RESUMEN
BACKGROUND: Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients. METHODS: This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel (n = 30). Group 2: TXA-Gel (n = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) days following extraction. The Kolmogorov-Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 (p < 0.05). RESULTS: The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 (p = 0.236) and t2 (p = 0.155). However, there was a statistically significance difference at the rest time points (p < 0.05). CONCLUSIONS: TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients. TRIAL REGISTRATION: The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).
Asunto(s)
Administración Tópica , Esponja de Gelatina Absorbible , Dolor Postoperatorio , Extracción Dental , Ácido Tranexámico , Warfarina , Humanos , Ácido Tranexámico/administración & dosificación , Ácido Tranexámico/uso terapéutico , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Masculino , Dolor Postoperatorio/prevención & control , Dolor Postoperatorio/tratamiento farmacológico , Femenino , Esponja de Gelatina Absorbible/uso terapéutico , Adulto , Dimensión del Dolor , Persona de Mediana Edad , Hemostáticos/uso terapéutico , Hemostáticos/administración & dosificación , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Antifibrinolíticos/administración & dosificación , Antifibrinolíticos/uso terapéutico , Diente Molar/cirugíaRESUMEN
Renal function significantly influences the appropriate warfarin dosage. However, studies investigating the impact of genetic factors on warfarin dosage, considering renal function, are limited. This study aimed to assess the role of genetic polymorphisms in VKORC1, CYP2C9, CYP2C19, CYP4F2, GGCX, and APOE in warfarin dosage adjustment considering renal function. A total of 108 outpatients receiving warfarin treatment with controlled prothrombin time-targeted international normalized ratio (1.5-3.0) were included. Patient data, warfarin dosage, and laboratory results were collected from electronic medical records. Each SNP [VKORC1 rs9923231, CYP2C9 rs1057910, CYP4F2 rs2108622, CYP2C19* 2 (rs4244285) and* 3 (rs4986893), GGCX rs699664 and rs12714145, and APOE rs7421] was analyzed. Multiple regression analysis revealed estimated glomerular filtration rate as the most significant factor influencing warfarin dose (p <0.001) (ß = -0.445). VKORC1 rs9923231 AA, CYP4F2 rs2108622 CT/TT, GGCX rs12714145 CT/TT, and CYP2C9 rs1057910 AC carriers were associated with warfarin dose (p <0.001, 0.015, 0.020, 0.038 and ß = -0.317, 0.191, -0.188, -0.162, respectively); however, other genes showed no significant association. In conclusion, after adjusting for renal function, genetic factors of VKORC1 rs9923231, CYP4F2 rs2108622, GGCX rs12714145, and CYP2C9 rs1057910 were found to contribute to warfarin dosage, having impact in that order. In contrast, the contribution of other genes to warfarin dosage was absent or negligible.
Asunto(s)
Anticoagulantes , Polimorfismo de Nucleótido Simple , Warfarina , Humanos , Warfarina/administración & dosificación , Femenino , Masculino , Anticoagulantes/administración & dosificación , Anciano , Persona de Mediana Edad , Pueblo Asiatico/genética , Japón , Relación Normalizada Internacional , Relación Dosis-Respuesta a Droga , Tasa de Filtración Glomerular , Vitamina K Epóxido Reductasas/genética , Anciano de 80 o más Años , Familia 4 del Citocromo P450/genética , Genotipo , Adulto , Pueblos del Este de AsiaRESUMEN
BACKGROUND: Treatment of isolated and non-obstructive atherosclerotic coronary artery ectasia (CAE) is still controversial. AIM: To assess the efficacy and safety of vitamin-K antagonist (VKA) versus dual antiplatelet (DAPT) therapy in management of patients with isolated and non-obstructive atherosclerotic CAE. METHODS: We prospectively enrolled 79 patients diagnosed on elective coronary angiography to have either isolated CAE or non-obstructive atherosclerotic CAE. Patients were assigned in 1:1 pattern to receive either VKA (warfarin) or DAPT (aspirin plus clopidogrel). Patients were followed-up for nine-months. The primary endpoint was the cumulative events rate including acute coronary event, target vessel intervention, or cardiac death. Analysis of cumulative events at different time intervals, its individual components, and bleeding were considered secondary endpoints. RESULTS: Cumulative events rate was 33%, with mortality rate of 2.5%. Both treatment groups showed comparable cumulative events during the nine-months follow-up duration. Nevertheless, Kaplan-Meier analysis beyond the first 3-months of follow-up showed significantly higher event-free survival among the VKA-group. Recurrent events (≥2) were significantly higher among the DAPT-group. Both groups showed no major bleeding events. Multivariable cox-regression analysis showed that presence of significant coronary tortuosity, use of DAPT in reference to VKA, and lower percent time in therapeutic range (%TTR) among those receiving VKA were significant independent predictors of clinical adverse events beyond the first 3-months of follow-up. CONCLUSION: Cumulative adverse events were comparable among both treatment groups for isolated non-obstructive CAE. However, adverse events were significantly more frequent in the DAPT-group beyond the first three months.
Asunto(s)
Enfermedad de la Arteria Coronaria , Terapia Antiplaquetaria Doble , Inhibidores de Agregación Plaquetaria , Vitamina K , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Anciano , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Vitamina K/antagonistas & inhibidores , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Estudios de Seguimiento , Terapia Antiplaquetaria Doble/métodos , Resultado del Tratamiento , Angiografía Coronaria , Dilatación Patológica , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Clopidogrel/uso terapéutico , Clopidogrel/administración & dosificación , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Manejo de la Enfermedad , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Warfarina/efectos adversosRESUMEN
BACKGROUND: Congenital portosystemic shunts (CPSS) are rare congenital abnormalities causing abnormal blood flow between the portal vein and systemic circulation. This study reports on the peri-operative anticoagulation management of CPSS patients post closure, focusing on the incidence of thrombotic and bleeding complications. METHODS: This is a single-center retrospective analysis of CPSS patients who underwent surgery or endovascular intervention between 2005 and 2021. The protocol included unfractionated heparin (UFH) during and immediately after surgery, followed by either warfarin or low molecular weight heparin (LMWH) postoperatively. Outcomes assessed included postoperative thrombotic and bleeding complications. RESULTS: A total of 44 patients were included. Postoperatively, 89% received treatment-dose UFH, transitioning to warfarin or LMWH at discharge. Thrombotic complications occurred in 16% of patients, predominantly in the superior mesenteric vein. Surgical interventions and continuous infusion of tissue plasminogen activator (tPA) were used for clot resolution. Bleeding complications were observed in 64% of patients, primarily managed with transfusions and temporary UFH interruption. No deaths related to thrombotic, or bleeding events were reported. CONCLUSIONS: Our findings underscore the delicate balance required in anticoagulation management for CPSS patients, revealing an occurrence of both thrombotic and bleeding complications postoperatively. LEVELS OF EVIDENCE: Level II, retrospective study.
Asunto(s)
Anticoagulantes , Heparina de Bajo-Peso-Molecular , Trombosis , Warfarina , Humanos , Estudios Retrospectivos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Femenino , Masculino , Lactante , Heparina de Bajo-Peso-Molecular/uso terapéutico , Heparina de Bajo-Peso-Molecular/administración & dosificación , Preescolar , Warfarina/uso terapéutico , Warfarina/efectos adversos , Warfarina/administración & dosificación , Trombosis/etiología , Trombosis/prevención & control , Trombosis/epidemiología , Niño , Vena Porta/anomalías , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Heparina/uso terapéutico , Heparina/administración & dosificación , Heparina/efectos adversos , Recién Nacido , Hemorragia Posoperatoria/etiología , Hemorragia Posoperatoria/epidemiología , Hemorragia Posoperatoria/prevención & control , Atención Perioperativa/métodos , Malformaciones Vasculares/complicaciones , Malformaciones Vasculares/cirugía , Sistema Porta/anomalías , AdolescenteRESUMEN
BACKGROUND: Stroke prevention guidance for patients with atrial fibrillation (AF) uses evidence generated from randomised controlled trials (RCTs). However, applicability to patient groups excluded from trials remains unknown. Real-world patient data provide an opportunity to evaluate outcomes in a trial analogous population of direct oral anticoagulants (DOACs) users and in patients otherwise excluded from RCTs; however, there remains uncertainty on the validity of methods and suitability of the data. Successful reference trial emulation can support the generation of evidence around treatment effects in groups excluded or underrepresented in trials. We used linked United Kingdom primary care data to investigate whether we could emulate the pivotal ARISTOTLE trial (apixaban versus warfarin) and extend the analysis to investigate the impact of warfarin time in therapeutic range (TTR) on results. METHODS AND FINDINGS: Patients with AF in the UK Clinical Practice Research Datalink (CPRD Aurum) prescribed apixaban or warfarin from 1 January 2013 to 31 July 2019 were selected. ARISTOTLE eligibility criteria were applied to this population and matched to the RCT apixaban arm on baseline characteristics creating a trial-analogous apixaban cohort; this was propensity-score matched to warfarin users in the CPRD Aurum. ARISTOTLE outcomes were assessed using Cox proportional hazards regression stratified by prior warfarin exposure status during 2.5 years of patient follow-up and results benchmarked against the trial results before treatment effectiveness was further evaluated based on (warfarin) TTR. The dataset comprised 8,734 apixaban users and propensity-score matched 8,734 warfarin users. Results [hazard ratio (95% confidence interval)] confirmed apixaban noninferiority for stroke or systemic embolism (SE) [CPRD 0.98 (0.82,1.19) versus trial 0.79 (0.66,0.95)] and death from any cause [CPRD 1.03 (0.93,1.14) versus trial 0.89 (0.80,0.998)] but did not indicate apixaban superiority. Absolute event rates for stroke/SE were similar for apixaban in CPRD Aurum and ARISTOTLE (1.27%/year), whereas a lower event rate was observed for warfarin (CPRD Aurum 1.29%/year, ARISTOTLE 1.60%/year). Analysis by TTR suggested similar effectiveness of apixaban compared with poorly controlled warfarin (TTR < 0.75) for stroke/SE [0.91 (0.73, 1.14)], all-cause death [0.94 (0.84, 1.06)], and superiority for major bleeding [0.74 (0.63, 0.86)]. However, when compared with well-controlled warfarin (TTR ≥ 0.75), apixaban was associated with an increased hazard for all-cause death [1.20 (1.04, 1.37)], and there was no significant benefit for major bleeding [1.08 (0.90, 1.30)]. The main limitation of the study's methodology are the risk of residual confounding, channelling bias and attrition bias in the warfarin arm, and selection bias and misclassification in the analysis by TTR. CONCLUSIONS: Analysis of noninterventional data generated results demonstrating noninferiority of apixaban versus warfarin consistent with prespecified benchmarking criteria. Unlike in ARISTOTLE, superiority of apixaban versus warfarin was not seen, possible due to the lower proportion of Asian patients and higher proportion of patients with well-controlled warfarin compared to ARISTOTLE. This methodological template can be used to investigate treatment effects of oral anticoagulants in patient groups excluded from or underrepresented in trials and provides a framework that can be adapted to investigate treatment effects for other conditions.
Asunto(s)
Anticoagulantes , Fibrilación Atrial , Pirazoles , Piridonas , Accidente Cerebrovascular , Warfarina , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Warfarina/uso terapéutico , Warfarina/efectos adversos , Warfarina/administración & dosificación , Anticoagulantes/uso terapéutico , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Reino Unido/epidemiología , Femenino , Anciano , Masculino , Piridonas/uso terapéutico , Piridonas/administración & dosificación , Piridonas/efectos adversos , Pirazoles/uso terapéutico , Pirazoles/administración & dosificación , Administración Oral , Anciano de 80 o más Años , Persona de Mediana Edad , Resultado del Tratamiento , Hemorragia/inducido químicamente , Inhibidores del Factor Xa/uso terapéutico , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificaciónRESUMEN
BACKGROUND: New-onset postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass grafting (CABG) surgery, increasing the risk of embolism and stroke. There is a lack of information on the use of anticoagulants in this context. The choice between Warfarin and Direct oral anticoagulants (DOACs) also is not well-established. This randomized study aimed to compare the feasibility and safety of Warfarin and Rivaroxaban in preventing thrombotic events in POAF patients after isolated CABG. METHODS: A total of 66 patients were randomized parallelly with 1:1 allocation to receive either Rivaroxaban (n = 34) or Warfarin (n = 32). Major bleeding events within 30 days after discharge were the primary outcome. Secondary outcomes included minor bleeding events and thrombotic episodes. Clinical characteristics, medication regimens, and left atrial diameter were assessed. Statistical analyses were performed using appropriate tests. RESULTS: No thrombotic episodes were observed in either treatment arm. No major bleeding events occurred in either group. Four minor bleeding events were reported, with no significant difference between the treatment groups (P = 0.6). Patients with atrial fibrillation had significantly larger left atrial diameters compared to those with normal sinus rhythm (40.5 vs. 37.8 mm, P = 0.01). CONCLUSIONS: This pilot study suggests that Warfarin and Rivaroxaban are both safe and effective for preventing thrombotic episodes in POAF patients after isolated CABG. No significant differences in major bleeding events were observed between the two anticoagulants. These findings may support the preference for DOACs like Rivaroxaban due to their convenience and easier maintenance. TRIAL REGISTRATION: Number IRCT20200304046696N1, Date 18/03/2020 https//irct.behdasht.gov.ir/ .
Asunto(s)
Anticoagulantes , Fibrilación Atrial , Puente de Arteria Coronaria , Inhibidores del Factor Xa , Hemorragia , Rivaroxabán , Warfarina , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etiología , Fibrilación Atrial/prevención & control , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/fisiopatología , Proyectos Piloto , Masculino , Puente de Arteria Coronaria/efectos adversos , Femenino , Anciano , Persona de Mediana Edad , Rivaroxabán/efectos adversos , Rivaroxabán/administración & dosificación , Resultado del Tratamiento , Warfarina/efectos adversos , Warfarina/administración & dosificación , Warfarina/uso terapéutico , Factores de Tiempo , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Hemorragia/inducido químicamente , Estudios de Factibilidad , Factores de Riesgo , Enfermedad de la Arteria Coronaria/cirugíaRESUMEN
BACKGROUND: The objective of this study is to compare and assess the efficacy and safety of low-molecular-weight heparin calcium (LMWH-Ca), followed by either warfarin or rivaroxaban, as treatment options for portal vein thrombosis (PVT) in patients with cirrhosis. METHODS: In this pilot study, cirrhotic (with liver function score of Child-Pugh A) patients diagnosed with PVT who were not on anticoagulant therapy received 2 weeks of subcutaneous injections of LMWH-Ca. They were then randomized to either warfarin (a full course of oral warfarin for 6 months) or rivaroxaban (a full course of oral rivaroxaban for 2 months), with 30 cases in each group. After a treatment period of up to 6 months, a comparative analysis was performed to assess the efficacy and safety of both groups. Volumetric changes in PVT were monitored dynamically using enhanced computed tomography scans before treatment at week 2 and month 6. RESULTS: There were no statistically significant differences in the clinical characteristics of the patients between the two groups. Rivaroxaban treatment reduced PVT median volume from 1.83 cm3 at week 2 to 0.0 cm3 at month 6 and prevented the worsening of PVT after 6 months of treatment with LMWH-Ca (Pâ <â 0.001). On the other hand, warfarin treatment increased PVT median volume from 1.95 cm3 at week 2 to 3.78 cm3 at month 6 (Pâ =â 0.002). None of the 30 patients in the rivaroxaban group had clinically significant gastrointestinal bleeding, while 2 of the 30 patients (7%) in the warfarin group had gastrointestinal bleeding (Pâ =â 0.317). CONCLUSION: Rivaroxaban followed by LMWH-Ca is an effective anticoagulant treatment strategy for PVT in cirrhosis.
Asunto(s)
Anticoagulantes , Heparina de Bajo-Peso-Molecular , Cirrosis Hepática , Vena Porta , Rivaroxabán , Trombosis de la Vena , Warfarina , Humanos , Proyectos Piloto , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Masculino , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Rivaroxabán/uso terapéutico , Vena Porta/diagnóstico por imagen , Femenino , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/diagnóstico por imagen , Persona de Mediana Edad , Cirrosis Hepática/complicaciones , Cirrosis Hepática/tratamiento farmacológico , Warfarina/administración & dosificación , Warfarina/efectos adversos , Heparina de Bajo-Peso-Molecular/administración & dosificación , Heparina de Bajo-Peso-Molecular/uso terapéutico , Heparina de Bajo-Peso-Molecular/efectos adversos , Administración Oral , Resultado del Tratamiento , Anciano , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/uso terapéutico , Adulto , Inyecciones Subcutáneas , Tomografía Computarizada por Rayos X , Quimioterapia CombinadaRESUMEN
OBJECTIVE: The standardization of warfarin anticoagulant therapy is the key to lifelong treatment for patients after heart valve replacement. The present study explored the possible risk factors for anxiety and depression during the coronavirus disease 2019 (COVID-19) pandemic and analyzed the influence of psychological state on medication safety. METHODS: Eligible patients received a web-based questionnaire survey via the Wenjuanxing platform during outpatient visits. Depression was evaluated by the Self-Rating Depression Scale (SDS). Anxiety was evaluated by the Self-Rating Anxiety Scale (SAS). Medication adherence was evaluated by the Morisky scale. RESULTS: A total of 309 patients (aged 52.2±11.4 years) were included in the present study. The SDS score of all included patients was 36.9±9.4 points, of which 11 (3.6%) patients were diagnosed as having depression. The SAS score of all included patients was 43.1±9.3 points, of which 71 (23%) patients were diagnosed as having anxiety. Seven patients (2.3%) had both anxiety and depression. Logistic regression analysis revealed that only monthly income was an independent influencing factor for depression. Regarding anxiety, patients who underwent repeated operations had a 2.264-fold greater risk, and patients who received combination medication had a 2.140-fold greater risk. More bleeding events and coagulation disorders could be observed in patients with anxiety, depression or both. When anxiety occurred, patients showed worse medication adherence. However, depression had no significant effect on medication adherence. CONCLUSION: During the COVID-19 pandemic, the detection rate of mental illnesses such as anxiety and depression was high, which seriously affected the medication safety of warfarin. Analysis of its influencing factors will provide a reference for further standardized regulation of warfarin anticoagulant therapy after valve replacement.
Asunto(s)
Anticoagulantes , Ansiedad , COVID-19 , Depresión , Implantación de Prótesis de Válvulas Cardíacas , Cumplimiento de la Medicación , Warfarina , Humanos , COVID-19/psicología , COVID-19/epidemiología , Warfarina/uso terapéutico , Warfarina/efectos adversos , Warfarina/administración & dosificación , Persona de Mediana Edad , Masculino , Femenino , Estudios Transversales , Anticoagulantes/uso terapéutico , Depresión/epidemiología , Depresión/tratamiento farmacológico , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Adulto , Cumplimiento de la Medicación/psicología , Anciano , SARS-CoV-2 , Factores de Riesgo , Encuestas y Cuestionarios , PandemiasRESUMEN
BACKGROUND: Prophylactic dose of rivaroxaban is often used in treatment of isolated calf muscle vein thrombosis (ICMVT); nevertheless, its effect is less reported. This study aims to evaluate short-term outcomes in patients with ICMVT who received prophylactic dose of rivaroxaban or warfarin therapy. METHODS: A retrospective analysis of 472 ICMVT patients who received 2 different treatment regimens was undertaken. Propensity score matching method was used to balance the confounding effect of baseline clinical data. Chi-squared test and logistic regression analysis were used to compare outcomes (venous thromboembolism events, bleeding events, complete clot resolution) according to the type of treatment regimens before and after propensity score matching. Univariate and multivariable analysis were used to investigate risk factors for incomplete clot resolution of ICMVT after propensity score matching. RESULTS: 242 ICMVT patients received prophylactic dose of rivaroxaban (rivaroxaban group, RG), and 230 received warfarin (warfarin group, WG). After propensity score matching, 156 patients were included in each group; Venous thromboembolism (VTE) events occurred in 14 (9.0%) patients in the RG and 10 (6.4%) in the WG (P = 0.395); no major bleeding events occurred in each group, and clinically relevant nonmajor bleeding events occurred in 5 (3.2%) patients in the RG and 10 (6.4%) in the WG (P = 0.186); complete clot resolution at 3 months occurred in 80 (51.3%) patients in the RG and 100 (64.1%) in the WG (P = 0.022). Logistic regression analysis showed that there were no significant differences between RG and WG in VTE events (odds ratio 1.439, 95% confidence interval 0.619-3.347, P = 0.397) and clinically relevant nonmajor bleeding events (odds ratio 0.483, 95% confidence interval 0.161-1.449, P = 0.194); it revealed that complete clot resolution rate at 3 months was different in the 2 groups (odds ratio 0.589, 95% confidence interval 0.375-0.928, P = 0.022). Treatment regimens (prophylactic dose of rivaroxaban), thrombosis (maximum diameter >7 mm), and risk factors for VTE (nonsurgery risk factors, mainly referring to active malignancy) were risk factors for incomplete clot resolution of ICMVT (P < 0.05). CONCLUSIONS: In this retrospective study with a short-term follow-up, ICMVT patients who received prophylactic dose of rivaroxaban had no significant differences in VTE and bleeding events compared to those who received warfarin therapy (the overall INR >2.0 for >50% of the time); but it was not conducive to complete clot resolution.
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Anticoagulantes , Inhibidores del Factor Xa , Hemorragia , Músculo Esquelético , Puntaje de Propensión , Rivaroxabán , Trombosis de la Vena , Warfarina , Humanos , Estudios Retrospectivos , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Warfarina/efectos adversos , Warfarina/administración & dosificación , Masculino , Femenino , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/prevención & control , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Persona de Mediana Edad , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Resultado del Tratamiento , Hemorragia/inducido químicamente , Factores de Riesgo , Factores de Tiempo , Músculo Esquelético/irrigación sanguínea , Adulto , Anciano , Distribución de Chi-Cuadrado , Modelos Logísticos , Análisis Multivariante , Oportunidad RelativaRESUMEN
BACKGROUND: Prevalence of bioprosthetic valve degeneration (BVD) is rising as the use of bioprosthetic aortic valves increases. Detecting early signs of BVD remains a challenge, with conventional imaging methods often failing to identify early deterioration stages. 18F-fuoride positron emission tomography (PET-CT) is an emerging technique that offers promising prospects to detect subclinical BVD. This study aimed to compare early PET parameters of fluoride uptake with echocardiographic hemodynamic parameters and compare outcomes according to anticoagulation in patients who received bioprosthetic valves. METHODS: This is a sub-study of the ANTIPRO clinical trial, which involved patients undergoing surgical aortic valve replacement (SAVR) with a porcine bioprosthesis and randomized them into anticoagulated and non-anticoagulated groups. Hemodynamic changes were assessed by transthoracic echocardiography (TTE), while 18F-fluoride PET-CT quantified fluoride uptake and divided the patients in two groups: high-uptake and low-uptake. Mean and maximum gradients by TTE at three years were compared between the two uptake groups. Fluoride uptake was also compared between the anticoagulated and control groups. RESULTS: We found no significant differences in transprosthetic gradients between high-uptake(21.4 ± 8.6 mmHg) and low-uptake(17.3 ± 11.2 mmHg.p = 0.244) PET-defined groups in this specific timeframe. Notably, anticoagulated patients exhibited significantly risk of higher fluoride uptake(OR = 4.34;95%CI:1.04-18.21.p = 0.045). CONCLUSIONS: No association was found between fluoride uptake and hemodynamic evaluation. Anticoagulation was associated with higher fluoride uptake. These findings highlight the emerging role of PET-CT in studying bioprosthetic aortic valves and emphasize the need for extended follow-up to evaluate the impact of anticoagulation on valve degeneration.
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Anticoagulantes , Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Warfarina , Bioprótesis/efectos adversos , Humanos , Femenino , Masculino , Prótesis Valvulares Cardíacas/efectos adversos , Anticoagulantes/administración & dosificación , Anciano , Warfarina/administración & dosificación , Warfarina/farmacocinética , Warfarina/uso terapéutico , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Radioisótopos de Flúor , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Persona de Mediana Edad , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estudios de Seguimiento , Falla de Prótesis , Tomografía de Emisión de Positrones/métodosRESUMEN
BACKGROUND: Most evidence for anticoagulation in aortic bioprosthesis is centered on embolic events, bleeding and re-intervention risk. The effect of anticoagulation on hemodynamics has not been previously assessed. Our hypothesis was that patients with anticoagulation (AC) early after aortic valve replacement (AVR) with porcine bioprosthesis have better hemodynamics at 3 years of follow-up. METHODS: This is a follow-up evaluation of the ANTIPRO trial. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The AC group received warfarin+aspirin and the non-AC(control) only aspirin. The primary outcome was mean gradient after 3 years of AVR and change in New York Heart Association (NYHA) class. Secondary outcomes were major and minor bleeding and embolic events. RESULTS: Of 140 participants in the study, 71 were assigned to the AC group and 69 to the control group. Mean age of the overall population was 72.4(SD: 7.1) years. Global euroSCORE was 7.65(SD: 5.73). At 3 years the mean gradient was similar between both groups (19.4(SD: 9.6 mmHg) and 18.6(SD: 8.2 mmHg) in the control and AC group respectively, p = 0.7). No differences in functional class at 3 years were found among groups. No differences were found among groups in the secondary outcomes. CONCLUSIONS: The addition of 3 months of oral anticoagulation to anti-aggregation treatment did not affect bioprosthetic hemodynamics nor functional class at years after AVR.
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Anticoagulantes , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Humanos , Bioprótesis/efectos adversos , Femenino , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Masculino , Anciano , Estudios de Seguimiento , Prótesis Valvulares Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Animales , Porcinos , Válvula Aórtica/cirugía , Factores de Tiempo , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Current guidelines recommend direct oral anticoagulants (DOACs) and warfarin for patients with atrial fibrillation (AF) who have a bioprosthetic valve (BPV). However, the data related to elderly patients (aged ≥80 years) with BPV replacement and AF are limited. METHODS: This post-hoc subgroup analysis of a BPV-AF Registry enrolled 752 patients with BPV replacement and AF. The primary net outcome was a composite of cardiac death, stroke, systemic embolism, major bleeding, and cardiovascular events. RESULTS: Among 752 patients, 429 (57%) patients were ≥ 80 and 323 (43%) were < 80 years old. The higher risk in patients aged ≥80 than <80 years was significant for the net outcome (hazard ratio [HR], 2.04; 95% confidence interval [CI], 1.31-3.17; P = 0.001). After adjustment for confounders, there was no statistically significant difference between warfarin (reference) and DOAC users in the risk of net outcomes (adjusted HR, 1.26; 95% CI, 0.71-2.24; P = 0.44), stroke and systemic embolism (adjusted HR, 2.01; 95% CI, 0.48-8.38; P = 0.34), and major bleeding (adjusted HR, 0.73; 95% CI, 0.11-4.98; P = 0.75) in patients aged ≥80 years old as well as those aged <80 years. Among 489 warfarin users, the cumulative incidence of net outcomes tended to be higher in patients aged ≥80 than <80 years (12.2% vs. 5.7% at 1 year, log-rank P = 0.002). Among 263 DOAC users, however, it was similar between patients aged ≥80 and < 80 years. CONCLUSIONS: The present study demonstrated that DOAC showed similar efficacy and safety compared with warfarin even in elderly patients aged ≥80 years with BPV replacement and AF.
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Anticoagulantes , Fibrilación Atrial , Bioprótesis , Prótesis Valvulares Cardíacas , Sistema de Registros , Humanos , Fibrilación Atrial/tratamiento farmacológico , Masculino , Femenino , Anciano de 80 o más Años , Anciano , Bioprótesis/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Administración Oral , Prótesis Valvulares Cardíacas/efectos adversos , Resultado del Tratamiento , Warfarina/administración & dosificación , Warfarina/uso terapéutico , Warfarina/efectos adversos , Estudios de SeguimientoRESUMEN
Importance: In older patients with atrial fibrillation who take anticoagulants for stroke prevention, bleeding is increased compared with younger patients, thus, clinicians frequently prescribe lower than recommended doses in older patients despite limited randomized data. Objective: To evaluate ischemic and bleeding outcomes in patients 80 years and older with atrial fibrillation receiving edoxaban, 60 mg vs 30 mg, and edoxaban, 30 mg vs warfarin. Design, Setting, and Participants: The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a parallel-design, double-blind, global clinical trial that randomized patients with atrial fibrillation to either one of 2 edoxaban dosing regimens or warfarin. This secondary analysis focused on patients 80 years or older without dose-reduction criteria receiving edoxaban, 60 mg vs 30 mg, as well as patients with or without dose-reduction criteria receiving edoxaban, 30 mg, vs warfarin. Study data were analyzed between October 2022 and December 2023. Interventions: Oral edoxaban, 30 mg once daily; edoxaban, 60 mg once daily; or warfarin. Main Outcomes and Measures: Primary net clinical outcome of death, stroke or systemic embolism, and major bleeding and each individual component. Results: The current analysis included 2966 patients 80 years and older (mean [SD] age, 83 [2.7] years; 1671 male [56%]). Among 1138 patients 80 years and older without dose-reduction criteria, those receiving edoxaban, 60 mg vs 30 mg, had more major bleeding events (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03), particularly gastrointestinal hemorrhage (HR, 2.24; 95% CI, 1.29-3.90; P = .004), with no significant difference in efficacy end points. Findings were supported by analyses of endogenous factor Xa inhibition, a marker of anticoagulant effect, which was comparable between younger patients receiving edoxaban, 60 mg, and older patients receiving edoxaban, 30 mg. In 2406 patients 80 years and older with or without dose-reduction criteria, patients receiving edoxaban, 30 mg, vs warfarin had lower rates of the primary net clinical outcome (HR, 0.78; 95% CI, 0.68-0.91; P = .001), major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001), and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046), whereas rates of stroke or systemic embolism were comparable. Conclusions and Relevance: In this post hoc analysis of the ENGAGE AF-TIMI 48 randomized clinical trial, in patients 80 years and older with atrial fibrillation, major bleeding events were lower in patients randomized to receive edoxaban, 30 mg per day, compared with either edoxaban, 60 mg per day (in patients without dose-reduction criteria), or warfarin (irrespective of dose-reduction status), without an offsetting increase in ischemic events. These data support the concept that lower-dose anticoagulants, such as edoxaban, 30 mg, may be considered in older patients with atrial fibrillation even in the absence of dose-reduction criteria. Trial Registration: ClinicalTrials.gov Identifier: NCT00781391.
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Fibrilación Atrial , Inhibidores del Factor Xa , Piridinas , Tiazoles , Warfarina , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Masculino , Tiazoles/administración & dosificación , Tiazoles/uso terapéutico , Femenino , Inhibidores del Factor Xa/uso terapéutico , Inhibidores del Factor Xa/administración & dosificación , Anciano de 80 o más Años , Piridinas/uso terapéutico , Piridinas/administración & dosificación , Método Doble Ciego , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Accidente Cerebrovascular/prevención & control , Relación Dosis-Respuesta a Droga , Reducción Gradual de MedicamentosRESUMEN
BACKGROUND: Recent practice guidelines favor direct oral anticoagulants (DOACs) over warfarin for primary stroke prevention in patients with non-valvular atrial fibrillation (NVAF). However, challenges persist in Iraq's private pharmaceutical sector. DOACs have been sold at high and inconsistent retail prices and lack insurance coverage, leading to significant out-of-pocket (OOP) costs. The objective of this study is to investigate the impact of OOP costs on oral anticoagulants (OAC) adherence among NVAF patients. RESEARCH DESIGN AND METHODS: This multicenter cross-sectional study interviewed 359 eligible patients attending three private cardiology clinics within Iraq's southern region from December 2022 to February 2023. The 8-item Morisky Adherence Scale evaluated patient adherence. Statistical analyses, including descriptive analysis, ANOVA, and chi-square. p < 0.05 was considered statistically significant. RESULTS: The most frequently prescribed OAC were DOACs (62.8%). Patient adherence level to OAC was chiefly medium (54.6%) with no significant difference in adherence based on OAC type. Patient adherence was significantly associated with monthly income (p = 0.001), number of daily pills (p = 0.006), and OACs' average monthly cost (p = 0.011). CONCLUSION: Addressing the issue of cost-related non-adherence to OACs requires multiple actions. These include ensuring comprehensive health insurance coverage for OACs, increasing the use of affordable generic alternatives, and establishing effective cost-related discussions between healthcare providers and patients.
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Anticoagulantes , Fibrilación Atrial , Gastos en Salud , Cumplimiento de la Medicación , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/tratamiento farmacológico , Estudios Transversales , Anticoagulantes/administración & dosificación , Anticoagulantes/economía , Cumplimiento de la Medicación/estadística & datos numéricos , Femenino , Masculino , Persona de Mediana Edad , Administración Oral , Gastos en Salud/estadística & datos numéricos , Anciano , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/economía , Irak , Adulto , Warfarina/administración & dosificación , Warfarina/economía , Anciano de 80 o más Años , Cobertura del Seguro , RentaRESUMEN
INTRODUCTION: Approximately 20 % of femoral fragility fracture patients take anticoagulants, typically warfarin or Direct Oral AntiCoagulant (DOAC). These can impact timing of surgery affecting patient survival. Due to several possible approaches and numerous factors to consider in the preoperative workup of anticoagulated patients, potential for variations in clinical practice exist. Some hospitals employ dedicated anticoagulation management protocols to address this issue, and to improve time to surgery. This study aimed to determine the proportion of hospitals with such protocols, compare protocol guidance between hospitals, and evaluate the effectiveness of protocols in facilitating prompt surgery. METHODS: Data was prospectively collected through a collaborative, multicentre approach involving hospitals across the UK. Femoral fragility fracture patients aged ≥60 years and admitted to hospital between 1st May to 31st July 2023 were included. Information from dedicated anticoagulation management protocols were collated on several domains relating to perioperative care including administration of reversal agents and instructions on timing of surgery as well as others. Logistic regression was used to evaluate effects of dedicated protocols on time to surgery. RESULTS: Dedicated protocols for management of patients taking warfarin and DOACs were present at 41 (52.6 %) and 43 (55.1 %) hospitals respectively. For patients taking warfarin, 39/41 (95.1 %) protocols specified the dose of vitamin k and the most common was 5 milligrams intravenously (n=21). INR threshold values for proceeding to surgery varied between protocols; 1.5 (n=28), 1.8 (n=6), and 2 (n=6). For patients taking DOACs, 35/43 (81.4 %) and 8/43 (18.6 %) protocols advised timing of surgery based on renal function and absolute time from last dose respectively. Analysis of 10,197 patients from 78 hospitals showed fewer patients taking DOACs received surgery within 36 h of admission at hospitals with a dedicated protocol compared to those without (adjusted OR 0.73, 95% CI 0.54-0.99, p=0.040), while there were no differences among patients taking warfarin (adjusted OR 1.64, 95% CI 0.75-3.57, p=0.219). CONCLUSIONS: Around half of hospitals employed a dedicated anticoagulation management protocol for femoral fragility fracture patients, and substantial variation was observed in guidance between protocols. Dedicated protocols currently being used at hospitals were ineffective at improving the defined targets for time to surgery.
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Anticoagulantes , Fracturas del Fémur , Tiempo de Tratamiento , Warfarina , Humanos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Femenino , Masculino , Anciano , Tiempo de Tratamiento/estadística & datos numéricos , Warfarina/administración & dosificación , Warfarina/uso terapéutico , Estudios Prospectivos , Fracturas del Fémur/cirugía , Reino Unido , Anciano de 80 o más Años , Protocolos Clínicos , Persona de Mediana Edad , Fracturas de Cadera/cirugíaRESUMEN
The gold standard therapy for end-stage heart failure is cardiac transplantation. However, in the face of a donor shortage, a mechanical assist device such as the left ventricular assist device HeartMate 3 (Abbott Laboratories, Abbott Park, IL, USA) serves as bridging therapy to transplantation and/or destination therapy. Current guidelines recommend anticoagulation with a vitamin K antagonist in combination with low-dose aspirin. We herein report a challenging anticoagulation regimen in a patient with a HeartMate 3 in whom systemic anticoagulation with warfarin was not feasible for 4 years because of low compatibility and a rare X-factor deficiency. This is a rare hematological disorder, estimated to affect approximately 1 in every 500,000 to 1,000,000 people in the general population. The patient finally received a modified anticoagulation regimen involving the combination of rivaroxaban and clopidogrel without warfarin. Under this regimen, the patient remained free of thromboembolic complications for 4 years with in situ placement of the left ventricular assist device. This case illustrates that under specific circumstances, long-term absence of warfarin therapy is feasible in patients with a HeartMate 3.
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Anticoagulantes , Corazón Auxiliar , Tromboembolia , Warfarina , Humanos , Corazón Auxiliar/efectos adversos , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Tromboembolia/etiología , Tromboembolia/prevención & control , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Masculino , Insuficiencia Cardíaca/cirugía , Persona de Mediana Edad , Clopidogrel/administración & dosificación , Clopidogrel/uso terapéutico , Clopidogrel/efectos adversos , Rivaroxabán/administración & dosificación , Rivaroxabán/uso terapéutico , Privación de TratamientoRESUMEN
INTRODUCTION: Patients with atrial fibrillation (AF) undergoing elective procedures are at risk for Major Adverse Cardiovascular Events (MACE) and symptomatic bleeding. We aimed to identify risk factors to guide perioperative risk stratification. METHODS: We conducted a post-hoc analysis of the "Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery" randomized trial. The primary outcomes were MACE and symptomatic bleeding. Our statistical approach encompassed standard univariate analysis, logistic stepwise regression, and Cox regression models. Additional interaction analyses evaluated the interplay between low-molecular-weight heparin bridge therapy and other identified risk factors. RESULTS: Among a total of 1,813 participants (mean age 71.6 ± 8.8, 73.3 % male), MACE occurred in 25 (1.4 %) individuals, with pre-procedure clopidogrel use (adjusted hazard ratio [aHR] 7.73, 95 % CI 2.63-22.72, p < 0.001) and CHA2DS2-VASc score ≥ 5 (aHR 2.89, 95 % CI 1.26-6.63, p = 0.012) identified as risk factors. Symptomatic bleeding occurred in 57 (3.1 %) individuals, with bridge therapy (aHR 1.84, 95 % CI 1.07-3.19, p = 0.029), renal disease (aHR 2.50, 95 % CI 1.34-4.67, p = 0.004), post-procedure aspirin use (aHR 2.86, 95 % CI 1.66-4.91, p < 0.001), post-procedure nonsteroidal anti-inflammatory drug use excluding aspirin (aHR 3.40, 95 % CI 1.22-9.43, p = 0.019), and major surgery (aHR 3.94, 95 % CI 2.26-6.85, p < 0.001) identified as risk factors. The interactions between risk factors and bridging therapy on MACE and symptomatic bleeding outcomes were not significant (p > 0.05). CONCLUSION: We identified predictors for MACE and symptomatic bleeding in AF patients undergoing elective procedures. These insights may help guide perioperative decisions to reduce the risk of adverse outcomes.
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Anticoagulantes , Fibrilación Atrial , Procedimientos Quirúrgicos Electivos , Hemorragia , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Fibrilación Atrial/epidemiología , Masculino , Femenino , Anciano , Factores de Riesgo , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Medición de Riesgo , Resultado del Tratamiento , Persona de Mediana Edad , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Procedimientos Quirúrgicos Electivos/efectos adversos , Anciano de 80 o más Años , Factores de Tiempo , Warfarina/efectos adversos , Warfarina/administración & dosificación , Esquema de Medicación , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Heparina de Bajo-Peso-Molecular/efectos adversos , Heparina de Bajo-Peso-Molecular/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
In Asian patients with atrial fibrillation (AF) and end-stage renal disease (ESRD) undergoing dialysis, the use of direct oral anticoagulants (DOACs) remains debatable. From the national health insurance claims data in South Korea, we included 425 new users of OAC among patients with non-valvular AF and ESRD undergoing dialysis between 2013 and 2020. Patients were categorized into DOAC (n = 106) and warfarin group (n = 319). Clinical outcomes, including ischemic stroke, myocardial infarction (MI), intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding, were compared between the two groups using inverse probability of treatment weighting (IPTW) analysis. During the median follow-up of 3.2 years, the incidence of ischemic stroke was significantly reduced in the DOAC compared to the warfarin group [Hazard ratio (HR) 0.07; P = 0.001]. However, the incidence of MI (HR 1.32; P = 0.41) and GI bleeding (HR 1.78; P = 0.06) were not significantly different between the two groups. No ICH events occurred in the DOAC group, although the incidence rate did not differ significantly between the two groups (P = 0.17). In Asian patients with AF and ESRD undergoing dialysis, DOACs may be associated with a reduced risk of ischemic stroke compared with warfarin. The MI, ICH, and GI bleeding rates may be comparable between DOACs and warfarin.
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Anticoagulantes , Fibrilación Atrial , Fallo Renal Crónico , Diálisis Renal , Warfarina , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Fallo Renal Crónico/terapia , Fallo Renal Crónico/complicaciones , Masculino , Femenino , Diálisis Renal/efectos adversos , Anciano , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Warfarina/uso terapéutico , Warfarina/efectos adversos , Warfarina/administración & dosificación , Administración Oral , Persona de Mediana Edad , República de Corea/epidemiología , Incidencia , Pueblo Asiatico , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/etiología , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Accidente Cerebrovascular Isquémico/epidemiología , Accidente Cerebrovascular Isquémico/etiología , Accidente Cerebrovascular Isquémico/prevención & control , Anciano de 80 o más AñosRESUMEN
ABSTRACT: Current guidelines recommend that direct anticoagulants should not be used in prevention of recurrent thrombosis in patients with antiphospholipid syndrome (APS). However, except for triple-positive APS and rivaroxaban use, little evidence supports such recommendation. In a real-life cohort study, we evaluated the risk of thromboembolism and bleeding in patients with APS on apixaban versus vitamin K antagonists (VKA). We enrolled 152 patients with APS (aged 44 years [interquartile range 36-56], 83% women), including 66 patients treated with apixaban 5 mg bid and 86 with warfarin (target international normalized ratio [INR] 2-3). During a median follow-up of 53 months, we recorded venous thromboembolism, ischemic stroke, or myocardial infarction, along with major bleeding. We observed 4 thrombotic events (6.1%, 3 venous thromboembolism and 1 ischemic stroke) in patients on apixaban and 12 events (14%, 9 venous thromboembolism, 2 ischemic strokes and 1 myocardial infarction) in VKA patients. Patients with APS on apixaban had similar risk of recurrent thromboembolism compared with those on warfarin (hazard ratio [HR] = 0.327, 95% confidence interval [CI]: 0.104-1.035). Thromboembolic events occurred less commonly in statin users (8% vs. 50%, P = 0.01) and more frequently in triple-positive APS (50% vs. 22.1%, P = 0.028) and in patients with higher D-dimer at baseline ( P = 0.023); the latter difference was present in the apixaban group ( P = 0.02). Patients on apixaban had similar risk of major bleeding compared with warfarin (HR = 0.54, 95% CI: 0.201-1.448). In real-life patients with APS, apixaban appears to be similar to VKA for the prevention of thromboembolism and risk of bleeding, which might suggest that some patients with APS could be treated with apixaban.
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Anticoagulantes , Síndrome Antifosfolípido , Inhibidores del Factor Xa , Hemorragia , Pirazoles , Piridonas , Vitamina K , Warfarina , Humanos , Femenino , Pirazoles/efectos adversos , Pirazoles/uso terapéutico , Piridonas/efectos adversos , Piridonas/uso terapéutico , Piridonas/administración & dosificación , Masculino , Síndrome Antifosfolípido/tratamiento farmacológico , Síndrome Antifosfolípido/complicaciones , Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/sangre , Persona de Mediana Edad , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Vitamina K/antagonistas & inhibidores , Adulto , Resultado del Tratamiento , Factores de Riesgo , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Warfarina/efectos adversos , Warfarina/uso terapéutico , Warfarina/administración & dosificación , Factores de Tiempo , Medición de Riesgo , Recurrencia , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/epidemiología , Infarto del Miocardio/prevención & control , Infarto del Miocardio/epidemiología , Accidente Cerebrovascular Isquémico/prevención & control , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/epidemiologíaRESUMEN
Different dosing strategies exist to initiate warfarin, most commonly fixed warfarin dosing (FWD), clinical warfarin dosing (CWD), and genetic-guided warfarin dosing (GWD). Landmark trials have shown GWD to be superior when compared to FWD in the EU-PACT trial or CWD in the GIFT trial. COAG trial did not show differences between GWD and CWD. We aim to compare the anticoagulation quality outcomes of CWD and FWD. This is a prospective cohort study with a retrospective comparator. Recruited subjects in the CWD (prospective) arm were initiated on warfarin according to the clinical dosing component of the algorithm published in www.warfarindosing.org. The primary efficacy outcome was the percentage time in the therapeutic range (PTTR) from day 3 to 6 till day 28 to 35. The study enrolled 122 and 123 patients in the CWD and FWD, respectively. The PTTR did not differ statistically between CWD and FWD (62.2 ± 26.2% vs. 58 ± 25.4%, p = 0.2). There was also no difference between both arms in the percentage of visits with extreme subtherapeutic international normalized ratio (INR) (<1.5; 15 ± 18.3% vs. 16.8 ± 19.1%, p = 0.44) or extreme supratherapeutic INR (>4; 7.7 ± 14.7% vs. 7.5 ± 12.4%, p = 0.92). We conclude that CWD did not improve the anticoagulation quality parameters compared to the FWD method.