artery pressure. The mean pulmonary artery pressure at the 6-month follow-up after surgery was 24 mm Hg (interquartile range, 20.3-29.25 mm Hg) in the dabigatran group and 23 mm Hg (interquartile range, 20.0-26.3 mm Hg) in the warfarin group. The groups did not differ statistically in the deep vein thrombosis dynamics. Partial recanalization occurred in 52.0% vs 73.1% in the dabigatran and warfarin groups, respectively (P = .15). Complete recanalization occurred in 28.0% vs 19.2% in the dabigatran and warfarin groups, respectively (P = .56). The groups did not differ in the frequency of major bleeding events according to the International Society for Thrombosis and Hemostasis (0% vs 3.2% in the dabigatran and warfarin groups, respectively; P = 1.00). However, there were more nonmajor bleeding events in the warfarin group than in the dabigatran group (16.1% vs 0%, respectively; P = .02). CONCLUSIONS: The results of the study show that dabigatran is comparable in effectiveness to warfarin. Dabigatran has greater safety in comparison with warfarin in the occurrence of all cases of bleeding in the postoperative and long-term periods. Thus, dabigatran may be recommended for the treatment and prevention of PE after CDT with RDT in patients with high and intermediate to high PE risk.