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1.
Thromb Haemost ; 120(1): 65-74, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31752042

RESUMO

BACKGROUND: Glycoprotein IIb/IIIa inhibitors (GPIs) in combination with clopidogrel improve clinical outcome in ST-elevation myocardial infarction (STEMI); however, finding a balance that minimizes both thrombotic and bleeding risk remains fundamental. The efficacy and safety of GPI in addition to ticagrelor, a more potent P2Y12-inhibitor, have not been fully investigated. METHODS: 1,630 STEMI patients who underwent primary percutaneous coronary intervention (PCI) were analyzed in this subanalysis of the ATLANTIC trial. Patients were divided in three groups: no GPI, GPI administration routinely before primary PCI, and GPI administration in bailout situations. The primary efficacy outcome was a composite of death, myocardial infarction, urgent target revascularization, and definite stent thrombosis at 30 days. The safety outcome was non-coronary artery bypass graft (CABG)-related PLATO major bleeding at 30 days. RESULTS: Compared with no GPI (n = 930), routine GPI (n = 525) or bailout GPI (n = 175) was not associated with an improved primary efficacy outcome (4.2% no GPI vs. 4.0% routine GPI vs. 6.9% bailout GPI; p = 0.58). After multivariate analysis, the use of GPI in bailout situations was associated with a higher incidence of non-CABG-related bleeding compared with no GPI (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.32-6.64; p = 0.03). However, routine GPI use compared with no GPI was not associated with a significant increase in bleeding (OR 1.78, 95% CI 0.88-3.61; p = 0.92). CONCLUSION: Use of GPIs in addition to ticagrelor in STEMI patients was not associated with an improvement in 30-day ischemic outcome. A significant increase in 30-day non-CABG-related PLATO major bleeding was seen in patients who received GPIs in a bailout situation.

2.
Am J Cardiovasc Drugs ; 19(2): 173-183, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30353444

RESUMO

BACKGROUND: Morphine adversely impacts the action of oral adenosine diphosphate (ADP)-receptor blockers in ST-segment elevation myocardial infarction (STEMI) patients, and is possibly associated with differing patient characteristics. This retrospective analysis investigated whether interaction between morphine use and pre-percutaneous coronary intervention (pre-PCI) ST-segment elevation resolution in STEMI patients in the ATLANTIC study was associated with differences in patient characteristics and management. METHODS: ATLANTIC was an international, multicenter, randomized study of treatment in the acute ambulance/hospital setting where STEMI patients received ticagrelor 180 mg ± morphine. Patient characteristics, cardiovascular history, risk factors, management, and outcomes were recorded. RESULTS: Opioids (97.6% morphine) were used in 921 out of 1862 patients (49.5%). There were no significant differences in age, sex or cardiovascular history, but more morphine-treated patients had anterior myocardial infarction and left-main disease. Time from chest pain to electrocardiogram and ticagrelor loading was shorter with morphine (both p = 0.01) but not total ischemic time. Morphine-treated patients more frequently received glycoprotein IIb/IIIa inhibitors (p = 0.002), thromboaspiration and stent implantation (both p < 0.001). No significant difference between the two groups was found regarding pre-PCI ≥ 70% ST-segment elevation resolution, death, myocardial infarction, stroke, urgent revascularization and definitive acute stent thrombosis. More morphine-treated patients had an absence of pre-PCI Thrombolysis in Myocardial Infarction (TIMI) 3 flow (85.8% vs. 79.7%; p = 0.001) and more had TIMI major bleeding (1.1% vs. 0.1%; p = 0.02). CONCLUSIONS: Morphine-treatment was associated with increased GP IIb/IIIa inhibitor use, less pre-PCI TIMI 3 flow, and more bleeding. Judicious morphine use is advised with non-opioid analgesics preferred for non-severe acute pain. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01347580.


Assuntos
Analgésicos Opioides/efeitos adversos , Morfina/efeitos adversos , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Ticagrelor/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/complicações , Dor/tratamento farmacológico , Inibidores da Agregação de Plaquetas/efeitos adversos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Ticagrelor/efeitos adversos , Resultado do Tratamento
3.
Am J Emerg Med ; 37(4): 664-671, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30001815

RESUMO

OBJECTIVES: The early identification of septic shock patients at high risk of poor outcome is essential to early initiate optimal treatments and to decide on hospital admission. Biomarkers are often used to evaluate the severity. In prehospital settings, the availability of biomarkers, such as lactate, is restricted. In this context, clinical tools such as skin mottling score (SMS) and capillary refill time (CRT) are more suitable. In this study, we describe prehospital SMS and CRT's ability to predict mortality of patients with septic shock initially cared in the prehospital setting by a mobile intensive care unit. METHODS: Patients with septic shock who received prehospital medical care admitted to the intensive care unit were retrospectively analyzed. RESULTS: Sixty-three patients were included. The origin of sepsis was mainly pulmonary (67%). Overall mortality reached 36%. No significant difference was observed in the duration of prehospital medical care between alive and deceased patients. Mean prehospital value of SMS was 3 ±â€¯2 and mean prehospital value of CRT was 5 ±â€¯1 s. A significant association was found between mortality and prehospital SMS (p = 0.02, OR[CI95] = 1.50 [1.08-2.15]) and prehospital CRT (p = 0.04, OR[CI95] = 1.53 [1.04-2.37]). After adjusting for confounding factors using propensity score, the relative risk of death was 6.58 for SMS > 2 and 2.03 for CRT > 4 s. CONCLUSION: In this study, we report an association between prehospital SMS and CRT, and mortality of patients with septic shock. SMS and CRT are simple tools that could be used to optimize the triage and to decide early intensive care admission.


Assuntos
Cuidados Críticos/métodos , Microcirculação , Choque Séptico/diagnóstico , Choque Séptico/fisiopatologia , Pele/patologia , Idoso , Idoso de 80 Anos ou mais , Serviços Médicos de Emergência , Feminino , França , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Índice de Gravidade de Doença , Choque Séptico/mortalidade , Triagem
4.
Am J Cardiovasc Drugs ; 18(6): 503-511, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30144017

RESUMO

BACKGROUND: The aim was to compare the peri-procedural biomarkers of coagulation and platelet activation in patients randomly allocated to intravenous enoxaparin or unfractionated heparin (UFH) in the ATOLL randomized trial (NCT00718471). METHODS AND RESULTS: A total of 129 patients (n = 58 enoxaparin and n = 71 UFH) admitted for ST-segment elevation myocardial infarction (STEMI) treated by percutaneous coronary intervention (PCI) were included in this substudy of the ATOLL trial. Activated partial thromboplastin time ratio, anti-Xa activity, von Willebrand factor antigen, prothrombin fragment 1 + 2 (F1 + 2), thrombin-antithrombin complex (TAT), tissue factor pathway inhibitor and soluble CD40 ligand were measured at sheath insertion (T1) and at the end of the PCI (T2) and correlated with 1-month clinical outcomes. Target anticoagulation levels at T2 were more readily achieved in patients receiving enoxaparin compared to those receiving UFH (80.3 vs 18.2%, p < 0.0001). Increased levels of F1 + 2 and TAT measured at T2 were associated with the incidence of the composite ischemic endpoint (p = 0.04 and p = 0.03) and all-cause mortality (p < 0.0001 and p = 0.002). Release of F1 + 2 between T1 and T2 also predicted the composite ischemic endpoint (312 ± 513 vs 37 ± 292, p = 0.04) and net clinical outcome (185 ± 405 vs 3.2 ± 278, p = 0.03). CONCLUSIONS: During primary PCI, enoxaparin achieved therapeutic levels more frequently than UFH. Higher level of thrombin generation measured at the end of the PCI procedure was associated with more frequent ischemic events.


Assuntos
Anticoagulantes/uso terapêutico , Enoxaparina/uso terapêutico , Heparina/uso terapêutico , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Antitrombina III , Biomarcadores , Ligante de CD40/sangue , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Fator Xa/análise , Feminino , Heparina/administração & dosagem , Heparina/efeitos adversos , Humanos , Lipoproteínas/análise , Masculino , Pessoa de Meia-Idade , Tempo de Tromboplastina Parcial , Peptídeo Hidrolases/sangue , Protrombina/análise , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Fator de von Willebrand/análise
5.
EuroIntervention ; 14(7): 789-797, 2018 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-29969431

RESUMO

AIMS: The aim of the study was to examine the main results of the ATLANTIC trial in patients with ST-elevation myocardial infarction (STEMI), randomised to pre- versus in-hospital ticagrelor, according to age. METHODS AND RESULTS: Patients were evaluated by age class (<75 vs. ≥75 years) for demographics, prior cardiovascular history, risk factors, management, and outcomes. Elderly patients (≥75 years; 304/1,862) were more likely to be women, diabetic, lean, with a prior history of myocardial infarction and CABG, and with comorbidities (p<0.01 for all). Elderly patients presented more frequently with acute heart failure and less frequently had thromboaspiration, a stent implanted (p<0.01) and an aggressive antithrombotic regimen. Elderly patients had lower rates of pre- and post-PCI ≥70% ST-segment elevation resolution (43.9% vs. 51.6%; p=0.035), of pre- and post-PCI TIMI 3 flow (17.1% vs. 27.5%, p=0.0002), and a higher rate of the composite of death/MI/stroke/urgent revascularisation (9.9% vs. 2.9%; OR 3.67, 95% CI [2.27; 5.93], p<0.0001) and mortality (8.5% vs. 1.5%; OR 6.45, 95% CI [2.75; 15.11], p<0.0001). There was a non-significant trend towards more frequent major bleedings among elderly patients (TIMI major 2.3% vs. 1.1%; OR 2.13, 95% CI [0.88; 5.18], p=0.095). There was no significant interaction between time of ticagrelor administration (pre-hospital versus in-lab) and class of age for all outcomes. CONCLUSIONS: Elderly patients, who represented one sixth of the patients randomised in the ATLANTIC trial, had less successful mechanical reperfusion and a sixfold increase in mortality at 30 days, probably due to comorbidities and possible undertreatment. The effect of early ticagrelor was consistent irrespective of age.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Adenosina , Idoso , Método Duplo-Cego , Feminino , Humanos , Antagonistas do Receptor Purinérgico P2Y , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Resultado do Tratamento
6.
Heart ; 104(22): 1843-1849, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29695512

RESUMO

BACKGROUND: Two recent randomised trials studied the benefit of mineralocorticoid receptor antagonists (MRAs) in ST-segment elevation myocardial infarction (STEMI) irrespective or in absence of heart failure. The studies were both undersized to assess hard clinical endpoints. A pooled analysis was preplanned by the steering committees. METHODS: We conducted a prespecified meta-analysis of patient-level data of patients with STEMI recruited in two multicentre superiority trials, randomised within 72 hours after symptom onset. Patients were allocated (1:1) to two MRA regimens: (1) an intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) versus standard therapy or (2) oral eplerenone (25-50 mg) versus placebo. The primary and key secondary outcomes, all-cause death and the composite of all-cause death or resuscitated sudden death, respectively, were assessed in the intention-to-treat population using a Cox model stratified on the study identifier. RESULTS: Patients were randomly assigned to receive (n=1118) or not the MRA regimen (n=1123). After a median follow-up time of 188 days, the primary and secondary outcomes occurred in 5 (0.4%) and 17 (1.5%) patients (adjusted HR (adjHR) 0.31, 95% CI 0.11 to 0.86, p=0.03) and 6 (0.5%) and 22 (2%) patients (adjHR 0.26, 95% CI 0.10 to 0.65, p=0.004) in the MRA and control groups, respectively. There were also trends towards lower rates of cardiovascular death (p=0.06) and ventricular fibrillation (p=0.08) in the MRA group. CONCLUSION: Our analysis suggests that compared with standard therapy, MRA regimens are associated with a reduction of death and death or resuscitated sudden death in STEMI.


Assuntos
Ácido Canrenoico/administração & dosagem , Eplerenona/administração & dosagem , Antagonistas de Receptores de Mineralocorticoides/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Espironolactona/administração & dosagem , Idoso , Ácido Canrenoico/efeitos adversos , Eplerenona/efeitos adversos , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas de Receptores de Mineralocorticoides/efeitos adversos , Estudos Multicêntricos como Assunto , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Espironolactona/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
7.
Int J Cardiol ; 244: 49-53, 2017 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-28622941

RESUMO

BACKGROUND: ATLANTIC was a randomized study comparing pre- and in-hospital treatment with a ticagrelor loading dose (LD) in ongoing ST-segment elevation myocardial infarction (STEMI). We sought to compare patient characteristics and clinical outcomes in France with other countries participating in ATLANTIC. METHODS: The population comprised 1862 patients, 660 (35.4%) from France and 1202 from 12 other countries. The main endpoints were reperfusion (≥70% ST-segment elevation resolution) and TIMI flow grade 3 before (co-primary endpoints) and after percutaneous coronary intervention (PCI). Other endpoints included a composite ischaemic endpoint (death/myocardial infarction/stroke/urgent revascularization/definite stent thrombosis) and bleeding events at 30days. RESULTS: In France, median times from first LD to angiography and between first and second LDs were 49 and 35min, respectively, and were similar to other countries. French patients were younger (mean 58.7 vs 61.9years, p<0.0001) and characterized by a higher rate of radial access (89.9% vs 54.8%, p<0.0001), more frequent use of pre-hospital glycoprotein (GP) IIb/IIIa inhibitors (14.1% vs 3.1%, p<0.0001) and intravenous enoxaparin (57.3% vs 10.1%, p<0.0001). In France, as in other countries, the co-primary endpoints did not differ between the two randomization groups. The composite ischaemic endpoint was numerically lower in France (3.3% vs 5.1%, p=0.07), with a lower mortality (1.4% vs 3.3%, p=0.01). PLATO major bleeding was numerically less frequent in France (1.8% vs 3.2%, p=0.07). CONCLUSIONS: The French population appears to have better outcomes than the rest of the study population, and seems related to differences in demographics and management characteristics. TRIAL REGISTRY: ClinicalTrials.gov (NCT01347580).


Assuntos
Adenosina/análogos & derivados , Serviços Médicos de Emergência/métodos , Vigilância da População , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Adenosina/administração & dosagem , Idoso , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Ticagrelor , Resultado do Tratamento
8.
J Am Coll Cardiol ; 68(1): 40-9, 2016 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-27364049

RESUMO

BACKGROUND: Preliminary data suggested a clinical benefit in treating out-of-hospital cardiac arrest (OHCA) patients with a high dose of erythropoietin (Epo) analogs. OBJECTIVES: The authors aimed to evaluate the efficacy of epoetin alfa treatment on the outcome of OHCA patients in a phase 3 trial. METHODS: The authors performed a multicenter, single-blind, randomized controlled trial. Patients still comatose after a witnessed OHCA of presumed cardiac origin were eligible. In the intervention group, patients received 5 intravenous injections spaced 12 h apart during the first 48 h (40,000 units each, resulting in a maximal dose of 200,000 total units), started as soon as possible after resuscitation. In the control group, patients received standard care without Epo. The main endpoint was the proportion of patients in each group reaching level 1 on the Cerebral Performance Category (CPC) scale (survival with no or minor neurological sequelae) at day 60. Secondary endpoints included all-cause mortality rate, distribution of patients in CPC levels at different time points, and side effects. RESULTS: In total, 476 patients were included in the primary analysis. Baseline characteristics were similar in the 2 groups. At day 60, 32.4% of patients (76 of 234) in the intervention group reached a CPC 1 level, as compared with 32.1% of patients (78 of 242) in the control group (odds ratio: 1.01; 95% confidence interval: 0.68 to 1.48). The mortality rate and proportion of patients in each CPC level did not differ at any time points. Serious adverse events were more frequent in Epo-treated patients as compared with controls (22.6% vs. 14.9%; p = 0.03), particularly thrombotic complications (12.4% vs. 5.8%; p = 0.01). CONCLUSIONS: In patients resuscitated from an OHCA of presumed cardiac cause, early administration of erythropoietin plus standard therapy did not confer a benefit, and was associated with a higher complication rate. (High Dose of Erythropoietin Analogue After Cardiac Arrest [Epo-ACR-02]; NCT00999583).


Assuntos
Epoetina alfa/administração & dosagem , Hematínicos/administração & dosagem , Parada Cardíaca Extra-Hospitalar/tratamento farmacológico , Idoso , Intervenção Médica Precoce , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego
9.
J Am Coll Cardiol ; 67(16): 1917-27, 2016 Apr 26.
Artigo em Inglês | MEDLINE | ID: mdl-27102506

RESUMO

BACKGROUND: Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF). OBJECTIVES: The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction. METHODS: We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months. RESULTS: The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001). CONCLUSIONS: The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136).


Assuntos
Ácido Canrenoico/administração & dosagem , Insuficiência Cardíaca/tratamento farmacológico , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Espironolactona/administração & dosagem , Disfunção Ventricular Esquerda/tratamento farmacológico , Fatores Etários , Idoso , Quimioterapia Combinada , Eletrocardiografia/métodos , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Modelos de Riscos Proporcionais , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Método Simples-Cego , Estatísticas não Paramétricas , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/mortalidade
11.
J Am Coll Cardiol ; 64(24): 2563-2571, 2014 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-25524333

RESUMO

BACKGROUND: After percutaneous coronary intervention (PCI) for non-ST-segment elevation myocardial infarction (NSTEMI), treatment with a P2Y12 antagonist with aspirin is recommended for 1 year. OBJECTIVES: The oral P2Y12 antagonists ticagrelor and prasugrel have higher recommendations than clopidogrel, but it is unknown if administration before the start of PCI is beneficial. METHODS: In the randomized, double-blind ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction) trial, 4,033 patients were diagnosed with NSTEMI and 68.7% underwent PCI; 1,394 received pre-treatment with prasugrel (30-mg loading dose), and 1,376 received placebo. At the time of PCI, patients who received pre-treatment with prasugrel received an additional 30-mg dose of prasugrel, and those who received placebo received a 60-mg loading dose of prasugrel. Primary efficacy was a composite of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa bailout through 7 days from randomization. Investigators captured the presence of thrombus on initial angiography and during PCI. RESULTS: The incidence of the primary endpoint through 7 days from randomization in the pre-treatment group versus the no pre-treatment group was 13.1% versus 13.1% (p = 0.93). Pre-treatment with prasugrel was not associated with decreases in any ischemic event, including total mortality. Patients with thrombus on angiography had a 3-fold higher incidence of the primary endpoint than patients without thrombus. There was no impact of pre-treatment with prasugrel on the presence of thrombus before PCI or on occurrence of stent thrombosis after PCI. There was a 3-fold increase in all non-coronary artery bypass graft Thrombolysis In Myocardial Infarction (TIMI) major bleeding and a 6-fold increase in non-coronary artery bypass graft life-threatening bleeding with pre-treatment with prasugrel; the same trends persisted in patients who had radial or femoral access even with use of a closure device. CONCLUSIONS: These findings support deferring treatment with prasugrel until a decision is made about revascularization in patients with NSTEMI undergoing angiography within 48 h of admission. (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction [ACCOAST]; NCT01015287).


Assuntos
Hemorragia , Complicações Intraoperatórias , Infarto do Miocárdio , Intervenção Coronária Percutânea , Piperazinas , Tiofenos , Idoso , Angiografia/métodos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Eletrocardiografia/métodos , Determinação de Ponto Final , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Complicações Intraoperatórias/induzido quimicamente , Complicações Intraoperatórias/prevenção & controle , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Piperazinas/administração & dosagem , Piperazinas/efeitos adversos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/análise , Cloridrato de Prasugrel , Cuidados Pré-Operatórios/métodos , Medição de Risco , Tiofenos/administração & dosagem , Tiofenos/efeitos adversos , Resultado do Tratamento
12.
N Engl J Med ; 371(11): 1016-27, 2014 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-25175921

RESUMO

BACKGROUND: The direct-acting platelet P2Y12 receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction (STEMI). Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown. METHODS: We conducted an international, multicenter, randomized, double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours' duration, comparing prehospital (in the ambulance) versus in-hospital (in the catheterization laboratory) treatment with ticagrelor. The coprimary end points were the proportion of patients who did not have a 70% or greater resolution of ST-segment elevation before percutaneous coronary intervention (PCI) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography. Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days. RESULTS: The median time from randomization to angiography was 48 minutes, and the median time difference between the two treatment strategies was 31 minutes. The two coprimary end points did not differ significantly between the prehospital and in-hospital groups. The absence of ST-segment elevation resolution of 70% or greater after PCI (a secondary end point) was reported for 42.5% and 47.5% of the patients, respectively. The rates of major adverse cardiovascular events did not differ significantly between the two study groups. The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group (0% vs. 0.8% in the first 24 hours; 0.2% vs. 1.2% at 30 days). Rates of major bleeding events were low and virtually identical in the two groups, regardless of the bleeding definition used. CONCLUSIONS: Prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion. (Funded by AstraZeneca; ATLANTIC ClinicalTrials.gov number, NCT01347580.).


Assuntos
Adenosina/análogos & derivados , Serviços Médicos de Emergência , Infarto do Miocárdio/tratamento farmacológico , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Idoso , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Clopidogrel , Angiografia Coronária , Método Duplo-Cego , Quimioterapia Combinada , Eletrocardiografia/efeitos dos fármacos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Reperfusão Miocárdica , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Tempo para o Tratamento
13.
Arch Cardiovasc Dis ; 105(12): 639-48, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23199619

RESUMO

BACKGROUND: In primary percutaneous coronary intervention (pPCI), conflicting data exist on the relative importance of patient presentation time (time from symptom onset (SO) to first medical contact [FMC]) and transfer time (time from FMC to sheath insertion). OBJECTIVES: To evaluate the impact of transfer time on mortality in an unselected ST-elevation myocardial infarction (STEMI) population treated with pPCI. METHODS: In a well-organized urban network, using mobile intensive care units (MICU) whenever possible, the impact of transfer time on inhospital mortality was evaluated in 703 unselected consecutive STEMI patients transferred for pPCI. RESULTS: Our STEMI population included patients with cardiogenic shock (5.3%) and out-of-hospital cardiac arrest (3.7%). Longer transfer times were found to be associated with a stepwise increase in mortality ranging from 2.99% in the first quartile (Q1) up to 8.65% in the fourth quartile (Q4) (P=0.005). This result was noted in patients presenting early (≤2h of SO, 0.96% for Q1 vs. 9.8% for Q4, P=0.006) but not in late presenters (>2h of SO, 7.00% for Q1 vs. 7.8% for Q4, P=0.85). After adjustment for confounding variables such as the severity of patients, the relationship between mortality and transfer time was no longer apparent. CONCLUSIONS: In a well-organized urban network dedicated to pPCI, including unselected STEMI patients, transfer time does not appear to be a major contributor to mortality. The relationship of transfer time to mortality seems to be dependent on presentation time and patients' clinical severity.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Angioplastia Coronária com Balão , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Transferência de Pacientes/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Estudos Prospectivos , Fatores de Tempo
14.
Circ Cardiovasc Interv ; 5(1): 69-76, S1, 2012 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-22319064

RESUMO

BACKGROUND: The value of prehospital initiation of glycoprotein IIb/IIIa inhibitors remains a controversial issue. We sought to investigate whether in-ambulance initiation of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) improves ST-segment elevation resolution (STR) after primary percutaneous coronary intervention (PCI). METHODS AND RESULTS: MISTRAL (Myocardial Infarction with ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace) is a prospective, randomized, double-blind study. Two hundred and fifty-six patients with acute STEMI were allocated to receive abciximab either in the ambulance (ambulance group, n=127) or in the catheterization laboratory (hospital group, n=129). The primary end point was complete (>70%) STR after PCI. Complete STR was not significantly different between the 2 groups (before PCI, 21.6% versus 15.5%, P=0.28; after PCI, 70.3% versus 65.8%, P=0.49). Thrombolysis In Myocardial Infarction (TIMI) 2 to 3 flow rates before PCI tended to be higher in the ambulance group (46.8% versus 35%, P=0.08) but not after PCI (70.3% versus 65.8%, P=0.49). Slow flow tended to be lower (5.6% versus 13.4%, P=0.07), and distal embolization occurred significantly less often in the ambulance group (8.1% versus 21.1%, P=0.008). One- and 6-month major adverse cardiac event rates were low and similar in both groups. CONCLUSIONS: Early ambulance administration of abciximab in STEMI did not improve either STR or TIMI flow rate after PCI. However, it tended to improve TIMI flow pre-PCI and decreased distal embolization during procedure. Larger studies are needed to confirm these results.


Assuntos
Angioplastia Coronária com Balão , Anticorpos Monoclonais/administração & dosagem , Anticoagulantes/administração & dosagem , Serviços Médicos de Emergência , Fragmentos Fab das Imunoglobulinas/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Abciximab , Idoso , Anticorpos Monoclonais/efeitos adversos , Anticoagulantes/efeitos adversos , Método Duplo-Cego , Eletrocardiografia , Feminino , Humanos , Fragmentos Fab das Imunoglobulinas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/cirurgia , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Estudos Prospectivos , Resultado do Tratamento
15.
Lancet ; 378(9792): 693-703, 2011 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-21856483

RESUMO

BACKGROUND: Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction has traditionally been supported by unfractionated heparin, which has never been directly compared with a new anticoagulant using consistent anticoagulation and similar antiplatelet strategies in both groups. We compared traditional heparin treatment with intravenous enoxaparin in primary PCI. METHODS: In a randomised open-label trial, patients presenting with ST-elevation myocardial infarction were randomly assigned (1:1) to receive an intravenous bolus of 0·5 mg/kg of enoxaparin or unfractionated heparin before primary PCI. Wherever possible, medical teams travelling in mobile intensive care units (ambulances) selected, randomly assigned (using an interactive voice response system at the central randomisation centre), and treated patients. Patients who had received any anticoagulant before randomisation were excluded. Patients and caregivers were not masked to treatment allocation. The primary endpoint was 30-day incidence of death, complication of myocardial infarction, procedure failure, or major bleeding. The main secondary endpoint was the composite of death, recurrent acute coronary syndrome, or urgent revascularisation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00718471. FINDINGS: 910 patients were assigned to treatment with enoxaparin (n=450) or unfractionated heparin (n=460). The primary endpoint occurred in 126 (28%) patients after anticoagulation with enoxaparin versus 155 (34%) patients on unfractionated heparin (relative risk [RR] 0·83, 95% CI 0·68-1·01, p=0·06). The incidence of death (enoxaparin, 17 [4%] vs heparin, 29 [6%] patients; p=0·08), complication of myocardial infarction (20 [4%] vs 29 [6%]; p=0·21), procedure failure (100 [26%] vs 109 [28%]; p=0·61), and major bleeding (20 [5%] vs 22 [5%]; p=0·79) did not differ between groups. Enoxaparin resulted in a significantly reduced rate of the main secondary endpoint (30 [7%] vs 52 [11%] patients; RR 0·59, 95% CI 0·38-0·91, p=0·015). Death, complication of myocardial infarction, or major bleeding (46 [10%] vs 69 [15%] patients; p=0·03), death or complication of myocardial infarction (35 [8%] vs 57 [12%]; p=0·02), and death, recurrent myocardial infarction, or urgent revascularisation (23 [5%] vs 39 [8%]; p=0·04) were all reduced with enoxaparin. INTERPRETATION: Intravenous enoxaparin compared with unfractionated heparin significantly reduced clinical ischaemic outcomes without differences in bleeding and procedural success. Therefore, enoxaparin provided an improvement in net clinical benefit in patients undergoing primary PCI. FUNDING: Direction de la Recherche Clinique, Assistance Publique-Hôpitaux de Paris; Sanofi-Aventis.


Assuntos
Angioplastia Coronária com Balão , Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Fibrinolíticos/administração & dosagem , Heparina/administração & dosagem , Infarto do Miocárdio/terapia , Idoso , Eletrocardiografia , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Inibidores da Agregação de Plaquetas/uso terapêutico , Recidiva
16.
Presse Med ; 40(6): 615-24, 2011 Jun.
Artigo em Francês | MEDLINE | ID: mdl-21511430

RESUMO

Thienopyridines have become the cornerstone of treatment of percutaneous coronary intervention although no survival benefit has ever been shown with clopidogrel despite increasing loading doses. Newly developed P2Y(12) inhibitors are more potent, more predictable and have a faster onset of action than clopidogrel, characteristics that make them particularly attractive for high-risk PCI. Four new P2Y(12) inhibitors have been tested each of them having particular individual properties. Prasugrel is an oral prodrug leading to irreversible blockade of the P2Y(12) receptor and is approved worldwide for ACS PCI. Ticagrelor is a direct-acting and reversible inhibitor of the P2Y(12) receptor with potentially more pleiotropic effects. Cangrelor is an intravenous direct and reversible inhibitor of the P2Y(12) receptor providing the highest level of inhibition and elinogrel is an intravenous and oral P2Y(12) antagonist with a direct and reversible action. Both prasugrel and ticagrelor, opposed to clopidogrel, have shown that stronger P2Y(12) inhibition led respectively to significant 19 % and 16 % relative risk reduction of a similar primary endpoint combining cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Both drugs showed a significant 0.6 % absolute excess of TIMI major bleeding not related to CABG surgery. The effect of these new compounds is prompt, predictable and powerful as compared to clopidogrel. Their net benefit is particularly marked in PCI for STEMI patients, in which there is no significant increase in major bleeding when compared with clopidogrel. However, because in clinical trials patients perceived to be at higher risk for bleeding usually are excluded, the risk of major and even fatal bleeding might even be higher in a "real-world" setting i.e. in the elderly patient with comorbidities.


Assuntos
Monofosfato de Adenosina/análogos & derivados , Adenosina/análogos & derivados , Gerenciamento Clínico , Infarto do Miocárdio/tratamento farmacológico , Reperfusão Miocárdica/métodos , Piperazinas/uso terapêutico , Inibidores da Agregação de Plaquetas/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Tiofenos/uso terapêutico , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Adenosina/farmacologia , Adenosina/uso terapêutico , Monofosfato de Adenosina/administração & dosagem , Monofosfato de Adenosina/efeitos adversos , Monofosfato de Adenosina/farmacologia , Monofosfato de Adenosina/uso terapêutico , Administração Oral , Ensaios Clínicos como Assunto , Clopidogrel , Terapia Combinada , Resistência a Medicamentos , Fibrinolíticos/administração & dosagem , Fibrinolíticos/farmacologia , Fibrinolíticos/uso terapêutico , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Injeções Intravenosas , Estudos Multicêntricos como Assunto , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Revascularização Miocárdica , Piperazinas/administração & dosagem , Piperazinas/efeitos adversos , Piperazinas/farmacologia , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Inibidores da Agregação de Plaquetas/farmacologia , Cloridrato de Prasugrel , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/farmacologia , Receptores Purinérgicos P2Y12/efeitos dos fármacos , Tiofenos/administração & dosagem , Tiofenos/efeitos adversos , Tiofenos/farmacologia , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico , Fatores de Tempo
17.
Am Heart J ; 160(4): 642-8, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20934557

RESUMO

BACKGROUND: Aldosterone is at its highest levels at presentation for acute myocardial infarction (AMI). High aldosterone levels are predictive of poor outcome regardless of heart failure. Angiotensin-converting enzyme inhibitors have delayed partial and temporary effects on aldosterone levels. We hypothesize that aldosterone receptor blockade, early after AMI onset on top of standard therapy, may improve clinical outcome. STUDY DESIGN: ALBATROSS is a nationwide, multicenter, open-labeled, randomized trial designed to assess the superiority of aldosterone blockade by a 200-mg intravenous bolus of potassium canrenoate followed by a daily 25-mg dose of spirinolactone for 6 months, on top of standard therapy compared to standard therapy alone among 1,600 patients admitted for ST-segment elevation or high risk non-ST-segment elevation acute AMI -TIMI score ≥3-within 72 hours after symptom onset regardless of heart failure and treatment strategy. The primary efficacy end point of the study is the 6-month rate of the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, class IA American College of Cardiology/American Heart Association/European Society of Cardiology indication for implantable cardioverter device, and new or worsening heart failure. Secondary end points include each of the components of the primary end point, different combinations of such components, the primary end point assessed at hospital discharge and 30-day follow-up, and rates of acute renal failure. Safety end points include rates of hyperkalemia and premature drug discontinuation. CONCLUSIONS: ALBATROSS will assess the cardiovascular benefit of a low-cost aldosterone receptor blocker on top of standard therapy in all-coming AMI patients.


Assuntos
Aldosterona/sangue , Ácido Canrenoico/administração & dosagem , Antagonistas de Receptores de Mineralocorticoides/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Idoso , Relação Dose-Resposta a Droga , Eletrocardiografia/efeitos dos fármacos , Feminino , Seguimentos , Humanos , Infusões Intravenosas , Masculino , Infarto do Miocárdio/sangue , Infarto do Miocárdio/fisiopatologia , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 3(2): 203-12, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20170878

RESUMO

OBJECTIVES: The aim of this study was to assess the risk-benefit of enoxaparin (Sanofi-Aventis, Paris, France) in primary percutaneous coronary intervention (PCI). BACKGROUND: Randomized studies have demonstrated the superiority of enoxaparin over unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytics. METHODS: In the FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) trial--a double-blind, placebo-controlled study-2,452 patients with STEMI were randomized to primary PCI or facilitated PCI with abciximab alone or with half-dose reteplase. In this prospective FINESSE substudy, centers pre-specified use of either enoxaparin (0.5 mg/kg intravenous [IV], 0.3 mg/kg subcutaneous [SC]) or UFH (40 U/kg IV, 3,000 U maximum) with PCI. A logistic-regression model and a propensity multivariate model, both adjusted for baseline variables, were used to evaluate primary safety and secondary efficacy end points for enoxaparin versus UFH. RESULTS: Enoxaparin was administered to 759 patients and UFH to 1,693 patients. Nonintracranial Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding was not significantly different, but lower nonintracranial TIMI major bleeding was found with enoxaparin (2.6% vs. UFH 4.4%, logistic-regression adjusted odds ratio [OR]: 0.55; 95% confidence interval [CI]: 0.31 to 0.99, p = 0.045), whereas intracranial hemorrhage was similar (0.27% vs. 0.24%, adjusted OR: 1.03; 95% CI: 0.11 to 9.68, p = 0.980). Lower death, myocardial infarction, urgent revascularization, or refractory ischemia through 30 days was also associated with enoxaparin (5.3%) versus UFH (8.0%, adjusted OR: 0.47, 95% CI: 0.31 to 0.72, p = 0.0005) as was all-cause mortality through 90 days (3.8% vs. 5.6%, respectively, adjusted OR: 0.59, 95% CI: 0.35 to 0.99, p = 0.046). End points evaluating the net clinical benefit also significantly favored enoxaparin over UFH. CONCLUSIONS: Enoxaparin seems to be associated with a lower risk of cardiovascular outcomes compared with UFH in patients with STEMI undergoing primary PCI. Confirmation of these findings in a randomized study is warranted. (A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction [Finesse]; NCT00046228).


Assuntos
Angioplastia Coronária com Balão , Anticoagulantes/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Enoxaparina/uso terapêutico , Heparina/uso terapêutico , Intervalos de Confiança , Doença da Artéria Coronariana/terapia , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Estudos Prospectivos , Fatores de Risco
19.
JACC Cardiovasc Interv ; 2(10): 909-16, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19850248

RESUMO

OBJECTIVES: The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. BACKGROUND: Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of "facilitated" PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups. METHODS: A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point. RESULTS: One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure <100 mm Hg, prior MI, age, Killip class >1, anterior MI, body mass index < or =25 kg/m(2), heart rate >100 beats/min, and no statin use. CONCLUSIONS: These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228).


Assuntos
Angioplastia Coronária com Balão , Anticorpos Monoclonais/uso terapêutico , Fibrinolíticos/uso terapêutico , Acesso aos Serviços de Saúde , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Infarto do Miocárdio/terapia , Inibidores da Agregação de Plaquetas/uso terapêutico , Terapia Trombolítica , Ativador de Plasminogênio Tecidual/uso terapêutico , Abciximab , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Anticorpos Monoclonais/efeitos adversos , Terapia Combinada , Método Duplo-Cego , Feminino , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Fragmentos Fab das Imunoglobulinas/efeitos adversos , Masculino , Infarto do Miocárdio/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Modelos de Riscos Proporcionais , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Medição de Risco , Fatores de Risco , Análise de Sobrevida , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/mortalidade , Fatores de Tempo , Ativador de Plasminogênio Tecidual/efeitos adversos , Resultado do Tratamento
20.
N Engl J Med ; 359(1): 21-30, 2008 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-18596271

RESUMO

BACKGROUND: During the administration of advanced cardiac life support for resuscitation from cardiac arrest, a combination of vasopressin and epinephrine may be more effective than epinephrine or vasopressin alone, but evidence is insufficient to make clinical recommendations. METHODS: In a multicenter study, we randomly assigned adults with out-of-hospital cardiac arrest to receive successive injections of either 1 mg of epinephrine and 40 IU of vasopressin or 1 mg of epinephrine and saline placebo, followed by administration of the same combination of study drugs if spontaneous circulation was not restored and subsequently by additional epinephrine if needed. The primary end point was survival to hospital admission; the secondary end points were return of spontaneous circulation, survival to hospital discharge, good neurologic recovery, and 1-year survival. RESULTS: A total of 1442 patients were assigned to receive a combination of epinephrine and vasopressin, and 1452 to receive epinephrine alone. The treatment groups had similar baseline characteristics except that there were more men in the group receiving combination therapy than in the group receiving epinephrine alone (P=0.03). There were no significant differences between the combination-therapy and the epinephrine-only groups in survival to hospital admission (20.7% vs. 21.3%; relative risk of death, 1.01; 95% confidence interval [CI], 0.97 to 1.05), return of spontaneous circulation (28.6% vs. 29.5%; relative risk, 1.01; 95% CI, 0.97 to 1.06), survival to hospital discharge (1.7% vs. 2.3%; relative risk, 1.01; 95% CI, 1.00 to 1.02), 1-year survival (1.3% vs. 2.1%; relative risk, 1.01; 95% CI, 1.00 to 1.02), or good neurologic recovery at hospital discharge (37.5% vs. 51.5%; relative risk, 1.29; 95% CI, 0.81 to 2.06). CONCLUSIONS: As compared with epinephrine alone, the combination of vasopressin and epinephrine during advanced cardiac life support for out-of-hospital cardiac arrest does not improve outcome. (ClinicalTrials.gov number, NCT00127907.)


Assuntos
Reanimação Cardiopulmonar/métodos , Epinefrina/uso terapêutico , Parada Cardíaca/tratamento farmacológico , Vasoconstritores/uso terapêutico , Vasopressinas/uso terapêutico , Adulto , Idoso , Quimioterapia Combinada , Serviços Médicos de Emergência/organização & administração , Feminino , Seguimentos , França , Parada Cardíaca/mortalidade , Parada Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Análise de Sobrevida , Resultado do Tratamento
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