RESUMO
OBJECTIVES: The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death. BACKGROUND: Few data exist on the optimal antithrombotic therapy following TAVR. METHODS: This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population. RESULTS: A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR. CONCLUSIONS: This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE Trial [ARTE], NCT01559298; Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI [ARTE], NCT02640794).
Assuntos
Valva Aórtica/cirurgia , Aspirina/administração & dosagem , Valvuloplastia com Balão , Fibrinolíticos/administração & dosagem , Próteses Valvulares Cardíacas , Inibidores da Agregação Plaquetária/administração & dosagem , Trombose/prevenção & controle , Ticlopidina/análogos & derivados , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Valvuloplastia com Balão/efeitos adversos , Canadá , Clopidogrel , Quimioterapia Combinada , Término Precoce de Ensaios Clínicos , Europa (Continente) , Feminino , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Ataque Isquêmico Transitório/etiologia , Ataque Isquêmico Transitório/prevenção & controle , Estimativa de Kaplan-Meier , Masculino , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/efeitos adversos , Desenho de Prótese , Fatores de Risco , América do Sul , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Trombose/diagnóstico , Trombose/etiologia , Trombose/mortalidade , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
BackgroundTwo large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.MethodsThe trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear...
Assuntos
Intervenção Coronária Percutânea , Trombectomia , TromboseRESUMO
Altered functional connectivity has been associated with acute and chronic nicotine use. Connectivity alterations, specifically in the right and left executive control networks (RECN/LECN) and the default mode network (DMN), may contribute to the addiction cycle. The objective of this study was to determine if executive control network (ECN) and DMN connectivity is different between non-smokers and smokers and whether reductions in connectivity are related to chronic cigarette use. The RECN, LECN, and DMN were identified in resting state functional magnetic resonance imaging data in 650 subjects. Analyses tested for group differences in network connectivity strength, controlling for age and alcohol use. There was a significant group effect on LECN and DMN connectivity strength with smokers (n = 452) having lower network strengths than non-smokers (n = 198). Smokers had lower connectivity than non-smokers associated with key network hubs: the dorsolateral prefrontal cortex, and parietal nodes within ECNs. Further, ECN connectivity strength was negatively associated with pack years of cigarette use. Our data suggest that chronic nicotine use negatively impacts functional connectivity within control networks that may contribute to the difficulty smokers have in quitting.
Assuntos
Mapeamento Encefálico/métodos , Função Executiva/fisiologia , Rede Nervosa/fisiopatologia , Lobo Parietal/fisiopatologia , Córtex Pré-Frontal/fisiopatologia , Fumar/fisiopatologia , Adulto , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Fumar/efeitos adversosRESUMO
Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation
myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with
thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical
trials have shown mixed results regarding thrombectomy.
Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during
PPCI compared with percutaneous coronary intervention alone in patients with STEMI.
Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes.
Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export
catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is
the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York
Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients.
Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically