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1.
Artigo em Inglês | MEDLINE | ID: mdl-32150341

RESUMO

OBJECTIVES: To define the impact of side branch (SB) lesion length on clinical outcomes after percutaneous coronary intervention (PCI) on bifurcation lesions. BACKGROUND: The role of the SB lesion length remains questionable in PCI planning and its implication on clinical outcome is controversial. METHODS: Data from the retrospective multicenter EBC-P2BiTO registry were analyzed. The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction excluding periprocedural, or stent thrombosis at 13 months median follow-up (IQR 11-28). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. RESULTS: Among 1,252 patients, SB was normal in 489 (39%), diseased in 763 (61%) cases. MACE occurred in 68 patients (5.4%). The optimal discriminant SB lesion length for MACE was ≥10 mm, with an area under the curve of 0.71 (p < .01). The incidence of MACE was higher among patients with SB lesions ≥10 mm (8%) than with normal SB (4.1%) (hazard ratio [HR], 2.8; 95% confidence interval [CI], 1.5-5.3; p = .001, IPTW-adjusted) or SB lesions <10 mm (5.1%) (HR, 1.5; 95% CI, 1.1-3.3; p = .048, IPTW-adjusted), being similar between these last two groups. CONCLUSIONS: In bifurcation PCI, SB lesion length ≥ 10 mm identifies patients at higher risk of MACE than those with <10 mm SB lesions and those without SB disease, considering that no differences were observed among these last two groups. Careful planning is mandatory when approaching bifurcations with long SB lesions.

2.
J Clin Med ; 8(12)2019 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-31810363

RESUMO

We aimed to investigate the predictive value of 24 h blood pressure (BP) patterns on adverse cardiovascular (CV) outcome in the initially untreated hypertensive patients during long-term follow-up. This study included 533 initially untreated hypertensive patients who were involved in this study in the period between 2007 and 2012. All participants underwent laboratory analysis, 24 h BP monitoring, and echocardiographic examination at baseline. The patients were followed for a median period of nine years. The adverse outcome was defined as the hospitalization due to CV events (atrial fibrillation, myocardial infarction, myocardial revascularization, heart failure, stroke, or CV death). During the nine-year follow-up period, adverse CV events occurred in 85 hypertensive patients. Nighttime SBP, non-dipping BP pattern, LV hypertrophy (LVH), left atrial enlargement (LAE), and LV diastolic dysfunction (LV DD) were risk factors for occurrence of CV events. However, nighttime SBP, non-dipping BP pattern, LVH, and LV DD were the only independent predictors of CV events. When all four BP pattern were included in the model, non-dipping and reverse dipping BP patterns were associated with CV events, but only reverse-dipping BP pattern was independent predictor of CV events. The current study showed that reverse-dipping BP pattern was predictor of adverse CV events independently of nighttime SBP and LV remodeling during long-term follow-up. The assessment of BP patterns has very important role in the long-time prediction in hypertensive population.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31613046

RESUMO

OBJECTIVES: To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes. BACKGROUND: For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain. METHODS: Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores. RESULTS: In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure. CONCLUSIONS: Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year.

4.
N. Engl. j. med ; 381(15): 1411-1421, Oct., 2019. tab., graf.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1023106

RESUMO

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P=0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P=0.62 and P=0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.). (AU)


Assuntos
Intervenção Coronária Percutânea , Infarto do Miocárdio , Revascularização Miocárdica
5.
N Engl J Med ; 381(15): 1411-1421, 2019 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-31475795

RESUMO

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).


Assuntos
Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Idoso , Doenças Cardiovasculares/mortalidade , Terapia Combinada , Doença da Artéria Coronariana/complicações , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Recidiva , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Prevenção Secundária , Stents
6.
Lancet ; 394(10207): 1415-1424, 2019 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-31500849

RESUMO

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.


Assuntos
Precondicionamento Isquêmico Miocárdico/métodos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Idoso , Terapia Combinada , Morte Súbita Cardíaca/prevenção & controle , Feminino , Insuficiência Cardíaca/etiologia , Hospitalização , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/cirurgia , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento , Reino Unido
7.
Can J Cardiol ; 35(10): 1377-1385, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31492492

RESUMO

BACKGROUND: Robust comparisons between oral P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in ST-elevation myocardial infarction (STEMI) patients who undergo primary percutaneous coronary intervention are lacking. We sought to evaluate outcomes on the basis of P2Y12 inhibitor therapy in patients from the Thrombectomy With PCI Versus PCI Alone in Patients With STEMI Undergoing Primary PCI (TOTAL) trial. METHODS: We grouped 9932 patients according to P2Y12 inhibitor at hospital discharge: clopidogrel (n = 6500; 65.5%), prasugrel (n = 1244; 12.5%), or ticagrelor (n = 2188; 22.0%). The primary composite end point of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure was examined at 1 year. Secondary efficacy and safety end points were also assessed. Cox proportional hazard ratios were determined and adjusted for confounders via propensity scoring. RESULTS: Baseline characteristics differing between the 3 groups were mainly age 75 years or older, diabetes, and previous stroke. After adjustment, ticagrelor use was associated with a lower rate of the primary composite outcome compared with clopidogrel (adjusted hazard ratio [aHR], 0.72; 95% confidence interval [CI], 0.57-0.91; P < 0.02) and prasugrel (aHR, 0.65; 95% CI, 0.48-0.89; P = 0.02). Prasugrel use was not associated with a lower rate of the primary outcome compared with clopidogrel (aHR, 1.09; 95% CI, 0.86-1.39; P > 0.99). Neither prasugrel nor ticagrelor were associated with increased risk of stroke compared with clopidogrel. Compared with clopidogrel, ticagrelor was associated with significantly lower rates of major bleeding. CONCLUSIONS: In this observational analysis of STEMI patients who underwent primary percutaneous coronary intervention, ticagrelor was associated with improved outcomes compared with clopidogrel and prasugrel. An appropriately powered randomized trial is needed to confirm these findings.

8.
Clin Biochem ; 73: 70-76, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31386834

RESUMO

BACKGROUND: Chromosomal region 9p21.3 is most robustly associated with coronary artery disease (CAD) in western European populations. However, heterogeneity in CAD phenotypes leads to uncertainty whether 9p21.3 is associated with stable and/or acute clinical presentations of CAD. 9p21.3 is rich in regulatory elements, but the underlying mechanisms of its actions in CAD remain unclear. We investigate the association of 9p21.3 two haplotype blocks lead variants (rs10757278 and rs518394) with first-ever non-fatal myocardial infarction (MI) in CAD patients and their association with CDKN2B mRNA expression in peripheral blood mononuclear cells 6 months after the event. METHODS: We included CAD patients with sustained first MI (n = 523) and controls (n = 583). Gene expression was assessed in 72 patients 6 months after MI and 43 healthy controls. TaqMan® technology was used for the gene expression and genotyping analysis. RESULTS: CDKN2B mRNA was significantly lower in MI patients compared with the controls (p = 0.002) and in patients carrying the rs10757278 G risk allele versus AA homozygotes (p = 0.012) 6 months after the event. While we confirmed the association of rs10757278 with CDKN2B expression in MI patients, we failed to find an association between the investigated variants and MI or disease burden. CONCLUSIONS: We suggest a dysregulation of gene expression in the 9p21.3 region six months after acute MI, which is affected by a genetic variant in patients. The rs10757278 rare allele is one factor that might lead to prolonged risk for proatherogenic complications.


Assuntos
Cromossomos Humanos Par 9/genética , Doença da Artéria Coronariana , Inibidor de Quinase Dependente de Ciclina p15/biossíntese , Regulação da Expressão Gênica , Haplótipos , Infarto do Miocárdio , Elementos de Resposta , Adulto , Idoso , Alelos , Cromossomos Humanos Par 9/metabolismo , Doença da Artéria Coronariana/enzimologia , Doença da Artéria Coronariana/genética , Inibidor de Quinase Dependente de Ciclina p15/genética , Feminino , Seguimentos , Homozigoto , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/enzimologia , Infarto do Miocárdio/genética
9.
Cells ; 8(6)2019 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-31208049

RESUMO

Parkinson's disease is associated with an increased risk of melanoma (and vice versa). Several hypotheses underline this link, such as pathways affecting both melanin and neuromelanin. For the first time, the fluorescence of melanin and neuromelanin is selectively accessible using a new method of nonlinear spectroscopy, based on a stepwise two-photon excitation. Cutaneous pigmentation and postmortem neuromelanin of Parkinson patients were characterized by fluorescence spectra and compared with controls. Spectral differences could not be documented, implying that there is neither a Parkinson fingerprint in cutaneous melanin spectra nor a melanin-associated fingerprint indicating an increased melanoma risk. Our measurements suggest that Parkinson's disease occurs without a configuration change of neuromelanin. However, Parkinson patients displayed the same dermatofluorescence spectroscopic fingerprint of a local malignant transformation as controls. This is the first comparative retrospective fluorescence analysis of cutaneous melanin and postmortem neuromelanin based on nonlinear spectroscopy in patients with Parkinson's disease and controls, and this method is a very suitable diagnostic tool for melanoma screening and early detection in Parkinson patients. Our results suggest a non-pigmentary pathway as the main link between Parkinson's disease and melanoma, and they do not rule out the melanocortin-1-receptor gene as an additional bridge between both diseases.


Assuntos
Melaninas/metabolismo , Melanoma/patologia , Doença de Parkinson/metabolismo , Adulto , Idoso , Idoso de 80 Anos ou mais , Animais , Encéfalo/patologia , Estudos de Casos e Controles , Feminino , Fluorescência , Humanos , Masculino , Pessoa de Meia-Idade , Mudanças Depois da Morte , Fatores de Risco , Pele/patologia , Pigmentação da Pele , Substância Negra/patologia
10.
Lancet ; 393(10190): 2503-2510, Jun. 2019. tabela, gráfico
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1046380

RESUMO

Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.Methods We did an individual patient data meta-analysis of randomized clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.Findings We obtained individual data for 26 616 patients in 20 randomized trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78­0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71­0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78­1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88­1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50­0·80, p<0·001) and target-vessel revascularization (0·55, 0·50­0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. Interpretation The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. (AU)


Assuntos
Angioplastia Coronária com Balão , Stents Metálicos Autoexpansíveis
11.
EuroIntervention ; 15(1): 90-98, 2019 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-31105066

RESUMO

The European Bifurcation Club recommends an approach to a bifurcation stenosis which involves careful assessment, planning and a sequential provisional approach. In the minority of lesions where two stents are required, careful deployment and optimal expansion are essential to achieve a long-term result.


Assuntos
Estenose Coronária , Intervenção Coronária Percutânea , Consenso , Angiografia Coronária , Humanos , Stents , Resultado do Tratamento
12.
Lancet ; 393(10190): 2503-2510, 2019 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-31056295

RESUMO

BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital.


Assuntos
Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/instrumentação , Stents/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Stents Farmacológicos/efeitos adversos , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Razão de Chances , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Resultado do Tratamento
13.
Heart ; 105(20): 1568-1574, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31129612

RESUMO

OBJECTIVES: The influence of the bleeding site on long-term survival after the primary percutaneous coronary intervention (PCI) is poorly understood. This study sought to investigate the relationship between in-hospital access site versus non-access site bleeding and very late mortality in unselected patients treated with primary PCI. METHODS: Data of the 2715 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI, enrolled in a prospective registry of a high volume tertiary centre, were analysed. Bleeding events were assessed according to the Bleeding Academic Research Consortium (BARC) criteria. The primary outcome was 4-year mortality. RESULTS: The BARC type ≥2 bleeding occurred in 171 patients (6.3%). Access site bleeding occurred in 3.8%, and non-access site bleeding in 2.5% of patients. Four-year mortality was significantly higher for patients with bleeding (BARC type ≥2) than in patients without bleeding (BARC type 0+1), (36.3% vs 16.2%, p<0.001). Patients with non-access site bleeding had higher 4 year mortality (50.7% vs 26.5%, p=0.001). After multivariable adjustment, BARC type ≥2 bleeding was the independent predictor of 4 year mortality (HR 2.01; 95% CI 1.49 to 2.71, p<0.001). Patients with a non-access site bleeding were at 2-fold higher risk of very late mortality than patients with an access site bleeding (HR 2.62; 1.78 to 3.86, p<0.001 vs HR 1.57; 1.03 to 2.38, p=0.034). CONCLUSIONS: Both access and non-access site BARC type ≥2 bleeding is independently associated with a high risk of 4-year mortality after primary PCI. Patients with non-access site bleeding were at higher risk of late mortality than patients with access site bleeding.

14.
Pulse (Basel) ; 6(3-4): 137-143, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31049313

RESUMO

Background/Aims: We assessed the feasibility of renal sympathetic denervation (RDN) treatment in patients with resistant hypertension using the Iberis® RDN system. This study was a prospective, multicenter, single-arm feasibility registry. Methods: We collected data from patients who underwent RDN treatment using the Iberis system. From November 2014 to February 2016, 16 patients from 6 centers in Europe were enrolled in this registry. Results: Consistent reductions in the 24-h systolic blood pressure (SBP) and diastolic blood pressure were obtained. At any follow-up point, more than 70% of the patients were responders. The change in the 24-h SBP at 1 month was strongly correlated with that at 12 months. Conclusion: The Iberis system is safe and effective in patients for the treatment of resistant hypertension. Furthermore, our results suggest that we can estimate the effect of RDN in the long term at the 1-month follow-up point using the 24-h SBP.

15.
Int. j. cardiol ; 15(283): 78-83, Maio 2019. tabela, gráfico
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1023866

RESUMO

BACKGROUND: The optimal treatment of patients undergoing percutaneous coronary interventions (PCI) for lesions located at coronary bifurcations is still debated. METHODS: Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centers between January 2012 and December 2014 were collected. RESULTS: Follow-up at a median 18 months (IQR 11-28) was available for 4506 patients (89%). Major Adverse Cardiac Events (MACE) occurred in 395 patients (8.8%): cardiac death in 152 (3.4%), myocardial infarction, excluding periprocedural, in 156 (3.5%) and stent thrombosis in 110 cases (2.4%). At multivariable Cox regression, left ventricular ejection fraction ≤30% (P < 0.001), bail-out stenting (beyond a planned strategy of either single or double stenting) (P < 0.001), admission for an acute coronary syndrome (P < 0.001), age >66 years (P < 0.001), multivessel disease (P < 0.001) and diabetes (P < 0.001) were independently associated with MACE. Sensitivity analysis identified premature discontinuation of dual antiplatelet therapy (DAPT) (P < 0.001) and side branch (SB) lesion length ≥9 mm (P < 0.05) as additional independent predictors of MACE. CONCLUSIONS: Beyond traditional risk factors, multivessel disease, the length of the SB lesion, "bail-out" stenting and premature DAPT discontinuation are independent predictors of mid-term MACE after PCI of coronary bifurcations. This highlights the importance of a carefully planned PCI strategy and adequate therapy adherence to improve the clinical outcomes in these patients. (AU)


Assuntos
Humanos , Stents Farmacológicos , Intervenção Coronária Percutânea , Avaliação de Resultados em Cuidados de Saúde
16.
Am Heart J ; 209: 97-105, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30703644

RESUMO

BACKGROUND: The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. DESIGN: MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. CONCLUSIONS: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.


Assuntos
Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Hemorragia Pós-Operatória/terapia , Idoso de 80 Anos ou mais , Feminino , Humanos , Imunossupressores/farmacologia , Masculino , Intervenção Coronária Percutânea/métodos , Hemorragia Pós-Operatória/etiologia , Sirolimo/farmacologia
17.
EuroIntervention ; 14(15): e1568-e1577, 2019 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-30479307

RESUMO

Coronary artery bifurcation lesions comprise approximately 15-20% of all percutaneous coronary interventions (PCI) and constitute a complex lesion subgroup. Intravascular optical coherence tomography (OCT) is a promising adjunctive tool for guiding coronary bifurcation with its unrivalled high resolution. Compared to angiography, intravascular OCT has a clear advantage in that it depicts ostial lesion(s) in bifurcation without the misleading two-dimensional appearance of conventional angiography such as overlap and foreshortening. In addition, OCT has the ability to reconstruct a bifurcation in three dimensions and to assess the side branch ostium from 3D reconstruction of the main vessel pullback, which can be applied to ensure the optimal recrossing position of the wire after main vessel stenting. Recently, online co-registration of OCT and angiography became widely available, helping the operator to position a stent in precise landing zones, reducing the risk of geographic miss. Despite these technological advances, the currently available clinical data are based mainly on observational studies with a small number of patients; there is little evidence from randomised trials. The joint working group of the European Bifurcation Club and the Japanese Bifurcation Club reviewed all the available literature regarding OCT use in bifurcation lesions and here provides recommendations on OCT guiding of coronary interventions in bifurcation lesions.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Tomografia de Coerência Óptica , Consenso , Angiografia Coronária , Vasos Coronários , Humanos , Japão , Stents , Resultado do Tratamento
18.
Int J Cardiol ; 283: 78-83, 2019 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-30528620

RESUMO

BACKGROUND: The optimal treatment of patients undergoing percutaneous coronary interventions (PCI) for lesions located at coronary bifurcations is still debated. METHODS: Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centers between January 2012 and December 2014 were collected. RESULTS: Follow-up at a median 18 months (IQR 11-28) was available for 4506 patients (89%). Major Adverse Cardiac Events (MACE) occurred in 395 patients (8.8%): cardiac death in 152 (3.4%), myocardial infarction, excluding periprocedural, in 156 (3.5%) and stent thrombosis in 110 cases (2.4%). At multivariable Cox regression, left ventricular ejection fraction ≤30% (P < 0.001), bail-out stenting (beyond a planned strategy of either single or double stenting) (P < 0.001), admission for an acute coronary syndrome (P < 0.001), age >66 years (P < 0.001), multivessel disease (P < 0.001) and diabetes (P < 0.001) were independently associated with MACE. Sensitivity analysis identified premature discontinuation of dual antiplatelet therapy (DAPT) (P < 0.001) and side branch (SB) lesion length ≥9 mm (P < 0.05) as additional independent predictors of MACE. CONCLUSIONS: Beyond traditional risk factors, multivessel disease, the length of the SB lesion, "bail-out" stenting and premature DAPT discontinuation are independent predictors of mid-term MACE after PCI of coronary bifurcations. This highlights the importance of a carefully planned PCI strategy and adequate therapy adherence to improve the clinical outcomes in these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01967615.


Assuntos
Doença da Artéria Coronariana/cirurgia , Vasos Coronários/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Medição de Risco/métodos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Vasos Coronários/diagnóstico por imagem , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
19.
Catheter Cardiovasc Interv ; 93(1): 57-63, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30291669

RESUMO

OBJECTIVES AND BACKGROUND: We attempted to test the feasibility of application of the MADS classification system in the largest stent trial to date and evaluate the preliminary clinical implications of this approach. METHODS: In the randomized GLOBAL LEADERS trial, testing two different antiplatelet strategies in patients undergoing PCI with bivalirudin and biolimus-eluting stents, the e-CRF was dedicated to bifurcation treatment according to the MADS classification. Based on this e-CRF, the techniques used for bifurcations treatment in GLOBAL LEADERS were described and compared with two large, all-comer registries of bifurcations treatment (I-BIGIS and COBIS), used as historical controls. RESULTS: Among 15,991 patients enrolled in the trial, 22,921 lesions treated at the index and staged procedure were available for analysis and 2,757 of these lesions were bifurcations and 7 were trifurcation lesions. The e-CRF-based MADS classification was achieved in 2,757 of these lesions (100%). 80.3% of bifurcations were treated using a single stent, 18.9% using 2 stents and 0.7% using 3 stents. Overall, the "main across side first" approach (A) was used in 77.4% with the "side branch first" approach (S) being the second most frequently used technique (10.2%). A single stent was used in the majority of the "A" approach (87.9%). A reduction in the use of 2-stent techniques (from 33.9 to 18.9%) was observed between GLOBAL LEADERS and I-BIGIS. The "A" approach was the most frequently used technique in GLOBAL LEADERS, while in COBIS the "S" strategy was most frequently employed. CONCLUSIONS: Application of the MADS classification through an e-CRF was feasible in the largest stent trial today and provided useful information about the trends observed overtime in the treatment of bifurcation lesions.


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Terminologia como Assunto , Antitrombinas/uso terapêutico , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/classificação , Estudos de Viabilidade , Hirudinas , Humanos , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/uso terapêutico , Valor Preditivo dos Testes , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/uso terapêutico , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados , Resultado do Tratamento
20.
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
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