Design and manufacture of a coronary stent INC-1 and initial tests in experimental animal model / Diseño y fabricación del stent coronario INC-1y pruebas iniciales en animales de experimentación

Abstract In this paper, we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing, and mechanic trials, we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 μm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion, and safety, as well as endothelial attachment, thrombogenicity, and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion, and complete endothelial attach. Furthermore, we obtained a good post-implant balloon withdrawal, functional integrity, and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.

Resumen En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 μm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.

Human pilot study of bare-metal stent: INC-01

ABSTRACT Background: The cost of performing a percutaneous coronary intervention is considerably high for the patient as well as for health systems, which have promoted the development of local technology to help meet the need for these devices. Methods: The INC-01 bare-metal stent was developed at the National Institute of Cardiology in Mexico City and was first implanted on porcine models with technical success in 100% of the evaluated parameters. Presentation of Cases: We present the first three cases of patients with ischemic heart disease, to whom the INC-01 bare-metal stent was implanted. Intracoronary ultrasonography was performed post-stent implantation, showing all the characteristics of implant success during evaluation and clinical follow-up. Conclusions: Angiography and intracoronary ultrasound were carried out demonstrating that the INC-01 bare-metal stent has physical, biological, and histological characteristics similar to those found in commercial metallic stents.

Study of efficacy and safety of drug eluting stent versus bare metal stent in ST elevation MI

Background: The present study was conducted with the aim of determining whether drug-elutingstents are superior to uncoated stents in the setting of primaryPCI in terms of occurrence of serious adverse cardiac events.Methods: In this prospective, single blind, randomized study, 20 to 80 years old patients with acute myocardial infarction with ST-segment elevation with >30 minutes of chest pain and at least 1 mm of ST-segment elevation in at least two standard leads or a new LBBB or 2 mm of ST-segment elevation in at least two contiguous leads were included. Patients were randomly assigned to receive either drug eluting stent (DES) (Everolimus Eluting stent, Endevour-Medtronics) or bare metal stent (BMS, Cordis-Dx sonic) in a 1:1 ratio. During follow ups at 30 days and 12 months, all serious adverse cardiac events like death from cardiac or non-cardiac cause, recurrent MI, revascularization of target vessel, coronary artery bypass grafting (CABG) or other intervention to target or non-target vessel etc. were recorded and compared between groups.Results: No significant differences were found between the two treatmentgroups for occurrence of adverse events during first 30 days after the intervention. At one year follow-up, trends were observed in favorof the DES group, none of the differences weresignificant.Conclusions: No significant benefit was observed with the use of Everolimus-eluting stents in primaryPCI for acute myocardial infarction with ST-segment elevation,in comparison with baremetal stents.

RESULT OF 7-YEAR STUDY ON RESTENOSIS AND THROMBOSIS IN AFTER PCI TREATMENT SETTING / Шинэ санаа Шинэ нээлт

@#BACKGROUND. The aim of this study was to investigate the prognostic impacts of drug-eluting stents (DES) and bare-metal stents (BMS) in patients undergoing percutaneous coronary intervention (PCI) and risk factors of stent restenosis. MATERIAL AND METHODS. We conducted a retrospective cohort study based on the Angiographic diagnostic and treatment Department of 3rd State Central Hospital of Mongolia. Patients who had undergone coronary stenting between 2000 and 2017 were recruited and monitored until the end of 2010. RESULTS. Among a total of 4520 selected patients with a mean age of 58±7 years, 2125 subjects had BMS and 2395 subjects had DES. The incidence of stent restenosis and stent thrombosis were significantly lower in the DES (37; 1,5%) group as compared with the BMS (201; 9,4%) group. Patients who have stent restenosis presented comorbidities, such as diabetes 214(47,8%), hypertension 54(22,6%), prior PCI 21(8,2%), re-infarction 12(5,04%), chronic kidney disease 16(6,7%), hyperlipidemia 21(8,2%). СONCLUSION. Implantation of DES was related to better outcomes than for BMS, in terms of reducing restenosis and stent thrombosis after PCI. STEMI patients who have co morbidities have greater risk of stent stenosis and thrombosis

Impact of free thyroxine levels and other clinical factors on bare metal stent restenosis

ABSTRACT Objective Thyroid hormones have both direct and indirect effects on thermogenesis such as modulating vascular smooth muscle cell proliferation. However, the influence of more subtle changes in thyroid hormones on coronary atherosclerosis remains a matter of speculation. Smooth muscle cells play a crucial role in the pathogenesis of in-stent restenosis (ISR). However, the relationship between free thyroxine (fT4) and ISR has not been studied. In the present study, we aimed to assess the role of preprocedural serum fT4 level on the development of ISR in patients undergoing coronary bare metal stent (BMS) implantation. Materials and methods We enrolled and analyzed clinical, biochemical, and angiographic data from 705 consecutive patients without a history of primary thyroid disease [mean age 60.3 ± 9.3 years, 505 (72%) male]; all patients had undergone BMS implantation and further control coronary angiography owing to stable or unstable angina pectoris. Patients were divided into 3 tertiles based on preprocedural serum fT4 levels. Results ISR was observed in 53 (23%) patients in the lowest tertile, 82 (35%) patients in the second tertile, and 107 (46%) patients in the highest fT4 tertile (p < 0.001). Using multiple logistic regression analysis, five characteristics emerged as independent predictors of ISR: diabetes mellitus, smoking, HDL-cholesterol, stent length, and preprocedural serum fT4 level. In receiver operating characteristics curve analysis, fT4 level > 1.23 mg/dL had 70% sensitivity and 73% specificity (AUC: 0.75, p < 0.001) in predicting ISR. Conclusion Higher preprocedural serum fT4 is a powerful and independent predictor of BMS restenosis in patients with stable and unstable angina pectoris.

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial

The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15–0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option. This was a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT01539603; http://www.clinicaltrials.gov/ct2/show/NCT01539603).

Effects of different reperfusion strategies on clinical outcome of ST-segment elevation myocardial ;infarction patients / 中国介入心脏病学杂志

Objective To evaluate the outcome of ST-segment elevation myocardial infarction (STEMI) patients received different reperfusion therapies. Methods The 238 consecutive STEMI patients were enrolled from February 2012 to December 2012. According to the current guideline of PCI and the choice of patients, the patients were divided into the groups of percutaneous coronary intervention (PCI), ifbrinolysis, and conservative medication. The major adverse cardiac events (MACE) was analyzed in a follow up of 6 months. Results (1) The enrolled patients included the 210 patients received PCI (88.2%), 14 patients received fibrinolysis (5.9%) and 14 patients received conservative medication (5.9%).The Median time of D2B was 110minutes.(2) The rate of late stent thrombosis was signiifcant higher in BMS than DES (n=2, 2.8%vs 0, P < 0.05) . (3) The PCI group had a signiifcantly higher incidence of stroke than the ifbrinolysis group and the conservative medication group (1.0%vs 0, P < 0.05;1.0%vs 0, P<0.05). (4) The PCI group had a signiifcantly higher incidence of bleeding compared to the thrombolysis group and the medication group (1.0% vs 0, P < 0.05; 1.0% vs 0%, P < 0.05). Conclusions The majority of STEMI patients received PCI;The D2B time, which was required<90 minutes in guideline of PCI, was found delayed in our study;Compared to ifbrinolysis and conservative medication, PCI showed better clinical outcomes of STEMI patients.

Evaluation of Long-term Efficacy and Safety for Hybrid Stent and Exclusive Drug Eluting Stent Implantation for Treating the Patients With Multi-lesion Coronary Disease / 中国循环杂志

Objective: To evaluate the hybrid of drug eluting stent (DES) with bare metal stent (BMS) and exclusive DES implantation for treating the patients with multi-lesion coronary disease. Methods: A total of 6495 patients with multi-lesion coronary disease received elective PCI in our hospital from 2004-04 to 2006-10 were retrospectively studied. The patients were divided into 2 groups, Hybrid group, n=848 and Exclusive DES group, n=5647. With 1:1 propensity score matching, there were 823 pair of patients were ifnally studied. The clinical outcomes included 1, 2 years post-operative all cause death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), major adverse cardiac events (MACE) and in-stent thrombosis. The relative risks of all outcomes were assessed by Cox’s proportional-hazard model after propensity match. Results: With propensity match, Cox’s proportional-hazard model analysis indicated that compared with Exclusive DES group, Hybrid group had the higher risks of TLR (HR 2.38, 95%CI 1.50-3.70), TVR (HR 1.61, 95%CI 1.15-2.27), MACE (HR 1.37, 95%CI 1.02-1.85), all P0.05. Conclusion:Compared with exclusive DES, the hybrid of DES with BMS implantation had the higher risk of TLR, TVR and MACE for treating the patients with multi-lesion coronary disease.

Hemodynamic characteristics of arterial lesions after drug-eluting stent implantation / 医用生物力学

Objective To study the hemodynamic characteristics after vascular drug eluting stent (DES) implantation, so as to provide theoretical guidance for clinical application of DES as well as improving the design of DES. Methods The geometry models of vascular lesions implanted with DES were constructed to numerically analyze drug concentration and wall shear stress (WSS) distributions in vessel by computational fluid dynamics (CFD) method. The results were compared with flow characteristics of the model with bare metal stent (BMS) implantation. Results Low WSS accompanied by high drug concentration would occur during blood flow in some areas after DES implantation, and vice versa. The presence of DES significantly reduced appearing such areas as either with low WSS only or with low drug concentration only. Theoretically, DES had more advantages than BMS at the stage of drug release. Conclusions DES could dramatically reduce the ratio of in-stent restenosis. Understanding the regular pattern of blood flow field distributions after DES implantation in detail will be beneficial to improve the design of DES, and further advance the overall performance of the stent, which can provide the theoretical basis for clinical research.

A novel high nitrogen nickel-free coronary stents system: evaluation in a porcine model / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it.</p><p><b>METHODS</b>Three types of stents were randomly implanted in different coronary arteries of the same pig: 316 L stainless steel BMS (316 L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis.</p><p><b>RESULTS</b>Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups: (0.21 ± 0.17) mm for 316 L-BMS, (0.16 ± 0.12) mm for NF-A-BMS, (0.24 ± 0.15) mm for NF-B-BMS (P>0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00 ± 0.63 vs. 2.83 ± 0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d.</p><p><b>CONCLUSION</b>The novel NF-BMS showed similar safety as 316 L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units.</p>

Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention-Our Experiences at a Tertiary Hospital.

Background: Aim of the study was to evaluate the primary procedural success of percutaneous coronary intervention of unprotected left main coronary artery stenosis using either Bare-metal stents or drug eluting stent. Methods: Total 33 patients were enrolled in this very preliminary non-randomized prospective cohort study. Among them, Male: 25 and Female: 8. Total 35 stents were deployed. Mean age were for Male: 59 yrs, for Female: 62 yrs. Associated coronary artery diseases risk factors were dyslipidemia, High Blood pressure, Diabetes Mellitus, Positive family history for coronary artery diseases and smoking. Results: Among the study group; 26 (78%) were Dyslipidemic, 24(70%) were hypertensive; 17 (51.5%) patients were Diabetic, 11(33%) were smoker and 7(21%) patients had family history of Ischaemic heart disease. Female patients were more obese (BMI M 26: F 27) and developed coronary artery diseases in advance age. Common stented territory were left main: 20 (60%), Left main to left anterior descending artery 7 (22%) and Left main to left circumflex artery 6 (18%). Average length and diameter of stent was 3.5 and 18 mm respectively. Stent used: Bare Metal Stent 5 (15%), Drug Eluting Stent: 28 (85%). Among the different Drug Eluting Stents, Everolimus eluting stents were 11 (39.3%), Sirolimus eluting 10(35.7%), Paclitaxel eluting 3 (10.7%), Biolimus eluting 3 (10.7%) and Zotarolimus eluting1 (3.6%). In the present study, overall survival outcome was 94% (31 patient), mortality of cardiac cause 3% (1 patient) and 1 patient (3%) died of hepatocellular carcinoma. Conclusion: Our study has shown that percutaneous coronary intervention of the unprotected left main is a safe and effective alternative to Coronary Artery Bypass Graft (CABG).

A study to evaluate the clinical outcome of drug-eluting vs. bare-metal stents for acute coronary syndrome patients during commercial use in real setting.

Background: This study compared clinical outcome of Drug Eluting Stents (DES) versus Bare Metal Stents (BMS) in coronary arteries in patients with Acute Coronary Syndromes. Methods: A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Results: A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (n=101) and BMS group (n=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (p=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, p=0.57), rate of MI (3.96% vs 4.95% p=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% p=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusions: The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.

Caracterización de la restenosis de stents coronarios convencionales y liberadores de medicamentos en pacientes incluidos en el registro DRug Eluting STent (DREST) / Characterization of conventional coronary stents restenosis and drug eluting stents in patients included in the Drug Eluting Stent Registry (DREST)

Introducción y objetivos: los stents convencionales presentan tasas de restenosis intrastent entre 10% y 60%, mientras los stents liberadores de fármacos alcanzan el 10%. Para Latinoamérica, no hay reportes de restenosis intrastent en comparación con los stents convencionales y los stents liberadores de fármacos. En este estudio se describen aspectos asociados a este evento en pacientes atendidos en un centro de alta complejidad en Colombia. Métodos: análisis retrospectivo de pacientes con restenosis intrastent incluidos en el registro DRug ELuting STent (DREST) entre los años 1994 y 2011, en el que se compararon características basales, datos técnicos y supervivencia de los pacientes con stent convencional y stent liberador de fármacos. Resultados: se evidenció restenosis intrastent en 269 con stent convencional (11,5%) y en 65 con stent liberador de fármacos (12,2%), sin diferencias significativas al comparar por género (p=0,983) o edad (p=0,55). La dislipidemia fue el factor de riesgo más significativo asociado a la restenosis intrastent de los stents liberadores de fármacos (p<0,002). El diámetro menor del vaso comprometido como de los stents implantados, se encontró principalmente en los stents liberadores de fármacos asociados a restenosis intrastent (p=0,000). El patrón de restenosis intrastent focal fue mayor con los stents liberadores de fármacos, mientras el difuso en con el stent convencional (p=0,000). La supervivencia a un año fue mayor en pacientes con stent liberador de fármacos. Conclusiones: las tasas de restenosis intrastent y las características relacionadas encontradas, son similares a lo publicado. La dislipidemia aparece como factor asociado significativo. La restenosis intrastent se manifestó como síndrome coronario agudo en 60% de los casos; no puede considerarse como un proceso benigno en esta población.

Introduction and Objectives: Bare metal stents have stent restenosis rates between 10% and 60%, while drug-eluting stents reach 10%. In Latin America, there are no reports of stent restenosis between bare-metal stents and drug eluting stents. This study describes aspects associated with this event in patients treated at a center of high complexity in Colombia. Methods: Retrospective analysis of patients with stent restenosis included in the Drug Eluting Stent Registry (DREST) between 1994 and 2011, which compared baseline characteristics, technical data and survival of patients with bare metal stents and drug eluting stents. Results: We found stent restenosis with bare metal stents in 269 patients (11.5%) and in 65 with drug-eluting stent (12.2%) without significant differences between gender (p = 0.983) or age (p = 0 , 55). Dyslipidemia was the most significant risk factor associated with stent restenosis of drug-eluting stents (p <0.002). We found smaller diameter of the vessel involved as well as smaller diameter of the implanted stent mainly in the drug-eluting stents associated with stent restenosis (p = 0.000). The focal pattern of stent restenosis was higher with drug eluting stents, while the diffuse pattern with standard stents (p = 0.000). The one-year survival was higher in patients with drug-eluting stent. Conclusions: The rates of stent restenosis and the related characteristics found are similar to those currently published. Dyslipidemia appears as a significant associated factor. The stent restenosis manifested as acute coronary syndrome in 60% of cases; it can not be regarded as a benign condition in this population.

Percutaneous Coronary Intervention (PCI) in Patients with Chronic Total Occlusion (CTO): A Single Center Experiences.

Background: Aim of the study was to evaluate the primary in-hospital success and 30-days survival outcome of PCI in patients with CTO lesions, using either Bare-metal stents (BMS) or Drug Eluting Stent (DES) like Sirolimus-eluting or Paclitaxel-eluting stent in our hospital setting. Methods: Total 50 patients were randomized as per the definition of CTO, from a total of 400 patients who had PCI at our center in the quantifying period. After the guidewire crossing and the balloon dilation, measurement of the culprit lesion was done by using Siemens QCA measuring system. Among the patients, Male: 41 and Female: 9. Mean age were for Male: 53.3yrs, for Female: 64.4 yrs. Associated CAD risk factors were Dyslipidemia, High Blood pressure, Diabetes Mellitus, Positive FH for CAD and Smoking. Results: Our study results show 50 patients (12.5%) had CTO lesion out of total 400 PCI procedures. Sex distribution in male 41 (82%), Female 9 (18%). Among the study group; 38 (76%) were Dyslipidemic, 31 (62%) were hypertensive; 20 (40%) patients were Diabetic, 9 (22%) were all male smoker, 5 (10%) were having positive FH for CAD. Female patients were more obese and developed CAD in advance age (male: 53.5 Versus Female: 64.4 yrs). Average diameter of stented vessel was greater in RCA than LAD and LCX. We found that the incidences of CTO lesions were more in LAD territory 20 (40%) followed by RCA 17 (34%) and LCX 13(26%). Single vessel Disease (SVD) in 45 (90%) patients was more common type of CTO lesion followed by Double vessel disease (DVD) in 5(10%). Post procedural, in-hospital and 30 days survival out comer was 100% in our present study. Conclusion: Our study has revealed that PCI in patients with CTO lesions has increased inhospital and 30 days survival outcome, are treated with BMS or DES. The incidence of CTO lesion is more common in male than in female. Female are developing heart disease in advance age and are more obese.

Incidencia de trombosis intrastent en pacientes sometidos a intervencionismo coronario percutáneo en el Centro Cardiovascular Regional Ascardio / Incidence of stent thrombosis on patients undergoing percutaneous coronary intervention at the Centro Cardiovascular Regional Ascardio

Determinar la incidencia de trombosis intrastent en pacientes sometidos a intervencionismo coronario del Centro Cardiovascular Regional ASCARDIO, comparar incidencia de trombosis intrastent entre stent bare y stent medicado, determinar la inicidencia de trombosis en pacientes diábeticos. Estudio retrospectivo, descriptivo. Se revisaron 500 casos de intervencionismo coronario de los cuales se obtuvo información completa de 244 pacientes. Se tomó en cuenta la nueva clasificación de trombosis intrastent de la Academic Research Consortium. La incidencia de trombosis intrastent fue de 5,74% (14 pacientes) y la de trombosis definitiva de 2,87% (7 pacientes), no hubo diferencia significativa entre stent medicados; la incidencia de trombosis en diábeticos fue de 10% vs el 4,4% en los no diábeticos (P=0,104). En los pacientes con trombosis definitiva recibían significativamente más terapia dual antiplaquetaria que los probables o posibles (P=0,02). La longitud de los stents medicados trombosados fue significativamente mayor (23,22 ± 4,73 mm) que en los stents convencionales (15,89 ± 5,2 mm) (P=0,01) y el diámetro fue menor (2,82 ± 0,22mm) que en los convencionales (3,07 ± 0,18 mm)(P=0,05). También se encontro una mayor incidencia de trombosis en los stent medicados colocados en la coronaria derecha (P=0,02). La incidencia de trombosis definitivas en nuestro centro es mayor a la reportada; las trombosis intrastent tempranas y tardías no tienen diferencia significativa entre stents convencionales y los medicados. La longitud de los stents convencionales y los medicados trombosados fue significativamente mayor y de menor diámetro, comparado con los stent bare; la trombosis intrastent en diabéticos no mostro diferencia en relación al tipo de stent.

To determine the incidence of stent thrombosis on patients undergoing coronary interventions at the Centro Cardiovascular Regional Ascardio; and to compare the incidence of stent thrombosis between BMS and DES; and to determine the incidence of thrombosis on diabetic patients. This was a retrospective descriptive study. From 500 cases of coronary interventions, data was obtained on 244. The new classification of stent thrombosis by American Researche Consortium was applied. The incidence of thrombosis was 5.74% (14 patients) and for definite thrombosis was 2.87% (7 patients). there was no significant diferences between BMS and DES (P=1). The incidence of thrombosis on diabetic patients was 10% as compared to 4.4% on nondiabetic patients (P=0,104). We shown that patients with definite thrombosis received significantly more dual antiplatelet therapy than likely or possible thrombosis cases (P=0,02). The length of thrombosed DES was significantly higher (23.22 ± 4.73mm) tha BMS (15.89 ± 5.2mm, P=0.01)and the diameter was significantly lower (2.82 ± 0.22mm) than BMS (3.07 ± 0.18 mm, P=0.05). We also found a higher incidence of thrombosis for DES implanted on the right coronary artery (P=0.02). The incidence of definite thrombosis in our center was mildly higher than the reported incidence; early and late stent thrombosis showed no significant difference between BMS and DES; however the length of DES was significantly higher and less diameter tha BMS; dibetes was no significamtly higher on thrombosed stents.

Efficacy of firebird stent in patients with type 2 diabetes and coronary heart disease / 重庆医科大学学报

Objective:To observe the efficacy of Firebird drug-eluting stent in patients with type 2 diabetes and coronary heart disease. Method:90 patients with type 2 diabetes and coronary heart disease from March 2005 to December 2006 were enrolled to have the treatment of percutaneous coronary invention,47 in Domestic Firebird Stent group and 43 in Bare Stent group. All patients were administered asprin and Clopidogrel regularly before and after procedures,meanwhile, medical treatment was used strongly and strictly. Followed up the patients after PCI,observed the major adverse cardiac events(MACE),and compared the efficacy between the two groups. Results:Coronary angiographic(CAG) showed that the patients with more than 2 lesion coronaries take 71.11 % of all.74 Firebird Stents were implanted in Firebird group and 55 Bare Stents were implanted in Bare metal stents group.Each patient has got an successful operation. Mean follow-up duration was 10.2?3.3 months after stent implanting. 3 patients suffered angina pectoris reoccurrence and 2 suffered major adverse cardiac events(MACE) in Firebird Stent group,while 13 patients suffered angina pectoris reoccurrence and 13 suffered MACE in Bare metal stent group. Rate of angina pectoris reoccurrence and MACE occurrence in Firebird Stent group were much lower than that of in Bare metal stent group,there was significant difference between the two groups(6.4% vs 30.2%,P0.05). Conclusion:Firebird stent in patients with type 2 diabetes and coronary heart disease has a definite clinical efficacy,which can reduce the occurrence of MACEs.

Comparison of clinical outcomes between dronestic sirolimus-eluting stent and bare metal stent in the primary percutaneous coronary intervention for patients with acute myocardial infarction / 中华急诊医学杂志

Objective To assess the safety and efficacy of domestic sirolimus-eluting stent(SES)compared with bare metal stent(BMS)in the primary percutaneous coronary intervention(PCI)for patients with ST-segment elevation AMI in a real-world scenario.Method From January 2005 to March 2006,a total of 143 patient with ST-segment elevation AMI were enrolled in this study,and all of them underwent primary percutaneous coronary intervention(PCI).Among the 143 patients,74 were treated with domestic SESs(Firebird stent)and 69 with BMSs.The incidence of major adverse cardiovascular events(MACE:death,reinfarction,and target vessel revascularization[TVR])was evaluated at 30 days and 180 days.Continuous variables were compared using Student's unpaired t test.Categorical variables were compared using Fisher's test.Cox proportional hazard survival models were used to assess risk reduction of adverse events.P value