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2.
J Thromb Haemost ; 17(8): 1319-1328, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31050868

RESUMO

BACKGROUND: Idarucizumab is a monoclonal antibody fragment that reverses dabigatran anticoagulation. Pharmacokinetics (PK) of idarucizumab have been described in healthy, elderly, or renally impaired (RI) volunteers, but PK data in patients are lacking. OBJECTIVES: This analysis describes the PK of idarucizumab and its target dabigatran in bleeding/surgical patients. PATIENTS AND METHODS: Results from the Reversal Effects of Idarucizumab on Active Dabigatran study, a prospective, multicenter, single-arm study demonstrated the reversal of dabigatran anticoagulation by idarucizumab in patients with uncontrollable bleeding (group A) or who needed urgent surgery (group B). Idarucizumab and unbound dabigatran concentrations, immunogenicity, and pharmacodynamics were assessed. RESULTS: Total and unbound dabigatran levels at baseline were 165 ng/mL vs 110 ng/mL and 103 ng/mL vs 69.5 ng/mL in group A and B patients, respectively. Maximum plasma concentrations and area under the curves (AUC0-24 ) of idarucizumab in group A vs B, respectively, were 24 900 nmol/L vs 25 000 nmol/L and 76 600 nmol/h/L vs 68 000 nmol/h/L. Idarucizumab AUC0-24 increased by 38% in mild, 90% in moderate, and 146% in severe RI patients vs normal renal function. Hepatic impairment or geographical region had no relevant effect on idarucizumab PK. Idarucizumab immediately decreased unbound dabigatran concentration (<20 ng/mL). A linear correlation was observed between unbound dabigatran and diluted thrombin time and ecarin clotting time. Antidrug antibody titers were low (1-64 at day 30; 0-16 at day 90) and had no impact on idarucizumab PK and pharmacodynamics. CONCLUSION: Idarucizumab PK in target patients was consistent with phase I data. Patient characteristics had no impact on PK, whereas RI increased the exposure of idarucizumab and dabigatran. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02104947.

3.
N Engl J Med ; 380(19): 1825-1833, 2019 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-30883047

RESUMO

BACKGROUND: Ticagrelor is an oral P2Y12 inhibitor that is used with aspirin to reduce the risk of ischemic events among patients with acute coronary syndromes or previous myocardial infarction. Spontaneous major bleeding and bleeding associated with urgent invasive procedures are concerns with ticagrelor, as with other antiplatelet drugs. The antiplatelet effects of ticagrelor cannot be reversed with platelet transfusion. A rapid-acting reversal agent would be useful. METHODS: In this randomized, double-blind, placebo-controlled, phase 1 trial, we evaluated intravenous PB2452, a monoclonal antibody fragment that binds ticagrelor with high affinity, as a ticagrelor reversal agent. We assessed platelet function in healthy volunteers before and after 48 hours of ticagrelor pretreatment and again after the administration of PB2452 or placebo. Platelet function was assessed with the use of light transmission aggregometry, a point-of-care P2Y12 platelet-reactivity test, and a vasodilator-stimulated phosphoprotein assay. RESULTS: Of the 64 volunteers who underwent randomization, 48 were assigned to receive PB2452 and 16 to receive placebo. After 48 hours of ticagrelor pretreatment, platelet aggregation was suppressed by approximately 80%. PB2452 administered as an initial intravenous bolus followed by a prolonged infusion (8, 12, or 16 hours) was associated with a significantly greater increase in platelet function than placebo, as measured by multiple assays. Ticagrelor reversal occurred within 5 minutes after the initiation of PB2452 and was sustained for more than 20 hours (P<0.001 after Bonferroni adjustment across all time points for all assays). There was no evidence of a rebound in platelet activity after drug cessation. Adverse events related to the trial drug were limited mainly to issues involving the infusion site. CONCLUSIONS: In healthy volunteers, the administration of PB2452, a specific reversal agent for ticagrelor, provided immediate and sustained reversal of the antiplatelet effects of ticagrelor, as measured by multiple assays. (Funded by PhaseBio Pharmaceuticals; ClinicalTrials.gov number, NCT03492385.).


Assuntos
Anticorpos Neutralizantes/uso terapêutico , Plaquetas/efeitos dos fármacos , Coagulantes/uso terapêutico , Inibidores da Agregação de Plaquetas , Ticagrelor/antagonistas & inibidores , Adulto , Anticorpos Neutralizantes/efeitos adversos , Plaquetas/fisiologia , Coagulantes/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Voluntários Saudáveis , Humanos , Infusões Intravenosas , Masculino , Ticagrelor/efeitos adversos , Ticagrelor/uso terapêutico
4.
Circulation ; 139(6): 748-756, 2019 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-30586692

RESUMO

BACKGROUND: Although dabigatran has a favorable risk-benefit profile compared with vitamin K antagonist therapy for venous thromboembolism and nonvalvular atrial fibrillation, major bleeding events, including gastrointestinal (GI) bleeding, may occur. Therefore, our aim was to provide insights into the efficacy and safety of idarucizumab for urgent dabigatran reversal in patients with major GI bleeding. METHODS: Patients with uncontrollable GI bleeding requiring reversal were enrolled from June 2014 through July 2016 in the RE-VERSE AD study (Reversal of Dabigatran Anticoagulant Effect With Idarucizumab), a prospective, multicenter, open-label study of idarucizumab, and were followed up for 90 days for primary and secondary outcomes. Patients were to receive a 5-g dose of intravenous idarucizumab, administered as 2 bolus infusions of 2.5 g no more than 15 minutes apart. The primary end point was the maximum reversal of dabigatran anticoagulation within 4 hours after administration of idarucizumab as measured by the dabigatran-specific assays diluted thrombin time and ecarin clotting time. Further end points included investigator-reported bleeding cessation within the first 24 hours and incidence of rebleeding, thromboembolic events, or mortality. RESULTS: GI bleeding occurred in 137 patients enrolled in RE-VERSE AD, of which 84% was adjudicated as major or life-threatening, 48 (35.0%) was upper GI tract in origin, 43 (31.4%) was lower GI in origin, and 46 (33.6%) was either both or unknown. Complete reversal of dabigatran was observed in 118 of 121 patients (97.5%) with an elevated diluted thrombin time at presentation and 95 of 131 patients (72.5%) with an elevated ecarin clotting time and was similar for upper and lower GI bleeding. Bleeding cessation within 24 hours was reported in 92 of 134 evaluable patients (68.7%) after a median duration of 2.4 hours (interquartile range, 2.0-3.9 hours). During the 90-day follow-up, 6 patients (4.4%) had a postreversal thromboembolic event, and 20 patients (14.6%) died. CONCLUSIONS: Idarucizumab showed a rapid and complete reversal of dabigatran activity in nearly all patients presenting with GI bleeding, facilitating emergency patient care without the additional presence of anticoagulation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02104947.

6.
Eur Heart J ; 39(32): 2959-2971, 2018 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-29659797

RESUMO

Aim: The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing cardioversion. Methods: One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. Results: There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Conclusions: Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion. Clinical Trials.gov number: NCT02100228.

7.
Acad Emerg Med ; 25(9): 1065-1075, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29524340

RESUMO

Atrial fibrillation and flutter (AF) is a common condition among emergency department (ED) patients in the United States. Traditionally, ED care for primary complaints related to AF focus on rate control, and patients are often admitted to an inpatient setting for further care. Inpatient care may include further telemetry monitoring and diagnostic testing, rhythm control, a search for identification of AF etiology, and stroke prophylaxis. However, many patients are eligible for safe and effective outpatient management pathways. They are widely used in Canada and other countries but less widely adopted in the United States. In this project, we convened an expert panel to create a practical framework for the process of creating, implementing, and maintaining an outpatient AF pathway for emergency physicians to assess and treat AF patients, safely reduce hospitalization rates, ensure appropriate stroke prophylaxis, and effectively transition patients to longitudinal outpatient treatment settings from the ED and/or observation unit. To support local pathway creation, the panel also reached agreement on a protocol development plan, a sample pathway, consensus recommendations for pathway components, sample pathway metrics, and a structured literature review framework using a modified Delphi technique by a technical expert panel of emergency medicine, cardiology, and other stakeholder groups.

10.
N Engl J Med ; 377(5): 431-441, 2017 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-28693366

RESUMO

BACKGROUND: Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran. METHODS: We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time. Secondary end points included the restoration of hemostasis and safety measures. RESULTS: A total of 503 patients were enrolled: 301 in group A, and 202 in group B. The median maximum percentage reversal of dabigatran was 100% (95% confidence interval, 100 to 100), on the basis of either the diluted thrombin time or the ecarin clotting time. In group A, 137 patients (45.5%) presented with gastrointestinal bleeding and 98 (32.6%) presented with intracranial hemorrhage; among the patients who could be assessed, the median time to the cessation of bleeding was 2.5 hours. In group B, the median time to the initiation of the intended procedure was 1.6 hours; periprocedural hemostasis was assessed as normal in 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%. At 90 days, thrombotic events had occurred in 6.3% of the patients in group A and in 7.4% in group B, and the mortality rate was 18.8% and 18.9%, respectively. There were no serious adverse safety signals. CONCLUSIONS: In emergency situations, idarucizumab rapidly, durably, and safely reversed the anticoagulant effect of dabigatran. (Funded by Boehringer Ingelheim; RE-VERSE AD ClinicalTrials.gov number, NCT02104947 .).


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Dabigatrana/antagonistas & inibidores , Hemorragia/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos/sangue , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/imunologia , Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Dabigatrana/efeitos adversos , Dabigatrana/sangue , Hipersensibilidade a Drogas , Feminino , Hemorragia/induzido quimicamente , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tempo de Trombina , Trombose/induzido quimicamente , Fatores de Tempo
11.
Clin Cardiol ; 40(6): 390-398, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28598510

RESUMO

BACKGROUND: Guidelines suggest that "upstream" P2Y12 receptor antagonists should be considered in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS). HYPOTHESIS: Early use of ticagrelor in patients managed with an invasive strategy would be more effective than clopidogrel because of its more rapid onset of action and greater potency. METHODS: In the PLATO trial, 6792 NSTE-ACS patients were randomized to ticagrelor or clopidogrel (started prior to angiography) and underwent angiography within 72 hours of randomization. We compared efficacy and safety outcomes of ticagrelor vs clopidogrel as a function of "early" (<3h) vs "late" (≥3h) time to angiography. Adjusted Cox proportional hazards models evaluated interaction between randomized treatment and time from randomization to angiography on subsequent outcomes. RESULTS: Overall, a benefit of ticagrelor vs clopidogrel for cardiovascular death/myocardial infarction/stroke was seen at day 7 (hazard ratio [HR]: 0.67, P = 0.002), day 30 (HR: 0.81, P = 0.042), and 1 year (HR: 0.80, P = 0.0045). There were no significant interactions in the <3h vs ≥3h groups at any timepoint. For major bleeding, overall there was no significant increase (HR: 1.04, 95% confidence interval: 0.85-1.27); but there was a significant interaction with no difference between ticagrelor and clopidogrel in the early group (HR: 0.79), but higher bleeding risk with ticagrelor in the late angiography group, at 7 days (HR: 1.51, Pint = 0.002). Patterns were similar at 30 days and 1 year. CONCLUSIONS: The benefit of ticagrelor over clopidogrel was consistent in those undergoing early and late angiography, supporting upstream use of ticagrelor.


Assuntos
Síndrome Coronariana Aguda/terapia , Adenosina/análogos & derivados , Eletrocardiografia/efeitos dos fármacos , Revascularização Miocárdica , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/fisiopatologia , Adenosina/administração & dosagem , Idoso , Clopidogrel , Angiografia Coronária , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Ticagrelor , Ticlopidina/administração & dosagem , Fatores de Tempo , Resultado do Tratamento
13.
Angiology ; 68(1): 29-39, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26861858

RESUMO

Elderly (≥75 years old) patients with ST-segment elevation myocardial infarction (STEMI) have higher ischemic and bleeding risk compared with those <75 years old. We investigated the efficacy and safety of intravenous (IV) enoxaparin versus IV unfractionated heparin (UFH) in elderly patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. A prespecified analysis of the Acute Myocardial Infarction Treated with Primary Angioplasty and Intravenous Enoxaparin or Unfractionated Heparin to Lower Ischemic and Bleeding Events at Short- and Long-term Follow-up (ATOLL) study was performed examining the 30-day outcomes in the elderly patients. Of the 165 elderly patients in the ATOLL study, 85 patients received IV enoxaparin 0.5 mg/kg and 80 patients received IV UFH. Intravenous enoxaparin did not reduce the primary end point, the main secondary efficacy end point, major bleeding, major or minor bleeding, and all-cause mortality compared with IV UFH. The rate of minor bleeding (5.9% vs 22.8%, P adjusted = .01) was significantly lower with IV enoxaparin compared with IV UFH. Intravenous enoxaparin appears to be a safe alternative to IV UFH in primary PCI of the elderly patients with STEMI.

14.
J Med Econ ; 20(5): 435-442, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-27981865

RESUMO

AIMS: Patients treated with anticoagulants may experience serious bleeding or require urgent surgery or intervention, and may benefit from rapid anticoagulant reversal. This exploratory analysis assessed healthcare resource utilization (HCRU) in patients treated with idarucizumab, a specific reversal agent for dabigatran etexilate. MATERIALS AND METHODS: RE-VERSE AD™ (NCT02104947), a prospective, multi-center open-label study, is evaluating idarucizumab for dabigatran reversal in patients with serious bleeding (Group A) or undergoing emergency surgery/procedures (Group B). HCRU outcome measures evaluated in the first 90 patients enrolled were use of blood products and pro-hemostatic agents, length of stay (LOS) in hospital, and LOS in intensive care unit (ICU). RESULTS: Blood products or pro-hemostatic agents were given to 63% (32/51) of patients in Group A and 23% (9/39) of patients in Group B on the day of/day after surgery. An overnight hospital stay was reported for 82% (42/51) of patients in Group A with median LOS = 7 (range = 1-71) bed-days. For Group B, 92% (36/39) had an overnight hospital stay with a median LOS = 9 (range = 1-92) bed-days. In Group A, 17 patients were admitted to the ICU for at least 1 day with median LOS = 4 (range = 1-44) days; in Group B the number was 15 with median LOS = 2 (range = 1-92) days. LIMITATIONS: The lack of a control group and the small patient numbers limit the strength of the conclusions. CONCLUSIONS: The use of idarucizumab may simplify emergency management of dabigatran-treated patients with life-threatening bleeds and reduce perioperative complications in patients undergoing emergency surgery.


Assuntos
Anticorpos Monoclonais Humanizados/economia , Anticorpos Monoclonais Humanizados/uso terapêutico , Hemorragia/tratamento farmacológico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Transfusão de Sangue/economia , Análise Custo-Benefício , Dabigatrana/efeitos adversos , Emergências , Feminino , Hemorragia/induzido quimicamente , Humanos , Unidades de Terapia Intensiva/economia , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Estudos Prospectivos , Fatores de Tempo
15.
Am J Emerg Med ; 34(11S): 33-38, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27697436

RESUMO

Idarucizumab is a monoclonal antibody fragment specifically targeted to dabigatran. It has demonstrated prompt and durable reversal of the anticoagulant effects of dabigatran in animal studies and phase 1 studies of young, elderly, and renally impaired volunteers. Although elective invasive procedures and most bleeding complications in dabigatran-treated patients can be managed by temporarily stopping dabigatran therapy and using supportive measures, there are rare clinical situations that require urgent reversal of the anticoagulant effect of dabigatran. The effectiveness and safety of 5 g of intravenous idarucizumab is being investigated in a prospective, open-label, single-cohort study in patients with serious bleeding or in those requiring an urgent procedure. In an interim analysis of the first 90 participants, idarucizumab rapidly and completely reversed the anticoagulant activity of dabigatran in 88%-98% of participants, and there were no safety concerns, with no deaths or serious adverse events being attributable to idarucizumab. Supported by these interim results, idarucizumab has been approved in the United States and the European Union for use when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in patients with life-threatening or uncontrolled bleeding. Clinical use of idarucizumab should follow the same processes as patient enrollment in this study, which is projected to be completed in 2016. The outcomes achieved with this specific reversal agent are likely to be of continued interest to treating physicians.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Dabigatrana/antagonistas & inibidores , Hemorragia/prevenção & controle , Anticorpos Monoclonais Humanizados/efeitos adversos , Dabigatrana/sangue , Emergências , Humanos , Tempo de Trombina , Tempo de Coagulação do Sangue Total
17.
Am Heart J ; 179: 59-68, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27595680

RESUMO

BACKGROUND: Stroke prevention in anticoagulation-naïve patients with atrial fibrillation undergoing cardioversion has not been systematically studied. OBJECTIVE: To determine outcomes in anticoagulation-naïve patients (defined as those receiving an anticoagulant for <48 hours during the index episode of atrial fibrillation) scheduled for cardioversion. METHODS: This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin. Early image-guided cardioversion is encouraged. For apixaban, the usual dose is 5 mg BID with a dose reduction to 2.5 mg BID if 2 of the following are present: age >80 years, weight <60 kg, or serum creatinine >1.5 mg/dL. If cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after cardioversion or 90 days postrandomization if cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded. STATISTICS: The warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable. CLINICAL CONTEXT: This first prospective cardioversion study of a novel anticoagulant in anticoagulation-naïve patients should influence clinical practice.


Assuntos
Fibrilação Atrial/terapia , Cardioversão Elétrica , Inibidores do Fator Xa/uso terapêutico , Heparina/uso terapêutico , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Humanos , Acidente Vascular Cerebral/etiologia
18.
Am J Med ; 129(11S): S31-S32, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27521288
19.
Am J Med ; 129(11S): S73-S79, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27568285

RESUMO

Idarucizumab is a monoclonal antibody fragment specifically targeted to dabigatran. It has demonstrated prompt and durable reversal of the anticoagulant effects of dabigatran in animal studies and phase 1 studies of young, elderly, and renally impaired volunteers. Although elective invasive procedures and most bleeding complications in dabigatran-treated patients can be managed by temporarily stopping dabigatran therapy and using supportive measures, there are rare clinical situations that require urgent reversal of the anticoagulant effect of dabigatran. The effectiveness and safety of 5 g of intravenous idarucizumab is being investigated in a prospective, open-label, single-cohort study in patients with serious bleeding or in those requiring an urgent procedure. In an interim analysis of the first 90 participants, idarucizumab rapidly and completely reversed the anticoagulant activity of dabigatran in 88%-98% of participants, and there were no safety concerns, with no deaths or serious adverse events being attributable to idarucizumab. Supported by these interim results, idarucizumab has been approved in the United States and the European Union for use when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in patients with life-threatening or uncontrolled bleeding. Clinical use of idarucizumab should follow the same processes as patient enrollment in this study, which is projected to be completed in 2016. The outcomes achieved with this specific reversal agent are likely to be of continued interest to treating physicians.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antídotos/uso terapêutico , Antitrombinas/efeitos adversos , Dabigatrana/efeitos adversos , Hemorragia/induzido quimicamente , Animais , Cromatografia Líquida de Alta Pressão , Hemorragia/prevenção & controle , Humanos , Tempo de Tromboplastina Parcial , Tempo de Protrombina , Espectrometria de Massas em Tandem , Tempo de Trombina , Tempo de Coagulação do Sangue Total
20.
Crit Pathw Cardiol ; 15(2): 60-8, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27183256

RESUMO

BACKGROUND: Professional society guidelines suggest early stress testing (within 72 hours) after an emergency department (ED) evaluation for suspected acute coronary syndrome (ACS). However, there is increasing concern that current practice results in over-testing without evidence of benefit. We test the hypothesis that early stress testing improves outcomes. METHODS: We analyzed prospectively collected data from 9 EDs on patients with suspected ACS, 1999-2001. We excluded patients with an ED diagnosis of ACS. The primary outcome was 30-day major adverse cardiac events (MACEs), including all-cause death, acute myocardial infarction, and revascularization. We used the HEART score to determine pretest ACS risk (low, intermediate, and high). To mitigate potential confounding, patients with and without early stress testing were matched within pretest risk strata in a 1:2 ratio using propensity scores. RESULTS: Of 7127 potentially eligible patients, 895 (13%) received early stress testing. The analytic cohort included 895 patients with early stress testing matched to 1790 without early stress testing. The overall 30-day MACE rate in both the source and analytic population was 3%. There were no baseline imbalances after propensity score matching (P > 0.1 for more than 30 variables). There was no association between early stress testing and 30-day MACE [odds ratio, 1.0; 95% confidence interval (CI), 0.6-1.7]. There was no effect modification by pretest risk (low: odds ratio, 1.0; 95% CI, 0.2-3.7; intermediate: 1.2; 95% CI, 0.6-2.6; high: 0.4; 95% CI, 0.1-1.6). CONCLUSIONS: Early stress testing is not associated with reduced MACE in patients evaluated for suspected ACS. Early stress testing may have limited value in populations with low MACE rate.


Assuntos
Síndrome Coronariana Aguda/diagnóstico , Serviço Hospitalar de Emergência , Teste de Esforço/métodos , Medição de Risco/métodos , Síndrome Coronariana Aguda/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Causas de Morte/tendências , Eletrocardiografia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Singapura/epidemiologia , Taxa de Sobrevida/tendências , Fatores de Tempo , Estados Unidos/epidemiologia
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