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1.
Thromb Haemost ; 118(5): 842-851, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29564837

RESUMEN

Oral factor Xa inhibitors are increasingly used for anticoagulation, but there is no approved reversal agent. Prothrombin complex concentrate (PCC) for the management of Xa-inhibitor-associated bleeding has been described in small case series and one cohort study. Patients on apixaban or rivaroxaban, suffering a major bleed, were treated at nine Canadian hospitals as per existing hospital protocol with a fixed dose of PCC 2,000 units and subsequently recruited for a 30-day follow-up. The treating physician evaluated the haemostatic effectiveness as observed during the first day as good, moderate or poor/none, using an assessment guide. Safety outcomes were thromboembolism or death. We recruited 66 patients with major bleeding who were treated with PCC and who were receiving rivaroxaban (56%) or apixaban (44%). The effectiveness was assessed as good in 65% (95% confidence interval [CI], 53-77), moderate in 20% (95% CI, 10-30) and poor/none in 15% (95% CI, 6-24). For the 36 patients with intracranial haemorrhage, the corresponding ratings were 67, 17 and 17%, and for 16 patients with gastrointestinal bleeding they were 69, 12 and 19%, respectively. There were nine deaths (14%) by 30 days, and five (8%) major thromboembolic events. In a post hoc analysis, according to International Society on Thrombosis and Haemostasis criteria, reversal was effective in 68% and ineffective in 32%. For major bleeding associated with oral Xa inhibitors, PCC may have a beneficial effect. The risk of thromboembolism after reversal of anticoagulation in patients with a prothrombotic background has to be taken into account.


Asunto(s)
Factores de Coagulación Sanguínea/uso terapéutico , Coagulantes/uso terapéutico , Inhibidores del Factor Xa/efectos adversos , Hemorragia Gastrointestinal/tratamiento farmacológico , Hemorragias Intracraneales/tratamiento farmacológico , Pirazoles/efectos adversos , Piridonas/efectos adversos , Rivaroxabán/efectos adversos , Administración Oral , Anciano , Anciano de 80 o más Años , Factores de Coagulación Sanguínea/efectos adversos , Canadá , Coagulantes/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Femenino , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/mortalidad , Hemostasis/efectos de los fármacos , Humanos , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/diagnóstico , Hemorragias Intracraneales/mortalidad , Masculino , Estudios Prospectivos , Pirazoles/administración & dosificación , Piridonas/administración & dosificación , Factores de Riesgo , Rivaroxabán/administración & dosificación , Tromboembolia/etiología , Factores de Tiempo , Resultado del Tratamiento
2.
Thromb Haemost ; 117(12): 2415-2424, 2017 12.
Artículo en Inglés | MEDLINE | ID: mdl-29212129

RESUMEN

Background The perioperative management of patients who take a direct oral anticoagulant (DOAC) for atrial fibrillation and require treatment interruption for an elective surgery/procedure is a common clinical scenario for which best practices are uncertain. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study is designed to address this unmet clinical need. We discuss the rationale for the PAUSE design and analysis plan as well as the rationale supporting the perioperative DOAC protocol. Methods PAUSE is a prospective study with three parallel cohorts, one for each DOAC, to assess a standardized but patient-specific perioperative management protocol for DOAC-treated patients with atrial fibrillation. The perioperative protocol accounts for DOAC type, patient's renal function and surgery/procedure-related bleeding risk. The primary study aim is to demonstrate the safety of the PAUSE protocol for the perioperative management of each DOAC. The secondary aim is to determine the effect of the pre-procedure interruption on residual anticoagulation when measured by the dilute thrombin time for dabigatran and anti-factor Xa levels for rivaroxaban and apixaban. The study hypothesis is that the perioperative management protocol for each DOAC is safe for patient care, defined by expected risks for major bleeding of 1% (80% power to exclude 2%), and for arterial thromboembolism of 0.5% (80% power to exclude 1.5%) in each DOAC group. Conclusion The PAUSE study has the potential to establish a standard-of-care approach for the perioperative management of DOAC-treated patients. The PAUSE management protocol is designed to be easily applied in clinical practice, as it is standardized and also patient specific.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Procedimientos Quirúrgicos Cardíacos , Hemorragia/tratamiento farmacológico , Periodo Perioperatorio , Complicaciones Posoperatorias/tratamiento farmacológico , Administración Oral , Adulto , Fibrilación Atrial/cirugía , Canadá , Estudios de Cohortes , Dabigatrán/uso terapéutico , Femenino , Hemorragia/etiología , Humanos , Masculino , Medicina de Precisión , Estudios Prospectivos , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Rivaroxabán/uso terapéutico
3.
Am J Cardiol ; 115(5): 641-6, 2015 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-25727083

RESUMEN

The objectives of this national chart audit (January to June 2013) of 6,346 patients with atrial fibrillation (AF; ≥18 years without a significant heart valve disorder) from 647 primary care physicians were to (1) describe the frequency of stroke and bleed risk assessments in patients with nonvalvular AF by primary care physicians, including the accuracy of these assessments relative to established predictive indexes; (2) outline contemporary methods of anticoagulation used; and (3) report the time in the therapeutic range among patients prescribed warfarin. An annual stroke risk assessment was not undertaken in 15% and estimated without a formal risk tool in 33%; agreement with CHADS2 score estimation was seen in 87% of patients. Major bleeding risk assessment was not undertaken in 25% and estimated without a formal risk tool in 47%; agreement with HAS-BLED score estimation was observed in 64% with physician overestimation in 26% of patients. Antithrombotic therapy included warfarin (58%), dabigatran (22%), rivaroxaban (14%), and apixaban (<1%). Among warfarin-treated patients, the median international normalized ratio was 2.4 and time in therapeutic range (TTR) was 73%; however, the TTR was <50% in 845 (25%), 50% to 69% in 674 (20%), and ≥70% in 1,827 (55%) patients. In conclusion, we describe a contemporary real-world elderly population with AF at important risk for stroke. There is apparent overestimation of bleeding risk in many patients. Warfarin was the dominant stroke prevention treatment; however, the suggested TTR target was achieved in only 55% of these patients.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Atención Primaria de Salud , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Warfarina/uso terapéutico , Anciano , Anciano de 80 o más Años , Bencimidazoles/uso terapéutico , Canadá , Dabigatrán , Hemorragia/diagnóstico , Hemorragia/etiología , Humanos , Masculino , Auditoría Médica , Morfolinas/uso terapéutico , Valor Predictivo de las Pruebas , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Medición de Riesgo , Rivaroxabán , Accidente Cerebrovascular/diagnóstico , Tiofenos/uso terapéutico , beta-Alanina/análogos & derivados , beta-Alanina/uso terapéutico
4.
Blood ; 124(7): 1020-8, 2014 Aug 14.
Artículo en Inglés | MEDLINE | ID: mdl-24923298

RESUMEN

The new oral anticoagulants (NOACs), which include dabigatran, rivaroxaban, apixaban, and edoxaban, are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE). With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs streamline VTE treatment. In phase 3 trials in patients with acute symptomatic VTE, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence and are associated with less bleeding. Rivaroxaban and dabigatran are already licensed for VTE treatment in the United States, and apixaban and edoxaban are under regulatory consideration for this indication. As the number of approved drugs increases, clinicians will need to choose the right anticoagulant for the right VTE patient. To help with this decision, this review (1) compares the pharmacologic profiles of the NOACs, (2) outlines the unique design features of the phase 3 trials that evaluated the NOACs for VTE treatment, (3) reviews the results of these trials highlighting similarities and differences in the findings, (4) provides perspective about which VTE patients should receive conventional treatment or are candidates for NOACs, and (5) offers suggestions about how to choose among the NOACs.


Asunto(s)
Anticoagulantes/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Anticoagulantes/administración & dosificación , Bencimidazoles/administración & dosificación , Bencimidazoles/uso terapéutico , Dabigatrán , Quimioterapia/tendencias , Humanos , Morfolinas/administración & dosificación , Morfolinas/uso terapéutico , Pirazoles/administración & dosificación , Pirazoles/uso terapéutico , Piridinas/administración & dosificación , Piridinas/uso terapéutico , Piridonas/administración & dosificación , Piridonas/uso terapéutico , Rivaroxabán , Tiazoles/administración & dosificación , Tiazoles/uso terapéutico , Tiofenos/administración & dosificación , Tiofenos/uso terapéutico , Resultado del Tratamiento , beta-Alanina/administración & dosificación , beta-Alanina/análogos & derivados , beta-Alanina/uso terapéutico
5.
Arterioscler Thromb Vasc Biol ; 28(3): 380-6, 2008 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-18296593

RESUMEN

Anticoagulant therapy is the cornerstone of treatment of venous thromboembolism (VTE). Such treatment is divided into 2 stages: Rapid initial anticoagulation is given to minimize the risk of thrombus extension and fatal pulmonary embolism, whereas extended anticoagulation is aimed at preventing recurrent VTE, thereby reducing the risk of postphlebitic syndrome. With currently available drugs, immediate anticoagulation can only be achieved with parenteral agents, such as heparin, low-molecular-weight heparin, or fondaparinux. Extended treatment usually involves the administration of vitamin K antagonists, such as warfarin. Emerging anticoagulants have the potential to streamline VTE treatment. These agents include idraparinux, a long-acting synthetic pentasaccharide that is given subcutaneously on a once-weekly basis, and new oral anticoagulants that target thrombin or factor Xa. This article (1) reviews the pharmacology of these agents, (2) outlines their potential strengths and weaknesses, (3) describes the results of clinical trials with these new drugs, and (4) identifies the evolving role of new anticoagulants in the management of VTE.


Asunto(s)
Anticoagulantes/uso terapéutico , Síndrome Posflebítico/prevención & control , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/mortalidad , Administración Oral , Anticoagulantes/farmacología , Bencimidazoles/uso terapéutico , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Dabigatrán , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Inyecciones Subcutáneas , Masculino , Dosis Máxima Tolerada , Morfolinas/uso terapéutico , Oligosacáridos/uso terapéutico , Pronóstico , Pirazoles/uso terapéutico , Piridinas/uso terapéutico , Piridonas/uso terapéutico , Rivaroxabán , Análisis de Supervivencia , Tiofenos/uso terapéutico , Resultado del Tratamiento , Tromboembolia Venosa/diagnóstico
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