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1.
N Engl J Med ; 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31475799

RESUMO

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary-end point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

2.
JACC Cardiovasc Interv ; 11(7): 638-644, 2018 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-29622141

RESUMO

OBJECTIVES: The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. BACKGROUND: Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. METHODS: A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. RESULTS: Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome. CONCLUSIONS: In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of "scaffold dismantling," this finding likely has ramifications for all bioresorbable scaffolds.

3.
JACC Cardiovasc Interv ; 10(18): 1809-1815, 2017 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-28935071

RESUMO

OBJECTIVES: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries. BACKGROUND: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique. METHODS: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome. RESULTS: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter <1.85 mm (odds ratio [OR]: 3.1; p = 0.004), off dual antiplatelet therapy (DAPT) status (OR: 3.1 to 3.5; p = 0.006 to 0.053), no post-dilatation with >1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036). CONCLUSIONS: Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation.


Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Angiografia Coronária , Trombose Coronária/diagnóstico por imagem , Doença Aguda , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Ensaios Clínicos como Assunto , Trombose Coronária/etiologia , Quimioterapia Combinada , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Inibidores da Agregação de Plaquetas/uso terapêutico , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
4.
JACC Cardiovasc Interv ; 10(18): 1809-1815, 2017.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-36824

RESUMO

OBJECTIVES: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries. BACKGROUND: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique. METHODS: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome. RESULTS: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter <1.85 mm (odds ratio [OR]: 3.1; p = 0.004), off dual antiplatelet therapy (DAPT) status (OR: 3.1 to 3.5; p = 0.006 to 0.053), no post-dilatation with >1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036).CONCLUSIONS:Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation.(AU)


Assuntos
Trombose , Stents Farmacológicos , Vasos Sanguíneos
5.
J Interv Card Electrophysiol ; 43(2): 135-44, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25917747

RESUMO

BACKGROUND: Monitoring respiratory rate (RR) is recommended at the time of hospital presentation for acute decompensation in heart failure (HF). Device-based continuous monitoring of RR may be helpful for diagnostic and prognostic stratification after implantable cardioverter-defibrillator (ICD) implantation. This study was undertaken to analyze short- and long-term changes in ICD-measured RR and to relate RR with the patient's clinical status and the occurrence of HF events. METHODS: One hundred twenty-four consecutive HF patients who received ICD endowed with this diagnostic capability (Boston Scientific Inc., Natick, MA, USA) were prospectively enrolled. Patients were followed up for 12 months. RESULTS: At the baseline, the proportion of New York Heart Association (NYHA) class III-IV was higher among patients with daily maximum RR >27 breaths/min (third tertile) than those with <24 breaths/min (first tertile) (43 vs. 23%, p < 0.05). Moreover, the ejection fraction was lower (27 ± 7 vs. 34 ± 8%, p < 0.05). In patients with HF hospitalizations (33 events) and urgent visits for HF (15 events), the weekly average of RR calculated over the 7 days preceding hospital accesses did not differ from values recorded at the baseline and before scheduled follow-up visits. However, the weekly variation in RR (i.e., the difference between maximum and minimum values collected over the week) was significantly higher prior to hospitalization (p < 0.05). A weekly variation >3 breaths/min in maximum RR predicted an impending hospital admission for HF with sensitivity of 73 % and specificity of 57%. CONCLUSIONS: In this study, elevated values of ICD-monitored RR identified patients with worse functional status and lower systolic function. The weekly variation in RR increased before HF exacerbation. This monitoring technology may represent a useful tool in the clinical management of patients with HF.


Assuntos
Desfibriladores Implantáveis , Insuficiência Cardíaca/fisiopatologia , Monitorização Fisiológica/instrumentação , Taxa Respiratória/fisiologia , Idoso , Feminino , Humanos , Masculino , Estudos Prospectivos , Sensibilidade e Especificidade
6.
Europace ; 16(5): 689-97, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24500787

RESUMO

AIMS: The OPTI-MIND study aims to collect 2-year clinical outcomes of pacemaker patients in real-world clinical practice, overall and according to patient characteristics and pacemaker settings. METHODS AND RESULTS: The present analysis of the OPTI-MIND study describes the programmed device settings after discharge from the pacemaker implant. The objective was to determine whether these settings fit recent guidelines for device-programmed physiological pacing based on the preservation of atrioventricular synchrony, avoiding unnecessary pacing, ensuring rate increase during exercise or preventing neurally mediated symptoms. A total of 1740 patients were enroled at 68 centres worldwide. Baseline patient characteristics and device programming settings are available in 1674 of 1740 patients (96%). Guidelines to ensure physiological pacing were followed in 41% of patients: in patients with sinus node disease (SND), and without atrioventricular block (AVB), device programming could have led to unnecessary right ventricular pacing in 38% of patients. In SND patients with chronotropic incompetence, assisted rate increase during exercise was not programmed in 42% of patients. In 11% of patients with AVB, atrioventricular (AV) synchrony was not pursued; the main drivers being advanced age and history of atrial fibrillation. Patients with both SND and AVB were generally programmed physiologically (87%). CONCLUSION: The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome.


Assuntos
Fibrilação Atrial/terapia , Bloqueio Atrioventricular/terapia , Estimulação Cardíaca Artificial/métodos , Marca-Passo Artificial , Síndrome do Nó Sinusal/terapia , Idoso , Idoso de 80 Anos ou mais , Estimulação Cardíaca Artificial/normas , Estudos de Coortes , Feminino , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Resultado do Tratamento
7.
Rev Esp Cardiol ; 62(4): 354-64, 2009 Apr.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-19401120

RESUMO

INTRODUCTION AND OBJECTIVES: The performance of drug-eluting stents (DESs) in high-risk patients with diabetes and acute ST-elevation myocardial infarction (STEMI) who have undergone primary angioplasty has not been previously studied. The objective was to evaluate the efficacy and safety of DESs in diabetic patients with STEMI. METHODS: We performed a pooled analysis of individual patient data from seven randomized trials that compared DESs (i.e., sirolimus- or paclitaxel-eluting stents) with bare-metal stents (BMSs) in patients with STEMI. The analysis involved 389 patients with diabetes mellitus from a total of 2476 patients. The outcomes of interest were target-lesion revascularization, stent thrombosis, death and the composite endpoint of death or recurrent myocardial infarction during a follow-up of 12-24 months. RESULTS: Overall, 206 diabetic patients received a DES and 183, a BMS. The risk of target-lesion revascularization was significantly lower in patients treated with a DES compared to those treated with a BMS (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.23-0.88; P=.02). There was no significant difference in the risk of stent thrombosis between those treated with a DES or a BMS (HR 0.33, 95% CI 0.09-1.13; P=.08). Similarly, the risk of the combined endpoint of death or myocardial infarction was not significantly different between patients treated with a DES or a BMS (HR 0.64, 95% CI 0.36-1.13; P=.12). CONCLUSIONS: Compared with BMSs, DES use improved clinical outcomes in diabetic patients undergoing primary angioplasty for STEMI: the need for reintervention was reduced, with no increase in mortality or myocardial infarction.


Assuntos
Angiopatias Diabéticas/cirurgia , Stents Farmacológicos , Infarto do Miocárdio/cirurgia , Stents , Idoso , Antineoplásicos Fitogênicos/administração & dosagem , Antineoplásicos Fitogênicos/uso terapêutico , Angiopatias Diabéticas/fisiopatologia , Eletrocardiografia/efeitos dos fármacos , Feminino , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Paclitaxel/administração & dosagem , Paclitaxel/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/administração & dosagem , Sirolimo/uso terapêutico , Resultado do Tratamento
8.
Rev. esp. cardiol. (Ed. impr.) ; 62(4): 354-364, abr. 2009. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-72639

RESUMO

Introducción y objetivos. Los resultados obtenidos con los stents liberadores de fármacos (SLF) en el grupo de pacientes de alto riesgo formado por los pacientes diabéticos con infarto agudo de miocardio con elevación del segmento ST (IAMCEST) tratados con angioplastia primaria no se han estudiado con anterioridad. Nuestro objetivo fue evaluar la eficacia y la seguridad de los SLF en pacientes diabéticos con IAMCEST. Métodos. Llevamos a cabo un análisis combinado de los datos de pacientes individuales de siete ensayos aleatorizados en los que se comparó el empleo de stents liberadores de sirolimus o de paclitaxel (SLF) con el de stents convencionales (SC) en el contexto de un IAMCEST. Se incluyó en este análisis a 389 pacientes con diabetes mellitus de un grupo total de 2.476. Los objetivos del estudio fueron la revascularización de la lesión diana, la trombosis del stent, la muerte y la variable combinada de muerte o infarto de miocardio recurrente durante un periodo de seguimiento de 12-24 meses. Resultados. Hubo 206 pacientes diabéticos tratados con SLF y 183 tratados con SC. El riesgo de que se practicara una revascularización de la lesión diana fue significativamente inferior en los pacientes tratados con SLF en comparación con los pacientes tratados con SC (razón de riesgos [HR] = 0,44; intervalo de confianza [IC] del 95%, 0,23-0,88; p = 0,02). El riesgo de trombosis del stent no presentó diferencias significativas entre los pacientes tratados con SLF y los tratados con SC (HR = 0,33; IC del 95%, 0,09-1,13; p = 0,08). De forma análoga, el riesgo de la variable de valoración combinada formada por la muerte y el infarto de miocardio no presentó diferencias significativas entre los pacientes tratados con SLF y los tratados con SC (HR = 0,64; IC del 95%, 0,36-1,13; p = 0,12). Conclusiones. En comparación con los SC, los SLF mejoran los resultados clínicos en los pacientes diabéticos a los que se practica una angioplastia primaria por un IAMCEST, al reducir la necesidad de reintervención sin incrementar la tasa de mortalidad o infarto de miocardio (AU)


Introduction and objectives. The performance of drug-eluting stents (DES) in high-risk patients with diabetes and acute ST-elevation myocardial infarction (STEMI) who have undergone primary angioplasty has not been previously studied. The objestive was to evaluate the efficacy and safety of DESs in diabetic patients with STEMI. Methods. We performed a pooled analysis of individual patient data from 7 randomized trials that compared DES (ie, sirolimus- or paclitaxel-eluting stents) with bare-metal stent (BMS) in patients with STEMI. The analysis involved 389 patients with diabetes mellitus from a total of 2476 patients. The outcomes of interest were target-lesion revascularization, stent thrombosis, death, and the composite endpoint of death or recurrent myocardial infarction during a follow-up of 12-24 months. Results. Overall, 206 diabetic patients received a DES and 183, a BMS. The risk of target-lesion revascularization was significantly lower in patients treated with a DES compared to those treated with a BMS (hazard ratio [HR] = 0.44; 95% CI, 0.23-0.88; P=.02). There was no significant difference in the risk of stent thrombosis between those treated with a DES or a BMS (HR=0.33; 95% CI, 0.09-1.13; P=.08). Similarly, the risk of the combined endpoint of death or myocardial infarction was not significantly different between patients treated with a DES or a BMS (HR=0.64; 95% CI, 0.36-1.13; P=.12). Conclusions. Compared with BMSs, DES use improved clinical outcomes in diabetic patients undergoing primary angioplasty for STEMI: the need for reintervention was reduced, with no increase in mortality or myocardial infarction. was significantly lower in patients treated with a DES compared to those treated with a BMS (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.23-0.88; P=.02). There was no significant difference in the risk of stent thrombosis between those treated with a DES or a BMS (HR 0.33, 95% CI 0.09-1.13; P=.08). Similarly, the risk of the combined endpoint of death or myocardial infarction was not significantly different between patients treated with a DES or a BMS (HR 0.64, 95% CI 0.36-1.13; P=.12). Conclusions. Compared with BMSs, DES use improved clinical outcomes in diabetic patients undergoing primary angioplasty for STEMI: the need for reintervention was reduced, with no increase in mortality or myocardial infarction (AU)


Assuntos
Humanos , Masculino , Feminino , Stents Farmacológicos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Diabetes Mellitus/diagnóstico , Revascularização Miocárdica/métodos , Angioplastia , Reestenose Coronária/terapia , Trombose/complicações , Stents Farmacológicos/estatística & dados numéricos , Stents Farmacológicos/tendências , Infarto do Miocárdio/terapia , Fatores de Risco
9.
J Thromb Thrombolysis ; 28(2): 200-10, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19190859

RESUMO

BACKGROUND: Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. RESULTS: A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2-3 years follow-up (data available from 4 trials including 569 patients). CONCLUSIONS: This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2-3 years follow-up.


Assuntos
Angioplastia Coronária com Balão , Antibióticos Antineoplásicos/administração & dosagem , Stents Farmacológicos , Infarto do Miocárdio/terapia , Sirolimo/administração & dosagem , Stents Farmacológicos/efeitos adversos , Humanos , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção Secundária , Trombose/etiologia
10.
Int J Cardiol ; 133(2): 213-22, 2009 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-18394731

RESUMO

BACKGROUND: Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. Thus, the aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of DES as compared to BMS in patients undergoing primary angioplasty for STEMI. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. RESULTS: A total of 11 trials were included in the meta-analysis, involving 3605 patients (1888 or 52.3% randomized to DES and 1719 or 47.7% randomized to BMS). At 12 months follow-up, no significant difference was observed in mortality (4.1% vs 4.4%, OR [95% CI]=0.91 [0.66-1.27], p=0.59, reinfarction (3.1% vs 3.4%, OR [95% CI]=0.85 [0.58, 1.23], p=0.38 or stent thrombosis (1.6% vs 2.2%, OR [95% CI]=0.76 [0.47, 1.23], p=0.22), whereas DES were associated with a significant reduction in TVR (5.0% vs 12.6%, OR [95% CI]=0.36 [0.28, 0.47], p<0.0001). Safety and efficacy of DES were confirmed at 18 to 24 months follow-up (data available from 4 trials including 1178 patients). CONCLUSIONS: This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES and PES, as compared to BMS, are safe and associated with a significant reduction in TVR at 1 and 2 years follow-up.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio/tratamento farmacológico , Angioplastia Coronária com Balão , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
11.
Int J Cardiol ; 132(3): 337-41, 2009 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-18234373

RESUMO

BACKGROUND: There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation. METHODS: We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents. RESULTS: During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002). CONCLUSIONS: During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.


Assuntos
Oclusão Coronária/terapia , Stents Farmacológicos , Imunossupressores/administração & dosagem , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão , Doença Crônica , Angiografia Coronária , Oclusão Coronária/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/epidemiologia , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Stents , Resultado do Tratamento
12.
BMJ ; 337: a1331, 2008 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-18757996

RESUMO

OBJECTIVE: To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. DESIGN: Collaborative network meta-analysis. DATA SOURCES: Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. REVIEW METHODS: Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. RESULTS: 35 trials in 3852 people with diabetes and 10,947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. CONCLUSION: In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.


Assuntos
Reestenose Coronária/prevenção & controle , Angiopatias Diabéticas/tratamento farmacológico , Inibidores da Agregação de Plaquetas/administração & dosagem , Stents , Prótese Vascular , Stents Farmacológicos , Humanos , Paclitaxel/administração & dosagem , Falha de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/administração & dosagem
13.
Lancet ; 370(9591): 937-48, 2007 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-17869634

RESUMO

BACKGROUND: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. METHODS: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. FINDINGS: Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021). INTERPRETATION: The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.


Assuntos
Antibacterianos/uso terapêutico , Doença das Coronárias , Infarto do Miocárdio , Paclitaxel/uso terapêutico , Sirolimo/uso terapêutico , Stents/efeitos adversos , Antibacterianos/administração & dosagem , Doença das Coronárias/etiologia , Doença das Coronárias/mortalidade , Doença das Coronárias/prevenção & controle , Feminino , Seguimentos , Humanos , Masculino , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Paclitaxel/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/administração & dosagem
14.
Eur Heart J ; 28(22): 2706-13, 2007 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-17901079

RESUMO

AIMS: To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. METHODS AND RESULTS: We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0-24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29-0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46-1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53-1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48-1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. CONCLUSION: The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.


Assuntos
Infarto do Miocárdio/terapia , Stents , Angioplastia Coronária com Balão/métodos , Angioplastia Coronária com Balão/mortalidade , Reestenose Coronária/mortalidade , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Humanos , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Modelos de Riscos Proporcionais , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida , Resultado do Tratamento
15.
J Am Coll Cardiol ; 49(19): 1924-30, 2007 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-17498576

RESUMO

OBJECTIVES: To confirm whether sirolimus-eluting stents (SES) safely reduce the incidence of restenosis in patients with ST-segment elevation acute myocardial infarction compared with bare-metal stents (BMS). BACKGROUND: In the setting of primary angioplasty, stent restenosis occurs in up to 27% of patients. The introduction of drug-eluting stents has drastically reduced the incidence of restenosis in clinically stable patients. METHODS: We conducted a randomized trial of 320 patients with acute ST-segment elevation myocardial infarction assigned to receive SES or BMS. The primary end point was binary restenosis at 1-year angiographic follow-up. RESULTS: At 1 year, the incidence of binary restenosis was lower in the SES group than in the BMS group (9.3% vs. 21.3%, respectively; p = 0.032), as were the rates of target lesion revascularization (4.3% vs. 11.2%; p = 0.02), target vessel revascularization (5% vs. 13.1; p = 0.015), major adverse cardiac events (6.8% vs. 16.8%; p = 0.005), and target vessel failure (8.7% vs. 18.7%; p = 0.007). The incidence of angiographically documented stent thrombosis was 1.2% (n = 2) in the SES group and 0.6% (n = 1) in the BMS group. CONCLUSIONS: In patients with acute myocardial infarction, SES are superior to BMS, reducing the incidence of binary restenosis by 56%, target lesion revascularization by 61%, target vessel revascularization by 62%, adverse cardiac events by 59%, and target vessel failure by 53% at 1 year. (Sirolimus Eluting Stenting in Acute Myocardial Infarction; http://www.clinicaltrials.gov/ct/show/NCT00288210; NCT00288210).


Assuntos
Angioplastia Coronária com Balão , Oclusão de Enxerto Vascular/epidemiologia , Imunossupressores/administração & dosagem , Infarto do Miocárdio/terapia , Sirolimo/administração & dosagem , Stents , Idoso , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico por imagem , Radiografia
16.
G Ital Cardiol (Rome) ; 8(2): 123-8, 2007 Feb.
Artigo em Italiano | MEDLINE | ID: mdl-17402357

RESUMO

We describe the case of a patient in whom evaluation of effort angina revealed a tight stenosis of a right coronary artery anomalously arising from the left sinus of Valsalva, which was successfully treated by stent implantation. The abnormal origin of the right coronary artery from the left aortic sinus coursing between the aorta and the pulmonary trunk is a rare congenital anomaly. It may remain asymptomatic, but can also cause major cardiac events, even in the absence of coronary atherosclerosis. We discuss the clinical importance of this anomaly and review the literature concerning current views and therapy.


Assuntos
Anomalias dos Vasos Coronários , Seio Aórtico/anormalidades , Adulto , Fatores Etários , Angioplastia Coronária com Balão , Aortografia , Angiografia Coronária , Anomalias dos Vasos Coronários/diagnóstico , Anomalias dos Vasos Coronários/diagnóstico por imagem , Anomalias dos Vasos Coronários/epidemiologia , Anomalias dos Vasos Coronários/cirurgia , Anomalias dos Vasos Coronários/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Medição de Risco , Fatores Sexuais , Seio Aórtico/diagnóstico por imagem , Stents , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
17.
N Engl J Med ; 356(10): 1030-9, 2007 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-17296823

RESUMO

BACKGROUND: The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established. METHODS: We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention. RESULTS: The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year. CONCLUSIONS: The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.


Assuntos
Doença das Coronárias/terapia , Trombose Coronária/etiologia , Imunossupressores/administração & dosagem , Sirolimo/administração & dosagem , Stents/efeitos adversos , Angioplastia Coronária com Balão , Doença das Coronárias/mortalidade , Reestenose Coronária/epidemiologia , Reestenose Coronária/terapia , Trombose Coronária/epidemiologia , Sistemas de Liberação de Medicamentos , Seguimentos , Humanos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Desenho de Prótese , Falha de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Regressão , Risco , Análise de Sobrevida
18.
J Cardiovasc Med (Hagerstown) ; 7(12): 847-51, 2006 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17122669

RESUMO

BACKGROUND: The prognosis of patients with diabetes mellitus and chronic coronary total occlusion (CTO) treated with percutaneous coronary angioplasty (PTCA) is poorly investigated. METHODS: To compare the long-term outcome of patients with CTO, with and without diabetes mellitus and undergoing successful PTCA with bare stent implantation performed in a single centre, 170 consecutive patients (mean age 62 +/- 10 years) with CTO aged > 1 month were analysed. Death, myocardial infarction, repeat angioplasty and coronary artery by-pass were considered as hard events in 167 patients with available long-term follow-up (mean 25 +/- 15 months). RESULTS: Vessel mean luminal diameter after the procedure and stent length were 2.5 +/- 0.4 mm and 21.9 +/- 9.4 mm, respectively. No differences were found in baseline clinical, angiographic and procedural variables between the groups, categorized on the basis of presence or absence of diabetes. There were 13 (27%) and 25 (21%) events in diabetic and non-diabetic groups, respectively (P = not significant). Multivariate analysis identified final mean luminal diameter (odds ratio = 4.7192, P = 0.0013) and stent length (odds ratio = 1.0655, P = 0.0003) but not diabetes (P = 0.78) as predictors of events at long-term follow-up. CONCLUSIONS: Patients with and without diabetes undergoing CTO re-opening with stent implantation do not differ at long-term follow-up in terms of death, myocardial infarction and target lesion revascularizations. Final mean luminal diameter and stent length are significant predictors of events during long-term follow-up.


Assuntos
Angioplastia Coronária com Balão , Estenose Coronária/terapia , Complicações do Diabetes/terapia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Angiografia Coronária , Ponte de Artéria Coronária , Estenose Coronária/complicações , Estenose Coronária/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Retratamento , Resultado do Tratamento
19.
Circulation ; 114(15): 1616-24, 2006 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-17015786

RESUMO

BACKGROUND: The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). METHODS AND RESULTS: Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital. CONCLUSIONS: Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica/fisiopatologia , Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiologia , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/terapia , Estenose da Valva Aórtica/fisiopatologia , Clopidogrel , Ecocardiografia , Feminino , Implante de Prótese de Valva Cardíaca/instrumentação , Hemodinâmica/fisiologia , Humanos , Masculino , Inibidores da Agregação de Plaquetas/uso terapêutico , Estudos Prospectivos , Fatores de Risco , Stents , Trombocitopenia/tratamento farmacológico , Trombocitopenia/etiologia , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico , Resultado do Tratamento
20.
G Ital Cardiol (Rome) ; 7(1): 50-5, 2006 Jan.
Artigo em Italiano | MEDLINE | ID: mdl-16528962

RESUMO

Background. Previous studies have shown that successful recanalization by stent implantation of a chronic total coronary occlusion (CTO) is associated with an improved clinical outcome. However, most of these studies have used first-generation stents and dated regimens of antithrombotic therapy. Methods. We retrospectively investigated the short- and long-term clinical results of current techniques of percutaneous revascularization in 126 consecutive patients with CTO who underwent successful implantation of a new-generation bare metal stent and dual antiplatelet therapy. Results. There were neither in-hospital deaths nor subacute stent thrombosis; periprocedural acute myocardial infarction occurred in 6 (2.3%) patients; 25 (20%) late major events were observed during a mean follow-up of 19 +/- 10 months: one sudden death, two myocardial infarctions, and 22 cases of target vessel revascularization. Length of CTO > 24 mm (odds ratio = 1.06, p < 0.0245) and final minimal lumen diameter < or = 2.5 mm (odds ratio = 0.224, p < 0.01) were identified as independent predictors of late events. Conclusions. The results of current practice of stenting of CTO are encouraging. Only angiographic variables are predictive of long-term clinical outcome.


Assuntos
Estenose Coronária/cirurgia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
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