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1.
Europace ; 26(6)2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38829189

ABSTRACT

AIMS: Elective cardioversion (ECV) is routinely used in atrial fibrillation (AF) to restore sinus rhythm. However, it includes a risk of thromboembolism even during adequate oral anticoagulation treatment. The aim of this study was to evaluate the risk of thromboembolic and bleeding complications after ECV in a real-life setting utilizing data from a large AF population. METHODS AND RESULTS: This nationwide register-based study included all (n = 9625) Finnish AF patients undergoing their first-ever ECV between 2012 and 2018. The thromboembolic and bleeding complications within 30 days after ECV were analysed. The mean age of the patients was 67.7 ± 9.9 years, 61.2% were men, and the mean CHA2DS2-VASc score was 2.6 ± 1.6. Warfarin was used in 6245 (64.9%) and non-vitamin K oral anticoagulants (NOACs) in 3380 (35.1%) cardioversions. Fifty-two (0.5%) thromboembolic complications occurred, of which 62% were ischaemic strokes, 25% transient ischaemic attacks, and 13% other systemic embolisms. Thromboembolic events occurred in 14 (0.4%) NOAC-treated patients and in 38 (0.6%) warfarin-treated patients (odds ratio 0.77; confidence interval: 0.42-1.39). The median time from ECV to the thromboembolic event was 2 days, and 78% of the events occurred within 10 days. Age and alcohol abuse were significant predictors of thromboembolic events. Among warfarin users, thromboembolic complications were more common with international normalized ratio (INR) <2.5 than INR ≥2.5 (0.9% vs. 0.4%, P = 0.026). Overall, 27 (0.3%) bleeding events occurred. CONCLUSION: The rate of thromboembolic and bleeding complications related to ECV was low without significant difference between NOAC- and warfarin-treated patients. With warfarin, INR ≥2.5 at the time of cardioversion reduced the risk of thromboembolic complications.


Subject(s)
Anticoagulants , Atrial Fibrillation , Electric Countershock , Hemorrhage , Registries , Thromboembolism , Humans , Atrial Fibrillation/epidemiology , Atrial Fibrillation/drug therapy , Male , Electric Countershock/adverse effects , Female , Aged , Thromboembolism/etiology , Thromboembolism/prevention & control , Thromboembolism/epidemiology , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Hemorrhage/epidemiology , Hemorrhage/chemically induced , Hemorrhage/etiology , Middle Aged , Finland/epidemiology , Risk Factors , Warfarin/adverse effects , Warfarin/therapeutic use , Risk Assessment , Time Factors
2.
Sci Rep ; 14(1): 11647, 2024 05 22.
Article in English | MEDLINE | ID: mdl-38773162

ABSTRACT

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.


Subject(s)
Anticoagulants , Atrial Fibrillation , International Normalized Ratio , Warfarin , Humans , Warfarin/administration & dosage , Warfarin/therapeutic use , Atrial Fibrillation/drug therapy , Male , Female , Aged , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Prospective Studies , Middle Aged , Aged, 80 and over , Treatment Outcome , Drug Monitoring/methods
3.
J Med Case Rep ; 18(1): 246, 2024 May 14.
Article in English | MEDLINE | ID: mdl-38741148

ABSTRACT

INTRODUCTION: Thrombotic events are more than twice as common in inflammatory bowel disease patients as in the general population. We report an interesting and rare case of portal vein thrombosis as a venous thromboembolic event in the context of extraintestinal manifestations of Crohn's disease. We also conducted a literature review on portal vein thrombosis associated with inflammatory bowel disease, with the following concepts: inflammatory bowel diseases, ulcerative colitis, Crohn's disease, portal vein, and thrombosis. CASE PRESENTATION: A 24-year-old Syrian female with active chronic Crohn's disease was diagnosed 11 years ago and classified as A1L3B1P according to the Montreal classification. She had no prior surgical history. Her previous medications included azathioprine and prednisolone. Her Crohn's disease activity index was 390 points. Gastroduodenoscopy revealed grade I esophageal varices, a complication of portal hypertension. Meanwhile, a colonoscopy revealed several deep ulcers in the sigmoid, rectum, and descending colon. An investigation of portal vein hypertension revealed portal vein thrombosis. We used corticosteroids to induce remission, followed by tapering; additionally she received ustekinumab to induce and maintain remission. She began on low-molecular-weight heparin for 1 week, warfarin for 3 months, and then apixaban, a novel oral anticoagulant, after excluding antiphospholipid syndrome. Primary prophylaxis for esophageal varices was not required. After 1 year, she achieved clinical, biochemical, and endoscopic remission. Despite 1 year of treatment, a computed tomography scan revealed no improvement in portal vein recanalization. CONCLUSION: Portal vein thrombosis is a rare and poorly defined complication of inflammatory bowel disease. It is usually exacerbated by inflammatory bowel disease. The symptoms are nonspecific and may mimic a flare-up of inflammatory bowel disease, making the diagnosis difficult. Portal vein Doppler ultrasound for hospital-admitted inflammatory bowel disease patients may contribute to the diagnosis and management of this complication.


Subject(s)
Anticoagulants , Crohn Disease , Portal Vein , Venous Thrombosis , Humans , Crohn Disease/complications , Female , Portal Vein/diagnostic imaging , Venous Thrombosis/etiology , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/drug therapy , Young Adult , Anticoagulants/therapeutic use , Warfarin/therapeutic use
4.
JAMA Netw Open ; 7(5): e249465, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38709533

ABSTRACT

Importance: The influence of race and ethnicity on initiation of direct oral anticoagulants (DOACs) is relatively understudied in Medicare data. Objective: To investigate disparities in the initiation of DOACs compared with warfarin by race, ethnicity, and social vulnerability. Design, Setting, and Participants: This retrospective cohort study used a 50% sample of Medicare fee-for-service data from January 1, 2010, to December 31, 2019 (mean patient enrollment duration, 7.7 years). Analysis took place between January 2023 and February 2024. A cohort of older adults (aged ≥65 years) with atrial fibrillation who newly initiated warfarin or DOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) was identified. Exposure: Patients were classified as non-Hispanic White, non-Hispanic Black, and Hispanic. Main Outcomes and Measures: The likelihood of starting use of DOACs compared with warfarin was modeled, adjusting for race, ethnicity, age, sex, county-level social vulnerability, and other clinical factors. Results: Among 950 698 anticoagulation initiations, consisting of 680 974 DOAC users and 269 724 warfarin users (mean [SD] age, 78.5 [7.6] years; 52.6% female), 5.2% were Black, 4.3% were Hispanic, and 86.7% were White. During the 10-year study period, DOAC use increased for all demographic groups. After adjustment, compared with White patients, Black patients were 23% less likely (adjusted odds ratio [AOR, 0.77; 95% CI, 0.75-0.79) and Hispanic patients were 13% less likely (AOR, 0.87; 95% CI, 0.85-0.89) to initiate DOAC use. Disparities in DOAC initiation were greatest among Black patients in the earlier years but attenuated during the study period. For instance, in 2010, the OR of Black patients initiating DOACs was 0.54 (95% CI, 0.50-0.57), attenuating linearly over time to 0.69 by 2013 (95% CI, 0.65-0.74) and 0.83 (95% CI, 0.78-0.89) by 2017. By 2019, these differences became nonsignificant (OR, 1.08; 95% CI, 0.99-1.18). Conclusions and Relevance: In this cohort study of Medicare patients with atrial fibrillation, Black and Hispanic patients were less likely to initiate DOACs for atrial fibrillation, although these differences diminished over time. Identifying the factors behind these early disparities is crucial for ensuring equitable access to novel therapies as they emerge for Black and Hispanic populations.


Subject(s)
Anticoagulants , Atrial Fibrillation , Healthcare Disparities , Medicare , Warfarin , Humans , Aged , Female , United States , Male , Medicare/statistics & numerical data , Retrospective Studies , Aged, 80 and over , Anticoagulants/therapeutic use , Warfarin/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/ethnology , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Pyridones/therapeutic use , Dabigatran/therapeutic use , Pyrazoles/therapeutic use , Administration, Oral , Hispanic or Latino/statistics & numerical data , Rivaroxaban/therapeutic use , Ethnicity/statistics & numerical data , Thiazoles/therapeutic use , White People/statistics & numerical data , Cohort Studies , Pyridines/therapeutic use
5.
Sci Rep ; 14(1): 12009, 2024 05 25.
Article in English | MEDLINE | ID: mdl-38796624

ABSTRACT

Spontaneous intracerebral hemorrhage (SICH) remains a devastating form of stroke. Prior use of antiplatelets or warfarin before SICH is associated with poor outcomes, but the effects of direct oral anticoagulants (DOACs) remain unclear. This study aimed to clarify trends in prior antithrombotic use and to assess the associations between prior use of antithrombotics and in-hospital mortality using a multicenter prospective registry in Japan. In total, 1085 patients were analyzed. Prior antithrombotic medication included antiplatelets in 14.2%, oral anticoagulants in 8.1%, and both in 1.8%. Prior warfarin use was significantly associated with in-hospital mortality (odds ratio [OR] 5.50, 95% confidence interval [CI] 1.30-23.26, P < 0.05) compared to no prior antithrombotic use. No such association was evident between prior DOAC use and no prior antithrombotic use (OR 1.34, 95% CI 0.44-4.05, P = 0.606). Concomitant use of antiplatelets and warfarin further increased the in-hospital mortality rate (37.5%) compared to warfarin alone (17.2%), but no such association was found for antiplatelets plus DOACs (8.3%) compared to DOACs alone (11.9%). Prior use of warfarin remains an independent risk factor for in-hospital mortality after SICH in the era of DOACs. Further strategies are warranted to reduce SICH among patients receiving oral anticoagulants and to prevent serious outcomes.


Subject(s)
Anticoagulants , Cerebral Hemorrhage , Fibrinolytic Agents , Hospital Mortality , Registries , Warfarin , Humans , Hospital Mortality/trends , Aged , Female , Male , Cerebral Hemorrhage/mortality , Cerebral Hemorrhage/drug therapy , Warfarin/therapeutic use , Warfarin/adverse effects , Japan/epidemiology , Aged, 80 and over , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/adverse effects , Middle Aged , Risk Factors , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies
6.
Sci Rep ; 14(1): 10784, 2024 05 11.
Article in English | MEDLINE | ID: mdl-38734732

ABSTRACT

Portal vein thrombosis (PVT) worsens the long-term prognosis of patients with cirrhosis; however, the optimal treatment remains to be determined. Reports on the efficacy of direct oral anticoagulants are increasing, and further evidence is needed. Therefore, we investigated the effectiveness of treatment with edoxaban in patients with PVT. We retrospectively reviewed the outcomes of edoxaban and warfarin as antithrombotic therapies for PVT. The median overall survival time was 4.2 years in patients with PVT, with a 1-year survival rate of 70.7% and a 5-year survival rate of 47.9%. The leading cause of death was hepatocellular carcinoma. The overall response rate for thrombolysis in the edoxaban group was 76.7% compared to 29.4% in the warfarin group, and edoxaban significantly improved PVT compared to warfarin. In addition, edoxaban provided long-term improvement of PVT. Warfarin, on the other hand, was temporarily effective but did not provide long-term benefits. The Child-Pugh and albumin-bilirubin scores did not change after edoxaban or warfarin use. No deaths occurred due to adverse events associated with edoxaban or warfarin. Edoxaban as a single agent can achieve long-term recanalization without compromising the hepatic reserves. Edoxaban is easy to initiate, even in an outpatient setting, and could become a major therapeutic agent for the treatment of PVT.


Subject(s)
Liver Cirrhosis , Portal Vein , Pyridines , Thiazoles , Venous Thrombosis , Warfarin , Humans , Thiazoles/therapeutic use , Thiazoles/administration & dosage , Pyridines/therapeutic use , Pyridines/adverse effects , Liver Cirrhosis/drug therapy , Liver Cirrhosis/complications , Portal Vein/pathology , Female , Male , Venous Thrombosis/drug therapy , Venous Thrombosis/etiology , Middle Aged , Aged , Retrospective Studies , Warfarin/therapeutic use , Warfarin/adverse effects , Anticoagulants/therapeutic use , Treatment Outcome , Factor Xa Inhibitors/therapeutic use , Adult
7.
Tex Heart Inst J ; 51(1)2024 May 15.
Article in English | MEDLINE | ID: mdl-38748549

ABSTRACT

BACKGROUND: Current venous thromboembolism guidelines recommend using direct oral anticoagulants (DOACs) over warfarin regardless of obesity status; however, evidence remains limited for the safety and efficacy of DOAC use in patients with obesity. This retrospective analysis sought to demonstrate the safety and efficacy of DOACs compared with warfarin in a diverse population of patients with obesity in light of current prescribing practices. METHODS: A retrospective cohort study was conducted at a large academic health system between July 2014 and September 2019. Adults with an admission diagnosis of deep vein thrombosis (DVT) or pulmonary embolism, with weight greater than 120 kg or a body mass index greater than 40, and who were discharged on an oral anticoagulant were included. Outcomes included occurrence of a thromboembolic event (DVT, pulmonary embolism, or ischemic stroke), bleeding event requiring hospitalization, and all-cause mortality within 12 months following index admission. RESULTS: Out of 787 patients included, 520 were in the DOAC group and 267 were in the warfarin group. Within 12 months of index hospitalization, thromboembolic events occurred in 4.23% of patients in the DOAC group vs 7.12% of patients in the warfarin group (hazard ratio, 0.6 [95% CI, 0.32-1.1]; P = .082). Bleeding events requiring hospitalization occurred in 8.85% of DOAC patients vs 10.1% of warfarin patients (hazard ratio, 0.93 [95% CI, 0.57-1.5]; P = .82). A DVT occurred in 1.7% and 4.9% of patients in the DOAC and warfarin groups, respectively (hazard ratio, 0.35 [95% CI, 0.15-0.84]; P = .046). CONCLUSION: No significant differences could be determined between DOACs and warfarin for cumulative thromboembolic or bleeding events, pulmonary embolism, ischemic stroke, or all-cause mortality. The risk of DVT was lower with apixaban and rivaroxaban. Regardless of patient weight or body mass index, physicians prescribed DOACs more commonly than warfarin.


Subject(s)
Anticoagulants , Obesity , Venous Thromboembolism , Warfarin , Humans , Retrospective Studies , Female , Male , Warfarin/adverse effects , Warfarin/administration & dosage , Warfarin/therapeutic use , Obesity/complications , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Middle Aged , Venous Thromboembolism/epidemiology , Venous Thromboembolism/drug therapy , Administration, Oral , Aged , Treatment Outcome , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Follow-Up Studies
8.
Medicine (Baltimore) ; 103(19): e38022, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38728459

ABSTRACT

Warfarin, a widely utilized anticoagulant, is paramount for preventing thromboembolic events in patients with mechanical heart valve replacements. However, its narrow therapeutic index can lead to over-anticoagulation and overdose, resulting in serious health risks. This study examines the efficacy of human prothrombin complex concentrate (PCC) in managing warfarin overdose, in comparison with traditional treatments. A retrospective analysis was conducted on 162 adults who presented with warfarin overdose (INR > 5.0) at a tertiary care hospital between 2016 and 2020. Participants were divided into 2 groups-those treated with PCC (n = 57) and those treated with conventional methods (n = 105), including vitamin K and fresh frozen plasma. The primary outcome was the rate of reaching the target (International Normalized Ratio) INR within 24 hours. Secondary outcomes included transfusion requirements, thromboembolic events, adverse reactions, 30-day mortality, and length of hospital stay. PCC demonstrated significant efficacy, with 89.5% of patients achieving the target INR within 24 hours, compared to 64.8% in the control group (P < .05). The PCC group also had reduced transfusion requirements and a shorter average hospital stay. There was no significant difference in thromboembolic events or adverse reactions between the 2 groups, and the reduced 30-day mortality in the PCC group was not statistically significant. Human prothrombin complex concentrate is associated with rapid reaching the target INR, decreased transfusion needs, and shortened hospitalization, making it a promising option for warfarin overdose management. While the results are encouraging, larger, multicenter, randomized controlled trials are necessary to further validate these findings and optimize PCC administration protocols.


Subject(s)
Anticoagulants , Blood Coagulation Factors , Drug Overdose , International Normalized Ratio , Warfarin , Humans , Warfarin/adverse effects , Warfarin/therapeutic use , Blood Coagulation Factors/therapeutic use , Blood Coagulation Factors/administration & dosage , Female , Male , Retrospective Studies , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Middle Aged , Drug Overdose/drug therapy , Drug Overdose/therapy , Aged , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Thromboembolism/prevention & control , Adult , Treatment Outcome , Blood Transfusion/statistics & numerical data , Length of Stay/statistics & numerical data , Vitamin K/therapeutic use
9.
J Int Med Res ; 52(5): 3000605241255507, 2024 May.
Article in English | MEDLINE | ID: mdl-38749907

ABSTRACT

Traumatic splenic rupture is rare in pregnant women; and multiple venous thromboses of the portal vein system, inferior vena cava and ovarian vein after caesarean section and splenectomy for splenic rupture has not been previously reported. This case report describes a case of multiple venous thromboses after caesarean section and splenectomy for traumatic splenic rupture in late pregnancy. A 34-year-old G3P1 female presented with abdominal trauma at 33+1 weeks of gestation. After diagnosis of splenic rupture, she underwent an emergency caesarean section and splenectomy. Multiple venous thromboses developed during the recovery period. The patient eventually recovered after anticoagulation therapy with low-molecular-weight heparin and warfarin. These findings suggest that in patients that have had a caesarean section and a splenectomy, which together might further increase the risk of venous thrombosis, any abdominal pain should be thoroughly investigated and thrombosis should be ruled out, including the possibility of multiple venous thromboses. Anticoagulant therapy could be extended after the surgery.


Subject(s)
Cesarean Section , Splenectomy , Splenic Rupture , Venous Thrombosis , Humans , Female , Venous Thrombosis/etiology , Venous Thrombosis/surgery , Venous Thrombosis/drug therapy , Adult , Splenic Rupture/etiology , Splenic Rupture/surgery , Splenic Rupture/diagnosis , Pregnancy , Cesarean Section/adverse effects , Postpartum Period , Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Warfarin/therapeutic use
10.
Clin Appl Thromb Hemost ; 30: 10760296241256938, 2024.
Article in English | MEDLINE | ID: mdl-38778542

ABSTRACT

OBJECTIVES: To assess the efficacy and safety of rivaroxaban compared to warfarin after inferior vena cava (IVC) filter implantation. METHOD: This retrospective analysis includes data from 100 patients with deep vein thrombosis (DVT) who underwent IVC filter implantation due to a free-floating thrombus (n = 64), thrombus propagation (n = 8), or acute bleeding (n = 8) on therapeutic anticoagulation, catheter-directed thrombolysis (n = 8), or had previously implanted filter with DVT recurrence. Patients were treated with warfarin (n = 41) or rivaroxaban (n = 59) for 3-12 months. Symptomatic venous thromboembolism (VTE) recurrence and bleeding events were assessed at 12 months follow-up. RESULTS: Three (7.3%) cases of VTE recurrence without IVC filter occlusion occurred on warfarin and none on rivaroxaban. The only (2.4%) major bleeding occurred on warfarin. Three (5.1%) clinically relevant non-major bleedings were detected on rivaroxaban. No significant differences existed between groups when full and propensity scores matched datasets were compared. CONCLUSIONS: Rivaroxaban seems not less effective and safe than warfarin after IVC filter implantation.


Subject(s)
Rivaroxaban , Vena Cava Filters , Warfarin , Humans , Warfarin/therapeutic use , Rivaroxaban/therapeutic use , Retrospective Studies , Male , Female , Middle Aged , Aged , Venous Thrombosis , Anticoagulants/therapeutic use , Adult , Administration, Oral , Hemorrhage
11.
J Am Heart Assoc ; 13(11): e028951, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38780169

ABSTRACT

BACKGROUND: Days alive out of hospital (DAOH) is an objective and patient-centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations. METHODS AND RESULTS: ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double-blind, double-dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator-reported event data for up to 12 months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean±SD number of days dead was 7.3±41.2, days hospitalized was 1.2±7.2, and mean DAOH was 350.7±56.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6±56.5 for those randomized to rivaroxaban and 350.7±55.8 for those randomized to warfarin (P=0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2±59.5 days and 349.1 days±59.3 days, respectively, P=0.88). CONCLUSIONS: DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.


Subject(s)
Anticoagulants , Atrial Fibrillation , Factor Xa Inhibitors , Rivaroxaban , Stroke , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Rivaroxaban/therapeutic use , Rivaroxaban/administration & dosage , Female , Male , Stroke/prevention & control , Stroke/etiology , Stroke/epidemiology , Aged , Warfarin/therapeutic use , Factor Xa Inhibitors/therapeutic use , Factor Xa Inhibitors/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Double-Blind Method , Middle Aged , Time Factors , Treatment Outcome , Morpholines/therapeutic use , Thiophenes/therapeutic use , Aged, 80 and over
12.
Thromb Res ; 238: 88-96, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38696925

ABSTRACT

INTRODUCTION: Recommendations about proper anticoagulation in obese patients, body mass index (BMI) > 30 kg/m2, are not yet clearly defined. Obese patients were included in randomized controlled trials comparing new anticoagulants (NOACs) with warfarin in patients with atrial fibrillation or thromboembolism. METHODS: We performed a medline search entering proper criteria and finally 6 post-hoc analysis of RCTs, reporting outcome according to BMI, were included in this meta-analysis. Two major outcomes were considered end points in our meta-analysis; thrombosis, including ischemic cerebral events (transient or not) and venous thrombosis (DVD) /pulmonary embolism (PE) and bleeding, including major bleeding and clinically relevant non-major bleeding. RESULTS: In the NOACs treated group, thrombosis occurred less frequently in obese vs non-obese patients; RR and 95 % CI 0,75 (0,58-0,97), p = 0,03, while low heterogeneity was observed (I2= 40 %). In the warfarin treated subgroup there was statistically significant difference with less thrombotic events occurring in the obese vs non-obese patients; RR and (95 % CI) 0,80 (0,66-0,98), p = 0,03, and heterogeneity was low (I2 = 24 %). This protective effect called the obesity paradox is limited to obese patients anticoagulated for non-valvular atrial fibrillation (NVAF); RR (95 % CI) was 0,70 (0,58-0,85) p = 0,03 and I2 = 24 %. Bleeding events were similar under both NOACs and warfarin in obese vs non-obese analysis. CONCLUSIONS: Obese patients anticoagulated for NVAF with either standard dose of xabans or INR guided warfarin are more efficiently protected against thrombosis compared to non-obese patients.


Subject(s)
Anticoagulants , Atrial Fibrillation , Obesity , Randomized Controlled Trials as Topic , Thrombosis , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Warfarin/therapeutic use , Obesity/complications , Obesity/drug therapy , Anticoagulants/therapeutic use , Thrombosis/prevention & control , Thrombosis/etiology , Hemorrhage/chemically induced , Factor Xa Inhibitors/therapeutic use
13.
Ann Hematol ; 103(6): 2133-2144, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38634917

ABSTRACT

BACKGROUND: Empirical use of pharmacogenetic test(PGT) is advocated for many drugs, and resource-rich setting hospitals are using the same commonly. The clinical translation of pharmacogenetic tests in terms of cost and clinical utility is yet to be examined in hospitals of low middle income countries (LMICs). AIM: The present study assessed the clinical utility of PGT by comparing the pharmacogenetically(PGT) guided- versus standard of care(SOC)- warfarin therapy, including the health economics of the two warfarin therapies. METHODS: An open-label, randomized, controlled clinical trial recruited warfarin-receiving patients in pharmacogenetically(PGT) guided- versus standard of care(SOC)- study arms. Pharmacogenetic analysis of CYP2C9*2(rs1799853), CYP2C9*3(rs1057910) and VKORC1(rs9923231) was performed for patients recruited to the PGT-guided arm. PT(Prothrombin Time)-INR(international normalized ratio) testing and dose titrations were allowed as per routine clinical practice. The primary endpoint was the percent time spent in the therapeutic INR range(TTR) during the 90-day observation period. Secondary endpoints were time to reach therapeutic INR(TRT), the proportion of adverse events, and economic comparison between two modes of therapy in a Markov model built for the commonest warfarin indication- atrial fibrillation. RESULTS: The study enrolled 168 patients, 84 in each arm. Per-protocol analysis showed a significantly high median time spent in therapeutic INR in the genotype-guided arm(42.85%; CI 21.4-66.75) as compared to the SOC arm(8.8%; CI 0-27.2)(p < 0.00001). The TRT was less in the PG-guided warfarin dosing group than the standard-of-care dosing warfarin group (17.85 vs. 33.92 days) (p = 0.002). Bleeding and thromboembolic events were similar in the two study groups. Lifetime expenditure was ₹1,26,830 in the PGT arm compared to ₹1,17,907 in the SOC arm. The QALY gain did not differ in the two groups(3.9 vs. 3.65). Compared to SOC, the incremental cost-utility ratio was ₹35,962 per QALY gain with PGT test opting. In deterministic and probabilistic sensitivity analysis, the base case results were found to be insensitive to the variation in model parameters. In the cost-effectiveness-acceptability curve analysis, a 90% probability of cost-effectiveness was reached at a willingness-to-pay(WTP) of ₹ 71,630 well below one time GDP threshold of WTP used. CONCLUSION: Clinical efficacy and the cost-effectiveness of the warfarin pharmacogenetic test suggest its routine use as a point of care investigation for patient care in LMICs.


Subject(s)
Anticoagulants , Cytochrome P-450 CYP2C9 , Economics, Pharmaceutical , International Normalized Ratio , Vitamin K Epoxide Reductases , Warfarin , Humans , Warfarin/economics , Warfarin/administration & dosage , Warfarin/therapeutic use , Female , Male , Middle Aged , Cytochrome P-450 CYP2C9/genetics , Aged , Vitamin K Epoxide Reductases/genetics , Anticoagulants/administration & dosage , Anticoagulants/economics , Anticoagulants/therapeutic use , Pharmacogenomic Testing/economics , Adult , Pharmacogenetics/economics , Cost-Benefit Analysis
15.
Sci Rep ; 14(1): 9838, 2024 04 29.
Article in English | MEDLINE | ID: mdl-38684879

ABSTRACT

Previous studies have rarely investigated the role of non-vitamin K oral anticoagulants (NOAC) and warfarin in the secondary prevention of ischemic stroke patients with nonvalvular atrial fibrillation (NVAF). In this study, we compared the effectiveness and safety of NOAC and warfarin for secondary prevention in Korean ischemic stroke patients with NVAF. Based on the Korean National Health Insurance Service Database, this study included 21,064 oral anticoagulants-naïve acute ischemic stroke patients with NVAF between July 2015 and June 2019. The main study outcomes included ischemic stroke, systemic embolism, major bleeding, and death. During the observational periods, NOAC users had a significantly decreased risk of ischemic stroke + systemic embolism (adjusted hazard ratio [aHR] 0.86; 95% confidence interval [CI] 0.78-0.95), ischemic stroke (aHR 0.89; 95% CI 0.81-0.99), major bleeding (aHR 0.78; 95% CI 0.68-0.89), and all-cause death (aHR 0.87; 95% CI 0.81-0.93). Standard-dose NOAC users had a lower risk of ischemic stroke, systemic embolism, and major bleeding events than warfarin users. In contrast, low-dose NOAC users did not differ in risk from warfarin users for all outcomes. In conclusion, NOACs were associated with a lower risk of secondary thromboembolic events and bleeding complications in Korean ischemic stroke patients with NVAF than warfarin.


Subject(s)
Anticoagulants , Atrial Fibrillation , Ischemic Stroke , Secondary Prevention , Warfarin , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Male , Female , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Ischemic Stroke/prevention & control , Ischemic Stroke/etiology , Aged , Warfarin/administration & dosage , Warfarin/therapeutic use , Warfarin/adverse effects , Secondary Prevention/methods , Administration, Oral , Middle Aged , Republic of Korea/epidemiology , Aged, 80 and over , Hemorrhage/chemically induced , Treatment Outcome , Embolism/prevention & control , Embolism/etiology
16.
Cell Mol Biol (Noisy-le-grand) ; 70(4): 225-230, 2024 Apr 28.
Article in English | MEDLINE | ID: mdl-38678600

ABSTRACT

This study compared the therapeutic effect and safety between warfarin anticoagulation and percutaneous left atrial appendage transcatheter occlusion (PLAATO) in non-valvular atrial fibrillation (NVAF). A total of 110 patients were selected and assigned to Control group (n=55) and Observation group (n=55). The control patients were used warfarin, while the observation patients were performed PLAATO. The coagulation function, stroke and bleeding scores were compared between the two groups at different times. Left ventricular function before therapy and 1 year after therapy and adverse events during follow-up were compared between the two groups. After one month of treatment, CHA2DS2-VASC, HAS-BLED score, serum ET-1 and hs-CRP levels were lower in the PLAATO patients than in warfarin patients, but serum PDGFs levels were higher than patients in the warfarin patients (P < 0.05). One month after treatment, the activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT) of the PLAATO patients was longer than that of the warfarin patients (P < 0.05), but the levels of fibrinogen (FIB) in the PLAATO patients were lower than that of the warfarin patients (P < 0.05). In addition, one year after therapy, the left atrial end-diastolic volume (LAEDV), left atrial end-systolic volume (LAESV) and left atrial inner diameter of the two groups were significantly reduced (P < 0.05). Left atrial appendage (LAA) occlusion can effectively improve the cardiac function and coagulation function of NVAF patients, with lower incidence of bleeding events, stroke events and higher safety.


Subject(s)
Anticoagulants , Atrial Appendage , Atrial Fibrillation , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/therapy , Warfarin/therapeutic use , Warfarin/adverse effects , Male , Atrial Appendage/surgery , Female , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Aged , C-Reactive Protein/metabolism , Middle Aged , Treatment Outcome , Stroke/etiology , Cardiac Catheterization/methods , Cardiac Catheterization/adverse effects
17.
Thromb Res ; 237: 88-93, 2024 May.
Article in English | MEDLINE | ID: mdl-38569453

ABSTRACT

Thrombotic antiphospholipid syndrome (TAPS) is characterized by thrombosis and persistently positive tests for antiphospholipid antibodies or lupus anticoagulant (LAC). Triple-positive APS has the highest risk of recurrent thrombosis, but no studies have focused on recurrent thrombosis in patients with single-positive TAPS. We conducted a retrospective cohort study of patients with single-positive TAPS diagnosed at Lifespan Health System, Rhode Island, to determine the rates and risk factors for recurrent thrombosis. Between January 2001 and April 2022, 128 patients were assessed who had single-positive APS (LAC = 98, aCL = 21, aß2GPI = 9) and who had been followed for a total of 1453.8 patient-years (median follow-up 3.04 years). The initial antithrombotic regimen was warfarin in 44 %, a direct oral anticoagulant (DOAC) in 34 %, enoxaparin in 2 %, and no antithrombotic therapy or antiplatelet therapy only in 20 %. Recurrent thrombosis occurred in 16 (12.5 %) with a recurrent thrombosis rate of 3.08 per 100 patient-years. Systemic lupus erythematosus was the only variable significantly associated with recurrent thrombosis in a model adjusted for age, sex, body mass index, and type of positive APS test. All 16 patients with recurrent thrombosis were initially treated with warfarin, and, at the time of recurrent thrombosis, 13 patients remained on warfarin and three were off anticoagulation. In conclusion, the recurrent thrombosis rate in single-positive APS is low, and not all patients with a single-positive test may need indefinite anticoagulation with warfarin. Larger prospective studies are required to confirm this finding and establish optimal anticoagulation regimens for low-risk TAPS.


Subject(s)
Anticoagulants , Antiphospholipid Syndrome , Recurrence , Thrombosis , Humans , Antiphospholipid Syndrome/complications , Antiphospholipid Syndrome/drug therapy , Antiphospholipid Syndrome/blood , Female , Male , Anticoagulants/therapeutic use , Thrombosis/etiology , Thrombosis/blood , Thrombosis/drug therapy , Retrospective Studies , Middle Aged , Adult , Risk Factors , Antibodies, Antiphospholipid/blood , Warfarin/therapeutic use , Aged
18.
Medicine (Baltimore) ; 103(17): e37750, 2024 Apr 26.
Article in English | MEDLINE | ID: mdl-38669384

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) is 1 of the most common types of arrhythmias. At present, the treatment for patients with AF mainly includes oral anticoagulants (OACs). Studies have shown that OACs are associated with cognitive decline in patients with atrial fibrillation; however, there is a lack of relevant evidence. This study used Bayesian network meta-analysis (NMA) to investigate the effects of different oral anticoagulants on cognitive decline in patients with AF. METHODS: We systematically searched for clinical studies on oral anticoagulants in patients with AF in PubMed, Web of Science, Embase, and the Cochrane Library as of July 3, 2023. Cochrane's randomized controlled trial bias risk assessment tool and the Newcastle-Ottawa Scale were used to assess the bias risk of the included studies. The main outcome measure was decreased cognitive functioning. RESULTS: Ten studies were included, including 2 RCTs and 7 RCSs, including 882,847 patients with AF. Five oral anticoagulants and 2 anticoagulants were included: VKAs (especially warfarin), Dabigatran, Edoxaban, Rivaroxaban, Apixaban, and Aspirin, Clopidogrel. The results of the mesh meta-analysis showed that VKAs were superior to warfarin in reducing the risk of cognitive decline in patients with AF (OR = -1.19, 95% CI (-2.35, -0.06), P < .05) (Table 5). The top 3 drugs in terms of the probability of reducing the incidence of cognitive impairment in patients with AF with different oral anticoagulants were VKAs (87%), rivaroxaban (62.2%), and dabigatran (60.8%). CONCLUSION: Based on the results of this study, VKAs may be the best intervention measure for reducing the risk of cognitive decline in patients with AF. Owing to the limitations of this study, more high-quality randomized controlled trials with large sample sizes and multiple centers are required to provide more evidence.


Subject(s)
Anticoagulants , Atrial Fibrillation , Bayes Theorem , Cognitive Dysfunction , Network Meta-Analysis , Humans , Administration, Oral , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Cognition/drug effects , Cognitive Dysfunction/etiology , Cognitive Dysfunction/prevention & control , Dabigatran/therapeutic use , Dabigatran/administration & dosage , Rivaroxaban/therapeutic use , Rivaroxaban/administration & dosage , Warfarin/therapeutic use , Warfarin/administration & dosage
19.
Am J Cardiovasc Drugs ; 24(3): 433-444, 2024 May.
Article in English | MEDLINE | ID: mdl-38583107

ABSTRACT

BACKGROUND: Landmark clinical trials have expended the indications for the direct oral anticoagulants (DOACs), but contemporary data on usage and expenditure patterns are lacking. OBJECTIVE: This study aimed to assess annual trends in oral anticoagulant (OAC) utilization and expenditure across the United States (US) from 2014 to 2020. METHODS: We utilized the Medical Expenditure Panel Survey (MEPS) to study the trends of use and expenditures of warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban between 2014 and 2020 in the US. Survey respondents reported OAC use within the past year, which was verified against pharmacy records. Payment information was obtained from the respondent's pharmacy and was categorized as third-party or self/out-of-pocket. Potential indications and medical conditions of interest for OAC therapy were identified from respondent-reported medical conditions. We estimated the national number of OAC users and total expenditures across age, sex, race, ethnicity, insurance, and medical condition subgroups. Trends of OAC users' characteristics, expenditure, and number of prescriptions were evaluated using the Mann-Kendall test for trends. RESULTS: Between 2014 and 2020, the number of warfarin users decreased from 3.8 million (70% of all OAC users) to 2.2 million (p = 0.007) [29% of all OAC users], while the number of DOAC users increased from 1.6 million (30% of all OAC users) to 5.4 million (p = 0.003) [70% of all OAC users]. The total expenditure of OACs in the US increased from $3.4 billion in 2014 to $17.8 billion in 2020 (p = 0.003), which was driven by the increase in DOAC expenditures (p = 0.003). CONCLUSIONS: DOACs have replaced warfarin as the preferred OAC in the US. The increased costs associated with DOAC use may decline when generic formulations are approved.


Subject(s)
Anticoagulants , Health Expenditures , Humans , United States , Anticoagulants/economics , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Female , Male , Administration, Oral , Health Expenditures/trends , Health Expenditures/statistics & numerical data , Aged , Middle Aged , Adult , Young Adult , Warfarin/economics , Warfarin/therapeutic use , Warfarin/administration & dosage , Adolescent , Aged, 80 and over
20.
Rinsho Ketsueki ; 65(3): 164-168, 2024.
Article in Japanese | MEDLINE | ID: mdl-38569860

ABSTRACT

Congenital protein C (PC) deficiency is one type of hereditary thrombosis. Patients with hereditary thrombosis are at high risk for thrombosis in the perioperative period, but a standard management strategy has not been established. Here we report a case of perioperative management of a fracture in a child with homozygous congenital PC deficiency. The patient was a 3-year-old boy who was diagnosed with congenital PC deficiency at birth. He sustained a traumatic supracondylar fracture of the right humerus and underwent emergency surgery. To prepare for open surgery for fixation of the fracture, warfarin was discontinued, and an activated PC (APC) concentrate was used in combination with vitamin K antagonism. However, warfarin was administered during the scheduled nail extraction because the operation was minimally invasive. No thrombotic or bleeding complications occurred in either operation. In emergency surgery in patients with congenital PC deficiency, the combination of vitamin K and APC concentrate is considered a maintenance option for PC deficiency. Postoperative PT-INR control was difficult in our patient due to the administration of vitamin K and withdrawal of warfarin, and this issue must be addressed in the future. Further case experience is desirable to standardize perioperative management.


Subject(s)
Fractures, Bone , Protein C Deficiency , Thrombosis , Child, Preschool , Humans , Infant, Newborn , Male , Anticoagulants , Fractures, Bone/complications , Protein C Deficiency/complications , Thrombosis/complications , Vitamin K , Warfarin/therapeutic use
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