The Alfalfa-inpatient-CAT assessment model: a thrombotic risk assessment model for inpatient cancer patients.

PURPOSE: To construct a venous thromboembolism (VTE) risk assessment model specifically for inpatients with cancer. METHOD: Patients were included according to the inclusion criteria. Univariate and multivariate analyses of all variables were included to develop a VTE risk assessment model applicable to the derivation cohort. Hosmer-Lemeshow test and receiver operating characteristic (ROC) curve were used to test the fit degree and identification validity of the model. The patient data from separate validation cohorts verified the external population. RESULT: A total of 944 cancer patients were included in this study. Alfalfa-inpatient-CAT model, a risk assessment model for VTE in hospitalized cancer patients, was established, which mainly includes hypertension, surgical history (nearly one month), history of VTE, peripherally inserted central venous catheters (PICC), chemotherapy, PT < 12.85 s, D-dimer ≥ 1.805 µg/mL, hemoglobin ≤ 114.5 g/L, CRP ≥ 7.575 mg/L. Hosmer-Lemeshow test results showed P = 0.353 > 0.05, (χ2 = 8.872, Df = 8). The area under ROC curve was 0.906 [95%CI (0.881-0.930), P < 0.001]. The authenticity evaluation in the model database showed that the risk of thrombosis in the high-risk group (score ≥ 3) was 72.63%, significantly higher than that in the low-risk group (score 0-2) (27.37%) [χ2 = 144.00, Df = 1, P < 0.001]. CONCLUSION: This study developed a new VTE risk assessment model - Alfalfa-inpatient-CAT model - for hospitalized cancer patients at high risk of thrombosis. This model has a good fitting degree and discriminant validity. It is expected to provide some reference for the clinical treatment of inpatients with cancer through continuous optimization.

Application of Alfalfa App in the management of oral anticoagulation in patients with atrial fibrillation: a multicenter randomized controlled trial.

BACKGROUND: In recent years, mobile medical technology has made great progress in chronic disease management, but its application in patients with atrial fibrillation (AF) still needs to be clarified. OBJECTIVE: This study aims to determine whether the newly developed smartphone app for patients with AF (Alfalfa App) can improve anticoagulation knowledge, drug treatment compliance, and satisfaction of AF patients. METHODS: Alfalfa App integrates the functions of patient education, remote consultation, and medication reminder through a simple user interface. From June 2020 to December 2020, patients with AF were recruited in five large tertiary hospitals in China. Patients were randomly divided into the Alfalfa App or routine nursing groups. Patients' knowledge, medication adherence, and satisfaction with anticoagulation were assessed using validated questionnaires at baseline, 1 month, and 3 months. RESULTS: In this randomized controlled trial, 113 patients with AF were included, 57 patients were randomly assigned to the Alfalfa App group, and 56 patients were randomly assigned to the routine nursing group. Forty-eight patients in the Alfalfa App group completed a three-month follow-up, and 48 patients in the routine nursing group completed a three-month follow-up. Basic demographic data were comparable between the two groups. The average age of AF patients was 61.65 ± 11.01 years old, and 61.5% of them were male. With time (baseline to 3 months), the knowledge scores of the Alfalfa App group (P<.001) and the routine nursing group (P = .002) were significantly improved, the compliance scores of the routine nursing group(P<.001) and Alfalfa App group(P<.001) significantly improved. Compared with the routine nursing group, patients' knowledge level and medication compliance using the Alfalfa App at 1 month and 3 months were significantly higher (all P < .05). There were significant differences in knowledge and compliance scores between the two groups with time (all P < .05). The satisfaction degree of drug treatment in the Alfalfa App group was significantly better than that in the routine nursing group (all P < .05). CONCLUSIONS: Alfalfa App significantly improved the anticoagulation knowledge, drug treatment compliance, and satisfaction of AF patients. In oral anticoagulation management for AF patients, mobile medical technology that integrates the functions of patient education, remote consultation, and medication reminder may be helpful. TRIAL REGISTRATION: Registration number, ChiCTR1900024455. Registered on July 12, 2019.

A new model to predict the risk of major gastrointestinal bleeding in patients on direct oral anticoagulants (dabigatran and rivaroxaban).

AIMS: The aim of this study was to identify factors associated with gastrointestinal bleeding (GIB) in patients on direct oral anticoagulants (DOACs) and develop a risk score that would provide an effective tool for the clinical assessment of GIB. METHODS: This was a multicentre retrospective analysis of clinical and follow-up data of patients treated with DOACs. The score was developed through logistic regression. The performance of score was evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Hosmer-Lemeshow test. RESULTS: The 11 903 patients had a mean age of 65.1 years. In multivariate analysis, age ≥65 years, alcohol use, history of peptic ulcer, history of major bleeding, abnormal liver function or renal function, cancer, platelet count <100 × 109 /L, anaemia, and concurrent antiplatelet agent or non-steroidal anti-inflammatory drug treatment were independent risk factors for GIB, and concurrent treatment with gastrointestinal protective agents were a protective factor. The Alfalfa-DOAC-GIB score was constructed using these 12 factors. The AUC of the Alfalfa-DOAC-GIB score was 0.77 (95% CI 0.74-0.81), which was higher than that of the HAS-BLED score (0.69; 95% CI 0.65-0.72) and the New score (0.65; 95% CI 0.61-0.68). CONCLUSIONS: Based on 12 factors, we developed a gastrointestinal bleeding risk score. The newly developed Alfalfa-DOAC-GIB score has better predictive value than the HAS-BLED score and the New score, and might be an effective tool to help reduce the occurrence of GIB in patients using DOACs.

Risk factors for thrombolysis-related intracranial hemorrhage: a systematic review and meta-analysis.

BACKGROUND: Thrombolysis-related intracranial hemorrhage has a high mortality rate, and many factors can cause intracranial hemorrhage. Until now, systematic reviews and assessments of the certainty of the evidence have not been updated. AIM: We conducted a systematic review to identify risk factors for thrombolysis-related intracranial hemorrhage. METHOD: The protocol for this systematic review was prospectively registered with PROSPERO (CRD42022316160). All English studies that met the inclusion criteria published before January 2022 were obtained from PubMed, EMBASE, Web of Science, and Cochrane Library. Two researchers independently screened articles, extracted data, and evaluated the quality and evidence of the included studies. Risk factors for intracranial hemorrhage were used as the outcome index of this review. Random or fixed-effect models were used in statistical methods. RESULTS: Of 6083 citations, we included 105 studies in our analysis. For intracranial hemorrhage, moderate-certainty evidence showed a probable association with age, National Institutes of Health stroke scale, leukoaraiosis, hypertension, atrial fibrillation, diabetes, total cholesterol, proteinuria, fibrinogen levels, creatinine, homocysteine, early infarct signs, antiplatelet therapy and anticoagulant therapy; In addition, we found low-certainty evidence that there may be little to no association between risk of intracranial hemorrhage and weight, sex, platelet count, uric acid, albumin and white matter hyperintensity. Leukoaraiosis, cardiovascular disease, total cholesterol, white blood cell count, proteinuria, fibrinogen levels, creatinine, homocysteine and early CT hypodensities are not included in most intracranial hemorrhage risk assessment models. CONCLUSION: This study informs risk prediction for thrombolysis-related intracranial hemorrhage, it also informs guidelines for intracranial hemorrhage prevention and future research.

Severe Bleeding Risk of Direct Oral Anticoagulants Versus Vitamin K Antagonists for Stroke Prevention and Treatment in Patients with Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.

PURPOSE: We aimed to determine the safety of direct oral anticoagulants (DOACs) for stroke prevention and treatment in patients with atrial fibrillation (AF). METHODS: A systematic search of four databases (PubMed, EMBASE, Web of Science, and Cochrane Library) was performed to identify randomized controlled trials (RCTs) reporting severe bleeding events in patients taking DOACs or vitamin K antagonists (VKAs). In this frequency-based network meta-analysis, odds ratios and 95% confidence intervals were used for reporting. Based on the surface under the cumulative ranking curves (SUCRA), the relative ranking probability of each group was generated. RESULTS: Twenty-three RCTs met the inclusion criteria, and a total of 87,616 patients were enrolled. The bleeding safety of DOACs for stroke prevention and treatment in patients with AF was ranked from highest to lowest as follows: fatal bleeding: edoxaban (SUCRA,80.2), rivaroxaban (SUCRA,68.3), apixaban (SUCRA,48.5), dabigatran (SUCRA,40.0), VKAs (SUCRA,12.9); major bleeding: dabigatran (SUCRA,74.0), apixaban (SUCRA,71.5), edoxaban (SUCRA,66.5), rivaroxaban (SUCRA,22.7), VKAs (SUCRA,15.4); gastrointestinal bleeding: apixaban (SUCRA,55.9), VKAs (SUCRA,53.7), edoxaban (SUCRA,50.5), rivaroxaban (SUCRA,50.4), dabigatran (SUCRA,39.5); intracranial hemorrhage: dabigatran (SUCRA,84.6), edoxaban (SUCRA,74.1), apixaban (SUCRA,65.8), rivaroxaban (SUCRA,24.4), VKAs (SUCRA,1.1). CONCLUSION: Based on current evidence, for stroke prevention and treatment in patients with AF, the most safe DOAC is edoxaban in terms of fatal bleeding; dabigatran in terms of major bleeding and intracranial hemorrhage and apixaban in terms of gastrointestinal bleeding. However, given the nature of indirect comparisons, more high-quality evidence from head-to-head comparisons is still needed to confirm them.

A new model (Alfalfa-Warfarin-GIB) for predicting the risk of major gastrointestinal bleeding in warfarin patients.

BACKGROUND: This study aimed to analyze the factors influencing warfarin-related major gastrointestinal bleeding (GIB) and to develop a score that would provide a reference for assessing the risk of major GIB associated with warfarin treatment. METHODS: This was a retrospective analysis of clinical and follow-up data from warfarin-treated patients. Scores were analyzed using logistic regression. The area under the subject working characteristic curve (AUC), sensitivity, specificity, and Hosmer-Lemeshow test were used to evaluate the scoring performance. RESULTS: A total of 1591 patients who met the requirements for warfarin use were included in this study, and 46 developed major GIB. After univariate analysis as well as multivariate logistic regression analysis, nine factors were found to be associated with increased risk of major GIB, namely age ≥ 65 years, history of peptic ulcer, history of major bleeding, abnormal liver function, abnormal renal function, cancer, anemia, labile international normalized ratio, and combination of antiplatelet agents/non-steroidal anti-inflammatory drugs. The Alfalfa-Warfarin-GIB score was constructed using these nine factors. The AUC and Bootstrap method-corrected AUC of the Alfalfa-Warfarin-GIB score were 0.916 (95% CI: 0.862-0.970, P < 0.001) and 0.919 (95% CI: 0.860-0.967, P < 0.001), respectively, which were higher than those of the HAS-BLED score (AUC = 0.868, 95% CI: 0.812-0.924, P < 0.001). CONCLUSION: Based on nine risk factors, the Alfalfa-Warfarin-GIB score was constructed to predict the risk of warfarin-related major GIB. The newly developed Alfalfa-Warfarin-GIB score has a better predictive value than the HAS-BLED score and may be an effective tool to help reduce the occurrence of major GIB in patients on warfarin.

Risk Factors for Anticoagulant-Associated Intracranial Hemorrhage: A Systematic Review and Meta-analysis.

BACKGROUND: Anticoagulant-associated intracranial hemorrhage has a high mortality rate, and many factors can cause intracranial hemorrhage. Until now, systematic reviews and assessments of the certainty of the evidence have not been published. METHODS: We conducted a systematic review to identify risk factors for anticoagulant-associated intracranial hemorrhage. The protocol for this systematic review was prospectively registered with PROSPERO (CRD42022316750). All English studies that met the inclusion criteria published before January 2022 were obtained from PubMed, EMBASE, Web of Science, and Cochrane Library. Two researchers independently screened articles, extracted data, and evaluated the quality and evidence of the included studies. Risk factors for intracranial hemorrhage were used as the outcome index of this review. Random or fixed-effect models were used in statistical methods. I2 statistics were used to evaluate heterogeneity. RESULTS: Of 7322 citations, we included 20 studies in our analysis. For intracranial hemorrhage, moderate-certainty evidence showed a probable association with race, Glasgow Coma Scale, stroke, leukoaraiosis, cerebrovascular disease, tumor, atrial fibrillation, previous bleeding, international normalized ratio, serum albumin, prothrombin time, diastolic blood pressure, and anticoagulant. Low-certainty evidence may be associated with age, cerebral microbleeds, smoking, alcohol intake, platelet count, and antiplatelet drug. In addition, we found very low-certainty evidence that there may be little to no association between the risk of intracranial hemorrhage and hypertension and creatinine clearance. Leukoaraiosis, cerebral microbleeds, cerebrovascular disease, and international normalized ratio are not included in most risk assessment models. CONCLUSIONS: This study informs risk prediction for anticoagulant-associated intracranial hemorrhage and informs guidelines for intracranial hemorrhage prevention and future research.

Editor's Choice - Severe Bleeding Risks of Direct Oral Anticoagulants in the Prevention and Treatment of Venous Thromboembolism: A Network Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: The aim of this study was to determine the severe bleeding safety of direct oral anticoagulants (DOACs) for the prevention and treatment of venous thromboembolism (VTE). METHODS: PubMed, EMBASE, Web of Science, and the Cochrane Library databases were searched up to 6 January 2021. The incidence of severe bleeding (major, gastrointestinal [GI], intracranial, and fatal) was investigated. Using frequentist network meta-analysis, interventions that were not compared directly could be compared indirectly by the 95% confidence interval (CI), making the search results more intuitive. Based on surface under the cumulative ranking curves (SUCRA), the relative ranking probability of each group was generated. RESULTS: Thirty-one randomised controlled trials (76 641 patients) were included. For the treatment of VTE, the risk of major bleeding with apixaban was significantly lower than dabigatran (odds ratio [OR] 2.10, 95% CI 1.07 - 4.12) and edoxaban (OR 2.64, 95% CI 1.36 - 5.15). The safety of the drugs was ranked from highest to lowest as follows: major bleeding: apixaban (SUCRA 98.0), rivaroxaban (SUCRA 69.6), dabigatran (SUCRA 50.7), edoxaban (SUCRA 26.5), and vitamin K antagonists (VKAs; SUCRA 5.1); GI bleeding: apixaban (SUCRA 80.7), rivaroxaban (SUCRA 66.8), edoxaban (SUCRA 62.3), VKAs (SUCRA 34.4), and dabigatran (SUCRA 5.8); intracranial bleeding: rivaroxaban (SUCRA 74.4), edoxaban (SUCRA 70.4), dabigatran (SUCRA 58.2), apixaban (SUCRA 44.4), and VKAs (SUCRA 5.6); fatal bleeding: edoxaban (SUCRA 82.7), rivaroxaban (SUCRA 59.2), dabigatran (SUCRA 48.6), apixaban (SUCRA 43.0), and VKAs (SUCRA 16.3). For the prevention of VTE, the risk of major bleeding with apixaban was significantly lower than rivaroxaban (OR 2.14, 95% CI 1.02 - 4.52). Among the four types of bleeding, apixaban had the lowest bleeding risk among DOACs (major bleeding: SUCRA 81.6; GI bleeding: SUCRA 75.4; intracranial bleeding: SUCRA 64.1; fatal bleeding: SUCRA 73.6). CONCLUSIONS: For the treatment of VTE, in terms of major bleeding and GI bleeding, apixaban had the lowest bleeding risk; in terms of intracranial bleeding, rivaroxaban had the lowest bleeding risk; in terms of fatal bleeding, edoxaban had the lowest bleeding risk. For the prevention of VTE, apixaban had the lowest bleeding risk.

Risk of nonmajor bleeding upon use of direct oral anticoagulants for preventing and treating venous thromboembolism: A network meta-analysis.

INTRODUCTION: Direct oral anticoagulants (DOACs) are associated with bleeding. Patients often stop taking DOACs due to nonmajor bleeding, which may lead to venous thromboembolism (VTE) recurrence. We aimed to determine the risk of nonmajor bleeding using different DOACs to prevent and treat VTE. METHODS: PubMed, Embase, Web of Science, and Cochrane Library databases were searched from inception until January 6, 2021. The incidence of clinically relevant nonmajor bleeding and minor bleeding was investigated. In frequentist-based network meta-analysis, we analyzed the odds ratio (OR) with 95% CI and the surface under the cumulative ranking curves (SUCRA). RESULTS: Twenty-seven randomized controlled trials (RCTs) (involving 64,493 patients) were included. For preventing VTE, the risk for clinically relevant nonmajor bleeding was lowest for apixaban, followed by that for low-molecular weight heparin (LMWH), dabigatran, edoxaban, and rivaroxaban. The risk for minor bleeding was lowest for apixaban, followed by that for rivaroxaban, LMWH, dabigatran, and edoxaban. For treating VTE, the risk for clinically relevant nonmajor bleeding was also lowest for apixaban, followed by that for edoxaban, vitamin K antagonists (VKAs), and rivaroxaban. The risk for minor bleeding was lowest for apixaban, followed by that for rivaroxaban and VKAs. CONCLUSIONS: Regardless of whether it was used for preventing or treating VTE, apixaban had the lowest risk of nonmajor bleeding. This suggests that apixaban may have a lower risk of nonmajor bleeding than other anticoagulants and may help provide some clinical reference for choosing a more appropriate drug for the patient.

Effect of gene polymorphism on bleeding complications in Chinese Han patients taking warfarin.

PURPOSE: The purpose of this study was to analyse the effects of demographic factors, clinical factors, and genetic polymorphisms of related gene loci on warfarin bleeding-related complications in the Han population. METHODS: Retrospective medical record review. The study cases were patients treated at the Fujian Medical University Union Hospital from March 2016 to February 2020, and all received regular warfarin anticoagulation treatment for at least 3 months, and were provided the initial standard dose and stable dose of warfarin. RESULTS: Data were collected from 451 qualifying patients (47% male, 53% female). The average age of patients was 53.8 ± 12.2 years, and the average body surface area was 1.6 ± 0.18 m2. There were nine major bleeding events and 141 minor bleeding events. In the univariate logistic analysis, the p-value of the four factors body weight, body surface area (BSA), amiodarone, and rs429358 was < 0.10. However, the final p-values for amiodarone and rs429358 were < 0.05 in the multifactorial logistic analysis. CONCLUSIONS: The ApoE (rs429358) gene polymorphism influences bleeding complications in Chinese Han patients treated with warfarin. The sample size of this study was relatively small; hence an international study with a larger sample size is needed in the future.

To establish a model for the prediction of initial standard and maintenance doses of warfarin for the Han Chinese population based on gene polymorphism: a multicenter study.

PURPOSE: The purpose of this paper is to study the correlation between demographic and clinical factors and warfarin dose of patients in Chinese Han population taking warfarin and study gene polymorphisms impact of related gene loci (CYP2C9*3, VKORC1-1639G > A) on warfarin doses, to establish a model to predict initial standard dose and maintenance dose based on CYP2C9*3, VKORC1-1639G > A genotype. METHODS: The study collects the data of patients in our hospital and other subcenters which incorporates 2160 patients to establish the initial dose model and 1698 patients for the stable dose model, and sequences 26 multigene sites in 451 patients. Based on the patient's dosage, clinical data, and demographic characteristics, the genetic and non-genetic effects on the initial dose and stable dose of warfarin are calculated by using statistical methods, and the prediction model of initial standard dose and maintenance dose can be established via multiple linear regression. RESULTS: The initial dose of warfarin (mg/day) was calculated as (1.346 + 0.350 × (VKORC1-1639G > A) - 0.273 × (CYP2C9*3) + 0.245 × (body surface area) - 0.003 × (age) - 0.036 × (amine-iodine) + 0.021 × (sex))2. This model incorporated seven factors and explained 55.3% of the individualization differences of the warfarin drug dose. The maintenance dose of warfarin (mg/day) was calculated as (1.336 + 0.299 × (VKORC1-1639G > A) + 0.480 × (body surface area) - 0.214 × (CYP2C9*3) - 0.074 × (amine-iodine) - 0.003 × (age) - 0.077 × (statins) - 0.002 × (height))2. This model incorporated six factors and explained 42.4% of the individualization differences in the warfarin drug dose. CONCLUSION: The genetic and non-genetic factors affecting warfarin dose in Chinese Han population were studied systematically in this study. The pharmacogenomic dose prediction model constructed in this study can predict anticoagulant efficacy of warfarin and has potential application value in clinical practice.

Direct oral anticoagulants for venous thromboembolism in cancer patients: a systematic review and network meta-analysis.

BACKGROUND: The efficacy and safety of direct oral anticoagulants (DOACs), including dabigatran, apixaban, rivaroxaban, and edoxaban, for preventing and treating venous thromboembolism (VTE) in patients with cancer is unclear. METHODS: We searched the PubMed, Embase, Web of Science, and Cochrane Library databases from the establishment to November 30, 2021. In the frequency-based network meta-analysis, the odds ratio with a 95% confidence interval was reported. The relative ranking probability of each group was generated based on the surface under the cumulative ranking curve (SUCRA). RESULTS: We included 15 randomized controlled trials involving a total of 6162 patients. Apixaban reduced the risk of VTE compared with low-molecular heparin [OR = 0.53, 95% CI (0.32, 0.89)]. The efficacy of drugs was ranked from highest to lowest as follows: apixaban (SUCRA, 81.0), rivaroxaban (73.0), edoxaban (65.9), dabigatran (51.4), warfarin (30.8), and low-molecular-weight heparin (LMWH) (27.4). Edoxaban increased the risk of major bleeding compared with LMWH [OR = 1.83, 95% CI (1.04, 3.22)]. The safety of drugs was ranked from highest to lowest as follows: major bleeding-apixaban (SUCRA, 68.5), LMWH (55.1), rivaroxaban (53.0), warfarin (35.9), dabigatran (29.2), edoxaban (16.5) and clinically relevant non-major bleeding-LMWH (73.0), apixaban (57.8), edoxaban (45.8), rivaroxaban (35.3), and warfarin (10.8). CONCLUSIONS: For preventing and treating VTE, in terms of VTE occurrence and major bleeding, apixaban had the lowest risk; in terms of clinically relevant non-major bleeding, LMWH had the lowest risk, followed by apixaban. Generally, apixaban is the most efficient and safest DOAC and presents better efficacy and relatively low bleeding risk among the VTE prevention and treatment drugs for patients with cancer.

Efficacy and safety of app-based remote warfarin management during COVID-19-related lockdown: a retrospective cohort study.

This study aimed to explore the effectiveness, and safety of internet-based warfarin management during the pandemic. In this single-center retrospective cohort study, we compared the safety and efficacy of online warfarin management using a smartphone app (the Alfalfa app) versus conventional outpatient clinic management from January 1, 2020 to March 31, 2020. Patients in the online management group used the Alfalfa app to communicate coagulation test results and other relevant information to a doctor or clinical pharmacist, who then responded with the dose adjustment plan and the date of the next blood test. The outcomes examined were the time in therapeutic range (TTR), incidence of clinical events (i.e., bleeding events, thrombotic events, warfarin-related emergency department visits, and warfarin-related hospital admissions), and the distribution of international normalized ratio (INR) values. Data from 117 patients were analyzed in this study. TTR was significantly higher in the online group than in the offline group (61.0% vs. 39.6%, P < 0.01). Incidence of major bleeding events, thrombotic events, and warfarin-related hospital admissions were comparable between the online and offline groups. However, minor bleeds (5.3% vs. 28.3%, P < 0.01) and warfarin-related emergency department visits (1.8% vs. 23.3%, P = 0.02) were significantly fewer in the online group than in the offline group. The proportion of INR values in the therapeutic range (53.8% vs. 40.1%, P < 0.01) was significantly higher in the online group. Warfarin management using the Alfalfa app appears to be a safe and effective method for warfarin management when patients cannot physically visit hospitals for follow-up.

Comparison of predictive value of risk scores for gastrointestinal bleeding in antiplatelet therapy.

Gastrointestinal bleeding (GIB) is the most common serious bleeding complication of antiplatelet therapy. The bleeding risk score (BRS) of GIB may help to determine the risk of bleeding, and provides a reference for the formulation of antiplatelet therapy regimen in clinical practice, but we found that no specific risk scores are available in East Asian patients. This study analyzed patients who were administered antiplatelet therapy from May 2015 to December 2018 in two medical centers. Patient's baseline data were obtained. We assessed four BRSs (New Score, RIETE Score, Cuschieri Score, de Groot Score) and compared them using the area under the receiver operating characteristic curve (AUC). The 4,052 patients enrolled in this study had an average age of 69.6 ± 10.8 years, and 65.9% of them were male. Among the 4,052 patients included, 171 patients experienced GIB within 6 months of follow-up. In the study population, the AUCs for the New, RIETE, Cuschieri, and de Groot scores were 0.673 (95% confidence interval (CI) 0.616-0.729, P < .001), 0.742 (95% CI 0.690-0.794, P < .001), 0.598 (95% CI 0.537-0.659, P = .002), and 0.875 (95% CI 0.839-0.912, P < .001), respectively. After validation, the de Groot Score has better performance. Among the four scores, the de Groot Score might be more suitable for helping Chinese clinicians to predict the risk of GIB in patients taking antiplatelet drugs, and reduce GIB events.

Risk factors for antiplatelet drug-associated intracranial hemorrhage: a systematic review and meta-analysis.

BACKGROUND: Antiplatelet drug-associated intracranial hemorrhage has a high mortality rate, and many factors can cause antiplatelet drug-associated intracranial hemorrhage. Until now, systematic reviews and assessments of the certainty of the evidence have not been published. AIM: We conducted a systematic review to identify risk factors of antiplatelet drug-associated intracranial hemorrhage. METHOD: The protocol for this systematic review was prospectively registered with PROSPERO (CRD42022311647). All studies written in English that met the inclusion criteria published before January 2022 were obtained from PubMed, EMBASE, Web of Science, and Cochrane Library. Two researchers independently screened articles, extracted data, and evaluated the quality and evidence of the included studies. Risk factors for antiplatelet drug-associated intracranial hemorrhage were used as the outcome index of this review. Random or fixed-effect models were used in statistical methods. I2 statistics were used to evaluate heterogeneity. RESULTS: Of 2844 citations, we included 6 studies in our analysis. For intracranial hemorrhage, moderate-certainty evidence showed a probable association with race, low BMI, GCS, severe bleeding, headache or vomiting, cerebrovascular disease, lacunar small vessel disease, cardiovascular disease, blood sugar, blood pressure, CT-defined white matter hypodensity, antihypertensive drugs, and antiplatelet therapy. In addition, we found low-certainty evidence that there may be little to no association between risk of intracranial hemorrhage and age, sex, and dual antithrombotic treatment or anticoagulant. CT-defined white matter hypodensity is not included in most intracranial hemorrhage risk assessment models. CONCLUSION: This study summarizes risk factors for antiplatelet drug-associated intracranial hemorrhage, which is significant in preventing intracranial hemorrhage.

Efficacy and safety of non-vitamin K antagonist oral anticoagulants combined with antiplatelet drugs for patients with peripheral artery disease: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) combined with antiplatelet drugs in patients with peripheral artery disease remain largely unknown. OBJECTIVE: The aim of this meta-analysis was to explore the effects of NOACs combined with antiplatelet drugs versus antiplatelet drugs alone in this population. METHODS: A comprehensive search of randomized controlled trials published in PubMed, EMBASE, Web of Science, and the Cochrane Library in 30 September 2020 and before. According to the I2 statistic, a random or fixed-effect model was used to analyze the safety and effectiveness of NOACs combined with antiplatelet drugs in peripheral artery disease patients. RESULTS: Three RCTs met the inclusion criteria, with a total sample size of 11,761 participants. Compared with antiplatelet drugs alone, NOACs combined with antiplatelet drugs resulted in lower risk of ischemic stroke events (OR = 0.75, 95%CI 0.57-0.98, p = 0.03), while other treatment effects were not worse than those of single antiplatelet drugs (p ≥ 0.05). In addition, although compared with single antiplatelet drugs alone, NOACs combined with antiplatelet drugs had a higher risk of major bleeding and clinically related nonmajor bleeding, their risk was not higher for intracranial hemorrhage, which may endanger the life of patients, or for fatal bleeding. CONCLUSIONS: In summary, for peripheral artery disease patients, a combination of NOACs plus antiplatelet drugs may offer additional benefit in reducing ischemic stroke outcome, yet it may increase the risk of bleeding.

A smartphone application for remote adjustment of warfarin dose: Development and usability study.

AIM: The aim of this article is (a) to design and develop a smartphone app called Alfalfa that can provide remote dose adjustment (b) to evaluate its usability. BACKGROUND: Patients taking warfarin need to spend substantial time, money, and energy frequently visiting the hospital in order to adjust its dose. Internet technology may be able to provide convenient dose adjustment services for these patients. METHODS: We thought and discussed repeatedly about how to ensure the safety and effectiveness of remote administration of warfarin, and finally designed and developed the Alfalfa app. In addition, patients and medical practitioners were invited to participate in a system usability scale (SUS) to assess the usability of Alfalfa. RESULTS: As of July 5, 2021, the number of Alfalfa accounts was 1736, including 1624 patients and 112 medical staff, and it provided a total of 12,968 remote dose adjustments. A total of 26 people participated in the questionnaire, including 15 patients and 11 medical staff. The results of SUS show that the usability score of patient terminal and medical terminal is 61.8 and 82.7, respectively. And age does not affect the usability of patient terminal. The usability of the Alfalfa app was rated similarly by younger and older adults (63.5 vs. 58.5, P = .535). CONCLUSIONS: This study proves that the Alfalfa app can be used for remote management of warfarin. The usability of medical terminal is acceptable to medical practitioners, while the usability of patient terminal needs further improvement. TRIAL REGISTRATION: ChiCTR1900021920.

Comparison of clinical performance of four gastrointestinal bleeding risk scores in Chinese patients with atrial fibrillation receiving oral anticoagulants.

Gastrointestinal bleeding is the most common bleeding complication during anticoagulant therapy. A reliable bleeding risk score can help the clinician assess risk of bleeding in individual patients and select the anticoagulant regimen. This study retrospectively analyzed the data of patients with atrial fibrillation who received anticoagulant therapy from July 2015 to December 2018 at two centers-the Fujian Medical University Union Hospital and Fuzhou Second Hospital Affiliated to Xiamen University. Demographic data, clinical findings, and laboratory results were collected from the hospital records. Patients were followed up for 6 months. The performance of four bleeding risk scores (New Score, RIETE Score, Cuschieri et al. Score, de Groot et al. Score) for prediction of gastrointestinal bleeding was assessed using the area under the curve. A total of 3462 patients (mean age, 66.3 ± 11.5 years; 59.6% males; 1055 direct oral anticoagulants users and 2407 warfarin users) were followed up for 6 months. While 99/3462 (2.9%) patients had gastrointestinal bleeding. The area under the curves for the New, RIETE, Cuschieri et al., de Groot et al. scores were 0.652 (95% CI 0.576-0.728), 0.862 (95% CI 0.809-0.914), 0.606 (95% CI 0.527-0.685), and 0.873 (95% CI 0.816-0.929), respectively. Among the four BRSs evaluated, the RIETE score and the de Groot et al. score appear to have the good predictive value, while the NEW score and the Cuschieri et al. score did not sufficiently predict gastrointestinal bleeding risk within the study Chinese population.