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 26â616 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.
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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 TratamentoRESUMO
INTRODUCTION: The safety and effectiveness of drug-eluting stent (DES) compared with bare metal stents (BMS) for the treatment of saphenous vein graft (SVG) disease is controversial, especially because of the lack of long-term follow-up. The aim of this study was to address the late outcome of DES versus BMS for the treatment of SVG lesions. METHODS: A matched, case-control study included 82 patients in each group. Patients groups were matched by gender, age, clinical presentation, and diabetes. The primary study end point was occurrence of major adverse cardiovascular events (MACE). Secondary end points included death, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). RESULTS: Clinical and angiographic characteristics were similar between the groups. At 6 months, TVR (hazard ratio [HR] 6.12, 95% confidence interval [CI] 1.39 to 26.93, P = 0.05), and MACE (HR 2.54, 95% CI 1.08 to 5.98, P = 0.04) were higher in the BMS group. At 4 years the risks of MI (P = 0.21), TVR (P = 0.99), and MACE (P = 0.21) were similar between both groups. However, the rates of death (HR 2.74, 95% CI 1.11 to 6.74, P = 0.04) and cardiac death (HR 4.26, 95% CI 1.59 to 11.35, P = 0.01) were significantly higher in the BMS group. CONCLUSIONS: These results suggest that the use of DES compared with BMS in the treatment of SVG lesions reduces TVR and MACE at 6 months of follow-up, a benefit that was lost over the next 3-4 years.
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Ponte de Artéria Coronária/efeitos adversos , Stents Farmacológicos , Oclusão de Enxerto Vascular/terapia , Metais , Intervenção Coronária Percutânea/instrumentação , Veia Safena/cirurgia , Stents , Idoso , Angiografia Coronária , Ponte de Artéria Coronária/mortalidade , Feminino , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/mortalidade , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Análise por Pareamento , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Veia Safena/diagnóstico por imagem , Veia Safena/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous™ endothelial progenitor cell capturing R stent™ placement in patients from the e-HEALING registry. BACKGROUND: Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended. METHODS: Patients were analyzed according to continuation or discontinuation of DAPT at a 30-day and 6-month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression. RESULTS: No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65-1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55-1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable. CONCLUSIONS: In a post-hoc analysis of e-HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding.
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Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Revascularização Miocárdica/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Vigilância de Produtos Comercializados/estatística & dados numéricos , Idoso , Bioengenharia , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Resultado do TratamentoRESUMO
The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.
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Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/normas , Reestenose Coronária/prevenção & controle , Estenose Coronária/terapia , Vasos Coronários/patologia , Células Endoteliais/patologia , Órgãos Governamentais/normas , Células-Tronco/patologia , Stents/normas , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Anticorpos/administração & dosagem , Antígenos CD34/imunologia , Materiais Revestidos Biocompatíveis/normas , Reestenose Coronária/etiologia , Reestenose Coronária/mortalidade , Reestenose Coronária/patologia , Estenose Coronária/mortalidade , Estenose Coronária/patologia , Vasos Coronários/imunologia , Células Endoteliais/imunologia , Feminino , Fidelidade a Diretrizes/normas , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Neointima , Seleção de Pacientes , Guias de Prática Clínica como Assunto/normas , Vigilância de Produtos Comercializados , Modelos de Riscos Proporcionais , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Células-Tronco/imunologia , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
New-generation drug-eluting stents (DES) strongly reduce restenosis and repeat revascularization compared with bare-metal stents (BMS) for percutaneous coronary intervention. There is residual uncertainty as to whether other prognostically relevant outcomes are affected by DES versus BMS concerning initial presentation (chronic coronary syndrome [CCS] vs acute coronary syndrome [ACS]). We performed an individual patient data meta-analysis of randomized trials comparing new-generation DES versus BMS (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction (MI). Outcomes were examined at maximum follow-up and with a 1-year landmark. Risk estimates are expressed as hazard ratio (HR) with 95% confidence interval (CI). A total of 22,319 patients were included across 14 trials; 7,691 patients (34.5%) with CCS and 14,628 patients (65.5%) with ACS. We found evidence that new-generation DES versus BMS consistently reduced the risk of cardiac death or MI in both patients with CCS (HR 0.83, 95% CI 0.70 to 0.98, p <0.001) and ACS (HR 0.83, 95% CI 0.75 to 0.92, p <0.001) (p-interaction = 0.931). This benefit was mainly driven by a similar reduction in the risk of MI (p-interaction = 0.898) for both subsets (HRCCS 0.80, 95% CI 0.65 to 0.97; HRACS 0.79, 95% CI 0.70 to 0.89). In CCS and ACS, we found a time-dependent treatment effect, with the benefit from DES accumulating during 1-year follow-up, without offsetting effects after that. In conclusion, patients with CCS were slightly underrepresented in comparative clinical trials. Still, they benefited similarly to patients with ACS from new-generation DES instead of BMS with a sustained reduction of cardiac death or MI because of lower event rates within 1 year.
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Síndrome Coronariana Aguda , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/complicações , Morte , Stents Farmacológicos/efeitos adversos , Humanos , Metais , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Risco , Stents/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: This study compared the 10-year follow-up of percutaneous coronary intervention (PCI), coronary artery surgery (CABG), and medical treatment (MT) in patients with multivessel coronary artery disease, stable angina, and preserved ventricular function. METHODS AND RESULTS: The primary end points were overall mortality, Q-wave myocardial infarction, or refractory angina that required revascularization. All data were analyzed according to the intention-to-treat principle. At a single institution, 611 patients were randomly assigned to CABG (n=203), PCI (n=205), or MT (n=203). The 10-year survival rates were 74.9% with CABG, 75.1% with PCI, and 69% with MT (P=0.089). The 10-year rates of myocardial infarction were 10.3% with CABG, 13.3% with PCI, and 20.7% with MT (P<0.010). The 10-year rates of additional revascularizations were 7.4% with CABG, 41.9% with PCI, and 39.4% with MT (P<0.001). Relative to the composite end point, Cox regression analysis showed a higher incidence of primary events in MT than in CABG (hazard ratio 2.35, 95% confidence interval 1.78 to 3.11) and in PCI than in CABG (hazard ratio 1.85, 95% confidence interval 1.39 to 2.47). Furthermore, 10-year rates of freedom from angina were 64% with CABG, 59% with PCI, and 43% with MT (P<0.001). CONCLUSIONS: Compared with CABG, MT was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularization, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events. PCI was associated with an increased need for further revascularization, a higher incidence of myocardial infarction, and a 1.46-fold increased risk of combined events compared with CABG. Additionally, CABG was better than MT at eliminating anginal symptoms. Clinical Trial Registration Information- URL: http://www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.
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Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença da Artéria Coronariana , Vasodilatadores/uso terapêutico , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Angioplastia Coronária com Balão/mortalidade , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervalo Livre de Doença , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous™ EPC capturing R stent™ during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. RESULTS: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).
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Doença da Artéria Coronariana/terapia , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Stents Farmacológicos , Idoso , Angioplastia Coronária com Balão , Estudos de Casos e Controles , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/prevenção & controle , Trombose Coronária/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Falha de Tratamento , Resultado do TratamentoRESUMO
BACKGROUND: We evaluated the Genous™ Bio-engineered R stent™ in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST). METHODS AND RESULTS: In the e-HEALING registry, 2,651 patients were <65, 1,403 were 65-74 and 869 were ≥ 75 years old. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related car-diac death or myocardial infarction and target vessel revascularization. Secondary outcomes included target lesion revascularization (TLR) and ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. TVF occurred significantly more often in elderly patients compared with younger patients (7.0% in patients aged < 65, 8.8% in patients aged 65-74 and 11.7% in patients aged ≥ 75 years, P<0.001). There was a trend to higher TLR with increasing age (log-rank P=0.06) and no difference in ST. CONCLUSIONS: The 1-year results of the Genous stent in a population of elderly patients show a significantly higher TVF rate compared with younger patients, mainly driven by a higher mortality. Although there was a trend to higher TLR rates with increasing age, there was no difference in ST. This attests to the safety of this therapy for the elderly, in whom there could be concerns with administering long-term dual antiplatelet therapy.
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Prótese Vascular/efeitos adversos , Infarto do Miocárdio , Vigilância de Produtos Comercializados , Sistema de Registros , Stents/efeitos adversos , Trombose , Fatores Etários , Idoso , Angioplastia Coronária com Balão , Clopidogrel , Morte , Feminino , Humanos , Masculino , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Fatores de Risco , Trombose/etiologia , Trombose/mortalidade , Trombose/prevenção & controle , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivadosRESUMO
Coronary artery fistulas, although rare, should be included in the differential diagnosis of atypical chest pain, generally unveiled by cardiac catheterization or multidetector computed tomography. Such anatomical findings in conjunction with detectable ischemia and severe symptoms should prompt their closure. Transcatheter closure of fistulas is an attractive alternative to surgery, especially with the novel devices such as the interlock fibered detachable coils, which can be safely and effectively performed in a variety of circumstances, including the coronary arteries with tortuous anatomies. We present a case of atypical chest pain and large burden of ischemia in the stress scintigraphy, due to multiple coronary fistulas to the bronchial arteries successfully occluded with percutaneous interlock coils.
RESUMO
BACKGROUND Coronary artery anomalies (CAAs) are rare congenital malformations with different clinical presentations and pathophysiological mechanisms. These anomalies are frequently the cause of sudden death in young patients. Most CAAs are incidental findings owing to the lack of symptoms; however, they may be associated with acute coronary syndrome in rare cases. CASE REPORT We describe the case of a 47-year-old man who presented with a 1-day history of progressive typical chest pain and elevated troponin levels. The patient underwent a coronary angiography, which unveiled the anomalous origin of the left main coronary artery arising from the right coronary artery, with an interarterial course between the ascending aorta and the pulmonary artery, without coronary artery disease. Coronary computed tomography angiography confirmed the CAA and its relationship with the symptoms. An uneventful coronary artery bypass graft was undertaken, and at the 1-year follow-up, the patient was asymptomatic, with a normal stress test. CONCLUSIONS This case depicts the presentation of atypical acute coronary syndrome in a young patient with a rare CAA. In such patients, coronary angiography and coronary computed tomography angiography are essential tools to confirm the diagnosis and to determine treatment. Although controversial, in young individuals presenting CAA with an interarterial course, such as the left main coronary artery arising from the right coronary artery, coronary artery bypass graft may be an important treatment option to avoid sudden death in the future.
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Síndrome Coronariana Aguda , Doença da Artéria Coronariana , Anomalias dos Vasos Coronários , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/etiologia , Angiografia Coronária , Anomalias dos Vasos Coronários/diagnóstico , Anomalias dos Vasos Coronários/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.
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Doença da Artéria Coronariana , Stents Farmacológicos , Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Humanos , Polímeros , Desenho de Prótese , Resultado do TratamentoRESUMO
Background New-generation drug-eluting stents (DES) reduce target-vessel revascularization compared with bare-metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no-LAD/LM]). Methods and Results The Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1-stage individual patient data meta-analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no-LAD/LM group. At 6-year follow-up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel (P-interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68-0.85) than in the no-LAD/LM territories (HR, 0.93; 95% CI, 0.83-1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70-0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65-0.85) in patients with LAD/LM disease randomized to DES. An interaction (P=0.004) was also found for all-cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76-0.97). Conclusions As compared with BMS, new-generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses. Registration URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42017060520.
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Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Desenho de Prótese , Doença da Artéria Coronariana/terapia , Morte , Humanos , Metais , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Stents , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD). BACKGROUND: Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far. METHODS: The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months. RESULTS: From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred. CONCLUSIONS: Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).
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Doença da Artéria Coronariana , Aspirina , Stents Farmacológicos , Humanos , Intervenção Coronária Percutânea , Projetos Piloto , Inibidores da Agregação Plaquetária , Cloridrato de Prasugrel , Resultado do TratamentoRESUMO
OBJECTIVES: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). BACKGROUND: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. METHODS: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. RESULTS: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. CONCLUSION: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Stents Farmacológicos , Metais , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Stents , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Brasil/epidemiologia , Doenças Cardiovasculares/diagnóstico por imagem , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/prevenção & controle , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Feminino , Humanos , Hiperplasia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Modelos de Riscos Proporcionais , Desenho de Prótese , Medição de Risco , Trombose/etiologia , Trombose/prevenção & controle , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Diabetes mellitus (DM) is associated with complex coronary artery disease (CAD), which in turn results in increased morbidity and mortality from cardiovascular disease. OBJECTIVES: This study sought to evaluate the utility of SYNTAX score (SS) for predicting future cardiovascular events in patients with DM and complex CAD undergoing either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS: The FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial randomized patients with DM and multivessel CAD to undergo either PCI with drug-eluting stents or CABG. The SS was calculated retrospectively by a core laboratory. The endpoint of hard cardiovascular events (HCE) was a composite of death from any cause, nonfatal myocardial infarction, and nonfatal stroke, while the endpoint of major adverse cardiac and cerebrovascular events (MACCE) was a composite of HCE and repeat revascularization. RESULTS: A total of 1,900 patients were randomized to PCI (n = 953) or CABG (n = 947). The SS was considered an independent predictor of 5-year MACCE (hazard ratio per unit of SS: 1.02; 95% confidence interval: 1.00 to 1.03; p = 0.014) and HCE (hazard ratio per unit of SS: 1.03; 95% confidence interval: 1.01 to 1.04; p = 0.002) in the PCI cohort, but not in the CABG group. There was a higher incidence of MACCE in PCI patients with low, intermediate, and high SS compared with those who underwent CABG (36.6% vs. 25.9%, p = 0.02; 43.9% vs. 26.8%, p < 0.001; 48.7% vs. 29.7%, p = 0.003, respectively). CONCLUSIONS: In DM patients with multivessel CAD, the complexity of CAD evaluated by the SS is an independent risk factor for MACCE and HCE only in patients undergoing PCI. The SS should not be utilized to guide the choice of coronary revascularization in patients with DM and multivessel CAD. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
Assuntos
Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/cirurgia , Revascularização Miocárdica/tendências , Intervenção Coronária Percutânea/tendências , Idoso , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus/fisiopatologia , Stents Farmacológicos/tendências , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: The National Cardiovascular Data Registry (NCDR®) Database is commonly used for quality-improvement initiatives in North America, but little is known about the application of this tool in other regions of the world. METHODS: All consecutive patients admitted due to myocardial infarction (MI) and/or undergoing percutaneous coronary intervention (PCI) from January 2012 until December 2015 in a Brazilian private cardiovascular hospital were included respectively in ACTION REGISTRY®-GWTG™ and CathPCI Registry®. Meetings including all hospital staff were performed quarterly to discuss every NCDR® report. Quality improvement initiatives were developed based on the reports which were also used for evaluation of changes after the interventions. The following indicators were considered a priority 1) Door-to-ECG and door-to-balloon (D2B) times; 2) PCI appropriateness; 3) length of stay; 4) delivery of guideline-based medication. Changes in the quality of care with respect to the over time were assessed using linear and logistic regression for continuous and binary outcomes, respectively. RESULTS: A total of 1.382 patients were included in the ACTION REGISTRY®-GWTG™ and 3.179 patients in the CathPCI Registry®. In the ACTION registry, the overall AMI performance composite of quality indicators improved along the 4â¯years from 95.0% to 99.6% (p for trend <0.001). The percentage of appropriate/uncertain PCI in acute and elective scenario increased along the years from 91.1% and 70.9% to 96.6% and 84.7%, respectively (p for trend <0.001). CONCLUSION: The present novel experience using the NCDR® registries as benchmarks to guide quality-improvement programs in an international site was associated with improvement in quality indicators.
Assuntos
Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Melhoria de Qualidade/organização & administração , Indicadores de Qualidade em Assistência à Saúde/normas , Idoso , Brasil/epidemiologia , Feminino , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Tempo de Internação/estatística & dados numéricos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Medição de Risco , Fatores de Risco , Tempo para o Tratamento/normas , Tempo para o Tratamento/estatística & dados numéricosRESUMO
Coronary artery anomalies (CAA) are congenital changes in their origin, course, and/or structure. Intercoronary communication (ICC) is a very rare subset with uni- or bidirectional blood flow between two or more coronary arteries. We present the case of a 58-year-old man with an acute coronary syndrome whose coronary angiography incidentally showed a surprising and very rare communication between the right coronary and left circumflex arteries.
RESUMO
Primary cardiac tumors are rare and approximately half of them are atrial myxomas. They rarely remain asymptomatic, especially if large. The imaging of a myxoma by contrast dye during coronary angiography is an infrequent sign, which clarifies the vascular supply of the tumor. We report herein an interesting and rare case of a left atrial myxoma hypervascularized from the right coronary artery.
RESUMO
Coronary artery anomalies are congenital changes in their origin, course, and/or structure. They are the second most frequent cause of sudden death in young athletes. Dual LAD artery is a rare coronary anomaly. We present the case of a 44-year-old man with recent onset exertional angina and documented ischemia whose coronary angiogram and computed tomography (CT) showed type 4 dual LAD artery, the rarest and most interesting variant.
RESUMO
Aneurysms of the sinus of Valsalva are very rare and mostly located in the right coronary sinus. They might course with dyspnea, fatigue, and acute coronary syndromes. We present herein an extremely rare case report of a 61-year-old woman diagnosed with external left main coronary compression by a giant aneurysm of the left sinus of Valsalva, which was successfully managed with percutaneous coronary intervention.