Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 135
Filtrar
1.
Catheter Cardiovasc Interv ; 95(2): 175-184, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31033154

RESUMO

OBJECTIVES: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BACKGROUND: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. METHODS: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. RESULTS: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. CONCLUSIONS: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Estenose Coronária/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Polímeros/química , Sirolimo/administração & dosagem , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Estenose Coronária/fisiopatologia , Europa (Continente) , Everolimo/efeitos adversos , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , República da Coreia , Fatores de Risco , Método Simples-Cego , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
2.
Am J Cardiovasc Drugs ; 19(5): 487-495, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30924021

RESUMO

INTRODUCTION: The goal of this study was to determine the association between the use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) and follow-up heart failure (HF) according to left ventricular ejection fraction (LVEF) in patients with acute myocardial infarction (AMI). METHODS: This cohort study used a retrospective registry of 8169 consecutive patients discharged with a diagnosis of AMI from two university hospitals in Spain between 2010 and 2016. We used a multivariable competing risk analysis, survival-time inverse probability weighting (IPW) propensity score adjusting, and propensity score matching (PSM) to investigate the association between ACEI/ARB treatment and follow-up HF. RESULTS: During the follow-up (3.3 ± 2.2 years), 1296 patients were admitted for HF (5.2 per 100 person-years). ACEI/ARB use was not associated with fewer follow-up HF admissions in patients with LVEF > 40% (univariate analysis: sub-hazard ratio [sHR] 1.10; 95% confidence interval [CI] 0.95-1.27; p = 0.197; IPW adjusting analysis: sHR 1.11; 95% CI 0.95-1.29; p = 0.192; PSM analysis: sHR 1.12; 95% CI 0.92-1.36; p = 0.248). However, ACEI/ARB use was associated with a significant reduction in HF admission rates in patients with LVEF ≤ 40% (univariate analysis: HR 0.70; 95% CI 0.56-0.88; p = 0.003; IPW adjusting analysis: HR 0.64; 95% CI 0.50-0.83; p = 0.001; PSM analysis: HR 0.65; 95% CI 0.46-0.92; p = 0.014). CONCLUSION: Among hospitalized survivors of AMI, the use of ACEIs/ARBs was associated with a lower risk of follow-up HF in patients with LVEF ≤ 40% but not in those with LVEF > 40%. Further prospective studies are needed to confirm our results.


Assuntos
Antagonistas de Receptores de Angiotensina/efeitos adversos , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Insuficiência Cardíaca/induzido quimicamente , Infarto do Miocárdio/tratamento farmacológico , Sistema Renina-Angiotensina/efeitos dos fármacos , Função Ventricular Esquerda/efeitos dos fármacos , Idoso , Feminino , Insuficiência Cardíaca/metabolismo , Hospitalização , Humanos , Masculino , Infarto do Miocárdio/metabolismo , Pontuação de Propensão , Modelos de Riscos Proporcionais , Sistema de Registros , Estudos Retrospectivos , Espanha , Volume Sistólico/efeitos dos fármacos , Fatores de Tempo
3.
JACC Cardiovasc Interv ; 12(1): 22-32, 2019 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-30621974

RESUMO

OBJECTIVES: The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with aspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI. BACKGROUND: Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence. METHODS: This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y12 reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued with aspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR. RESULTS: A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR. CONCLUSIONS: HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Aspirina/administração & dosagem , Plaquetas/efeitos dos fármacos , Clopidogrel/administração & dosagem , Inibidores da Agregação Plaquetária/administração & dosagem , Ticagrelor/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/sangue , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Aspirina/efeitos adversos , Plaquetas/metabolismo , Clopidogrel/efeitos adversos , Resistência a Medicamentos , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Sistema de Registros , Espanha , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
4.
EuroIntervention ; 14(18): e1836-e1842, 2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-29957593

RESUMO

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Polímeros , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Método Simples-Cego , Sirolimo , Resultado do Tratamento
5.
Rev. esp. cardiol. (Ed. impr.) ; 71(10): 829-836, oct. 2018. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-178825

RESUMO

Introducción y objetivos: El impacto de un infarto de miocardio (IM) sobre la mortalidad, comparado con la gravedad de la hemorragia ocurrida tras el alta por síndrome coronario agudo, no está bien caracterizado. Definir esta relación puede ayudar a que se logre un balance riesgo-beneficio terapéutico favorable. Métodos: Utilizando modelos de Cox con fragilidad compartida, se evaluó la relación de la mortalidad con el IM y la gravedad de la hemorragia -clasificada según el Bleeding Academic Research Consortium (BARC)- en 4.229 pacientes con síndrome coronario agudo tratados con coronariografía entre enero de 2012 y diciembre de 2015. Resultados: Tanto el IM como la hemorragia se asociaron con la mortalidad (respectivamente HR = 5,8; IC95%, 3,7-9,8, y HR = 5,1; IC95%, 3,6-7,7). El IM tuvo mayor impacto en la mortalidad que las hemorragias BARC 2 y 3a: (RRR = 3,8 y RRR = 1,9; p < 0,05), pero equivalente al de las BARC 3b (RRR = 0,9; p = 0,88). El riesgo de muerte tras el IM fue menor que tras una hemorragia BARC 3c (RRR = 0,25; p < 0,001). La mortalidad tras un IM fue mayor entre los pacientes en tratamiento antiagregante plaquetario doble (TAPD) (HR = 2,9; IC95%, 1,8-4,5) que entre aquellos sin TAPD (HR = 1,5; IC95%, 0,7-3,4). Sin embargo, tras una hemorragia la mortalidad fue menor entre los pacientes en TAPD (HR = 1,6; IC95%, 1,1-2,6) que sin TAPD (HR = 3,2; IC95%, 1,7-5,8). Conclusiones: El efecto en la mortalidad del IM o las hemorragias tras el alta por un síndrome coronario agudo depende de la gravedad de la hemorragia. Estar en TAPD en el momento del IM o la hemorragia es un modificador del ulterior riesgo de muerte


Introduction and objectives: The impact on mortality of myocardial infarction (MI) compared with the specific degree of bleeding severity occurring after discharge in acute coronary syndrome is poorly characterized. Defining this relationship may help to achieve a favorable therapeutic risk-benefit balance. Methods: Using Cox-based shared frailty models, we assessed the relationship between mortality and postdischarge MI and bleeding severity-graded according to Bleeding Academic Research Consortium (BARC)-in 4229 acute coronary syndrome patients undergoing in-hospital coronary arteriography between January 2012 and December 2015. Results: Both MI (HR, 5.8; 95%CI, 3.7-9.8) and bleeding (HR, 5.1; 95%CI, 3.6-7.7) were associated with mortality. Myocardial infarction had a stronger impact on mortality than BARC type 2 and 3a bleedings: (RRr, 3.8 and 1.9; P < .05), respectively, but was equivalent to BARC type 3b (RRr, 0.9; P = .88). Mortality risk after MI was significantly lower than after BARC type 3c bleeding (RRr, 0.25; P < .001). Mortality was higher after an MI in patients on dual antiplatelet therapy (DAPT) at the time of the event (HR, 2.9; 95%CI, 1.8-4.5) than in those off-DAPT (HR, 1.5; 95%CI, 0.7-3.4). In contrast, mortality was lower after a bleeding event in patients on-DAPT (HR, 1.6; 95%CI, 1.1-2.6) than in those off-DAPT (HR, 3.2; 95%CI, 1.7-5.8). Conclusions: The differential effect on mortality of a postdischarge MI vs bleeding largely depends on bleeding severity. The DAPT status at the time of MI or bleeding is a modifier of subsequent mortality risk


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Síndrome Coronariana Aguda/complicações , Infarto do Miocárdio/complicações , Hemorragia/epidemiologia , Fibrinolíticos/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/mortalidade , Estudos Retrospectivos , Índice de Gravidade de Doença
6.
EuroIntervention ; 14(3): e343-e351, 2018 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-29790479

RESUMO

AIMS: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). METHODS AND RESULTS: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. CONCLUSIONS: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Europa (Continente) , Humanos , Japão , Polímeros , Estudos Prospectivos , Desenho de Prótese , República da Coreia , Método Simples-Cego , Resultado do Tratamento
8.
Rev Esp Cardiol (Engl Ed) ; 71(10): 829-836, 2018 Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29656987

RESUMO

INTRODUCTION AND OBJECTIVES: The impact on mortality of myocardial infarction (MI) compared with the specific degree of bleeding severity occurring after discharge in acute coronary syndrome is poorly characterized. Defining this relationship may help to achieve a favorable therapeutic risk-benefit balance. METHODS: Using Cox-based shared frailty models, we assessed the relationship between mortality and postdischarge MI and bleeding severity-graded according to Bleeding Academic Research Consortium (BARC)-in 4229 acute coronary syndrome patients undergoing in-hospital coronary arteriography between January 2012 and December 2015. RESULTS: Both MI (HR, 5.8; 95%CI, 3.7-9.8) and bleeding (HR, 5.1; 95%CI, 3.6-7.7) were associated with mortality. Myocardial infarction had a stronger impact on mortality than BARC type 2 and 3a bleedings: (RRr, 3.8 and 1.9; P < .05), respectively, but was equivalent to BARC type 3b (RRr, 0.9; P = .88). Mortality risk after MI was significantly lower than after BARC type 3c bleeding (RRr, 0.25; P < .001). Mortality was higher after an MI in patients on dual antiplatelet therapy (DAPT) at the time of the event (HR, 2.9; 95%CI, 1.8-4.5) than in those off-DAPT (HR, 1.5; 95%CI, 0.7-3.4). In contrast, mortality was lower after a bleeding event in patients on-DAPT (HR, 1.6; 95%CI, 1.1-2.6) than in those off-DAPT (HR, 3.2; 95%CI, 1.7-5.8). CONCLUSIONS: The differential effect on mortality of a postdischarge MI vs bleeding largely depends on bleeding severity. The DAPT status at the time of MI or bleeding is a modifier of subsequent mortality risk.


Assuntos
Síndrome Coronariana Aguda/complicações , Stents Farmacológicos , Hemorragia/epidemiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco/métodos , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Idoso , Angiografia Coronária , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Hemorragia/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Inibidores da Agregação Plaquetária/uso terapêutico , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Fatores de Tempo
11.
EuroIntervention ; 12(16): 1962-1968, 2017 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-27973334

RESUMO

AIMS: The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications. METHODS AND RESULTS: A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027). The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009). CONCLUSIONS: Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.


Assuntos
Cateterismo Cardíaco/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Complicações Pós-Operatórias , Sistema de Registros , Dispositivo para Oclusão Septal , Idoso , Idoso de 80 Anos ou mais , Ecocardiografia Tridimensional/métodos , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Dispositivo para Oclusão Septal/efeitos adversos , Resultado do Tratamento
12.
Eur Heart J ; 38(13): 961-969, 2017 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-27190095

RESUMO

Aims: Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. Methods and results: Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005). Conclusion: We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.


Assuntos
Stents Farmacológicos , Hemorragia/etiologia , Imunossupressores/administração & dosagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Sirolimo/análogos & derivados , Síndrome Coronariana Aguda/cirurgia , Idoso , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Oclusão de Enxerto Vascular/etiologia , Humanos , Masculino , Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/administração & dosagem , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Sirolimo/administração & dosagem , Resultado do Tratamento
13.
Eur. heart j ; 38(13): 961-969, 2017. tab, graf
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1062641

RESUMO

Aims Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing per cutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with im plantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. Methods and results Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleed ing risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P » 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P » 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P » 0.049) and myocardial infarction (6.9 vs. 13.8%, P » 0.005). Conclusion We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9- DCS should currently be considered as the device with the strongest evidence to support its use for this indication.


Assuntos
Intervenção Coronária Percutânea , Síndrome Coronariana Aguda
14.
N Engl J Med ; 373(21): 2038-47, 2015 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-26466021

RESUMO

BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Sirolimo/análogos & derivados , Idoso , Terapia Combinada , Doença da Artéria Coronariana/tratamento farmacológico , Método Duplo-Cego , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Polímeros , Desenho de Prótese , Sirolimo/administração & dosagem , Stents/efeitos adversos
15.
Rev. esp. cardiol. (Ed. impr.) ; 68(10): 861-868, oct. 2015. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-143223

RESUMO

Introducción y objetivos: El síndrome de QT largo es una canalopatía hereditaria que se asocia a síncope y muerte súbita. La heterogeneidad fenotípica de esta enfermedad hace que el estudio genético sea fundamental para detectar a los sujetos con síndrome de QT largo oculto. En este trabajo se exponen las características de una familia con 13 portadores de la mutación missense KCNH2-H562R que afecta a la región del poro del canal HERG. Métodos: Se describió la mutación KCNH2-H562R en un varón de 65 años con intervalo QTc prolongado que presentó un episodio de torsade de pointes. Posteriormente, se identificaron 13 portadores de la mutación en la familia. Se realizó evaluación clínica, electrocardiograma y ecocardiograma a los portadores (edad, 48 ± 26 años; el 46% varones). Resultados: El QTc medio en los portadores fue de 493 ± 42 ms (3 [23%] mostraron QTc normal); 6 (46%) tuvieron síntomas (4, síncope; 1, muerte súbita; 1, muerte súbita resucitada [probando]). Durante el tratamiento con bloqueadores beta, 11 (92%) de los 12 portadores permanecieron asintomáticos a los 5 años de seguimiento (1 paciente requirió simpatectomía cardiaca izquierda). El acortamiento del QTc con bloqueadores beta fue de 50 ± 37 ms. Hubo 1 muerte súbita en un paciente que rechazó tratamiento con bloqueadores beta. Conclusiones: El estudio familiar es fundamental en la interpretación de los resultados de los tests genéticos en la actualidad. Este artículo describe el fenotipo variable y heterogéneo de una amplia familia portadora de la mutación KCNH2-H562R y destaca el papel del estudio genético en la identificación de los individuos en riesgo que se beneficiarían del tratamiento con bloqueadores beta (AU)


Introduction and objectives: Long QT syndrome is an inherited ion channelopathy that leads to syncope and sudden death. Because of the heterogeneous phenotype of this disease, genetic testing is fundamental to detect individuals with concealed long QT syndrome. In this study, we determined the features of a family with 13 carriers of the KCNH2-H562R missense mutation, which affects the pore region of the HERG channel. Methods: We identified the KCNH2-H562R mutation in a 65-year-old man with a prolonged QTc interval who had experienced an episode of torsade de pointes. Subsequently, a total of 13 mutation carriers were identified in the family. Carriers (age 48 [26] years; 46% males) underwent clinical evaluation, electrocardiography and echocardiography. Results: The mean (standard deviation) QTc in carriers was 493 (42) ms (3 [23%] showed normal QTc); 6 (46%) had symptoms (4, syncope; 1, sudden death; 1, aborted sudden death [proband]). While under treatment with beta-blockers, 11 of 12 carriers (92%) remained asymptomatic at 5 years of follow-up (1 patient required left cardiac sympathectomy). The QTc shortening with beta-blockers was 50 (37) ms. There was 1 sudden death in a patient who refused treatment. Conclusions: Family study is essential in the interpretation of a genetic testing result. This article describes the heterogeneous and variable phenotype of a large family with the KCNH2-H562R mutation and highlights the role of genetic study for the appropriate identification of at-risk individuals who would benefit from treatment (AU)


Assuntos
Idoso , Humanos , Masculino , Torsades de Pointes/genética , Síndrome do QT Longo/genética , Morte Súbita Cardíaca/epidemiologia , Técnicas Genéticas , /métodos , Eletrocardiografia , Ecocardiografia , Fenótipo , Bisoprolol/uso terapêutico , Claritromicina , Hipopotassemia/complicações
16.
Arch. cardiol. Méx ; 85(2): 111-117, abr.-jun. 2015. ilus, tab
Artigo em Espanhol | LILACS | ID: lil-754933

RESUMO

Introducción: La fibrilación auricular (FA), con una incidencia aproximada del 30%, es la arritmia más frecuente tras cirugía cardiaca. Se han asociado a la FA factores como la inflamación, la presencia de fibrosis cardiaca, el estrés y la apoptosis de cardiomiocitos. Objetivos: Consideramos que el remodelado auricular es un proceso preexistente en los pacientes con FA posquirúrgica. Analizamos los factores relacionados con la incidencia de FA en el postoperatorio de cirugía cardiaca. Métodos: Incluimos a pacientes consecutivos, estables hemodinámicamente y en ritmo sinusal, sometidos a cirugía cardiaca programada con circulación extracorpórea. Se valora la caída en FA posquirúrgica. Resultados: Se incluyeron un total de 100 pacientes sometidos a cirugía de revascularización coronaria (59) o sustitución valvular aórtica (41) por estenosis aórtica grave. La FA postoperatoria se produjo en 29 pacientes con predominio de la cirugía valvular respecto a la cirugía coronaria. Los factores predictivos de la aparición de FA postoperatoria en el análisis multivariable fueron el sexo masculino, la ausencia de terapia crónica con betabloqueadores, la perfusión de fibrinógeno intraoperatorio, valores bajos de colesterol HDL y valores elevados de troponina T ultrasensible en el preoperatorio. Conclusiones: El colesterol HDL y la troponina T ultrasensible pueden ser biomarcadores útiles para predecir la aparición de FA postoperatoria. La identificación precoz de estos pacientes nos permite adoptar medidas preventivas para minimizar sus efectos negativos.


Introduction: Atrial fibrillation (AF) has an incidence rate of approximately 30% and is the most frequent arrhythmia following heart surgery. Factors such as inflammation, the presence of heart fibrosis, stress and cardiomyocyte apoptosis, have all been associated with AF. Objectives: We believe that atrial remodelling is a pre-existent process in patients with post-surgical AF. We have analyzed the factors related to the incidence of atrial fibrillation in the period after heart surgery. Methods: We included consecutive, hemodynamically stable patients with a sinusal rhythm who were subjected to programmed heart surgery with extracorporeal circulation. An assessment was made of the fall in atrial fibrillation after surgery using prolonged electrocardiographic monitoring. Results: A total of 100 patients were included in the study and were subjected to either coronary revascularisation surgery (59) or aortic valve substitution due to severe aortic stenosis (41). Postoperative AF occurred in 29 patients who received predominantly more valve surgery than coronary surgery. The following factors were predictive of postoperative AF in the multivariate analysis: Male sex; beta-blocker therapy for chronic disease; the use of intraoperative; fibrinogen perfusion; low HDL cholesterol values; and high sensitive troponin T values, in the preoperative period. Conclusions: HDL cholesterol and high sensitive troponin T can be useful biomarkers to predict the occurrence of AF after surgery. The early identification of these patients who develop of FA allows us to take preventive measures to minimize the negative effects.


Assuntos
Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fibrilação Atrial/sangue , HDL-Colesterol/sangue , Complicações Pós-Operatórias/sangue , Troponina T/sangue , Biomarcadores/sangue , Procedimentos Cirúrgicos Cardíacos , Valor Preditivo dos Testes
17.
EuroIntervention ; 11(1): 30-6, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25982648

RESUMO

The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.


Assuntos
Aterectomia Coronária/normas , Estenose Coronária/terapia , Calcificação Vascular/terapia , Aterectomia Coronária/efeitos adversos , Consenso , Estenose Coronária/diagnóstico , Humanos , Padrões de Prática Médica/normas , Resultado do Tratamento , Calcificação Vascular/diagnóstico
18.
Rev Esp Cardiol (Engl Ed) ; 68(10): 861-8, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25819988

RESUMO

INTRODUCTION AND OBJECTIVES: Long QT syndrome is an inherited ion channelopathy that leads to syncope and sudden death. Because of the heterogeneous phenotype of this disease, genetic testing is fundamental to detect individuals with concealed long QT syndrome. In this study, we determined the features of a family with 13 carriers of the KCNH2-H562R missense mutation, which affects the pore region of the HERG channel. METHODS: We identified the KCNH2-H562R mutation in a 65-year-old man with a prolonged QTc interval who had experienced an episode of torsade de pointes. Subsequently, a total of 13 mutation carriers were identified in the family. Carriers (age 48 [26] years; 46% males) underwent clinical evaluation, electrocardiography and echocardiography. RESULTS: The mean (standard deviation) QTc in carriers was 493 (42) ms (3 [23%] showed normal QTc); 6 (46%) had symptoms (4, syncope; 1, sudden death; 1, aborted sudden death [proband]). While under treatment with beta-blockers, 11 of 12 carriers (92%) remained asymptomatic at 5 years of follow-up (1 patient required left cardiac sympathectomy). The QTc shortening with beta-blockers was 50 (37) ms. There was 1 sudden death in a patient who refused treatment. CONCLUSIONS: Family study is essential in the interpretation of a genetic testing result. This article describes the heterogeneous and variable phenotype of a large family with the KCNH2-H562R mutation and highlights the role of genetic study for the appropriate identification of at-risk individuals who would benefit from treatment.


Assuntos
DNA/genética , Canal de Potássio ERG1/genética , Eletrocardiografia , Sistema de Condução Cardíaco/fisiopatologia , Síndrome do QT Longo/genética , Mutação , Linhagem , Idoso , Idoso de 80 Anos ou mais , Pré-Escolar , Análise Mutacional de DNA , Canal de Potássio ERG1/metabolismo , Feminino , Testes Genéticos , Heterozigoto , Humanos , Síndrome do QT Longo/fisiopatologia , Masculino , Fenótipo , Adulto Jovem
19.
Arch Cardiol Mex ; 85(2): 111-7, 2015.
Artigo em Espanhol | MEDLINE | ID: mdl-25716679

RESUMO

INTRODUCTION: Atrial fibrillation (AF) has an incidence rate of approximately 30% and is the most frequent arrhythmia following heart surgery. Factors such as inflammation, the presence of heart fibrosis, stress and cardiomyocyte apoptosis, have all been associated with AF. OBJECTIVES: We believe that atrial remodelling is a pre-existent process in patients with post-surgical AF. We have analyzed the factors related to the incidence of atrial fibrillation in the period after heart surgery. METHODS: We included consecutive, hemodynamically stable patients with a sinusal rhythm who were subjected to programmed heart surgery with extracorporeal circulation. An assessment was made of the fall in atrial fibrillation after surgery using prolonged electrocardiographic monitoring. RESULTS: A total of 100 patients were included in the study and were subjected to either coronary revascularisation surgery (59) or aortic valve substitution due to severe aortic stenosis (41). Postoperative AF occurred in 29 patients who received predominantly more valve surgery than coronary surgery. The following factors were predictive of postoperative AF in the multivariate analysis: Male sex; beta-blocker therapy for chronic disease; the use of intraoperative; fibrinogen perfusion; low HDL cholesterol values; and high sensitive troponin T values, in the preoperative period. CONCLUSIONS: HDL cholesterol and high sensitive troponin T can be useful biomarkers to predict the occurrence of AF after surgery. The early identification of these patients who develop of FA allows us to take preventive measures to minimize the negative effects.


Assuntos
Fibrilação Atrial/sangue , HDL-Colesterol/sangue , Complicações Pós-Operatórias/sangue , Troponina T/sangue , Idoso , Biomarcadores/sangue , Procedimentos Cirúrgicos Cardíacos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...