RESUMEN
BACKGROUND: Tremendous efforts have been made to establish the concept of vascular restoration therapy with a fully bioresorbable scaffold for coronary artery disease. With an improved scaffold design and technologies, the novel NeoVas scaffold has shown promising clinical performance at 6 months follow-up. OBJECTIVE: The aim of this study was to investigate the 1 year clinical outcomes and multislice computed tomography (MSCT) angiographic results after implantation of the NeoVas scaffold in patients with single de novo coronary artery lesions. METHODS: The NeoVas first-in-man study was a prospective, two-center, single-arm study enrolling 31 patients who were eligible for the treatment. The composite endpoint of target lesion failure (TLF)-defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (TLR)-was assessed. Of the 31 patients scheduled for 1 year clinical follow-up, 29 patients received MSCT examinations. RESULTS: At 1 year follow-up, there was only 1 (3.2%) TLF, attributed to 1 patient who suffered ischemia-driven TLR at 181 days postprocedure. No cardiac deaths or scaffold thrombosis were observed. MSCT analysis demonstrated excellent vessel patency, with a median in-scaffold lumen area of 10.6 mm2 (interquartile range [IQR]: 8.2-11.7 mm2 ) and a minimal lumen diameter of 2.7 mm (IQR: 2.4-3.0 mm). CONCLUSIONS: This study demonstrated the safety and efficacy of the NeoVas scaffold for patients with single de novo coronary artery lesions at 1 year of follow-up. Noninvasive MSCT data confirmed vessel patency and the maintenance of vessel dimensions following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold.
Asunto(s)
Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Angiografía por Tomografía Computarizada , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Tomografía Computarizada Multidetector , Intervención Coronaria Percutánea/instrumentación , Sirolimus/administración & dosificación , Anciano , Fármacos Cardiovasculares/efectos adversos , China , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Sirolimus/efectos adversos , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Ultrasonografía Intervencional , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: To investigate the clinical outcomes influenced by distal extension of false lumen in acute type B aortic dissection (TBAD) patients following thoracic endovascular aortic repair (TEVAR). METHODS: From April 2002 to January 2013, 264 TBAD patients treated with TEVAR were retrospectively enrolled. The IIIa group exhibited a distal false lumen above the diaphragm (n = 70), and the IIIb group exhibited a distal false lumen under the diaphragm (n = 194). The morphological characteristics and adverse events (30-day and >30 days) were recorded and evaluated. RESULTS: There were no significant differences between the two groups regarding the demographics, comorbidity profiles, or initial feature of computed tomography angiography. The incidence of true lumen compression and branch involvement were significantly increased in the IIIb group compared with the IIIa group (8.6% vs. 25.3%, respectively; 15.7% vs. 36.1%, respectively, both P < 0.05). The 30-day mortality rate was 1.0% (2/194) in the IIIb group, whereas the IIIa group was zero. The incidence of early adverse events, the 5-year cumulative freedom from adverse events, and the 5-year cumulative freedom from all-cause mortality rate were not significantly different between the IIIa and IIIb groups (2.9% vs. 6.7%, 81.4%, and 80.4%, and 95.7% vs. 93.8%, respectively, all P > 0.05). Log-rank tests also indicated there was no significant difference. CONCLUSIONS: There was no significant difference between the IIIa and IIIb groups in the 5-year morality and adverse aortic events following TEVAR. The distal extension of false lumen prior to TEVAR does not influence the long-term morality and adverse aortic events in acute TBAD.
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Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/cirugía , Disección Aórtica/cirugía , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Complicaciones Posoperatorias/etiología , Enfermedad Aguda , Anciano , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/mortalidad , Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/mortalidad , Distribución de Chi-Cuadrado , Angiografía por Tomografía Computarizada , Dilatación Patológica , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Análisis Multivariante , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/mortalidad , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains controversial. The primary aim of our study was to evaluate the impact of optimal DAPT duration on bleeding events between 6 and 12 months after biodegradable polymer-coated DES implantation. The secondary aim is to determine the predictors and prognostic implications of bleeding. METHODS: This study is a post hoc analysis of the Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents (CREATE) study population. A total of 2,040 patients surviving at 6 months were studied, including 1,639 (80.3%) who had received 6-month DAPT and 401 (19.7%) who had received DAPT greater than 6 months. Bleeding events were defined according to the bleeding academic research consortium (BARC) definitions as described previously and were classified as major/minor (BARC 2-5) and minimal (BARC 1). A left censored method with a landmark at 6 months was used to determine the incidence, predictors, and impact of bleeding on clinical prognosis between 6 and 12 months. RESULTS: At 1-year follow-up, patients who received prolonged DAPT longer than 6 months had a significantly higher incidence of overall (3.0% vs. 5.5%, P = 0.021) and major/minor bleeding (1.1% vs. 2.5%, P = 0.050) compared to the patients who received 6-month DAPT. Multivariate analysis showed that being elderly (OR = 1.882, 95% CI: 1.109-3.193, P = 0.019), having diabetes (OR = 1.735, 95% CI: 1.020-2.952, P = 0.042), having a history of coronary artery disease (OR = 2.163, 95% CI: 1.097-4.266, P = 0.026), and duration of DAPT longer than 6 months (OR = 1.814, 95% CI: 1.064-3.091, P = 0.029) were independent predictors of bleeding. Patients with bleeding events had a significantly higher incidence of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis. CONCLUSIONS: Prolonged DAPT (greater than 6 months) after biodegradable polymer-coated DES increases the risk of bleeding, and is associated with adverse cardiac events at 1-year follow-up. (J Interven Cardiol 2014;27:119-126).
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Stents Liberadores de Fármacos , Hemorragia/inducido químicamente , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Aspirina/administración & dosificación , Aspirina/efectos adversos , Plásticos Biodegradables , Clopidogrel , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ticlopidina/administración & dosificación , Ticlopidina/efectos adversos , Ticlopidina/análogos & derivadosRESUMEN
The importance of matrix metalloproteinase 8 (MMP8) expression during the progression of thoracic aortic dissection (TAD) has been recently emphasized. Genetic variations that affect proteinase expression or activity might contribute to the pathogenesis of TAD. In this study, we investigated whether the MMP8 C-799T genotype is associated with TAD. The frequency distributions of the MMP8 C-799T polymorphism were determined by direct sequencing. Associations between the polymorphism and disease progression in TAD were investigated. The level of plasma and tissue MMP8 was measured by enzyme-linked immunosorbent assay and western blotting. The MMP8 C-799T polymorphism was significantly associated with susceptibility to disease progression in TAD patients (n = 152) than in controls (n = 147) (P = 0.004, OR = 0.62, 95 % CI 0.45-0.86). The TT homozygotes had a significantly higher risk of TAD compared to C allele carriers in a logistic regression model, after adjustment for the conventional risk factors for TAD. The plasma MMP8 concentration was significantly higher in TAD patients compared to control patients (P < 0.05). TT genotypes had increased MMP8 levels compared to CC and CT genotype carriers in both TAD and control subjects (P < 0.05). The C-799T polymorphism in the MMP8 promoter is part of the genetic variation underlying the susceptibility of individuals to the progression of TAD.
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Aorta Torácica/patología , Disección Aórtica/genética , Pueblo Asiatico/genética , Etnicidad/genética , Predisposición Genética a la Enfermedad , Metaloproteinasa 8 de la Matriz/genética , Polimorfismo de Nucleótido Simple/genética , Disección Aórtica/enzimología , Aorta Torácica/enzimología , Western Blotting , Estudios de Casos y Controles , Demografía , Ensayo de Inmunoadsorción Enzimática , Femenino , Frecuencia de los Genes/genética , Humanos , Masculino , Persona de Mediana Edad , Factores de RiesgoRESUMEN
OBJECTIVE: To evaluate the efficacy and safety of intra-aortic balloon pump (IABP) counter pulsation in the treatment of ST-segment elevation myocardial infarction (STEMI) with concurrent left main coronary artery (LMCA) disease. METHODS: A retrospective analysis was performed on 305 patients with confirmed STEMI due to LMCA occlusion (≥ 50%) by coronary angiography. They were divided into IABP and non-IABP groups according to the application of IABP or not. Two groups were further divided into 2 subgroups according to the treatment with percutaneous coronary intervention (PCI) or drug alone. Short and long-term clinical efficacies and the incidence of complications caused by the application of IABP were analyzed in all groups and subgroups. RESULTS: (1) PCI procedure: Successful rate of immediate post-procedure was 100%. No death, major cardiovascular event and cerebrovascular accident occurred during the procedure. The average number of stents per patient was 2.1 ± 0.7 and the average diameter and length of stent were (3.9 ± 0.6) and (24.2 ± 7.1) mm respectively. (2) SAFETY: No significant difference existed between the IABP and non-IABP groups in in-hospital massive bleeding rate (0.94% vs 1.00%, P > 0.05). However, the IABP group had a higher prevalence of mild in-hospital bleeding than the non-IABP group. (3) In-hospital and long-term major adverse cardiac event (MACE) rate: (1) IABP group had a lower MACE rate (25.3% (24/95) vs 38.5% (57/148), P < 0.05). (2) In spite of IABP implantation, the PCI subgroup had significantly a lower mortality rate than the drug subgroup (7.2% (6/83) vs 25.0% (6/24), P < 0.05). (3) The combined use of PCI and IABP was superior to other regimens with regards to decreasing short and long-term mortality (11.2% (12/107) and 25.3% (50/198), P < 0.01). CONCLUSION: PCI is feasible and safe for the STEMI patients with LMCA and better short and long-term efficacies may be achieved. The use of IABP in the treatment of LMCA-related STEMI reduces MACE rate and improves survival rate.
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Enfermedad de la Arteria Coronaria/terapia , Contrapulsador Intraaórtico , Infarto del Miocardio/terapia , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To explore the effects of intensive antiplatelet therapy for patients with high on-treatment platelet reactivity (HPR) after coronary stent implantation. METHODS: Between March 2009 and February 2011, a total of 3316 consecutive acute coronary syndrome patients undergoing drug-eluting stent implanting from 3 hospitals were enrolled. Among them, 840 patients (25.3%) were identified as HPR (defined as 20 µmol/L adenosine diphosphate induced platelet aggregation of ≥ 55% at 24 hours after administration of 300 mg clopidogrel loading dose and 300 mg aspirin). The HPR patients were randomly assigned to receive standard (aspirin 300 mg/d and clopidogrel 75 mg/d, n = 280) or intensified (n = 560) antiplatelet therapy by the ratio of 1:2. Patients in the intensive group were initially treated with a double maintenance dose of clopidogrel (150 mg/d) and aspirin (300 mg/d). After 3 days, patients with unsolved HPR received additional cilostazol treatment (50 - 100 mg, bid). The reversion rate of HPR and clinical events were observed. RESULTS: In the intensive group, HPR reversed in 304 out of 560 patients (54.3%) at 3 days post therapy and the remaining 256 patients with HPR were treated with additional cilostazol regimen for another 3 days and the total reversion rate of HPR was 81.1% (454/560). The reversion rate of HPR at 30 days in the intensified group was significantly higher than that of the standard group (69.9% vs. 55.7%, P = 0.000). At 30 days after percutaneous coronary intervention, 1 patient suffered from subacute stent thrombosis (0.2%) in intensified group and no stent thrombosis was observed in standard group (P = 1.000). There were no death, major or minor bleeding in both two groups. Minimal bleeding was also similar in the two groups (intensive: 4.28% vs. standard: 2.14%, P = 0.166). CONCLUSIONS: The intensified antiplatelet therapy regimens could significantly increase the reversion rate of HPR in acute coronary syndrome patients undergoing coronary stenting without increasing the risk of bleeding. The clinic impact of this strategy needs to be elucidated by long term follow-up outcome studies.
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Síndrome Coronario Agudo/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Adulto , Anciano , Aspirina/administración & dosificación , Aspirina/uso terapéutico , Plaquetas/efectos de los fármacos , Cilostazol , Clopidogrel , Quimioterapia Combinada , Stents Liberadores de Fármacos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea , Agregación Plaquetaria/efectos de los fármacos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Tetrazoles/administración & dosificación , Tetrazoles/uso terapéutico , Ticlopidina/administración & dosificación , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéuticoRESUMEN
OBJECTIVE: To assess the therapeutic effect and safety of drug eluting stent for the patients with anterior wall myocardial infarction by left anterior descending artery occluded abruptly. METHODS: From January 2004 to December 2008, 302 patients with anterior wall myocardial infarction in 12 hours from chest pain to treatment were treated. But only 189 patients were recruited and randomly divided into drug eluting stent group (n = 95) and bare metal stent group (n = 94). The occurrence of cardiac death, stent thrombosis, reinfarction, target vessel revascularization and re-hospitalization because of heart function failure was compared. RESULTS: There was no difference in cardiac death [3/95 (3%) vs 7/94 (7%), P = 0.206], reinfarction [1/95 (1%) vs 5/94 (5%), P = 0.112] and re-hospitalization because of heart function failure [8 (8%) vs 5 (5%), P = 0.434]. Compared with those in bare metal stent group, the patients in drug eluting stent group has a lower rate of target vessel revascularization [2 (2%) vs 13 (14%), P = 0.009] and composite therapeutic effect endpoints [12 (13%) vs 25 (27%), P = 0.011]. There was no difference in safety endpoint or stent thrombosis [1 (1%) vs 4 (4%), P = 0.204]. CONCLUSION: In patients with anterior wall myocardial infarction by left anterior descending artery occluded abruptly, drug eluting stent decreases the rate of target vessel revascularization. But it has no increased stent thrombosis.
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Angioplastia Coronaria con Balón/efectos adversos , Infarto de la Pared Anterior del Miocardio/terapia , Stents Liberadores de Fármacos , Adulto , Anciano , Infarto de la Pared Anterior del Miocardio/fisiopatología , Electrocardiografía , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: The purpose of this study was to analyze the anatomy variation of coronary vein system in patients with ischemic heart disease (IHD) and non-ischemic heart disease (NIHD). METHOD: Forty-one patients with IHD and 87 patients with NIHD [101 men, mean age (63.5 +/- 10.6) years] were included in this study. RESULTS: Coronary sinuses were successfully cannulated and venographies were obtained in 127 cases. Transvenous LV pacing leads were successfully placed in optimal coronary vein in 123 cases (96.09%). The majority (76.38%) patients had at least one or more vessel abnormalities (thinness, stenosis, tortuousity, lack of lateral marginal vein or postero-lateral vein). The incidence of thin and tortuousity was significantly higher in lateral marginal vein than that in postero-lateral vein (P < 0.05-0.01). The incidence of lack of postero-lateral marginal vein was more frequent than the lack of lateral vein (P < 0.05). The rate of abnormality in both vessels was 25.2%. Incidence of vein lack in male was more frequent than in female (P < 0.05). The thin and tortuousity of vessels in female were more frequent than in male (P < 0.05). The incidence of thin and tortuousity of postero-lateral and abnormality of both vessels was significantly higher in IHD than in NIHD patients (P < 0.05). All coronary sinus myocardial bridges occurred in NIHD. Stenoses of left anterior descending (LAD) and left circumflex (LCX) were mostly associated with abnormality of lateral vessels. CONCLUSIONS: The anatomic variations of lateral and postero-lateral coronary vein were more frequent in this patient cohort. Vein lack in male was more frequent and the thin and tortuousity of vessels were less in male than in female patients. The ratio of vessel abnormality is higher in patients with IHD. Coronary arteries stenosis and position of infarction are associated with anatomic variations of coronary vein system.
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Cardiomiopatías/terapia , Anomalías Cardiovasculares/terapia , Electrodos Implantados , Adulto , Anciano , Anciano de 80 o más Años , Estimulación Cardíaca Artificial/métodos , Vasos Coronarios , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
Background Acute penetrating aortic ulcers (PAUs) are reported to dynamically evolve into different clinical outcomes ranging from regression to aortic rupture, but no practice guidelines are available in China. Methods and Results All 109 patients with acute PAUs were monitored clinically. At 30 days follow-up, 31 patients (28.44%) suffered from aortic-related adverse events, a composite of aortic-related mortality, aortic dissection, or an enlarged ulcer. In addition, 7 (6.42%) patients had clinically related adverse events, including all-cause mortality, cerebral stroke, nonfatal myocardial infarction, acute heart failure alone or acute exacerbation of chronic heart failure, acute renal failure, arrhythmia, and bleeding events. In the present study, the intervention criteria for the Chinese PAU population included a PAU diameter of 12.5 mm and depth of 9.5 mm. The multivariate analysis showed that an ulcer diameter >12.5 mm (hazard ratio [HR], 3.846; 95% CI, 1.561-9.476; P=0.003) and an ulcer depth >9.5 mm (HR, 3.359; 95% CI, 1.505-7.494; P=0.003) were each independent predictors of aortic-related events. Conclusions Patients with acute PAUs were at high risk for aortic-related adverse events and clinically related adverse events within 30 days after onset. Patients with an ulcer diameter >12.5 mm or an ulcer depth >9.5 mm have a higher risk for disease progression, and early intervention may be recommended.
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Enfermedades de la Aorta/diagnóstico por imagen , Úlcera/diagnóstico por imagen , Enfermedad Aguda , Anciano , Enfermedades de la Aorta/diagnóstico , Enfermedades de la Aorta/patología , Rotura de la Aorta/etiología , Angiografía por Tomografía Computarizada , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Úlcera/complicaciones , Úlcera/diagnóstico , Úlcera/patologíaRESUMEN
BACKGROUND: None of study mentioned about contrast-induced acute kidney injury (CI-AKI) in people who have received contrast agents twice within in a short period of time. This study is trying to identify the predictors. METHODS: We enrolled 607 patients between Oct. 2010 and Jul. 2015 who received contrast agents twice within 30 days in the Department of Cardiology of the General Hospital of Shenyang Military Region. The primary outcome was CI-AKI within 72 h after contrast agent exposure. Patients were divided into groups A (n = 559) and group B (n = 48) according to whether CI-AKI occurred after the second agent. RESULTS: Patients in group B (CI-AKI occurred after the second agent) had a more rapid heart rate and more usage of diuretics and digitalis. In group B, CI-AKI occurred more frequently after the first agent. Multivariate logistic regression showed that diuretic (P = 0.006) and intra-aortic balloon pump (IABP) usage (P = 0.012) were independent predictors of CI-AKI after the first agent. Angiotensin-converting enzyme inhibitor/Angiotensin II receptor antagonist (ACEI/ARB) usage (P = 0.039), IABP usage (P = 0.040) and CI-AKI occurring after administration of the first agent (P = 0.015) were independent predictors of CI-AKI after the second. Furthermore, dividing the patients into tertiles of the time interval between the two agents showed that CI-AKI occurred more frequently when the second agent was administered within 1-3 days after the first exposure than within 4-6 days (12.4% vs. 5.0%, P = 0.008) or ≥ 7 days (12.4% vs. 6.4%, P = 0.039). CONCLUSIONS: Diuretic and IABP usage are independent predictors of CI-AKI following exposure to a first contrast agent. The major predictors of CI-AKI after exposure to a second agent are time since the first contrast exposure, ACEI/ARB usage, and IABP usage. More importantly, a three-day interval between the two agents is associated with a higher incidence of CI-AKI following the second administration.
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Lesión Renal Aguda/etiología , Medios de Contraste/administración & dosificación , Factores de Tiempo , Lesión Renal Aguda/fisiopatología , Anciano , Medios de Contraste/uso terapéutico , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Factores de RiesgoRESUMEN
OBJECTIVE: This study aims to investigate failure factors in retrograde wire-guided cannulation (retrograde approach) for the treatment of coronary chronic total occlusion (CTO). METHODS: Data of 285 patients treated for CTO using retrograde approach in the General Hospital of Shenyang Military Region from August 2004 to May 2016 were collected. RESULTS: The average age of the 285 patients was 63.89 ± 11.3 years old. Multivariate analysis revealed that the operation risk factors include the number of diseased vessels, collateral circulation, as well as whether anterograde intervention for CTO target vessels was previously performed (OR = 0.875, 95% CI = 0.779-0.940, P= 0.026) and whether other vessels were intervened (OR = 22.372, 95% CI = 2.059-243.031, P= 0.011). CONCLUSION: Based on the present study, the success rate of retrograde approach for CTO was negatively correlated with the number of diseased vessels and collateral circulation. It was furthermore of importance whether anterograde intervention for CTO target vessels was previously performed and whether other vessels beside CTO vessels were intervened, which were also risk factors.
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Cateterismo Cardíaco/métodos , Oclusión Coronaria/cirugía , Factores de Edad , Anciano , Cateterismo Cardíaco/instrumentación , Circulación Colateral/fisiología , Comorbilidad , Circulación Coronaria/fisiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores SexualesRESUMEN
BACKGROUND: Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. METHODS: Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (nâ=â113) and a BA group (nâ=â109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. RESULTS: At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0%â±â19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06â±â0.32 vs. 0.18 ± 0.34âmm, Pâ<â0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, Pâ=â0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, Pâ=â0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group. CONCLUSIONS: In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.
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Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Anciano , China , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Intervención Coronaria Percutánea , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the long-term therapeutic effects of atorvastatin via cytochrome P450 (CYP)3A4 pathway or a non-CYP 3A4 pathway statin, pravastatin, combined with clopidogrel for the patients undergoing coronary stenting. METHODS: Between February 2006 and March 2007, a total of 1275 patients undergoing successful coronary stenting were randomly assigned to receive atorvastatin 20 mg/d (n = 638) or pravastatin 20 mg/d (n = 637). All patients received standard clopidogrel therapy. The primary end point was cardiac and cerebral ischemic events at 12 months, defined as a composite of cardiac death, non-fatal myocardial infarction (MI) or stroke. The secondary end points were major adverse cardiac and cerebral events (MACCE), stent thrombosis and TIMI hemorrhagic events at 12 months. RESULTS: The baseline clinical characteristics, angiographic and PCI result were comparable between two groups. At 12 month follow-up, no significant difference was observed in cardiac and cerebral ischemic events between two groups (4.7% vs 5.5%, P > 0.05). Also no significant difference existed in rate of cardiac death (1.9% vs 2.5%, P > 0.05), non-fatal MI (0.5% vs 0.3% , P > 0.05), stroke (2.4% vs 2.7%, P > 0.05) and TVR (7.7% vs 5.5%, P > 0.05) between two groups. The rates of MACCE (12.4% vs 11.0%, P > 0.05), stent thrombosis (2.0% vs 2.5%, P > 0.05) and hemorrhagic events (13.0% vs 12.2%, P > 0. 05) were similar between two groups. CONCLUSION: The 12 month clinical outcomes were similar between patients receiving atorvastatin 20 mg/d or pravastatin 20 mg/d combined with clopidogrel after coronary stenting. It confirmed the efficacy and safety of the combination of clopidogrel with statins via different metabolic pathways.
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Ácidos Heptanoicos/administración & dosificación , Pravastatina/administración & dosificación , Pirroles/administración & dosificación , Ticlopidina/análogos & derivados , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón , Anticolesterolemiantes/administración & dosificación , Anticolesterolemiantes/uso terapéutico , Atorvastatina , Clopidogrel , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Ticlopidina/administración & dosificación , Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: To evaluate the feasibility and efficacy of percutaneous coronary intervention (PCI) for graft occlusion post coronary artery bypass graft (CABG). METHODS: The clinical data of 135 post-CABG patients with bypass graft occlusion and angina pectoris symptoms admitted to our department between June 2003 and June 2007 were analyzed. The mean interval from CABG to index angiography was 33.8 +/- 23.5 months. Among 318 grafts, 29 left internal mammary artery (LIMA, 29/128, 22.7%) and 117 saphenous vein bypass grafts (117/188, 62.2%) were occluded. A total of 158 target lesions from these 146 vessels were treated with PCI. All target lesions were B2/C type lesion with 29.7% (47/158) chronic total occlusions. RESULTS: A total of 310 DES were implanted. The total success rate of PCI procedure was 96. 3% (130/135), and lesion success rate was 96.8% (153/158). No major clinical complications occurred during peri-intervention period. All patients underwent PCI were followed at 12 month. Angiographic follow-up was obtained in 89 patients and the angiographic restenosis rate was 5.6% (5/89) in these patients. The major adverse cardiac events and target vessel revascularization rates were 5.4% (7/130) and 6.2% (8/130), respectively. CONCLUSION: This study demonstrates that PCI procedure for graft occlusion post-CABG is feasible and safe and associated with a high procedure success rate and favorable long-term clinical and angiographic outcomes.
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Angioplastia Coronaria con Balón , Puente de Arteria Coronaria Off-Pump/efectos adversos , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/terapia , Anciano , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To evaluate the long-term outcomes of successful or failed revascularization in patients with chronic total occlusions (CTO). METHODS: The clinical data of 1332 consecutive patients underwent percutaneous coronary intervention (PCI) for CTO between June 1993 and December 2006 in our hospital were analyzed. These patients were divided into two groups according to the procedural success (n = 1202) or failure (n = 130). RESULTS: Overall success rate of procedure was 90.2% (1202/1332). The patients in CTO success group experienced a superior 10-year survival rate (76.9% vs. 64.6%, log rank P = 0.012) and a significantly higher no major adverse cardiovascular event (MACE) survival rate (41.8% vs. 27.6%, log rank P < 0.001) compared to the patients in CTO failure group. During the long-term follow-up, the proportion of patients who accepted coronary artery bypass grafting (CABG) was significantly lower in CTO success group than that in the CTO failure group (4.3% vs. 14.6%, P < 0.001). CONCLUSION: Successful PCI procedure leads to increased long-term survival and MACE-free survival and the reduced need for CABG for patients with CTO lesions.
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Angioplastia Coronaria con Balón , Arteriosclerosis Obliterante/terapia , Oclusión Coronaria/terapia , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Resultado del TratamientoRESUMEN
BACKGROUND: Chronic total occlusion (CTO) is found in 18-31% of patients who undergo coronary angiography. Successful recanalization of CTOs is associated with reduced recurrent angina pectoris rates and increased long-term survival. Although the success rate of CTO percutaneous coronary intervention (CTO-PCI) has improved, CTO-PCI remains technically challenging. The Fielder XT guidewire was designed for CTO lesions. To validate whether the use of the guidewire increases the success rate, we compared the results of CTO-PCI with or without the guidewire. We hypothesized that the use of Fielder XT guidewire can increase the success rate of CTO-PCI. AIM: To investigate whether the use of Fielder XT guidewire increases the final procedural success of CTO-PCI via the anterograde approach. METHODS: Between January 2013 and December 2015, a retrospective study was conducted on 1230 consecutive patients with CTO who received PCI via the anterograde approach at the General Hospital of Northern Theater Command. The patients were divided into an XT Group (n = 686) and a no-XT Group (n = 544) depending on whether Fielder XT guidewire was used. Both groups were compared for clinical parameters, lesion-related characteristics, procedural outcomes and in-hospital complications. The data were statistically analyzed using Pearson's χ 2 test for categorical variables, and Students' t test was used to compare the quantitative data. Significant independent factors and a risk ratio with 95% confidence interval (CI) were assessed by multivariate logistic regression analysis. RESULTS: In total, 1230 patients were recruited; 75.4% of the patients were male, and 55.8% of the patients were in the XT group. The overall success rate was 83.9%, with 87.8% in the XT group. Based on multivariate logistic regression analysis, factors positively associated with procedural success were the use of Fielder XT guidewire (P = 0.005, 95%CI: 1.172-2.380) and systolic blood pressure (P = 0.011, 95%CI: 1.003-1.022), while factors negatively associated with procedural success were blunt stump (P = 0.013, 95%CI: 1.341-11.862), male sex (P = 0.016, 95%CI: 0.363-0.902), New York Heart Association (NYHA) class (P = 0.035, 95%CI: 0.553-0.979), contrast amount (P = 0.018, 95%CI: 0.983-0.998) and occlusion time (P = 0.009, 95%CI: 0.994-0.999). No significant differences were found between the XT group and the no-XT group with respect to clinical parameters, lesion-related characteristics, coronary artery rupture [3 (0.4%) vs 8 (1.5%), P = 0.056], in-hospital death [2 (0.3%) vs 6 (1.1%), P = 0.079] or in-hospital target lesion revascularization [3 (0.4%) vs 7 (1.3%), P < 0.099]. However, there were significant differences between the groups with respect to success rate [602 (87.8%) vs 430 (79.0%), P < 0.001], procedure time [(74 ± 23) vs (83 ± 21), P < 0.001], stent length [(32.0 ± 15.8) vs (37.3 ± 17.6), P < 0.001], contrast amount [(148 ± 46) vs (166 ± 43), P < 0.001], post-PCI myocardial infarction [43 (6.3%) vs 59 (10.8%), P = 0.004], major adverse cardiovascular event [44 (6.4%) vs 57 (10.7%), P = 0.007], side branch loss [31 (4.5%) vs 44 (8.1%), P = 0.009], contrast-induced nephropathy [29 (4.2%) vs 40 (7.4%), P = 0.018] and no reflow [8 (1.2%) vs 14 (2.9%), P = 0.034]. CONCLUSION: The use of Fielder XT guidewire shortens the Procedure and increases the success rate of CTO-PCI, and is also associated with reduced complication rates.
RESUMEN
The development of gene therapy puts forward the requirements for efficient delivery of genetic information into diverse cells. However, in some cases of transfection, especially those for transfecting some primary cells and for delivering large size plasmid DNA (pDNA), the existing conventional transfection methods show poor efficiency. How to further improve transfection efficiency in these hard-to-achieve issues remains a crucial challenge. Here, we report a photothermal-assisted surface-mediated gene delivery based on a polydopamine-polyethylenimine (PDA-PEI) surface. The PDA-PEI surface was prepared through PEI-accelerated dopamine polymerization, which showed efficiency in the immobilization of PEI/pDNA polyplexes and remarkable photothermal properties. Upon IR irradiation, we observed improved transfection efficiencies of two important hard-to-achieve transfection issues, namely the transfection of primary endothelial cells, which are kinds of typical hard-to-transfect cells, and the transfection of cells with large-size pDNA. We demonstrate that the increases of transfection efficiency were due to the hyperthermia-induced pDNA release, the local cell membrane disturbance, and the polyplex internalization. This work highlights the importance of local immobilization and release of pDNA to gene deliveries, showing great potential applications in medical devices in the field of gene therapy.
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Células Endoteliales/química , Indoles/química , Plásmidos/genética , Polietileneimina/química , Polímeros/química , Terapia Genética , Células HEK293 , Calor , Células Endoteliales de la Vena Umbilical Humana , Humanos , Rayos Infrarrojos , Tamaño de la Partícula , Plásmidos/efectos de la radiación , Propiedades de Superficie , TransfecciónRESUMEN
BACKGROUND: Failure of balloon catheter passing through the occluded segment accounts for 10% - 15% of all procedures during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). We sought to investigate an original technique for facilitating balloon catheter passing by multi-wire plaque crushing. METHODS: Between July 2000 and October 2007, 152 patients with 164 CTO lesions who had failed balloon passing were treated by multi-wire plaque crushing technique. The main process of this technique was to insert 1 or 2 wires along with the original wire located in the true lumen of CTO lesions after balloon failure for plaque crushing and then to withdraw the crushing wires to get an enlarged lumen inside of the occlusion segment, thus facilitating the balloon passing. RESULTS: Both overall lesion and technique success rates were 91.5% (150/164). A total of 211 crushing wires were used during PCI, including 1 crushing wire for 117 (71.3%) lesions and 2 crushing wires for 47 (28.7%) lesions. Approximately 57.3% (121/211) of all crushing wires were those already used in the same procedure. Technique failure occurred in 14 lesions (8.5%). Technique failure was due to crushing wires entering false lumen (92.9%, 13/14) and coronary perforation (7.1%, 1/14). Major procedural complications included coronary perforation (1 case) and severe coronary dissection (2 cases), all of which were successfully treated. CONCLUSIONS: Multi-wire plaque crushing technique is effective in facilitating balloon catheter passing during CTO PCI. It is feasible, economical and relatively safe with a low rate of procedural complications.
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Angioplastia Coronaria con Balón/métodos , Estenosis Coronaria/terapia , Adulto , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Enfermedad Crónica , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To compare the clinical therapeutic results of percutaneous transluminal stenting between patients with acute and chronic aortic dissections. METHODS: From May 2002 to October 2007, 42 patients with acute type B aortic dissection and 40 patients with chronic aortic dissection underwent stenting. The clinical data of the patients were analyzed. RESULTS: Comparing with the chronic aortic dissection group, the acute aortic dissection group had higher percentage of pleural effusion (16.7% vs 0, P =0.01) and visceral/leg ischemia (23.8% vs 2.5%, P = 0.01). The acute aortic dissection group had higher complications in early term (38.1% vs 15.0%, P = 0.02). All patients were followed up for an average of (18.7 +/- 17.3) months. The rate of complications were higher in the patients with acute aortic dissection than those with chronic aortic dissection (21.4% vs 5.0%, P = 0.03). Kaplan-Meier analysis showed no difference of survival rate between the 2 groups during follow-up period (P = 0.38). The 5-year survival rate was 90.0% in acute aortic dissection group years and 92.5% in chronic aortic dissection group, respectively. The event-free survival rate was higher in the patients with chronic dissection than that with in the patients acute aortic dissection (P = 0.04). CONCLUSIONS: Percutaneous transluminal stenting is effective in the treatment of type B aortic dissection, but there are more complications in acute than in chronic aortic dissection group.