The difference effect on the prognosis between drug-coated balloon and drug eluting stent interventional therapy in patients with coronary heart disease: a retrospective comparative study / 中国医师进修杂志

Objective:To compare the effect of prognosis between drug-coated balloon (DCB) and drug eluting stent (DES) interventional therapy in patients with coronary heart disease.Methods:The clinical data of 346 coronary heart disease patients underwent interventional therapy because of small vessel lesion, in-stent restenosis and bifurcation lesion in Xuanwu Hospital, Capital Medical University from December 2018 to July 2021 were retrospectively analyzed. Among them, 179 patients were treated with DES (DES group), including small vessel lesion 81 cases, in-stent restenosis 35 cases, and bifurcation lesion 63 cases; 167 patients were treated with DCB (DCB group), including small vessel lesion 69 cases, in-stent restenosis 62 cases, and bifurcation lesion 36 cases. The major adverse cardiac and cerebrovascular event (MACCE) within 1 year after discharge was compared between two groups. Non-inferiority was analyzed, and non-inferiority margin was set to be 4%.Results:There was no statistical difference in the incidence of MACCE between DCB group and DES group: 3.59% (6/167) vs. 7.26% (13/179), P>0.05. There were no statistical differences in the incidences of MACCE in patients with small vessel lesion, in-stent restenosis and bifurcation lesion between DCB group and DES group: 1.45% (1/69) vs. 4.94% (4/81), 8.06% (5/62) vs. 14.29% (5/35) and 0 vs. 6.35% (4/63); P>0.05. Non-inferiority analysis result showed that DCB was non-inferior to DES on the prognosis in patients with coronary heart disease (95% CI - 8.41% to 1.07%). Conclusions:Non-inferiority of DCB versus DES is shown in coronary heart disease patients with small vessel lesion, in-stent restenosis and bifurcation lesion.

Avaliação no Mundo Real de um Stent Eluidor de Sirolimus de Hastes Ultrafinas em Pacientes com Infarto do Miocárdio com Supradesnivelamento do Segmento ST Submetidos à Intervenção Coronária Percutânea Primária (Registro INSTEMI) / Real-World Assessment of an Ultrathin Strut, Sirolimus-Eluting Stent in Patients with ST-Elevation Myocardial Infarction Submitted to Primary Percutaneous Coronary Intervention (INSTEMI Registry)

Resumo Fundamento O padrão-ouro atual dos stents farmacológicos (SF) coronários consiste em ligas metálicas com hastes mais finas e polímeros bioabsorvíveis. Objetivos Nosso objetivo foi comparar um stent eluidor de sirolimus de hastes ultrafinas (Inspiron®) com outras plataformas de SF de terceira geração em pacientes com infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos à intervenção coronária percutânea (ICP) primária. Métodos Analisamos dados de um registro multicêntrico de IAMCSST de centros de referência da Região Sul do Brasil. Todos os pacientes foram submetidos à ICP primária, seja com Inspiron® ou outro SF de segunda ou terceira geração. Foi calculado pareamento por escore de propensão (PEP) para gerar grupos semelhantes (Inspiron® versus outros stents) em relação às características clínicas e do procedimento. Todos os testes de hipótese tiveram um nível de significância bilateral de 0,05. Resultados De janeiro de 2017 a janeiro de 2021, 1.711 pacientes foram submetidos à ICP primária, e 1.417 pacientes preencheram nossos critérios de inclusão (709 pacientes no grupo Inspiron® e 708 pacientes no grupo dos outros SF de segunda ou terceira geração). Após PEP, a amostra do estudo foi composta por 706 pacientes (353 pacientes no grupo Inspiron® e 353 pacientes no grupo dos demais SF de segunda ou terceira geração). As taxas de revascularização do vaso alvo (odds ratio [OR] 0,52; intervalo de confiança [IC] 0,21 a 1,34; p = 0,173), trombose de stent (OR 1,00; IC 0,29 a 3,48;p = 1,000), mortalidade (hazard ratio 0,724; IC 0,41 a 1,27; p = 0,257) e os desfechos cardiovasculares maiores (OR 1,170; IC 0,77 a 1,77; p = 0,526) foram semelhantes entre os grupos após um acompanhamento mediano de 17 meses. Conclusão Nossos achados mostram que o stent Inspiron® foi eficaz e seguro quando comparado a outros SF de segunda ou terceira geração em uma coorte contemporânea do mundo real de pacientes com IAMCSST submetidos à ICP primária.

Abstract Background The current gold standard of coronary drug-eluting stents (DES) consists of metal alloys with thinner struts and bioresorbable polymers. Objectives Our aim was to compare an ultrathin strut, sirolimus-eluting stent (Inspiron®) with other third-generation DES platforms in patients with ST-elevation myocardial infarction (STEMI) submitted to primary percutaneous coronary intervention (PCI). Methods We analyzed data from a STEMI multicenter registry from reference centers in the South Region of Brazil. All patients were submitted to primary PCI, either with Inspiron® or other second- or third-generation DES. Propensity score matching (PSM) was computed to generate similar groups (Inspiron® versus other stents) in relation to clinical and procedural characteristics. All hypothesis tests had a two-sided significance level of 0.05. Results From January 2017 to January 2021, 1711 patients underwent primary PCI, and 1417 patients met our entry criteria (709 patients in the Inspiron® group and 708 patients in the other second- or third-generation DES group). After PSM, the study sample was comprised of 706 patients (353 patients in the Inspiron® group and 353 patients in the other the other second- or third-generation DES group). The rates of target vessel revascularization (OR 0.52, CI 0.21 - 1.34, p = 0.173), stent thrombosis (OR 1.00, CI 0.29 - 3.48, p = 1.000), mortality (HR 0.724, CI 0.41 - 1.27, p = 0.257), and major cardiovascular outcomes (OR 1.170, CI 0.77 - 1.77, p = 0.526) were similar between groups after a median follow-up of 17 months. Conclusion Our findings show that Inspiron® was effective and safe when compared to other second- or third-generation DES in a contemporary cohort of real-world STEMI patients submitted to primary PCI.

Impact of drug-eluting stent-associated coronary artery spasm on 3-year clinical outcomes: A propensity score matching analysis

Background: It has been reported that significant endothelial dysfunction or clinically evident vasospasm can be associated with drug-eluting stents (DESs). However, the impact of DES associated coronary artery spasm (CAS) on long-term clinical outcomes has not been fully elucidated as compared with those of patients with vasospastic angina. Methods: A total of 2797 consecutive patients without significant coronary artery lesion (<70%), who underwent the Acetylcholine (Ach) provocation test, were enrolled between Nov 2004 and Oct 2010. DES-associated spasm was defined as significant CAS in proximal or distal to previously implanted DES site at follow-up angiography with Ach test. Patients were divided into two groups (DES-CAS; n ¼ 108, CAS; n ¼ 1878). For adjustment, propensity score matching (PSM) was done (C-statistics ¼ 0.766, DESCAS; n ¼ 102, CAS; n ¼ 102). SPSS 20 (Inc., Chicago, Illinois) was used to analyze this data. Results: Baseline characteristics were worse in the DES-CAS group. After PSM, both baseline characteristics and the Ach test results were balanced except higher incidence of diffuse CAS and ECG change in the DES-CAS group. During Ach test, the incidence of diffuse spasm (93.1% vs. 81.3%, p ¼ 0.012) and ST-T change (10.7% vs. 1.9%, p ¼ 0.010) were higher in the DES-CAS group. At 3-year, before and after adjustment, the DES-CAS group showed a higher incidence of coronary revascularization (9.8% vs. 0.0%, p ¼ 0.001), recurrent chest pain requiring follow up coronary angiography (CAG, 24.5% vs. 7.8%, p ¼ 0.001) and major adverse cardiac events (MACEs, 9.8% vs. 0.9%, p < 0.005). Conclusion: In this study, DES associated CAS was associated with higher incidence of diffuse spasm, ST-T change and adverse 3-year clinical outcomes. Special caution should be exercised in this particular subset of patients.

Clinical and angiographic assessment of the culotte technique for the treatment of complex coronary bifurcation lesions / Valoración clínica y angiográfica de la técnica de culotte para el tratamiento de lesiones complejas en bifurcaciones coronarias

Abstract Introduction: The current standard treatment for bifurcation lesions is the provisional stent technique, by implanting only one stent in the main branch; however, in certain cases, the use of more complex techniques that require double stenting should be considered. Objective: To perform a clinical and angiographic assessment of patients with true bifurcation lesions treated with the two-stent culotte technique. Materials and methods: A prospective study was done, which included patients diagnosed with significant obstructive coronary artery disease in bifurcation areas, who were candidates for angioplasty with culotte technique. The study included 44 patients with proved diagnosis of coronary bifurcation lesions; 66% of the treated bifurcation lesions compromised the anterior descending artery and the diagonal branch and 27%, the circumflex artery with the marginal branch. It was found that 68% of the cases had Medina 1,1,1 lesions and 23% had Medina 0,1,1 lesions. Six months later, it was found that 12.5% of the patients followed up by angiography had in-stent restenosis (ISR) > 50% that involved at least one of the bifurcation areas. In 9% of these patients, the ISR was at the origin of the side branch only, and in 3%, the ISR was confined to the distal segment of the main branch stent. Conclusion: The use of the culotte technique with two new-generation stents to treat complex coronary bifurcation lesions is an effective option and does not increase the risk of complications during the procedure nor the risk of the appearance of ISR.

Resumen Introducción: El tratamiento estándar actual para las lesiones en bifurcaciones es la técnica de stent provisional, implantando solo un stent en la rama principal, sin embargo, en ciertos casos, se debería considerar el uso de técnicas más complejas que requieren de doble stent. Objetivo: Realizar una evaluación clínica y angiográfica de pacientes con verdaderas lesiones en bifurcaciones tratados con la técnica culotte de doble stent. Material y métodos: Se realizó un estudio prospectivo que incluyó pacientes diagnosticados con enfermedad obstructiva significativa de arterias coronarias en bifurcaciones, quienes eran candidatos a angioplastia con la técnica culotte. El estudio incluyó 44 pacientes con un diagnóstico comprobado de lesiones coronarias en bifurcaciones; el 66% de las lesiones en bifurcaciones tratadas comprometían la arteria descendente anterior y la rama diagonal, y el 27% la arteria circunfleja con la rama marginal. Se encontró que el 68% de los casos tenían lesiones Medina 1,1,1 y el 23% tenían lesiones Medina 0,1,1. A los seis meses, se encontró que el 12,5% de los pacientes en seguimiento con angiografía presentaban reestenosis intrastent (RIS) mayor al 50%, que comprometía al menos una de las áreas de bifurcación. En el 9% de estos pacientes, la RIS se ubicaba únicamente en el origen de la rama lateral, y en el 3%, la RIS se restringió al segmento distal del stent de la rama principal. Conclusiones: El uso de la técnica culotte empleando dos stents de nueva generación es una opción efectiva para tratar las lesiones complejas en bifurcaciones coronarias, y no aumenta el riesgo de complicaciones durante el procedimiento ni el riesgo de la aparición de reestenosis intrastent.

Rapamycin and Paclitaxel Affect Human Aortic Smooth Muscle Cells-Derived Foam Cells Viability and Proliferation

Abstract Introduction: Drug-eluting stents (DES) coated with rapamycin or paclitaxel as antiproliferative substances significantly reduced the incidence of clinical restenosis and had fewer side effects after percutaneous coronary intervention. However, DES coated with rapamycin or paclitaxel still cause restenosis due to abnormal tissue growth which remained a therapeutic problem, particularly in certain subgroups, possibly due to drug concentrations. This study examined the impact of different concentrations of rapamycin and paclitaxel on cytokine, cell viability and proliferation in human aortic smooth muscle cells (HASMC)-derived foam cells. Methods: The foam cell model was established in vitro by incubating HASMC with 20 µg/mL oxidized low-density lipoprotein (ox-LDL) for 48 hours. Subsequently, foam cells were treated with different concentrations (0.01 µg/mL, 0.1 µg/mL, 0.5 µg/mL, 1 µg/mL, 5 µg/mL and 10 µg/mL) of rapamycin or paclitaxel for 48 hours, to measure cytokine, cell viability and proliferation by ELISA and MTT, respectively. Finally, viability and proliferation were measured by MTT after the foam cells were treated with 1 µg/mL rapamycin or paclitaxel combined with cytokine antibody for 48 hours. Results: After incubation of HASMC with ox-LDL, the ratios of cholesterol ester and total cholesterol increased significantly (55.29%) (P<0.01). Lipid staining with Oil Red O showed many lipid vacuoles and red dye particles in the cells. Meanwhile, cell viability and proliferation significantly increased compared with the control. This indicated that HASMC had been transformed into foam cells (P<0.01) while rapamycin or paclitaxel concentrations ≥0.1 µg/mL can significantly decrease the foam cell proliferation (P<0.05 or P<0.01), and 1 µg/mL of rapamycin or paclitaxel appeared the most effective concentration. As for cytokines, rapamycin or paclitaxel concentrations ≥1 ug/mL could significantly increase the level of inflammatory cytokines IL-6 (P<0.05 or P<0.01), which was enhanced with the increase of drug concentration. However, rapamycin or paclitaxel concentrations ≥1 µg/mL could significantly reduce the levels of anti-inflammatory cytokines IL-35 and transforming growth factor beta (TGF-β) (P<0.05 or P<0.01), which decreased with the increase of drug concentration. In addition, rapamycin or paclitaxel combined with anti-IL-1β, anti-IL-6, anti- TNF-α or anti-IL-35 had no significant effect on foam cell proliferation compared to the drug alone. However, rapamycin or paclitaxel combined with anti-IL-10 or anti-TGF-β can significantly enhance foam cell proliferation (P<0.01). In addition, there was no difference in the effects of the same concentrations of rapamycin and paclitaxel on foam cells. Conclusion: Although rapamycin or paclitaxel can reduce foam cell proliferation, too high or too low concentrations could decrease effectiveness. In particular, a high dose can induce foam cells to increase inflammatory cytokines secretion, reduce anti-inflammatory cytokines secretion, and thus affect the inhibiting proliferation. For rapamycin- and paclitaxel-eluting stents, this conclusion may explain the clinical observation of in-stent restenosis after percutaneous coronary intervention. DES coated with an appropriate concentration of rapamycin or paclitaxel may, at least to some extent, contribute significantly to reducing incidence of late in-stent restenosis.

Aterectomia coronária com Excimer Laser como tratamento adjuvante da subexpansão grave do stent com calcificação volumosa / Excimer Laser coronary atherectomy as adjunctive treatment of severe stent underexpansion with bulky calcification

A aterectomia coronária com Excimer Laser melhorou significativamente nos últimos anos, utilizando emissão ultravioleta de alta energia e comprimento de onda curto, com menor penetração e menor emissão de calor, resultando em menos danos aos tecidos e menos complicações. Descrevemos o caso de um paciente do sexo masculino, 66 anos, ex-tabagista, hipertenso, diabético, dislipidêmico. Foi submetido a múltiplas intervenções coronárias percutâneas na artéria descendente anterior com stents não farmacológicos e farmacológicos. Na última intervenção coronária percutânea, o stent foi subexpandido, e o paciente apresentou trombose aguda do stent e reestenose recorrente do stent. Foram realizadas novas intervenções coronárias percutâneas com aterectomia coronária com Excimer Laser adjuvante, devido à angina refratária, com uso de carga progressiva e injeção de soro fisiológico, seguidas de posterior insuflação de balão de alta pressão e implante de stent farmacológico, com resultado excelente. No acompanhamento de 8 meses, o paciente se manteve assintomático.

Excimer Laser coronary atherectomy has improved significantly in recent years, emitting high-energy ultraviolet and short wavelength with less penetration and heat emission, ultimately leading to less tissue damage and fewer complications. We described a case of a 66-year-old male patient, former smoker and suffering from hypertension, diabetes mellitus, and dyslipidemia. He underwent multiple percutaneous coronary interventions in the left anterior descending artery with bare metal and drug-eluting stents. In the last percutaneous coronary intervention, the stent was underexpanded and the patient presented acute stent thrombosis and recurrent stent restenosis. New percutaneous coronary interventions with adjunctive Excimer Laser coronary atherectomy were undertaken due to refractory angina, using progressive load and saline injection, followed by subsequent high-pressure balloon inflation and drug-eluting stent implantation with an excellent result. At 8-month follow-up, the patient was asymptomatic.

Análise dos desfechos em intervenção coronária percutânea de tronco de coronária esquerda não protegido / Analysis of percutaneous coronary intervention outcomes in unprotected left main coronary artery lesions

Introdução: Lesões significativas no tronco de coronária esquerda são encontradas em aproximadamente 5% dos pacientes submetidos à coronariografia, sendo a maioria dos casos multiarteriais e com envolvimento do tronco distal. A cirurgia de revascularização do miocárdio é considerada o tratamento preferencial para lesões de tronco de coronária esquerda não protegido. No entanto, com o avanço de técnicas e a introdução dos novos stents liberadores de fármacos, a intervenção coronariana percutânea tem sido considerada estratégia viável, apresentando resultados favoráveis. O objetivo deste estudo foi analisar os desfechos em pacientes com lesões de tronco de coronária esquerda não protegido submetidos à intervenção coronariana percutânea. Métodos: Foram analisados dados eletrônicos de pacientes submetidos à intervenção coronariana percutânea entre dezembro de 2017 e janeiro de 2020 em um único centro, com o objetivo de avaliar características clínicas, angiográficas e os desfechos clínicos. Resultados: Foram incluídos 103 pacientes portadores de lesões significativas de tronco não protegido, 66% eram do sexo masculino, 88,3% eram hipertensos, e 87,4% possuíam função ventricular normal. Lesões envolvendo a bifurcação foram identificadas em 73,8% dos pacientes, 36,9% apresentavam lesões concomitantes nos três grandes vasos epicárdicos e 42,7% com escore SYNTAX intermediário (23 a 32 pontos). O sucesso angiográfico foi obtido em 100% dos casos, com quatro (3,9%) eventos cardíacos e cerebrovasculares adversos, sendo 2,9% de mortalidade. Conclusão: Os resultados hospitalares sustentam a intervenção coronariana percutânea como um procedimento seguro, de excelente resultado angiográfico e eventos cardíacos e cerebrovasculares adversos comparáveis aos da cirurgia de revascularização do miocárdio, configurando opção bastante viável em relação ao tratamento cirúrgico.

Background: Significant lesions in the left main coronary artery are found in approximately 5% of patients undergoing coronary angiography, with most cases involving multiple vessels and affecting the distal bifurcation. A coronary artery bypass graft surgery is considered the preferred treatment for unprotected left main coronary artery lesions. However, with the advancement of techniques and the introduction of new drug-eluting stents, percutaneous coronary intervention has been considered a viable strategy, with favorable results. The objective of this study was to analyze the outcomes in patients with unprotected left main coronary artery lesions undergoing percutaneous coronary intervention. Methods: Electronic data from patients undergoing percutaneous coronary intervention between December 2017 and January 2020 at a single center were analyzed to assess clinical and angiographic characteristics and clinical outcomes. Results: A total of 103 patients with significant unprotected left main coronary artery lesions were included; in that, 66% were male, 88.3% were hypertensive, and 87.4% had normal ventricular function. Lesions involving the bifurcation were identified in 73.8% of patients, 36.9% had concomitant lesions in the three major epicardial vessels, and 42.7% had an intermediate SYNTAX score (23 to 32 points). Angiographic success was achieved in 100% of cases, with four (3.9%) adverse cardiac and cerebrovascular events, with 2.9% mortality. Conclusion: Hospital results support percutaneous coronary intervention as a safe procedure, with excellent angiographic results and low rates of adverse cardiac and cerebrovascular events. We concluded that percutaneous coronary intervention is an option to coronary artery bypass graft surgery and is a very viable option for surgical treatment of unprotected left main coronary artery lesions.

Intervenção coronária percutânea no paciente com alto risco de hemorragia / Percutaneous coronary intervention in the patient at high risk of bleeding

Na atualidade, as intervenções coronárias percutâneas são responsáveis por mais de 80% dos procedimentos de revascularização miocárdica. Esse resultado é possível por dois grandes avanços: o desenvolvimento de stents farmacológicos eficazes e seguros, somado a uma farmacoterapia antitrombótica potente e efetiva na prevenção de eventos aterotrombóticos, a qual, em geral, deve ser mantida por cerca de 6 a 12 meses após a intervenção índice. No entanto, expressivo contingente de casos, que a literatura situa em até 20% dos pacientes tratados, apresenta risco para desenvolver hemorragias significantes, que podem ter grave impacto no prognóstico. Assim, essa população requer uma série de cuidados relacionados com a indicação, a realização e o acompanhamento tardio. O processo se inicia pela identificação dos casos mais predispostos, o que, na maior parte das situações, é simples, havendo inclusive escores de risco que auxiliam o car­ diologista. Na sequência, a indicação do procedimento deve ser feita com propriedade. Os cuidados são iniciados pela prescrição preferencial do clopidogrel ao invés dos demais inibidores da P2Y12; no momento do procedimento, sempre que viável, a opção pela via radial é vantajosa, em especial em síndromes coronárias agudas. O uso de um modelo de stent com liberação de medicamentos também é recomendado nesses casos, pois os stents contemporâneos são seguros a ponto de permitirem a abreviação com segurança do tempo de uso do esquema antiplaquetário duplo. Por fim, mais recentemente, tem sido discutida a monoterapia com inibidores do receptor P2Y12, na qual a suspensão precoce do ácido acetilsalicílico não comprometeria a segurança e, ao mesmo tempo, seria capaz de prevenir eventos hemorrágicos de vulto.

Currently, percutaneous coronary interventions account for more than 80% of myocardial revascularization procedures. This result was enabled by two major advances: the development of effective and safe drug­eluting stents, in addition to a potent and effective antithrombotic pharmacotherapy in the prevention of atherothrombotic events, which, in general, should be maintained for about 6 to 12 months after the index intervention. However, a significant number of cases (up to 20% of treated patients according to literature) are at risk for developing significant bleeding, which can have a serious impact on prognosis. Therefore, this population requires a series of care measures related to indication, performance of the procedure, and late follow­up. The process begins with the identification of the most predisposed cases, which, in most situations, is simple, and there are risk scores that help the cardiologist. Next, the indication of the procedure should be done appropriately. Care begins with the preferential prescription of clopidogrel instead of other P2Y12 inhibitors; at the time of the procedure, whenever feasible, the option for the radial access is advantageous, especially in acute coronary syndromes. The use of a drug­eluting stent is also recommended in these cases, since contemporary stents are safe enough to safely shorten the duration of use of the dual antiplatelet regimen. Finally, more recently, monotherapy with P2Y12 receptor inhibitors has been discussed, in which early withdrawal of acetylsalicylic acid would not compromise safety and, at the same time, it would be able to prevent major bleeding events.

Clinical study on the efficacy of domestic Firebird2 TM rapamycin eluting stent and imported Endeavor Resolute stent / 中国综合临床

Objective:To compare the safety and efficacy of domestic Firebird2 TM rapamycin eluting stent and imported Endeavor Resolute stent in the treatment of coronary heart disease patients. Methods:The clinical data of 889 patients with coronary heart disease who underwent percutaneous coronary intervention (PCI) in Wuhan Asian heart hospital from 2010 to 2015 were analyzed retrospectively A case-control study was conducted. According to the type of stent used, 550 cases were divided into domestic Firebird 2TM group and 325 cases were divided into imported endeavor resolve group The incidence of major adverse cardiovascular events (MACE) was compared between the two groups. All patients was followed up for 1 year.Results:There was no significant difference in gender, age, body mass index, medical diseases, whether it was emergency PCI, previous PCI history, coronary artery bypass grafting history and left ventricular between the two groups (all P>0.05). The success rate of PCI in the two groups was 100%. The TIMI blood flow of target vessels in the two groups was grade 3. There was no stent unloading during the operation, and balloon pretreatment and post-treatment were performed. The results of one-year follow-up showed that there was no significant difference in the incidence of mace (3.1% (17/550) and 2.2%(7/325)) and the incidence of independent end points between domestic Firebird 2 TM group and endeavor group (all P>0.05); There was no significant difference in survival without mac between the two groups ( P>0.05). Conclusion:The domestic Firebird2 TM rapamycin eluting stent has the same clinical efficacy as the imported Endeavor Resolute drug eluting stent.

Application of drug-coated balloons in percutaneous coronary intervention / 中国基层医药

Percutaneous coronary intervention is the main treatment of coronary heart disease. Both the original bare metal stent and drug-coated stent have the possibility of developing in-stent restenosis, and have poor therapeutic effect on small vessel lesions and bifurcation lesions, which limit their clinical application. In recent years, drug-coated balloons have made considerable progress. They provide a new treatment method for in-stent restenosis, chronic total occlusion, bifurcation lesions and small vessel lesions, and can shorten the duration of dual antiplatelet therapy and reduce the risk of bleeding. This paper reviews the clinical research progress of drug-coated balloon.

Research progress in ureter stents / 国际生物医学工程杂志

Ureteral stents play an important role in the treatment of ureteral strictures. It supports the narrow urethra and ensures the smooth flow of urine, thus alleviating the impact of ureteral stricture on kidney function. Traditional ureteral stents are prone to complications such as stones, bacterial infections, inflammation, and restenosis when indwelling in the body. This paper reviews the performance requirements of ureteral stents, introduces ureteral stents of different structures, functions, materials, and preparation as well as processing techniques, and analyzes the key problems and future research directions of ureteral stents, which provides a reference basis for the research of ideal ureteral stents.

The correlation of serum lipoprotein-associated phospholipase A2 with intra-stent restenosis after drug-eluting stent implantation / 中国医师杂志

Objectives:To investigate the correlation of serum lipoprotein-associated phospholipase A2 (Lp-PLA2) with intra-stent restenosis (ISR) after drug-eluting stent (DES) implantation.Methods:A total of 227 patients with coronary artery disease, who were diagnosed with severe epicardial coronary stenosis by coronary angiography (CAG) and treated by percutaneous coronary intervention (PCI) and DES implantation were enrolled in our study. After follow-up for 1-1.5 years, the CAG was performed and the patients were divided into ISR group and non-ISR (nISR) group according to the consequence of CAG. Biochemical data and multiple serum inflammatory factors such as Lp-PLA2, hypersensitive C-reactive protein (hs-CRP), interleukin 2 (IL-2), interleukin 6 (IL-6) and tumor necrosis factor-α (TNF-α) were analyzed before the CAG. Multivariate logistic regression and multiple linear regression were used to analyze the influencing factors of stent restenosis after DES implantation.Results:The level of serum Lp-PLA2 and the proportion of hypertension in ISR group were significantly higher than those in nISR group, and the level of high density lipoprotein cholesterol (HDL-C) was significantly lower than that in nISR group (all P<0.05), but there was no significant difference in other biochemical indexes and inflammatory factors between the two groups (all P>0.05). The minimum lumen diameter of stent segment in ISR group was significantly lower than that in nISR group ( t=14.975, P<0.01), and the stenosis degree of stent segment diameter was significantly higher than that in nISR group ( P<0.01). Multivariate logistic regression analysis showed that Lp-PLA2 remained an independent predictor for ISR (1.011, 95% CI: 1.005-1.017). Only the serum levels of Lp-PLA2 had linear relationship with the degree of ISR by multivariate linear regression analysis ( β=0.790, P<0.01). Conclusions:Serum Lp-PLA2 level is independently associated with an increased risk of ISR in patients with coronary heart disease.

Intervenção Coronariana Percutânea em Lesões não Protegidas de Tronco / Percutaneous Coronary Intervention in Unprotected Left Main Coronary Artery Lesions

Resumo Fundamento O advento dos stents farmacológicos permitiu que a intervenção coronariana percutânea apresentasse resultados seguros nas lesões de tronco da artéria coronária esquerda. Objetivos Analisar os resultados do tratamento percutâneo da lesão não protegida de tronco da artéria coronária com a utilização de ultrassom intravascular. Métodos Estudo de série de casos consecutivos realizado no período de janeiro de 2010 a dezembro de 2018. Coletaram-se dados clínicos dos pacientes, assim como escores prognósticos e dados da lesão coronariana. Considerou-se de sucesso a lesão residual menor que 50% à angiografia e a área mínima da luz maior que 6 mm 2 ao ultrassom intravascular. O nível de significância adotado foi de 5%. Resultados Analisaram-se 107 casos. A lesão multiarterial foi predominante, sendo com maior frequência (39,25%) encontradas lesões em três vasos além do tronco coronariano. O escore SYNTAX apresentou média de 46,80 (DP: 22,95), e 70 (65,42%) pacientes tiveram escore SYNTAX acima de 32 pontos. Considerou-se sucesso angiográfico da intervenção percutânea em 106 (99,06%) pacientes. A taxa geral de evento maior cardíaco e cerebrovascular no desfecho hospitalar foi 6,54%, sendo semelhante nos pacientes com escore SYNTAX ≤ 32 (8,10%) e ≥ 33 (5,71%; p = 0,68) . Conclusões A intervenção percutânea em casos de lesão não protegida de tronco coronariano foi realizada com segurança e apresentou ótimos resultados. Atingiu-se alto sucesso angiográfico de tratamento guiado pelo ultrassom intravascular. A taxa de eventos cardíacos e cerebrovasculares maiores foi semelhante entre os pacientes de menor e de maior risco.

Abstract Background The advent of drug-eluting stents allowed the percutaneous coronary intervention to present safe results in lesions in the left main coronary artery. Objectives To analyze the results of the percutaneous treatment of unprotected left main coronary artery lesion with the use of intravascular ultrasound. Methods Study of consecutive case series carried out from January 2010 to December 2018. Clinical data were collected from patients as well as prognostic scores and data on coronary lesion. Low-grade residual lesion (less than 50%) on angiography and minimum luminal area greater than 6 mm2on intravascular ultrasound were considered successful. The adopted significance level was 5%. Results 107 cases were analyzed. The multivessel lesion was predominant, with most (39.25%) of the lesions being found in three vessels in addition to the left main coronary artery. The SYNTAX score had a mean of 46.80 (SD: 22.95), and 70 (65.42%) patients had a SYNTAX score above 32 points. Angiographic success of percutaneous intervention was considered in 106 (99.06%) patients. The overall rate of major cardiac and cerebrovascular events in the hospital outcome was 6.54%, being similar in patients with SYNTAX score ≤ 32 (8.10%) and ≥ 33 (5.71%; p = 0.68). Conclusions Percutaneous intervention in cases of unprotected left main coronary artery lesion was safely performed and presented excellent results. Considerable angiographic success of treatment guided by intravascular ultrasound was achieved. The rate of major cardiac and cerebrovascular events was similar between patients at low and high risks.

Custo-efetividade do Stent Farmacológico na Intervenção Coronariana Percutânea no SUS / Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazils Unified Public Health System (SUS)

Resumo Fundamento O uso do stent farmacológico (SF) comparado ao stent não farmacológico (SNF) na intervenção coronariana percutânea (ICP) reduziu o percentual de reestenose, porém sem impacto na mortalidade, com aumento no custo. A literatura carece de estudos randomizados que comparem economicamente esses dois grupos de stents na realidade do Sistema Único de Saúde (SUS). Objetivo Estimar a razão custo-efetividade incremental (RCEI) entre SF e SNF na coronariopatia uniarterial em pacientes do SUS Métodos Pacientes com coronariopatia uniarterial sintomática foram randomizados em 3 anos para uso de SF ou SNF durante a ICP, na proporção de 1:2, com seguimento clínico de 12 meses. Foram avaliados reestenose intrastent (RIS), revascularização da lesão-alvo (RLA), eventos adversos maiores e custo-efetividade (CE) de cada grupo. Os valores de p < 0,05 foram considerados significativos. Resultados No grupo SF, dos 74 pacientes (96,1%) que completaram o acompanhamento, ocorreu RIS em 1(1,4%), RLA em 1 (1,4%), óbito em 1 (1,4%), sem trombose. No grupo SNF, dos 141 pacientes (91,5%),ocorreu RIS em 14 (10,1%), RLA em 10 (7,3%), óbito em 3 (2,1%) e trombose em 1 (0,74%). Na análise econômica, o custo do procedimento foi de R$ 5.722,21 no grupo SF e de R$4.085,21 no grupo SNF. A diferença de efetividade a favor do grupo SF por RIS e RLA foi 8,7% e 5,9%, respectivamente, com RCEI de R$ 18.816,09 e R$ 27.745,76. Conclusões No SUS, o SF foi custo-efetivo, em concordância com o limiar de CE preconizado pela Organização Mundial da Saúde. (Arq Bras Cardiol. 2020; 115(1):80-89)

Abstract Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89)

Características clínicas y epidemiológicas del infarto de miocardio agudo en un hospital peruano de referencia / Clinical and epidemiological characteristics of acute myocardial infarction in a referral peruvian hospital

RESUMEN Con el objetivo de determinar las características clínicas y epidemiológicas de los pacientes con infarto de miocardio agudo (IMA), se realizó un estudio descriptivo en 175 pacientes de un hospital peruano de referencia. La edad promedio de los pacientes fue de 68,7 años y el 74,8% fueron de sexo masculino. La principal estrategia de reperfusión utilizada fue la angioplastia coronaria transluminal percutánea + stent, aunque su uso primario resultó ser bajo; además, el porcentaje de revascularización quirúrgica fue alto. Casi el 60% de los pacientes tuvo una estancia hospitalaria mayor a siete días. La mortalidad intra hospitalaria fue de 3,4%, siendo el shock cardiogénico la causa más frecuente de muerte. Se concluye que el IMA afecta principalmente a varones mayores de 60 años y que la principal estrategia de reperfusión es la angioplastia, además, los tiempos para la realización de la reperfusión son mayores a lo recomendado con porcentajes altos de revascularización quirúrgica.

ABSTRACT To determine the epidemiological and clinical characteristics of patients with acute myocardial infarc tion, a descriptive study was conducted in 175 patients in a referral hospital in Lima. The average age of the patients was 68.7 ± 10.8 years and 74.8% were male. The main reperfusion strategy used was percutaneous transluminal coronary angioplasty + stent, however, the use of primary angioplasty was low (19.5% of patients with ST elevation myocardial infarction). Time to reperfusion therapies (angio plasty or fibrinolysis) were longer than recommended and the percentage of surgical revascularization was high. Almost 60% of the patients had a length of stay longer than seven days. In-hospital mortality was 3.4%, with cardiogenic shock being the most frequent cause of death. Myocardial infarction mainly affects men over 60 years, the clinical and epidemiological variables are like other regional reports. The main reperfusion strategy is angioplasty, although the use of primary angioplasty is low. Time to perfor ming reperfusion is longer than recommended and the percentage of surgical revascularization is high.

Clinical outcomes of drug-eluting balloons and drug-eluting stents for the treatment of in-stent restenosis / 中国组织工程研究

BACKGROUND: A series of studies have shown that both drug-eluting balloons and drug-eluting stents are better than the other treatments for drug-eluting in-stent restenosis lesions, but both of them have limitations. OBJECTIVE: To evaluate the long-term therapeutic efficacy of drug-eluting balloons and drug-eluting stents in the treatment of coronary in-stent restenosis. METHODS: A total of 63 patients with in-stent restenosis who received treatment in the First Affiliated Hospital of Inner Mongolia Medical University between January 2016 and December 2017 were included in this study. Among these patients, 32 patients received treatment with drug-eluting balloons (drug-eluting balloon group) and 31 patients were treated with drug-eluting stents (drug-eluting stent group). Coronary artery status before and immediately after surgery, coronary angiography 1 year after surgery, adverse events, and the risk factors of in-stent restenosis were recorded in both groups. The study was approved and supported by the Medical Ethics Committee of Inner Mongolia Medical University. RESULTS AND CONCLUSION: All patients were followed up for 1 year. There were no significant differences in minimum in-stent diameter, target vessel diameter, in-stent lumen loss in the late period between patients receiving treatment with drug-eluting balloons and patients receiving drug-eluting stents (all P > 0. 05). There were no significant differences in secondary restenosis rate (18% vs. 16%, P=0. 216), target lesion revascularization rate (6% vs. 6%, P=0. 513), and incidence of adverse events (9% vs. 10%, P=0. 334) between drug-eluting balloon and drug-eluting stent groups. There were two cases of gastrointestinal bleeding in the drug-eluting stent group, and no gastrointestinal bleeding occurred in the drug-eluting balloon group. Significant difference in gastrointestinal bleeding occurred between these two groups (P < 0. 01). Multi-factor analysis showed that smoking, diabetes and hyperhomocysteinemia are the risk factors of in-stent restenosis. These results suggest that both drug-eluting balloons and drug-eluting stents are the ideal treatments of in-stent restenosis. In clinical practice, individualized treatment options should be considered based on multiple factors.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.