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1.
J Stroke Cerebrovasc Dis ; 29(4): 104632, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32037269

RESUMO

AIMS: The REDUCE study demonstrated a reduction in the risk of recurrent stroke with patent foramen ovale closure and antiplatelet therapy compared to antiplatelet therapy alone. The clinicians were allowed to choose among aspirin, clopidogrel, or aspirin/dipyridamole with the expectation that all antiplatelet therapies would have similar efficacy in this population. We tested that presumption by comparing recurrent stroke rates among antiplatelet agents within the control arm of the trial. METHODS: We evaluated patients in REDUCE study who were randomized to the medical arm. The primary endpoint for this analysis was freedom from clinical ischemic stroke through at least 2 years of follow-up, to a maximum of 5 years. In the primary analysis, antiplatelet treatment was defined as the agent during the week prior to a recurrent stroke or last known contact. RESULTS: Of 223 patients in the medical treatment arm, the initial agent was aspirin 52%, clopidogrel 30%, and aspirin/dipyridamole 12%. Patients treated with aspirin were similar to those treated with alternatives, but were more likely to be enrolled in the United States. The last reported agent was aspirin alone in 55%, clopidogrel alone in 31%, aspirin/dipyridamole in 7%, and other/nothing/missing in 7%. Recurrent stroke rates were similar for all 3 antiplatelet regimens in unadjusted and adjusted analyses, with no overall difference among agents (P= .17). CONCLUSIONS: Among patients with patent foramen ovale-associated stroke who were managed medically, there were no differences among antiplatelet agents in the risk of recurrent stroke, though confidence intervals were wide.


Assuntos
Aspirina/uso terapêutico , Clopidogrel/administração & dosagem , Dipiridamol/administração & dosagem , Forame Oval Patente/tratamento farmacológico , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Aspirina/efeitos adversos , Clopidogrel/efeitos adversos , Dipiridamol/efeitos adversos , Quimioterapia Combinada , Feminino , Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Intervalo Livre de Progressão , Estudos Prospectivos , Recidiva , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Adulto Jovem
2.
Stroke ; 50(11): 3135-3140, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31547797

RESUMO

Background and Purpose- It is unclear whether treatment with anticoagulants or antiplatelets is the optimal strategy in patients with stroke or transient ischemic attack of undetermined cause and patent foramen ovale that is not percutaneously closed. We aimed to perform a systematic review and meta-analysis of randomized controlled trials to compare anticoagulant or antiplatelet treatment in this population. Methods- We searched PubMed until July 16, 2019 for trials comparing anticoagulants and antiplatelet treatment in patients with stroke/transient ischemic attack and medically treated patent foramen ovale using the terms: "cryptogenic or embolic stroke of undetermined source" and "stroke or cerebrovascular accident or transient ischemic attack" and "patent foramen ovale or patent foramen ovale or paradoxical embolism" and "trial or study" and "antithrombotic or anticoagulant or antiplatelet." The outcomes assessed were stroke recurrence, major bleeding, and the composite end point of stroke recurrence or major bleeding. We used 3 random-effects models: (1) a reference model based on the inverse variance method with the Sidik and Jonkman heterogeneity estimator; (2) a strict model, implementing the Hartung and Knapp method; and (3) a commonly used Bayesian model with a prior that assumes moderate to large between-study variance. Results- Among 112 articles identified in the literature search, 5 randomized controlled trials were included in the meta-analysis (1720 patients, mean follow-up 2.3±0.5 years). Stroke recurrence occurred at a rate of 1.73 per 100 patient-years in anticoagulant-assigned patients and 2.39 in antiplatelet-assigned patients (hazard ratio, 0.68; 95% CI, 0.32-1.48 for the Sidik and Jonkman estimator). Major bleeding occurred at a rate of 1.16 per 100 patient-years in anticoagulant-assigned patients and 0.68 in antiplatelet-assigned patients (hazard ratio, 1.61; 95% CI, 0.72-3.59 for the Sidik and Jonkman estimator). The composite outcome occurred in 52 anticoagulant-assigned and 54 antiplatelet-assigned patients (odds ratio, 1.05; 95% CI, 0.65-1.70 for the Sidik and Jonkman estimator). Conclusions- We cannot exclude a large reduction of stroke recurrence in anticoagulant-assigned patients compared with antiplatelet-assigned, without significant differences in major bleeding. An adequately powered randomized controlled trial of a non-vitamin K antagonist versus aspirin is warranted.


Assuntos
Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Fibrinolíticos/uso terapêutico , Forame Oval Patente , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Forame Oval Patente/complicações , Forame Oval Patente/tratamento farmacológico , Humanos , Ataque Isquêmico Transitório/tratamento farmacológico , Ataque Isquêmico Transitório/etiologia , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia
4.
J Med Econ ; 22(2): 131-139, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30424680

RESUMO

AIMS: Percutaneous closure of a patent foramen ovale (PFO) is known to lower the risk of recurrent stroke in patients with a cryptogenic stroke. However, the economic implications of transcatheter PFO closure are less well known. From a UK payer perspective, a detailed economic appraisal of PFO closure was performed for prevention of recurrent ischemic stroke in patients with a PFO who had experienced a cryptogenic stroke. MATERIALS AND METHODS: A Markov cohort model was constructed using a 5-year time-horizon with a patient mean age of 45.2 years, reflecting the characteristics reported in the REDUCE trial. Transition probabilities, clinical inputs, costs, and utility values were ascertained from published and national costing sources. Total costs, incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios were calculated, utilizing a discount rate of 3.5%. A range of univariate and probabilistic sensitivity analyses were also performed. RESULTS: When applying a willingness-to-pay (WTP) threshold of £20,000/QALY in accordance with NICE guidelines, PFO closure compared with antiplatelet therapy alone showed a beneficial cost/QALY of £18,584, attained at 4 years. Applying discount rates of 0% and 6% had a negligible effect on the base-case model findings. PFO closure demonstrated a 76.9% probability of being cost-effective at a WTP threshold of £20,000/QALY at a 5-year time-horizon. LIMITATIONS: This model focused specifically on UK stroke patients and typically enrolled young (mean age <65 years old) patients. Hence, caution should be taken when comparing data vs non-UK populations, and it remains unclear how older patients might have affected cost-effectiveness findings, as the risk of paradoxical embolism can persist as patients age. CONCLUSION: Percutaneous closure of a PFO is cost-effective compared with antiplatelet therapy alone, underlining the economic benefits potentially afforded by this treatment in selected patients.


Assuntos
Procedimentos Endovasculares/economia , Procedimentos Endovasculares/métodos , Forame Oval Patente/cirurgia , Acidente Vascular Cerebral/prevenção & controle , Anticoagulantes/administração & dosagem , Anticoagulantes/economia , Análise Custo-Benefício , Feminino , Forame Oval Patente/tratamento farmacológico , Gastos em Saúde , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econométricos , Prevenção Secundária , Acidente Vascular Cerebral/economia , Reino Unido
5.
Lancet Neurol ; 17(12): 1053-1060, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30274772

RESUMO

BACKGROUND: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. METHODS: NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. FINDINGS: Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; pinteraction=0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51-8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69-4·70; pinteraction=0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24-0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity. INTERPRETATION: Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted. FUNDING: Bayer and Janssen.


Assuntos
Aspirina/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Forame Oval Patente/tratamento farmacológico , Inibidores da Agregação de Plaquetas/uso terapêutico , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Idoso , Estudos de Coortes , Método Duplo-Cego , Feminino , Humanos , Cooperação Internacional , MEDLINE/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estatísticas não Paramétricas , Resultado do Tratamento
7.
Int J Cardiol ; 273: 74-79, 2018 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-30119914

RESUMO

BACKGROUND: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. METHODS AND RESULTS: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2-3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329-$642,674). After 55.4 years (95%CI 51.1-60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27-0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02-0.57)). CONCLUSIONS: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.


Assuntos
Análise Custo-Benefício , Forame Oval Patente/economia , Forame Oval Patente/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/cirurgia , Análise Custo-Benefício/métodos , Seguimentos , Forame Oval Patente/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Acidente Vascular Cerebral/tratamento farmacológico , Resultado do Tratamento
8.
Internist (Berl) ; 59(9): 981-992, 2018 09.
Artigo em Alemão | MEDLINE | ID: mdl-29978350

RESUMO

BACKGROUND: Approximately 40-50% of patients with cryptogenic stroke have a patent foramen ovale (PFO). A concomitant atrial septal aneurysm aggravates the risk of recurrent stroke. OBJECTIVE: The most important changes regarding the evidence for interventional closure of a PFO in patients with cryptogenic stroke are described. This includes the prerequisites for making a diagnosis and the indications for interventional treatment. The article also provides an overview about platelet aggregation inhibitor treatment with and without oral anticoagulation. CURRENT DATA: The balance between benefits and risks of interventional versus pharmaceutical treatment in patients with cryptogenic stroke and PFO has so far not been sufficiently proven. In 2017 two prospective randomized trials (CLOSE and REDUCE) and the long-term follow-up results of the RESPECT study were published, followed by the results of the DEFENSE-PFO study in 2018. A better assessment of the weighing up of the treatment options can now be made. All four studies showed that the interventional treatment of PFO is superior to pharmaceutical treatment alone for patients with cryptogenic stroke under 60 years of age. CONCLUSION: There was a significant reduction in the incidence of recurrent stroke in patients with interventional PFO closure compared with pharmaceutical treatment. The complication rate of PFO closure is very low and younger patients (<60 years) in particular benefit from PFO closure.


Assuntos
Forame Oval Patente , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/cirurgia , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
9.
Stroke ; 49(6): 1443-1450, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29720435

RESUMO

BACKGROUND AND PURPOSE: Percutaneous transcatheter closure of patent foramen ovale (PFO closure) plus antiplatelet therapy has been shown to reduce the risk of recurrent stroke compared with medical therapy alone in carefully selected patients after cryptogenic stroke presumed to be from paradoxical embolism. Our objective was to determine the cost-effectiveness of PFO closure after cryptogenic stroke compared with conservative medical management from a US healthcare payer perspective. METHODS: A decision analytic Markov model estimated the 15-year cost and outcomes associated with the additional benefit of PFO closure compared with medical management alone. Model inputs were obtained from published literature, national databases, and a meta-analysis of 5 published randomized clinical trials on PFO closure. Health outcomes were measured in quality-adjusted life years (QALY). Cost-effectiveness used the incremental cost per QALY gained, whereas the net monetary benefit assumed a willingness to pay of $150 000/QALY. One-way and probabilistic sensitivity analyses estimated the uncertainty of model results. RESULTS: At 15 years, PFO closure compared with medical therapy alone improved QALY by 0.33 at a cost saving of $3568, representing an incremental net monetary benefit of $52 761 (95% interval -$8284 to $158 910). When the meta-analysis hazard ratio for stroke was increased to the 95% interval's upper bound of 0.77, one-way sensitivity analyses suggested that PFO closure's cost-effectiveness was $458 558 per additional QALY. Probabilistic sensitivity analysis suggested cost-effectiveness in 90% of simulation runs. CONCLUSIONS: PFO closure for cryptogenic strokes in the right setting is cost-effective, producing benefit in QALYs gained and potential cost savings. However, patient selection remains vitally important as marginal declines in treatment effectiveness can dramatically affect cost-effectiveness.


Assuntos
Análise Custo-Benefício , Forame Oval Patente/tratamento farmacológico , Prevenção Secundária , Acidente Vascular Cerebral/tratamento farmacológico , Cateterismo Cardíaco/economia , Cateterismo Cardíaco/métodos , Forame Oval Patente/complicações , Humanos , Modelos de Riscos Proporcionais , Fatores de Risco , Prevenção Secundária/métodos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
10.
Eur Heart J ; 39(18): 1638-1649, 2018 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-29590333

RESUMO

Aims: The efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO. Methods and results: We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). Five studies (3440 patients) were included. In all, 1829 patients were randomized to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke [hazard ratio (HR) 0.32, 95% confidence interval (95% CI) 0.13-0.82; P = 0.018, I2 = 73.4%]. The risk of AF was significantly increased with device closure [risk ratio (RR) 4.68, 95% CI 2.19-10.00, P<0.001, heterogeneity I2 = 27.5%)]. In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16-0.72; P = 0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50-1.60; P = 0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (P = 0.994). Conclusion: In selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.


Assuntos
Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/cirurgia , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Forame Oval Patente/complicações , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
11.
J Neurol ; 265(6): 1259-1268, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29383514

RESUMO

OBJECTIVE: This systematic review and meta-analysis was performed to investigate the efficacy and safety of transcatheter device closure (TDC) plus anti-thrombotic drugs over medical management alone for patients with cryptogenic stroke and patent foramen oval. METHODS: PubMed, Embase and Cochrane Library database were searched for randomized controlled clinical trials (RCTs). The primary endpoint is the composite of stroke and transient ischemic attack. The secondary endpoints are all-cause mortality, total serious adverse events, atrial fibrillation and bleeding. RESULTS: Five RCTs with a total of 3440 participants were included. TDC significantly decreased the risk of primary endpoint when compared to medical therapy alone (RR 0.54, 95% CI 0.43-0.69). Further subgroup analyses showed that patients with male gender and with substantial shunt size of foramen ovale significantly benefited from TDC as compared to those with female gender and with no substantial shunt size of foramen oval separately. Moreover, TDC was superior to medical therapy with anti-platelet drug alone (not with anti-coagulation). On the other hand, the incidence of atrial fibrillation was higher in TDC group (RR 4.49, 95% CI 2.02-9.97), with the risk of other adverse events equivalent between the two groups. CONCLUSIONS: TDC plus anti-thrombotic drugs is superior than medical therapy alone for secondary prevention of stroke, especially for those with male gender and with substantial shunt size of foramen ovale. Though it may increase the risk of postoperative atrial fibrillation, it would not bring higher risk of all-cause mortality, total adverse events and bleeding.


Assuntos
Fibrinolíticos/uso terapêutico , Forame Oval Patente/complicações , Forame Oval Patente/cirurgia , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/tratamento farmacológico , Forame Oval Patente/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção Secundária , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/cirurgia
13.
J Stroke Cerebrovasc Dis ; 27(6): e92-e94, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29373226

RESUMO

A 51-year-old man was diagnosed with eosinophilic granulomatosis with polyangiitis 6 years ago due to asthma, sinusitis, hypereosinophilia, and peripheral neuropathy based on the diagnostic criteria of American College of Rheumatology, and corticosteroid therapy achieved a remission. One year ago, he was hospitalized due to deep venous thrombosis (DVT) and pulmonary embolism, and rivaroxaban was administrated. He was admitted to our hospital for acute onset of diplopia and right hemiparesis. Peripheral blood examinations disclosed leukocytosis with hypereosinophilia. Perinuclear anti-neutrophil cytoplasmic antibodies were positive. Diffusion-weighted imaging showed multiple fresh ischemic lesions. Chronic ischemic lesions were seen in subcortical cerebral region. No stenosis or occlusion was shown in extracranial and intracranial arteries on magnetic resonance angiography. Ultrasonography of leg vein showed DVT. Right-to-left shunt through patent foramen ovale after Valsalva maneuver was seen on transesophageal echocardiography. Treatment with corticosteroid and cyclophosphamide alleviated clinical deterioration. Rivaroxaban was changed to warfarin. Diplopia and muscle strength of right limbs were improved. This is a first case of multiple cerebral infarction caused by paradoxical embolism due to patent foramen ovale with DVT based on hypercoagulable state of hypereosinophilia. Overall this case illustrates that eosinophilic granulomatosis with polyangiitis can be a risk factor for multiple cerebral infarction in the systemic phase and that transesophageal echocardiography and ultrasonography of leg vein should be conducted in stroke patient with eosinophilic granulomatosis with polyangiitis.


Assuntos
Infarto Cerebral/etiologia , Embolia Paradoxal/complicações , Forame Oval Patente/complicações , Granulomatose com Poliangiite/complicações , Encéfalo/diagnóstico por imagem , Infarto Cerebral/sangue , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/tratamento farmacológico , Embolia Paradoxal/sangue , Embolia Paradoxal/diagnóstico por imagem , Embolia Paradoxal/tratamento farmacológico , Forame Oval Patente/sangue , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/tratamento farmacológico , Granulomatose com Poliangiite/sangue , Granulomatose com Poliangiite/diagnóstico por imagem , Granulomatose com Poliangiite/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade
14.
Am J Cardiol ; 121(5): 649-655, 2018 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-29306484

RESUMO

New evidence suggests that closure of a patent foramen ovale (PFO) plus medical therapy (MT; antiplatelet or anticoagulation) is superior to MT alone to prevent recurrent cryptogenic stroke. We performed a meta-analysis of randomized controlled trials that compared PFO closure plus MT with MT alone in patients with cryptogenic stroke. The efficacy end points were recurrent stroke, transient ischemia attack, and death. The safety end points were major bleeding and newly detected atrial fibrillation. Trials were pooled using random effects and fixed effects models. A trial sequential analysis was performed to assess if the current evidence is sufficient. Risk ratios (RR) were calculated for pooled estimates of risk. Five randomized controlled trials (3,440 patients) were included. Mean follow-up was 4.1 years. PFO closure reduced the risk of recurrent stroke by 58% (RR 0.42, 95% CI 0.20 to 0.91, p = 0.03). The number needed to treat was 38. The cumulative Z-line crossed the trial sequential boundary, suggesting there is adequate evidence to conclude that PFO closure reduces the risk of recurrent stroke by 60%. PFO closure did not reduce the risk of transient ischemia attack (RR 0.78, 95% CI 0.53 to 1.15, p = 0.21), mortality (RR 0.74, 95% CI 0.35 to 1.60, p = 0.45), or major bleeding (RR 0.96, 95% CI 0.42 to 2.20, p = 0.93); it did increase the risk of atrial fibrillation (RR 4.69, 95% CI 2.17 to 10.12, p <0.0001).


Assuntos
Anticoagulantes/uso terapêutico , Procedimentos Cirúrgicos Cardíacos , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/cirurgia , Inibidores da Agregação de Plaquetas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Humanos , Recidiva
15.
Rev. esp. anestesiol. reanim ; 64(9): 522-527, nov. 2017. tab
Artigo em Espanhol | IBECS | ID: ibc-167092

RESUMO

A pesar de la importancia del manejo hemodinámico en los pacientes sometidos a trasplante hepático, en la actualidad no existe consenso acerca del tipo de monitorización más apropiada a emplear. En este contexto, la ecocardiografía transesofágica puede aportar información muy útil a los profesionales implicados, aunque sus limitaciones impiden que se extienda su uso aún más en la actualidad (AU)


Despite the importance of haemodynamic management in patients undergoing liver transplantation, there is currently no consensus on the most appropriate type of monitoring to use. In this context, transoesophageal echocardiography can provide useful information to professionals, although their use constraints prevent further spread today (AU)


Assuntos
Humanos , Ecocardiografia Transesofagiana/instrumentação , Transplante de Fígado/instrumentação , Hemodinâmica , Cateteres , Análise de Onda de Pulso/instrumentação , Ecocardiografia Transesofagiana , Reperfusão/instrumentação , Forame Oval Patente/complicações , Forame Oval Patente/tratamento farmacológico , Embolia Pulmonar/complicações , Hipertensão Portal/tratamento farmacológico
16.
Med Princ Pract ; 26(5): 491-494, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29035892

RESUMO

OBJECTIVE: To present a case of sudden sensorineural hearing loss (SSNHL) and the related diagnostic workup. CLINICAL PRESENTATION AND INTERVENTION: A 54-year-old man presented with a unilateral SSNHL episode and vertigo. A severe patent foramen ovale (PFO) that included a complete ear nose and throat, audiological, and neurological examination was discovered during the diagnostic workup. Audiometry, blood, and serological tests were performed. Magnetic resonance imaging and color Doppler echography of the supra-aortic trunks and lower limbs were carried out. Finally, transthoracic followed by transesophageal echocardiography and transcranial Doppler were performed in order to confirm the diagnosis of PFO. Medical therapy with systemic steroid and antiplatelet drugs was administered. CONCLUSIONS: This case showed a small PFO associated with an aneurysmatic interatrial septum. The PFO and paradoxical thromboembolism could be involved in the pathogenesis of SSNHL.


Assuntos
Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico por imagem , Perda Auditiva Neurossensorial/diagnóstico , Perda Auditiva Neurossensorial/etiologia , Corticosteroides/uso terapêutico , Ecocardiografia Doppler , Ecocardiografia Transesofagiana , Forame Oval Patente/tratamento farmacológico , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/uso terapêutico
17.
N Engl J Med ; 377(11): 1033-1042, 2017 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-28902580

RESUMO

BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging. RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure. CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).


Assuntos
Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Fibrilação Atrial/etiologia , Terapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Método Simples-Cego , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto Jovem
19.
N Engl J Med ; 377(11): 1011-1021, 2017 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-28902593

RESUMO

BACKGROUND: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).


Assuntos
Anticoagulantes/uso terapêutico , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/etiologia , Terapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Aneurisma Cardíaco/complicações , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto Jovem
20.
N Engl J Med ; 377(11): 1022-1032, 2017 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-28902590

RESUMO

BACKGROUND: Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown. METHODS: In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory. RESULTS: We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group. CONCLUSIONS: Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270 .).


Assuntos
Anticoagulantes/uso terapêutico , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Quimioterapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Forame Oval Patente/mortalidade , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Método Simples-Cego , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Tromboembolia Venosa/etiologia , Adulto Jovem
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