Implantação de stent na bifurcação do tronco da coronária esquerda: uma análise em 2023 / Left main bifurcation stenting: a 2023 appraisal

Por várias décadas, a revascularização do miocárdio foi considerada o tratamento padrão-ouro de lesões não protegidas do tronco da coronária esquerda. No entanto, a acessibilidade anatômica e o grande calibre dos vasos tornam as lesões de tronco uma opção atraente para a intervenção coronária percutânea. A aplicação dessa intervenção nesse cenário foi expandida ainda mais como resultado da introdução de novos stents farmacológicos, com rápidos avanços em técnicas, dispositivos e farmacoterapias adjuvantes. As evidências atuais têm demonstrado que pacientes com complexidade coronariana baixa ou intermediária têm desfechos similares com a intervenção coronária percutânea ou a revascularização cirúrgica do miocárdio por até 10 anos. O tratamento das lesões da bifurcação do tronco da coronária esquerda continua tecnicamente complexo, apesar dos recentes avanços. A abordagem provisional é a estratégia padrão na maioria dos tipos de lesões da bifurcação do tronco da coronária esquerda. No entanto, algumas lesões complexas da bifurcação do tronco da coronária esquerda justificariam uma técnica eletiva com implante de dois stents. A abordagem integrada, que incorpora técnicas dedicadas, uma avaliação fisiológica e anatômica adjuvante e agentes farmacológicos, é fundamental para abordar com sucesso esse desafio ímpar e melhorar os desfechos clínicos.

For several decades coronary bypass grafting has been considered the gold standard treatment for unprotected left main coronary artery lesions. However, the anatomic accessibility and the large caliber of the vessel render the percutaneous coronary intervention a very attractive treatment option for left main coronary artery lesions. The use of percutaneous coronary intervention in this subset of lesions has been further expanded as a result of the introduction of newer drug-eluting stents along with rapid advancements in techniques, devices, and adjunctive pharmacotherapies. The current evidence has demonstrated that patients with low or intermediate coronary complexity treated with percutaneous coronary intervention or coronary bypass grafting have comparable outcomes, for up to 10 years. Treatment of left main bifurcation lesions remains technically demanding despite recent developments. The provisional approach is the default strategy in most types of left main bifurcation lesions. However, a few complex left main bifurcation lesions would warrant an elective two-stent technique. An integrated approach incorporating custom- tailored techniques, adjunctive physiological and morphologic evaluation, and pharmacologic agents is critical to tackle this unique challenge and improve clinical outcomes.

Reestenosis de stents liberadores de paclitaxel frente a stents convencionales

RESUMEN Introducción: La reestenosis de los stents liberadores de paclitaxel utilizados en Cuba no ha sido estudiada. Objetivo: Evaluar la reestenosis de los stents liberadores de paclitaxel y los convencionales. Métodos: Se incluyeron 64 pacientes con reestenosis de stent, de un estudio prospectivo previo; en 318 pacientes seguidos por 3 años luego de intervención coronaria percutánea; 25 con stent liberador de paclitaxel y 39 stent metálico convencional. Se consideró reestenosis como nueva lesión ≥ 50 % de la luz del vaso con isquemia demostrada. Se describió el tiempo de aparición, patrón angiográfico y alternativa de revascularización. Resultados: La reestenosis en el grupo de stents liberadores de paclitaxel fue 15,7 % con tiempo medio de supervivencia sin reestenosis de 32,4 meses vs. 24,5 % en stents convencionales, con supervivencia sin reestenosis de 29,8 meses, (p= 0,047). En el grupo de stents liberadores de paclitaxel predominó el patrón IB, (30,3 %) y stent convencional el III (28,3 %). En el 28,0 % del grupo de stents liberadores de paclitaxel, se recurrió a la cirugía de revascularización vs. 5,1 % en el grupo de stent convencional. Conclusiones: El stent liberador de paclitaxel logra una supervivencia libre de reestenosis superior y más perdurable que el stent convencional. La reestenosis en los de stents liberadores de paclitaxel es focal, con mayor frecuencia de nueva revascularización por cirugía y en los stents convencionales es mayormente difusa.

ABSTRACT Introduction: The restenosis of the paclitaxel-eluting stents used in Cuba has not been studied. Objective: To evaluate the restenosis of paclitaxel-eluting stents and conventional stents. Methods: 64 patients with stent restenosis were included, from a previous prospective study; in 318 patients followed up for 3 years after percutaneous coronary intervention; 25 with a paclitaxel-eluting stent and 39 conventional metal stent. Restenosis was considered as a new lesion ≥ 50 % of the vessel lumen with proven ischemia. The time to onset, angiographic pattern and alternative revascularization were described. Results: Restenosis in the group with paclitaxel-eluting stents was 15.7 % with a mean survival time without restenosis of 32.4 months vs. 24.5 % in conventional stents, with restenosis-free survival of 29.8 months, (p = 0.047). In the group with paclitaxel-eluting stents, the IB pattern predominated (30.3 %) and the conventional stent III (28.3 %). In 28.0 % of the paclitaxel-eluting stent group, revascularization surgery was used vs. 5.1 % in the conventional stent group. Conclusions: The paclitaxel-eluting stent achieves a superior and more durable restenosis-free survival than the conventional stent. Restenosis in paclitaxel-eluting stents is focal, with a higher frequency of revascularization by surgery, and in conventional stents it is mostly diffuse.

Application of rapamycin eluting stent in popliteal artery acute plaque events: a report of four cases / 中国综合临床

Short segment lesions in the middle and upper segment of popliteal artery caused by acute plaque events can lead to moderate and severe limb ischemia, but there is little professional attention and research reports. The effect of rapamycin eluting stent in the treatment of short segment popliteal artery lesions was reviewed. The characteristics, operation methods and follow-up results of 4 cases were analyzed to summarize the operation experience and evaluate the treatment effect. In 4 cases, the operation time was short, the operation was smooth, and the technical success rate was 100%. The blood flow of the stent was good, no complications such as displacement, rupture and vascular injury were found, and the blood supply of the lower limbs was improved satisfactorily. Rapamycin eluting stent implantation can achieve good medium and long-term results in the treatment of specific middle and upper popliteal artery lesions.

Design and Finite Element Analysis of a Novel Retrievable Vascular Stent / 医用生物力学

Objective In order to avoid early restenosis after drug-eluting stent (DES) implantation, the retrievable structure of the NiTi alloy stent and its biomechanical analysis were studied. Methods The geometric models of the retrievable vascular stent and the retrieval system were established. The retrieval part of the stent consisted of four symmetrically distributed tendons, which were designed as circular meshes. The distribution of the maximum strain during stent compression and its uniformity during compression and self-expansion were analyzed, and the simulation experiments of the retrieval process were also performed. Results The maximum strain of the stent was 3.7% and the index of non-uniformity (INU) was 0.62% when the stent was compressed to the minimum size. While the IBU was 1.31% after the self-expansion process completed. The maximum strain was 1.2% when half of the stent was retrieved into the outer sheath. Conclusions The stent could be safely and successfully retrieved into the outer sheath as the strain was within the bearable range of the material and the compression and self-expansion process was relatively uniform. The research findings provide important references for structural design, biomechanical analysis and potential clinical applications of the novel retrievable vascular stent.

Advances in Preparation and Evaluation of Non-vascular Drug-eluting Stents / 中国医疗器械杂志

In recent years, the application of stent intervention in the treatment of non-vascular stenosis caused by benign and malignant factors has been widely concerned by researchers at home and abroad. The high incidence of malignant tumor diseases, further promotes the development of stent intervention. The conventional bare stents are prone to irritate luminal mucosa and produce restenosis and other complications. The emergence of drug-eluting stent is expected to solve this problem and become one of the important development trends of non-vascular stents. In this paper, the drug loading materials, drug loading layer drugs, preparation technology and quality evaluation methods of non-vascular drugeluting stent are described based on the recent research and clinical application documents, so as to provide basis and direction for the follow-up research and development.

Endovascular stenting with a drug-eluting stent of transplanted renal artery stenosis in a dual kidney transplanted patient / Tratamento endovascular com stent farmacológico em estenose de artéria renal transplantada de paciente com transplante renal duplo

Abstract Renal transplant remains the preferred therapy for end-stage renal disease (ESRD). Given the shortage of suitable donor kidneys, use of an expanded criteria donor (ECD) allows marginal kidneys to be transplanted; albeit at risk of increased graft failure due to lower nephron mass. To reduce the risk of graft failure, double kidney transplant (DKT) is advocated, with favorable outcomes. Transplant renal artery stenosis (TRAS) is one of the most common vascular complications following renal transplant. Unlike single kidney transplants, where TRAS usually presents with fluid overload, uncontrolled hypertension, and worsening kidney functions; it may be clinically silent in DKT patients since they have two functional transplanted kidneys. We hereby report a case of TRAS in a DKT patient who had 2 years of favorable clinical outcomes following successful endovascular stenting. He however recently died of COVID-19 associated pneumonitis.

Resumo O transplante renal continua sendo a terapia preferida para doenças renais em fase terminal. Dada a escassez de rins de doadores adequados, o doador com critérios expandidos permite que rins marginais sejam transplantados, embora haja um maior risco de falha do enxerto devido à diminuição da massa nefrótica. Para diminuir o risco de falha do enxerto, recomenda-se o transplante renal duplo (TRD), com resultados favoráveis. A estenose de artéria renal transplantada (EART) é uma das complicações vasculares mais comuns após o transplante renal. Ao contrário dos transplantes de rim simples, nos quais a EART geralmente se manifesta como sobrecarga de fluido, hipertensão descontrolada e piora das funções renais, ela pode ser clinicamente silenciosa em pacientes com TRD, pois eles têm dois rins funcionais transplantados. Relatamos aqui um caso de EART em um paciente com TRD que teve resultados clínicos favoráveis por dois anos após o sucesso do implante de stent endovascular. No entanto, ele morreu recentemente de pneumonite associada à covid-19.

Effects of nicorandil combined with thrombus aspiration during percutaneous coronary intervention on reperfusion arrhythmia in patients with acute ST-elevation myocardial infarction / 中国基层医药

Objective:To investigate the effects of nicorandil combined with thrombus aspiration during percutaneous coronary intervention on reperfusion arrhythmia in patients with acute ST-elevation myocardial infarction.Methods:180 patients with acute ST-elevation myocardial infarction who received treatment in Yidu Central Hospital, Weifang Medical University, China between January 2019 and June 2020 were included in this study. They were randomly assigned to receive either nicorandil combined with thrombus aspiration during percutaneous coronary intervention (NPCI group, n = 90) or conventional PCI (PPCI group, n = 90). Myocardial perfusion (myocardial blush grade 3 blood flow) and the occurrence of reperfusion arrhythmia within 24 hours after treatment were compared between the NPCI and PPCI groups. Results:The incidence of myocardial blush grade 3 blood flow in the NPCI group was significantly higher than that in the PPCI group [84.44% (76/90) vs. 68.88% (62/90), χ2 = 6.01, P = 0.01]. There was no significant difference in the total incidence of reperfusion arrhythmia between NPCI and PPCI groups ( χ2 = 1.19, P = 0.27). The incidence of severe reperfusion arrhythmia in the NPCI group was significantly lower than that in the PPCI group [13.33% (12/90) vs. 27.77% (25/90), χ2 = 5.75, P = 0.02]. The influential factor of severe reperfusion arrhythmia was analyzed by logistic regression taking whether NPCI treatment was used as the variable ( OR = 0.40, 95% CI 0.18-0.89, P = 0.02). The other factors that affect severe reperfusion arrhythmia included age ( OR = 0.71, 95% CI 0.19-0.92, P = 0.04), time from onset to reperfusion of infarct related artery ( OR = 0.62, 95% CI 0.21-0.98, P = 0.02), dcuhistory of pre-infarct angina pectoris ( OR = 0.67, 95% CI 0.19-0.98, P = 0.03), admission blood glucose level ( OR = 1.96, 95% CI 1.05-5.78, P = 0.03), admission leukocyte count ( OR = 1.99, 95% CI 1.02-6.18, P = 0.03) and cardiac function ( OR = 1.71, 95% CI 1.06-6.91, P = 0.04). Conclusion:Nicorandil combined with thrombus aspiration during percutaneous coronary intervention for the treatment of acute ST-elevation myocardial infarction can not only improve myocardial perfusion, but also reduce the incidence of reperfusion arrhythmia. The combined therapy is superior to monotherapy, has certain clinical significance and is innovative.

Refractory vasospasm of the left anterior descending artery causing hemodynamic instability after percutaneous coronary intervention

Refractory coronary vasospastic angina is prone to fatal outcomes. Therefore, it is crucial that the most suitable treatment strategy be promptly elected so as to avert further cardiac complications. Here, authors present the clinical course of profound refractory coronary vasospastic angina in a 50-year-old man. Authors elected to manage the patient through stent implantation. Despite, a complication of perforation followed by refractory coronary vasospasm, authors elected to implant a second stent to relieve the patient from all symptoms.

Efficacy of cutting balloon versus semi-compliant balloon for predilation of coronary bifurcation lesions / 中国组织工程研究

BACKGROUND: There is no efficient and unified optimal scheme for treating coronary bifurcation diseases. Simple strategies such as drug-eluting stent implantation in the main branch and drug-coated balloon dilation in the sub-branches are mostly adopted. However, direct drug-coated balloon dilation cannot overcome the problem of elastic retraction of vascular wall, and there is still a risk of branch loss in the long term. OBJECTIVE: To investigate the efficacy and safety of a cutting balloon versus a semi-compliant balloon for predilation of coronary bifurcation lesions. METHODS: From August 2016 to May 2018, 110 patients with coronary bifurcation lesions admitted at Jiaozuo People’s Hospital were selected, including 83 males and 27 females, aged 18-88 years. The patients were randomized into observation and control groups (n=55/group) and received percutaneous coronary intervention. The main branch in the observation group was predilated by a cutting balloon prior to drug-eluting stent implantation, and the sub-branches were predilated by a cutting balloon prior to drug-coated balloon dilation. The main branch in the control group was predilated by a semi-compliant balloon prior to drug-eluting stent implantation, and the sub-branches were predilated by a semi-compliant balloon prior to drug-coated balloon dilation. Immediate postoperative angiography was performed to determine the forward blood flow TIMI grading of main branches and sub-branches and whether vascular dissection occurred. Coronary angiography quantitative analysis was used to detect the reference diameter, minimum inner diameter and stenosis degree of main and sub-branches before, immediately, 6 and 12 months after surgery. Major cardiovascular adverse events within 12 months after surgery were recorded in both groups. The study was approved by the Ethics Committee of Jiaozuo People’s Hospital. RESULTS AND CONCLUSION: (1) Immediate postoperative angiography showed that the TIMI level 3 rate of the main branches and sub-branches in the observation group was higher than that in the control group (P=0.007, 0.015), the incidence of vascular dissection was lower than that in the control group (P=0.023, 0.012), and the emergency target vessel reconstruction rate was lower than that in the control group (P=0.006, 0.026). (2) The success rate of coronary artery maintenance immediately and at 6 and 12 months after surgery in the observation group was higher than that in the control group (all P < 0.001). (3) The minimum inner diameter of main branches and sub-branches in the observation group was larger than that in the control group immediately and at 6 and 12 months after surgery (all P < 0.01). The degree of inner diameter stenosis was smaller than that in the control group (all P < 0.01). (4) The target vessel restenosis rate of main branch and sub-branches in the observation group was lower than that in the control group within 12 months after surgery (P=0.038, 0.043). The incidence of major cardiovascular adverse events was lower than that in the control group (P=0.025). (5) These results indicate that in coronary bifurcation lesions, drug-eluting stent implantation is suitable for main branch lesions and drug coated balloon is suitable for sub-branch lesion. Cutting balloon predilation is safer and more effective than semi-compliant balloon predilation. Cutting balloon predilation can also reduce the rate of target restenosis and the incidence of major cardiovascular adverse events.

Safety of drug-coated balloon versus drug-eluting stents in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients / 中国组织工程研究

BACKGROUND: It has been found that drug-coated balloons can reduce the loss of lumen in the advanced stage of coronary small-vessel disease, and the incidence of major adverse cardiovascular events at 6 months after surgery with drug-coated balloons is similar to that of drug-eluting stents. However, clinical studies on the efficacy of drug-eluting stents in older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease are still lacking. OBJECTIVE: To investigate the efficacy and safety of drug-coated balloon versus drug-eluting stent in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients. METHODS: A total of 122 older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease who received treatment in Jiaozuo People’s Hospital between January 2016 and September 2018 were included in this study. These patients were randomly divided into a drug-eluting stent group (n=62) and a drug-coated balloon group (n=60). Patients in both groups underwent coronary artery predilation with a semi-compliant balloon, followed by implantation of corresponding stents. Selective quantitative coronary angiography was performed before surgery, immediately, 6 months and 12 months after surgery. The minimum lumen diameter, residual stenosis, lumen increase and late lumen loss of target lesions were observed in the two groups. At 6 and 12 months after surgery, major adverse cardiovascular events and bleeding events were followed up. This study was approved by the Medical Ethics Committee of Jiaozuo People’s Hospital, China (approval No. 201503). RESULTS AND CONCLUSION: (1) The success rate of surgery in the drug-coated balloon group was significantly higher than that in the drug-eluting group (P=0.028). (2) Immediately after surgery, the minimum lumen diameter and lumen increase in the drug-coated balloon group were less than those in the drug-eluting stent group (both P < 0.01). The residual stenosis in the drug-coated balloon group was significantly greater than that in the drug-eluting stent group (P < 0.01). (3) At 6 months after surgery, late lumen loss of target vessels in the drug-coated balloon group was smaller than that in the drug-eluting stent group (P < 0.001). The rates of target vessel revascularization and major adverse cardiovascular events in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.028, 0.010). (4) At 12 months after surgery, the minimum lumen diameter in the drug-coated balloon group was larger than that in the drug-eluting stent group (P=0.033). The residual stenosis and late lumen loss in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.008, 0.002, 0.019). (5) These results suggest that drug-coated balloon for treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease is simple and easy to operate, with a high surgical success rate. Drug-coated balloon can reduce residual stenosis degree and late lumen loss, decrease the revascularization rate of target vessels, and reduce the incidences of major adverse cardiovascular disease and bleeding events. The clinical prognosis of drug-coated balloon is superior to that of drug-eluting stent.

Clinical and angiographic profile of symptomatic patients undergoing percutaneous transluminal coronary angioplasty and drug-eluting stent implantation

Background: There are limited number of studies in India which have looked at this clinical and angiographic characteristic of the disease. Thus, this study was conducted to assess the clinical and angiographic profile of symptomatic patients who underwent percutaneous transluminal coronary angioplasty (PTCA) and drug-eluting stent (DES) implantation.Methods: This was an observational study conducted at a tertiary-care center in India between November 2014 and November 2015. A total of 106 consecutive patients who received either Cypher/Xience/BioMime stent presented with anginal symptoms were included in the study. Based on the type of stent received, patients were divided into two groups: (A) Limus group; (B) Paclitaxel group. Coronary angiogram was done in all the patients. Angioplasty data were collected from patient records. Angiographic profiles of the two groups were compared and analysed.Results: Among the 106 patients, 54 patients were included in the Limus group and 52 patients were included in the Taxus stent. De novo lesions were found to be significantly higher in the Limus group (40(74%), p = 0.06) whereas the in-stent restenosis was found to be significantly higher in the paclitaxel group (22(42.3%), p = 0.08). At follow-up, the incidence of death was 0% and no patients suffered by myocardial infarction. One (1.8%), two (3.8%) patients from the Limus and Paclitaxel groups had target vessel revascularization, respectively.Conclusions: Development of lesions in new areas rather than in-stent restenosis is the cause for angina in the majority of patients who underwent angioplasty presenting with anginal symptoms.

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.

Complex coronary intervention outcomes: real world left main coronary artery angioplasty experience from a tertiary care center in South India

Background: Left Main Coronary Artery (LMCA) Disease is among the most complex forms of the coronary artery stenosis, the leading cause of mortality in the world.Methods: In this analysis, 102 patients with elective angioplasty for LMCA stenosis with PCI from 6/2013 to 5/2016, 3 years (70 in GenxSync™ arm and 32 in other devices arm; 100 DES and 2 BMS) were included. RADHIKa Analysis compared post-hoc subgroups of GenxSync™ and control groups.Results: Mean population age was 59.99±12.03 years; 60.27±10.49 years in GenxSync™ arm, and 58.31±14.32 years in control arm. A significant population (44, 43.14%) had diabetes, renal impairment (14, 13.73%) and hypertension (25, 24.51%). The MACCE in GenxSync™ arm was 17 13(18.58%) Versus 5(15.63%) [RR=0.93, RR’=-0.07, ?=-14.01. p=0.3). Most patients presented with unstable Angina (41, 40.20%) in all, 31(44.29%) in GenxSync™ and 10 (31.25%) in Control arm. AWMI and IWMI were 18, 17.65% each, attributed to 12 (17.14%) in GenxSync™ 6 (18.75%) in Control. Effort angina was 15(21.43%) in GenxSync™ and 10 (31.25%) in Control and NSTEMI was 25,24.51% (18 (25.71%)- GenxSync™ 7(21.88%) Control). The MACE in GenxSync™ arm at 24, 12 and 6 months was 12(17.15%), 8(11.43%) and 4(5.71%) respectively versus corresponding MACE in the control arm as 5(15.63%), 2(2.86%) and 2(6.25%) respectively. The TVR was present only in GenxSync™ Arm, which was contributed by 2 CABGs and 12 months and 1 additional PCI at 24 months.Conclusions: In real-world scenario of LMCA cases, performance and safety of various stents were similar. GenxSync™ Sirolimus Eluting Stent, in the post-hoc bifurcation had results similar to other real-world cases, based upon RADHIKa analysis.

In-stent restenosis assessed with frequency domain optical coherence tomography shows smooth coronary arterial healing process in second-generation drug-eluting stents

INTRODUCTION@#The pathophysiology and mechanism of in-stent restenosis (ISR) after implantation of second-generation drug-eluting stents (DESs) are not fully clear. We compared the morphological characteristics of ISR between first- and second-generation DESs using frequency domain optical coherence tomography (OCT).@*METHODS@#Patients who underwent follow-up coronary angiography (CAG) after first-generation (CYPHER™ and TAXUS™) and second-generation (Nobori®, PROMUS Element™, Resolute Integrity and XIENCE) DES implantations were examined. ISR was defined as lesions of over 50% diameter stenosis at follow-up CAG. Frequency domain OCT was performed at the time of revascularisation of ISR. Tissue morphology was assessed at minimum lumen area. OCT images of DESs at both early (≤ 1 year) and late (> 1 year) phase follow-up were compared.@*RESULTS@#On qualitative OCT assessment, the ratios of homogeneous, layered, heterogeneous without-attenuation and heterogeneous with-attenuation morphologies were 57.1%, 17.1%, 20.0% and 5.7%, respectively, for second-generation DES ISR (n = 35), and 16.7%, 25.0%, 25.0% and 33.3%, respectively, for first-generation DES ISR (n = 36). At late phase follow-up, homogeneous morphology was significantly more common for second-generation DES ISR compared to first-generation DES ISR (first-generation: 8.0% vs. second-generation: 50.0%; p < 0.01) while heterogeneous with-attenuation morphology was significantly more common for first-generation DES ISR (first-generation: 44.0% vs. second-generation: 5.6%; p < 0.01).@*CONCLUSION@#Homogeneous tissue morphology was more frequently found for second-generation than first-generation DES ISR, especially in the late phase. This suggested that neointimal hyperplasia was the main mechanism in second-generation DES ISR, and that the neointima was stabilised, much like in bare metal stent implantation.

Safety Evaluation of Paclitaxel-Eluting Biliary Metal Stent with Sodium Caprate in Porcine Biliary Tract

BACKGROUND/AIMS: Metallic stents designed to relieve malignant biliary obstruction are susceptible to occlusive tumor ingrowth or overgrowth. In a previous report, we described metallic stents covered with paclitaxel-incorporated membrane (MSCPM-I, II) to prevent occlusion from tumor ingrowth via antitumor effect. This new generation paclitaxel-eluting biliary stent is further endowed with sodium caprate (MSCPM-III) for enhanced drug delivery. The purpose of this study is to examine the safety of its drug delivery system in the porcine biliary tract. METHODS: MSCPM-III (10% [wt/vol] paclitaxel) and covered metal stents (CMSs) were endoscopically inserted in porcine bile ducts in vivo. Histologic biliary changes, levels of paclitaxel released, and various serum analytes (albumin, alkaline phosphate, aspartate transaminase, alanine transaminase, total protein, total bilirubin, and direct bilirubin) were assessed. RESULTS: Based on the intensity of reactive inflammation and fibrosis, changes in porcine biliary epithelium secondary to implanted MSCPM-III were deemed acceptable (i.e., safe). Histologic features in the MSCPM-III and CMS groups did not differ significantly. In a related serum analysis, paclitaxel release from MSCPM-III stents was below the limit of detection for 28 days. Biochemical analyses were also similar for the two groups, and no evidence of hepatic or renal toxicity was found in animals receiving MSCPM-III stents. CONCLUSIONS: In a prototypic porcine trial, this newly devised metal biliary stent incorporating both paclitaxel and sodium caprate appears to be safe in the porcine bile duct.

Coronary Artery Aneurysm after Second-Generation Drug-Eluting Stent Implantation

PURPOSE: We evaluated the incidence, predictors, and prognosis of coronary artery aneurysm (CAA) after second-generation drug-eluting stent (DES) implantation. MATERIALS AND METHODS: A total of 976 consecutive patients (1245 lesions) who underwent follow-up angiography after second-generation DES implantation were analyzed. Incidence and predictors of CAA were assessed, and clinical prognosis was compared with 34 cases of CAA after first-generation DES implantation using previous CAA registry data. RESULTS: All 10 cases of CAA (0.80% per lesion) in 10 patients (1.02% per patient) were detected at follow up. Compared to lesions without CAA, those with CAA had greater involvement of the proximal segment (90% vs. 51%, p=0.014), a higher proportion of pre-intervention, a Thrombolysis in Myocardial Infarction score of 0 or 1 flow (80% vs. 16%, p<0.001), more chronic total occlusions (40% vs. 10%, p<0.001), and longer implanted stents (41.9±23.2 mm vs. 28.8±14.8 mm, p=0.006). As for CAA morphology, instances of CAA after second-generation DES were predominantly the single fusiform type (90%), whereas instances of CAA after first-generation DES were multiple saccular (47%) and single saccular (35%) types (p<0.001). Myocardial infarction with stent thrombosis occurred in 5 patients with CAA after first-generation DES (15%), and no adverse events were observed in patients with CAA after second-generation DES over a median follow-up duration of 4.3 years (p=0.047, log-rank). CONCLUSION: Although CAAs after second-generation DES implantation were detected at a similar incidence to that for CAAs after first-generation DES implantation, second-generation DES-related CAAs had different morphologies and more benign clinical outcomes versus first-generation DES-related CAAs.

Effect of Cardiac Rehabilitation on Outcomes in Patients with ST-Elevation Myocardial Infarction

PURPOSE: Whether cardiac rehabilitation (CR) improves clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) has not been thoroughly evaluated. Moreover, few studies have sought to identify patients who would benefit most from CR among STEMI patients. MATERIALS AND METHODS: Consecutively, 265 STEMI patients who underwent primary PCI with implantation of DESs and follow-up angiography were examined. Seventy-six patients (30%) who received CR were assigned to the CR+ group. Another 178 patients (70%) who did not participate in CR were assigned to the CR− group. Second generation DESs were implanted in 238 (94%) patients. RESULTS: Major adverse cardiovascular events (MACEs), including death, myocardial infarction, and revascularization, were compared. The CR+ group tended to have lower MACE than the CR− group at 3 years, although the difference was not statistically significant (9.9% vs. 18.3%, hazard ratio=0.54, p=0.138). Subgroup analysis revealed a significant interaction according to CR and preprocedural thrombolysis in myocardial infarction (TIMI) flow (p value for interaction=0.011). In patients with low preprocedural TIMI flow (TIMI flow ≤1, n=161), those in the CR+ group had significantly lower MACE than those in the CR− group (p=0.005), whereas MACE was not different among patients with higher TIMI flow (TIMI flow ≥2, n=93). CONCLUSION: CR including exercise training was associated with lower MACE, particularly in patients with lower preprocedural TIMI flow during primary PCI for STEMI in the current DES era.

Effect of Lp(a) on in-stent restenosis and non-target coronary lesions in CAD patients with drug-eluting stents / 解放军医学杂志

Objective To explore the effect of lipoprotein(a) [Lp(a)] on in-stent restenosis and non-target coronary lesions in coronary artery disease (CAD) patients implanted with drug-eluting stents. Methods One hundred and seventy-four patients, diagnosed as CAD and underwent percutaneous coronary intervention (PCI) with the implantation of drug-eluting stents (DES), were enrolled in present study; all of them were performed another elective PCI or revascularization within 1-4 years after their previous procedures. Thirty-one of enrolled patients were discovered to have in-stent restenosis. The relationship between Lp(a) and in-stent restenosis and the development of non-target coronary lesions were analyzed in groups stratified by the presence of in-stent stenosis or Lp(a) levels, and the independent risk factors of both in-stent restenosis and non-target lesions were also analyzed by multivariate logistic regression analysis. Results In CAD patients with DES, Lp(a) level in patients with in-stent restenosis showed a significant increase than those with the Lp(a) level non-restenosis [(437.57±391.60) mg vs. (279.46±288.06) mg, P=0.04]. In following analysis comparing lipid profiles and coronary angiography results between low and high Lp(a) groups, the percentage of triple-vessel disease and left main plus triple-vessel disease appeared to be statistically higher in high Lp(a) group than those in low Lp(a) group (P=0.022). Multivariate logistic regression analysis revealed that high level of Lp(a) and much number of stents implanted were the independent risk factors for in-stent restenosis of DES. In comparing the characteristics of coronary angiography and results of quantitative coronary angiography, number of cases with non-target lesions, presence of in-stent restenosis, minimal lumen diameter and in-stent late lumen loss were all significantly higher in high Lp(a) group than those in low Lp(a) group (P<0.05), and high level of Lp(a) was again proved to be an independent risk factor for non-target lesions in patients with DES (P=0.001). Conclusion Elevated Lp(a) level is an independent risk factor for both in-stent restenosis and the development of non-target coronary lesions, and is closely related to the relapse and aggravation of coronary artery disease.

Long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases / 中华心血管病杂志

Objective@#To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases.@*Methods@#CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium′s (ARC) definition.@*Results@#Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285).@*Conclusion@#3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.