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BACKGROUND: Clinical trials have assessed the effect of direct oral antagonists (DOACs) in patients with atrial fibrillation (AF) after percutaneous coronary interventions (PCI). Studies were designed to test the effect on bleeding incidence, but concerns related to safety on ischemic events remain. METHODS: We performed a meta-analysis with currently available studies involving DOACs versus Vitamin-K antagonist (VKA) in patients with AF after PCI. The primary endpoint was the incidence of cardiac ischemic events, including myocardial infarction and stent thrombosis. Secondary endpoints were the incidence of stroke, all-cause mortality, and major bleeding. RESULTS: Eleven thousand twenty-three patients were included in the analysis: 5510 receiving DOACs and 5513 VKA. A total of 190 cases of myocardial infarction were registered in patients treated with DOACs and 177 in patients on VKA, and no statistical difference was noted [relative risk (RR): 1.07 95% confidence interval (CI) 0.88-1.31]. The incidence of stent thrombosis was very low with no differences between both treatment strategies (RR: 1.14 95% CI 0.76-1.71). The incidence of cardiac ischemic events was the same in patients receiving DOACs or VKA (HR 1.09 95% CI 0.91-1.30). No differences were observed in the incidence of stroke (RR: 0.86 95% CI 0.61-1.23) or mortality (RR: 1.09, 95% CI 0.90-1.31). Treatment with DOACs was associated with 34% reduction in major bleeding (RR: 0.66, 95% CI 0.54-0.81). CONCLUSIONS: Treatment with DOACs in patients with AF after a PCI do not increase the risk of cardiac ischemic events, stroke, or death and reduce the incidence of major bleeding by 34% as compared with VKA.
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Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Isquemia Miocárdica/terapia , Intervenção Coronária Percutânea , Vitamina K/antagonistas & inibidores , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Trombose Coronária/mortalidade , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Incidência , Infarto do Miocárdio/mortalidade , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Medição de Risco , Fatores de Risco , Stents , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. BACKGROUND: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. METHODS: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study. RESULTS: At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred. CONCLUSIONS: The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.
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Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/tratamento farmacológico , Stents Farmacológicos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Intervenção Coronária Percutânea/instrumentação , Polímeros/química , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk. AIMS: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients. METHODS: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy). RESULTS: A total of 1,135 patients were included. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049). CONCLUSIONS: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.
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Apêndice Atrial , Fibrilação Atrial , Fibrinolíticos , Hemorragia , Inibidores da Agregação Plaquetária , Humanos , Apêndice Atrial/cirurgia , Masculino , Feminino , Idoso , Estudos Retrospectivos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Idoso de 80 Anos ou mais , Fibrinolíticos/uso terapêutico , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Resultado do Tratamento , Fatores de Risco , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/etiologia , Medição de Risco , Terapia Antiplaquetária Dupla/métodos , Pessoa de Meia-Idade , Oclusão do Apêndice Atrial EsquerdoRESUMO
BACKGROUND: a significant proportion of octogenarian patients with atrial fibrillation (AF) undergo percutaneous coronary intervention (PCI) with stenting. Dual antiplatelet therapy is recommended in these patients, requiring a period of triple therapy with dual antiplatelet agent plus oral anticoagulation (OAC). Concerns remain regarding the appropriateness of OAC in octogenarians. METHODS: we reviewed 604 patients (15.7% ≥80 years) with AF undergoing PCI. Clinical follow-up was performed, recording any bleeding episode, thrombo-embolism and major adverse cardiac events (MACE = death, acute myocardial infarction and/or revascularisation of target lesion). We compared octogenarian patients in relation to treatment with OAC at discharge. A secondary aim was to compare octogenarian patients with non-octogenarian patients in terms of their clinical and demographic characteristics, management and clinical outcome. RESULTS: among the 604 patients, 95(15.7%) were aged ≥80 years. Octogenarians had a higher median CHADS2 score (2.78 versus 2.01; P < 0.001) and HAS-BLED score (3.05 versus 2.84; P = 0.028). After a follow-up of 17 ± 14 months, all-cause death occurred in 33%, MACE in 44%, and major bleeding in 21%. OAC was associated with less MACE (28.9 versus 58.3%; P = 0.012) and a similar rate of major bleeding. On multivariable analysis, non-use of OAC at discharge was associated with increased MACE (OR = 4.3; 95% CI = 1.3-14.6; P = 0.02). CONCLUSION: octogenarian AF patients undergoing PCI/stenting have a high mortality rate and MACE, which can be reduced by means of OAC therapy.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Stents/efeitos adversos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/mortalidade , Intervenção Coronária Percutânea/reabilitação , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
IMPORTANCE: The optimal anticoagulant for patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. OBJECTIVE: To compare the clinical efficacy and safety of otamixaban, a novel intravenous direct factor Xa inhibitor, with that of unfractionated heparin plus downstream eptifibatide in patients with NSTE-ACS undergoing a planned early invasive strategy. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, active-controlled superiority trial that enrolled 13,229 patients with NSTE-ACS and a planned early invasive strategy, at 568 active sites in 55 countries and conducted between April 2010 and February 2013. A planned interim analysis was conducted for otamixaban dose selection. INTERVENTIONS: Eligible participants were randomized to otamixaban (bolus and infusion, at 1 of 2 doses) or unfractionated heparin plus, at the time of percutaneous coronary intervention, eptifibatide. The otamixaban dose selected at interim analysis was an intravenous bolus of 0.080 mg/kg followed by an infusion of 0.140 mg/kg per hour. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. RESULTS: Rates of the primary efficacy outcome were 5.5% (279 of 5105 patients) randomized to receive otamixaban and 5.7% (310 of 5466 patients) randomized to receive unfractionated heparin plus eptifibatide (adjusted relative risk, 0.99 [95% CI, 0.85-1.16]; P = .93). There were no differences for the secondary end points, including procedural thrombotic complications. The primary safety outcome of Thrombosis in Myocardial Infarction major or minor bleeding through day 7 was increased by otamixaban (3.1% vs 1.5%; relative risk, 2.13 [95% CI, 1.63-2.78]; P < .001). Results were consistent across prespecified subgroups. CONCLUSIONS AND RELEVANCE: Otamixaban did not reduce the rate of ischemic events relative to unfractionated heparin plus eptifibatide but did increase bleeding. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01076764.
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Síndrome Coronariana Aguda/tratamento farmacológico , Anticoagulantes/uso terapêutico , Óxidos N-Cíclicos/uso terapêutico , Inibidores do Fator Xa , Hemorragia/induzido quimicamente , Heparina/uso terapêutico , Peptídeos/uso terapêutico , Piridinas/uso terapêutico , Síndrome Coronariana Aguda/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Causas de Morte , Óxidos N-Cíclicos/efeitos adversos , Método Duplo-Cego , Eptifibatida , Feminino , Humanos , Infusões Intravenosas , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Piridinas/efeitos adversos , Risco , Análise de Sobrevida , Resultado do TratamentoRESUMO
The introduction of high-sensitivity troponin (hsTn) assays has reduced the diagnosis of unstable angina (UA) in favor of non-ST elevation myocardial infarction (NSTEMI) in the context of non-ST elevation acute coronary syndrome (NSTEACS). It is unclear whether the detection of these hsTn levels affects the prognosis and therefore whether a different therapeutic approach is warranted. This study aims to determine whether using hsTn results in medium-term prognostic differences in patients with UA and NSTEMI. Methods: This multicenter, prospective registry study included consecutive patients who underwent hsTn assays and were discharged with a diagnosis of NSTEACS. Patients were followed for two years. Outcomes were the occurrence of major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke), major bleeding, and all-cause mortality. Results: Patients with UA and NSTEMI did not show differences in terms of the invasive interventions received, the coronary artery disease diagnosed, the type of revascularization performed, or the proportion presenting MACE (UA 18.1% vs. NSTEMI 18.9%; p = 0.79). However, patients with NSTEMI had higher cardiovascular mortality at two years (UA 4% vs. NSTEMI 9.2%; p = 0.012), as well as, all-cause mortality (UA vs. 7.9% vs. NSTEMI 16.4%; p = 0.002). Conclusions: Medium-term incidence of MACE was similar in patients with UA and NSTEMI, but cardiovascular and all-cause mortality in NSTEMI patients was over twice that of patients with UA.
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INTRODUCTION AND OBJECTIVES: There are models for cardiovascular risk prediction in the general population, but the prediction of risk in postmenopausal women has not been specifically studied. This study aimed to determine the association of lifestyle habits and chronic diseases with cardiovascular risk in menopausal women, as well as to build a risk scale. METHODS: Retrospective population-based cohort study using data from the 2011 National Health Survey of Spain as a data source, Women ≥ 50 years were included. The characteristics that best defined the life habits of the study women were collected, as well as their health status and self-reported medical history at the time of the survey. Follow-up data on all-cause mortality were obtained from participants from 2011 to 2017. RESULTS: A total of 5953 women ≥ 50 years of age were included, with a mean age of 66.4 ± 11.4 years. The incidence of cardiovascular mortality in the follow-up period was 4%. Vegetable consumption less than 1 time/week (HR, 1.758), smoking (HR, 1.816) or excess hours of sleep (≥ 9h/day, HR, 1.809), or o have main daily activity sitting most of the time (HR, 2.757) were related to cardiovascular mortality. The predictive model presents an honest C-index in test sample of 0.8407 (95%CI, 0.8025-0.8789). CONCLUSIONS: Life habits such as the consumption of vegetables, daily main activity, sleeping hours or smoking are risk factors for cardiovascular mortality of great relevance among menopausal women. A simple 6-year self-reported risk scale with high predictive capacity is provided.
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Doenças Cardiovasculares , Idoso , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Feminino , Humanos , Estilo de Vida , Menopausa , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.
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Few studies have addressed to date the interaction between sex and diabetes mellitus (DM) in the prognosis of elderly patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). Our aim was to address the role of DM in the prognosis of non-selected elderly patients with NSTEACS according to sex. A retrospective analysis from 11 Spanish NSTEACS registries was conducted, including patients aged ≥70 years. The primary end point was one-year all-cause mortality. A total of 7211 patients were included, 2,770 (38.4%) were women, and 39.9% had DM. Compared with the men, the women were older (79.95 ± 5.75 vs. 78.45 ± 5.43 years, p < 0.001) and more often had a history of hypertension (77% vs. 83.1%, p < 0.01). Anemia and chronic kidney disease were both more common in women. On the other hand, they less frequently had a prior history of arteriosclerotic cardiovascular disease or comorbidities such as peripheral artery disease and chronic pulmonary disease. Women showed a worse clinical profile on admission, though an invasive approach and in-hospital revascularization were both more often performed in men (p < 0.001). At a one-year follow-up, 1090 patients (15%) had died, without a difference between sexes. Male sex was an independent predictor of mortality (HR = 1.15, 95% CI 1.01 to 1.32, p = 0.035), and there was a significant interaction between sex and DM (p = 0.002). DM was strongly associated with mortality in women (HR: 1.45, 95% CI = 1.18-1.78; p < 0.001), but not in men (HR: 0.98, 95% CI = 0.84-1.14; p = 0.787). In conclusion, DM is associated with mortality in older women with NSTEACS, but not in men.
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INTRODUCTION AND OBJECTIVES: To evaluate the interaction between comorbidity burden and the benefits of in-hospital revascularization in elderly patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). METHODS: This retrospective study included 7211 patients aged ≥ 70 years from 11 Spanish NSTEACS registries. Six comorbidities were evaluated: diabetes, peripheral artery disease, cerebrovascular disease, chronic pulmonary disease, renal failure, and anemia. A propensity score was estimated to enable an adjusted comparison of in-hospital revascularization and conservative management. The end point was 1-year all-cause mortality. RESULTS: In total, 1090 patients (15%) died. The in-hospital revascularization rate was 60%. Revascularization was associated with lower 1-year mortality; the strength of the association was unchanged by the addition of comorbidities to the model (HR, 0.61; 95%CI, 0.53-0.69; P=.0001). However, the effects of revascularization were attenuated in patients with renal failure, peripheral artery disease, and chronic pulmonary disease (P for interaction=.004, .007, and .03, respectively) but were not modified by diabetes, anemia, and previous stroke (P=.74, .51, and .28, respectively). Revascularization benefits gradually decreased as the number of comorbidities increased (from a HR of 0.48 [95%CI, 0.39-0.61] with 0 comorbidities to 0.83 [95%CI, 0.62-1.12] with ≥ 5 comorbidities; omnibus P=.016). The results were similar for the propensity score model. The same findings were obtained when invasive management was considered the exposure variable. CONCLUSIONS: In-hospital revascularization improves 1-year mortality regardless of comorbidities in elderly patients with NSTEACS. However, the revascularization benefit is progressively reduced with an increased comorbidity burden. Renal failure, peripheral artery disease, and chronic lung disease were the comorbidities with the most detrimental effects on revascularization benefits.
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Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/cirurgia , Idoso , Comorbidade , Humanos , Pontuação de Propensão , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: Drug-eluting stents (DES) have never been sufficiently studied in patients with atrial fibrillation (AF). The latter are considered as a high-risk population with uncertainty over the optimal antithrombotic therapy strategy to prevent stroke, stent thrombosis, and recurrent cardiac ischaemia, balanced against the high risk of haemorrhage. The aim of this study was to evaluate the safety and efficacy of the use of DES vs. bare-metal stents (BMS) in a cohort of patients with AF. METHODS AND RESULTS: We reviewed 604 patients with AF who had undergone percutaneous coronary intervention with stent over a period of 7 years (January 2001-January 2008). After a propensity score selection, we identified two matched cohorts who received DES (n = 207) or BMS (n = 207). Clinical follow-up was performed, and all bleeding episodes, thrombo-embolism, and major adverse cardiac events (MACE; i.e. death, acute myocardial infarction, target vessel failure) were recorded. Complete follow-up was achieved in 95.9% of the cohort (mean: 693 +/- 427 days, median: 564). The incidence density of MACE as well as the incidence of all-cause mortality in both groups was similar. There was a higher incidence of major bleeding in DES group (2.26 vs. 1.19 per 10 000 days of exposure; P = 0.03). In a multivariate analysis, age, chronic AF, chronic renal failure, and non-use of dicoumarin were predictors of MACE and of all-cause mortality. The use of DES was not a predictor of reduced events. CONCLUSION: On the basis of this study, the routine use of DES in patients with AF does not seem to be justified. A higher risk of major bleeding with DES in comparison with BMS raises the possibility that DES should be limited to lesions or patients with a high risk of restenosis.
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Fibrilação Atrial/terapia , Stents Farmacológicos , Idoso , Angioplastia Coronária com Balão , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Reestenose Coronária/prevenção & controle , Estenose Coronária/terapia , Feminino , Seguimentos , Hemorragia/etiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Fatores de Risco , Trombose/etiologia , Resultado do TratamentoRESUMO
OBJECTIVE: A systematic review and meta-analysis was performed to evaluate the safety and efficacy of drug-eluting stents (DES) vs bare-metal stents (BMS) in atrial fibrillation (AF) patients. METHODS: We systematically searched 5 engines until May 2019 for cohort studies and randomized controlled trials (RCTs). Primary outcomes were major bleeding and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target vessel revascularization (TVR) or stent thrombosis. Effects of inverse variance random meta-analyses were described with relative risks (RR) and their 95% confidence intervals (CI). We also stratified analyses by type (triple [TAT] vs dual [DAT]) and duration (short-vs long-term) of antithrombotic therapy. RESULTS: Ten studies (3 RCTs; 7 cohorts) including 10,353 patients (DES: 59.6%) were identified. DES did not show higher risk of major bleeding than BMS (5.6% vs 6.9%, RR 1.07; 95%CI, 0.89-1.28, p = 0.47; I2 = 0%) or MACE (12% vs 13.6%; RR 0.96; 95%CI 0.81-1.13, p = 0.60; I2 = 44%). Although, DES almost decreased TVR risk (6.4% vs 8.4%, RR 0.78; 95%CI, 0.61-1.01, p = 0.06; I2 = 15%). Stratified analyses by type and duration of antithrombotic therapy showed no differences in major bleeding or MACE between both types of stents. In DES, long-term TAT showed higher major bleeding risk than long-term DAT (7.7% vs 4.7%, RR 1.48, 95%CI 1.08-2.03, p = 0.01; I2 = 12%). For both types of stents, MACE risk was similar between TAT and DAT. CONCLUSIONS: In patients with AF undergoing PCI, DES had similar rate of major bleeding and MACE than BMS. DAT seems to be a safer antithrombotic therapy compared with TAT.
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Fibrilação Atrial , Stents Farmacológicos , Intervenção Coronária Percutânea , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Stents Farmacológicos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Risco , Stents/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Anemia is frequent in acute coronary syndrome (ACS) patients and is associated with worse clinical outcomes. We aimed to investigate the therapeutic strategies, the use of novel P2Y12 inhibitors, and the prognostic implication of anemia in a "real world" cohort of ACS patients. METHODS: This is an observational and prospective registry including 1717 ACS patients from three tertiary hospitals. During hospitalization we recorded the clinical management and the antiplatelet therapy at discharge. Patients were divided into 2 groups according to the baseline hemoglobin level, i.e. anemic (hemoglobinâ¯<â¯13â¯g/dL in men and <12â¯g/dL in women) and non-anemic patients. Bleeding events, mortality and major adverse cardiovascular events (MACEs) were recorded during 1-year of follow-up. RESULTS: Anemia was present in 445 (25.9%) patients. Cardiac catheterization (83.8% vs. 94.5%, pâ¯<â¯.001), and revascularization by percutaneous coronary intervention (53.5% vs. 70.5%, pâ¯<â¯.001) were less frequent in these patients. Excluding anticoagulated patients, novel P2Y12 inhibitors were less prescribed in anemic patients (OR 2.80 [95% CI 2.13-3.67], pâ¯<â¯.001). Anemia was independently associated with major bleeding (HR 2.26 [95% CI 1.07-4.78], pâ¯=â¯.033) and all-cause mortality (HR 1.62 [95% CI 1.03-2.56], pâ¯=â¯.038), but not with MACE. At 1-year of follow-up, the risk of mortality in anemic patients taking clopidogrel was higher (HR 2.38 [95% CI 1.01-5.67]; pâ¯=â¯.049). CONCLUSIONS: In this registry involving ACS patients, anemia had influence on clinical management and antiplatelet therapy. Patients suffering from anemia had higher risk for major bleeding and mortality. In particular, anemic patients treated with clopidogrel had even more mortality events.
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Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/mortalidade , Anemia/complicações , Hemorragia/etiologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Hemoglobinas/análise , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Modelos de Riscos Proporcionais , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Espanha/epidemiologiaRESUMO
BACKGROUND AND OBJECTIVE: Dual antiplatelet therapy is one of the main treatments in acute coronary syndrome (ACS). Switching antiplatelet agents may be necessary in some patients to improve efficacy or safety. The objective of this study was to determine the prevalence, predictors, and implications of clinical switching in patients during hospital admission and 1-year follow-up at discharge. METHODS: Observational, prospective, multicenter registry study in patients discharged following an admission for ACS and followed up for 1 year. We analyzed ischemic and bleeding events as well as treatment changes. RESULTS: We recruited 1717 patients; in-hospital switching occurred in 425 (24.8%): 15.1% to clopidogrel and 84.9% to newer antiplatelet drugs (prasugrel or ticagrelor). Those switched to newer antiplatelets were younger, with lower scores on the GRACE and CRUSADE scales, admitted more frequently for ST-elevation myocardial infarction and underwent more invasive management and percutaneous revascularization. The clinical cardiologist was responsible for most in-hospital switching to newer antiplatelets (79.6%). The loading dose of the second antiplatelet did not affect incidence of bleeding events. Post-discharge switching was infrequent (2%) and depended mainly on clinical indications; only 30% was related to a new ACS. CONCLUSIONS: In a contemporary registry with ACS, in-hospital switching of antiplatelet drugs was frequent. Those switched to newer antiplatelets were younger and admitted more frequently for ST-elevation myocardial infarction. Post-discharge switching was infrequent.
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Síndrome Coronariana Aguda/tratamento farmacológico , Clopidogrel/administração & dosagem , Cloridrato de Prasugrel/administração & dosagem , Ticagrelor/administração & dosagem , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Feminino , Hemorragia/epidemiologia , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Prevalência , Prognóstico , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Sistema de Registros , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológicoRESUMO
BACKGROUND: Patients with acute coronary syndrome (ACS) and previous cardiovascular disease (CVD) (stroke, peripheral arterial disease [PAD] or coronary artery disease [CAD]) are at high risk of serious events and mortality. Current clinical guidelines recommend new antiplatelet drugs (NADs) for high cardiovascular risk patients with ACS; however, these drugs are underused in different scenarios. METHODS: This study included 1717 ACS patients from 3 tertiary hospitals. Of them, 641 (37.33%) suffered from previous CVD: 149 patients with stroke, 154 patients with PAD and 541 patients with CAD. Bleeding, mortality and major adverse cardiac events (MACE) at 1 year of follow-up after hospital discharge were analyzed. RESULTS: NADs administration during hospital stay and at discharge was less frequent in patients with previous CVDs (P<0.001, for both). Cox analysis in this cohort of patients showed that clopidogrel prescription at discharge was independently associated with MACEs (HR: 1.59 [95% CI: 1.03-2.45]; P=0.036) and with death (HR: 1.99 [95% CI: 1.00-3.98]; P=0.049) in multivariate analysis. More specifically, when ticagrelor prescription at discharge was compared with clopidogrel, a significant death reduction was found in both, the univariate and the multivariate Cox analysis (HR: 4.54 [95% CI: 2.26-9.13]; P<0.001 and HR: 2.61 [95% CI: 1.16-5.90]; P=0.021, respectively). CONCLUSIONS: New antiplatelet drugs, especially ticagrelor, showed lower rates of mortality in patients with CVD without differences for bleeding. Despite the recommendations of current clinical guidelines for high risk patients with ACS, the use of NADs is very low in "real-life" patients with previous CVD.
Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Doença das Coronárias/complicações , Doença Arterial Periférica/complicações , Inibidores da Agregação Plaquetária/uso terapêutico , Acidente Vascular Cerebral/complicações , Síndrome Coronariana Aguda/etiologia , Síndrome Coronariana Aguda/mortalidade , Assistência ao Convalescente , Clopidogrel/efeitos adversos , Clopidogrel/uso terapêutico , Comorbidade , Uso de Medicamentos/estatística & dados numéricos , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Síndrome Metabólica/epidemiologia , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/uso terapêutico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fumar/epidemiologia , Espanha , Centros de Atenção Terciária/estatística & dados numéricos , Ticagrelor/efeitos adversos , Ticagrelor/uso terapêuticoRESUMO
INTRODUCTION AND AIMS: Patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) are often managed conservatively. Clinical practice guidelines recommend treating these patients with the same pharmacological drugs as those who receive invasive treatment. We analyze the use of new antiplatelet drugs (NADs) and other recommended treatments in people discharged following an NSTE-ACS according to the treatment strategy used, comparing the medium-term prognosis between groups. METHODS: Prospective observational multicenter registry study in 1717 patients discharged from hospital following an ACS; 1143 patients had experienced an NSTE-ACS. We analyzed groups receiving the following treatment: No cardiac catheterization (NO CATH): n = 134; 11.7%; Cardiac catheterization without revascularization (CATH-NO REVASC): n = 256; 22.4%; percutaneous coronary intervention (PCI): n = 629; 55.0%; and coronary artery bypass graft (CABG): n = 124; 10.8%. We assessed major adverse cardiovascular events (MACE), all-cause mortality, and hemorrhagic complications at one year. RESULTS: NO CATH was the oldest, had the most comorbidities, and was at the highest risk for ischemic and hemorrhagic events. Few patients who were not revascularized with PCI received NADs (NO CATH: 3.7%; CATH-NO REVASC: 10.6%; PCI: 43.2%; CABG: 3.2%; p<0.001). Non-revascularized patients also received fewer beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARB), and statins (p<0.001). At one year, MACE incidence in NO CATH group was three times that of the other groups (30.1%, p<0.001), and all-cause mortality was also much higher (26.3%, p<0.001). There were no significant differences in hemorrhagic events. Belonging to NO CATH group was an independent predictor for MACE at one year in the multivariate analysis (HR 2.72, 95% CI 1.29-5.73; p = 0.008). CONCLUSIONS: Despite current invasive management of NSTE-ACS, patients not receiving catheterization are at very high risk for under treatment with recommended drugs, including NADs. Their medium-term prognosis is poor, with high mortality. Patients treated with PCI receive better pharmacological management, with high use of NADs.
Assuntos
Síndrome Coronariana Aguda/terapia , Tratamento Conservador , Síndrome Coronariana Aguda/epidemiologia , Idoso , Cateterismo Cardíaco , Fármacos Cardiovasculares/uso terapêutico , Comorbidade , Ponte de Artéria Coronária , Feminino , Seguimentos , Humanos , Masculino , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Fatores de Risco , Resultado do TratamentoAssuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Cateterismo Cardíaco , Ecocardiografia Transesofagiana , Humanos , Sistema de Registros , Diálise Renal , Resultado do Tratamento , VarfarinaRESUMO
BACKGROUND: Being overweight increases the risk of cardiovascular diseases and mortality. However, among high-body-weight patients with established acute coronary syndrome (ACS) this evidence is not clear. In this scenario, a low body weight (LBW) has been proposed to confer higher prognostic risk and higher bleeding risk with new P2Y12 inhibitors. AIMS: We aimed to examine differences in mortality, catheterizations/revascularizations, antiplatelet therapy and ischemic/bleeding adverse events between ACS patients with LBW. METHODS: This is a multicenter registry involving 1576 consecutive ACS patients (ST-elevation myocardial infarction (STEMI), non-STEMI, or unstable angina) from three tertiary institutions. Patients were divided into two groups: LBW (weight < 60 kg, n = 176) and non-LBW (weight ⩾ 60 kg, n = 1400). During 12 months follow-up, we recorded management (catheterizations/revascularizations), antiplatelet therapy, major adverse cardiovascular events (MACEs), bleeding events (BARC classification), and mortality. RESULTS: Catheterizations (86.4% vs. 93.4%; p = 0.001) and revascularizations (64.8% vs. 76.1%; p = 0.001) were significantly lower in the LBW group. At discharge, prescription of new P2Y12 inhibitors was also lower in LBW patients (24.4% vs. 37.8%; p = 0.001). After 12-month follow-up, the incidence of MACE (HR 1.61 (95% CI 1.03-2.50]; p = 0.038) and mortality (HR 2.18 (95% CI 1.33-3.58); p = 0.002) was higher in LBW patients compared with non-LBW. In contrast, there were no significant differences for bleeding events. CONCLUSIONS: LBW in ACS patients was associated with higher incidence of MACE and mortality. In this group of patients less catheterizations and coronary revascularizations were performed. Despite there being no differences in bleeding rates, new P2Y12 inhibitors were less prescribed in LBW patients.