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Meta-analysis of outcomes from Drug-eluting Stent implantation in infrapopliteal arteries

World Journal of Clinical Cases 2023年第22期11卷 5273-5287页

作者： Ming-Xuan Li Hai-Xia Tu Meng-Chen Yin Department of Vascular Surgery Beijing Fengtai You'anmen HospitalBeijing 100069China

BACKGROUND Percutaneous Drug-eluting Stent implantation(DESI)is an emerging and promising treatment modality for infrapopliteal artery diseases(IPADs).This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio(HR),which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.AIM To explore the superiority of Drug-eluting Stents(DESs)vs traditional treatment modalities for IPADs.METHODS The following postoperative indicators were the outcomes of interest:All-cause death(ACD)-free survival,major amputation(MA)-free survival,target lesion revascularization(TLR)-free survival,adverse event(AE)-free survival,and primary patency(PP)survival.The outcome measures were then compared according to their respective HRs with 95%confidence intervals(CIs).The participants were human IPAD patients who underwent treatments for infrapopliteal lesions.DESI was set as the intervention arm,and traditional percutaneous transluminal angioplasty(PTA)with or without bare metal stent implantation(BMSI)was set as the control arm.A systematic search in the Excerpta Medica Database(Embase),PubMed,Web of Science,and Cochrane Library was performed on November 29,2022.All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included.When studies did not directly report the HRs but gave a corresponding survival curve,we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs.Then,meta-analyses were conducted using a random-effects model.RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included.The ACDfree and MA-free survival HR values for DESI were not statistically significant from those of the control treatment(P>0.05);however,the HR values for TLR-free,AE-free,and PP-survival differed significantly[2.65(95%CI:1.56-4.50),1.57(95%CI:1.23-2.01),and 5.67(95%

关键词： Infrapopliteal Drug-eluting Stent Below-the-knee Meta-analysis Hazard ratio

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A Case Summary of the Application of a Drug-eluting Stent Combined with a drug-Coated Balloon in Left Main Coronary Artery Disease

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Cardiovascular Innovations and Applications 2022年第1期6卷 127-134页

作者： Rong-Xue Xiao Xu wang Jun-Qing Gao Zong-Jun Liu Shanghai Putuo Central School of Clinical Medicine Anhui Medical UniversityDepartment of CardiologyShanghai Putuo District Central Hospital200062 ShanghaiPeople’s Republic of China Shanghai Putuo District Central Hospital 200062 ShanghaiPeople’s Republic of China

Objective:To evaluate the clinical efficacy of a Drug-eluting Stent(DES)combined with a drug-coated balloon(DCB)in the treatment of left main coronary artery bifurcation lesions.Methods:A retrospective analysis was conducted on the clinical data of eight patients with left main coronary artery bifurcation lesions treated with a DES combined with a DCB who were admitted to our hospital from July 2016 to July 2017.These eight patients all underwent DES treatment for their left main coronary artery and left anterior descending coronary artery lesions,and DCB treatment at the ostium of the left circumflex artery;six of the patients underwent surgical procedures under the guidance of intravascular ultrasonography.Immediate postoperative angiography was used to evaluate the patency of the diseased vessels,and the restenosis rate at the 6-month follow-up after the operation and the incidence of serious clinical events within 6 months were assessed as well.Results:The use of a DES combined with a DCB in the treatment of left main coronary artery bifurcation lesions had a low restenosis rate(left main coronary artery(8.4±5.3)%,left anterior descending coronary artery(18.2±5.0)%,left circumflex artery(30.5±16.5)%).No serious clinical events occurred in any patients.Conclusion:A DES combined with a DCB is a safe and effective interventional treatment for left main artery coro-nary bifurcation lesions.

关键词： Left main coronary artery bifurcation lesions drug-coated balloon Drug-eluting Stent

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Impact of admission creatinine level on clinical outcomes of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with Drug-eluting Stent implantation

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Chinese Medical Journal 2008年第23期121卷 2379-2383页

作者： ZHANG Qi ZHANG Rui-yan SHEN Jie ZHANG Jian-sheng HU Jian YANG Zheng-kun ZHANG Xian ZHENG Ai-fang SHEN Wei-feng Department of Cardiology Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025 China

Background Prognosis of patients with acute ST-elevation myocardial infarction （STEMI） and renal dysfunction （RD） who received primary percutaneous coronary intervention （PCI） has not been fully investigated in the Drug-eluting Stent （DES） era. This study aimed to evaluate the impact of admission serum creatinine level on short-term outcomes in patients with acute STEMI undergoing DES-based primary PCI. Methods Primary PCI with DES implantation was attempted in 619 consecutive STEMI patients within 12 hours of symptom onset. Among them, 86 patients had a serum creatinine level ≥115 μmol/L on admission （RD group）, and the remaining 533 patients had normal renal function （non-RD group）. The primary endpoint was 30-day major adverse cardiac events （MACE, including death, non-fatal reinfarction, and target vessel revascularization）, and the secondary endpoint was subacute stent thrombosis. Results Patients in the RD group were older than those in the non-RD group. There are more female patients in the RD group and they had a history of hypertension, myocardial infarction and revascularization. The occurrence rates of Killip class ≥2 （29.1% vs 18.6%, P=0.02） and multi-vessel （62.8% vs 44.5%, P=0.001） and triple vessel disease （32.6% vs 18.2%, P=0.002）, in-hospital mortality （9.3% vs 3.8%, P=0.03）, and MACE rate during hospitalization （17.4% vs 7.7%, P=-0.006） were higher in the RD group than those in the non-RD group. At a 30-day clinical follow-up, the MACE-free survival rate was significantly reduced in the RD group （76.7% vs 89.9%, P=-0.0003）. Angiographic stent thrombosis occurred in 3 （3.5%） and 7 （1.3%） of patients in the RD group and non-RD group, respectively （P=0.15）. Multivariate analysis revealed that the serum creatinine level 〉115 μmol/L on admission was an independent predictor for MACE rate at a 30-day follow-up （Hazard ratio （HR） 3.31,95% CI 1.19-9.18, P 〈0.001）. Conclusion Despite similar prevalence of stent thrombosis at a 30-day clinical follow-up, the short-term prognosis of STEMI patients wi

关键词： acute myocardial infarction percutaneous coronary intervention Drug-eluting Stent renal dysfunction prognosis

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Vascular brachytherapy revisited for in-stent restenosis in the Drug-eluting Stent era： current status and future perspective

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Chinese Medical Journal 2009年第18期122卷 2174-2179页

作者： LI Xiong-jie Seung-Woon Rha Sunil-P Wani WANG Lin Kanhaiya-L Poddar Dong-Joo Oh Department of Cardiology Sino-Korea Yanbian University Fuzhi Hospital Yanji Jilin 133002 China Cardiovascular Center Korea University Guro Hospital Seoul Korea

Percutaneous coronary intervention （PCI） with Drug-eluting Stents （DESs） has revolutionized the management of atherosclerotic coronary artery disease. However, in-stent restenosis （ISR） has been the downside of all coronary interventions with the devices that have been tested so far, even in the DES era. The impact of ISR is still an important issue due to the recurrent costs from need for repeat PCI and bypass surgery in some patients who underwent PCI with DES. A safe and cost-effective method is desired to overcome this unfavorable burden following PCI with DES. Vascular brachytherapy （VBT） is one of the approved indications and has evolved over a decade as a valuable alternative to treat ISR. Although VBT has been regarded as a standard therapy in ISR, it has cumbersome logistics and global applicability is decreasing, leading more extensive introduction of DES.

关键词： percutaneous coronary intervention brachytherapy restenosis Drug-eluting Stent

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Efficacy and safety of Drug-eluting Stent implantation for the treatment of in-stent restenosis occurring within bare-metal stent and Drug-eluting Stent

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2010年第8期11卷 553-560页

作者： Heng GE Qing ZHANG WeiZHOU Qing HE Zhi-hua HAN Ben HE Department of Cardiology Shanghai Renji Hospital School of Medicine Shanghai Jiao Tong University Shanghai 200001 China Department of Radiology Shanghai Renji Hospital School of Medicine Shanghai Jiao Tong University Shanghai 200001 China

Objective:Although Drug-eluting Stent(DES) implantation is the primary treatment modality for bare-metal stent(BMS) in-stent restenosis(ISR),little is known about the efficacy and safety profile of DES in the treatment of DES-ISR.The goal of this study was to compare the clinical outcomes following DES treatment for BMS-ISR and DES-ISR.Methods:Rates of major adverse cardiac events(MACE) were compared in 97 consecutive patients who underwent DES implantation for the treatment of ISR(56 BMS-ISR and 41 DES-ISR) from January 2004 to December 2008.Results:Baseline clinical and procedural characteristics were comparable,except that the DES used in the BMS-ISR group was longer and had a larger diameter.The length of follow-up was(28.60±1.96) and(20.34±1.54) months for the BMS-ISR and DES-ISR groups,respectively.One patient(1.8%) experienced non-cardiac mortality and one(1.8%) had target-vessel revascularization(TVR) in the BMS-ISR group.In the DES-ISR group,three patients(7.3%) died of sudden death with a documented acute ST-segment elevation myocardial infarction,and three suffered TVR(7.3%).Kaplan-Meier analysis indicated that cumulative survival probability and MACE-free probability were both significantly lower for the DES-ISR group(log rank test P=0.047 and P=0.005,respectively).In Cox regression analysis,DES-ISR remained an independent predictor for future MACE occurrence after adjustment for other factors(compared with BMS-ISR,risk ratio(RR)=8.743,95% confidence interval(CI) 1.54-49.54,P=0.014).Switching to a different type of DES to treat DES-ISR did not improve the prognosis.Conclusion:DES-ISR patients had a poorer prognosis than BMS-ISR patients after DES therapy.

关键词：关键词动脉粥样硬化 In-stent 狭窄赤裸金属的 stent Drug-eluting Stent

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Clinical characteristics of early and late Drug-eluting Stent in-stent restenosis and mid-term prognosis after repeated percutaneous coronary intervention

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Chinese Medical Journal 2020年第22期133卷 2674-2681页

作者： Jian-Feng Zheng Ting-Ting Guo Yuan Tian Yong Wang Xiao-Ying Hu Yue Chang Hong Qiu Ke-Fei Dou Yi-Da Tang Jin-Qing Yuan Yong-Jian Wu Hong-Bing Yan Shu-Bin Qiao Bo Xu Yue-Jin Yang Run-Lin Gao Department of Cardiology Fuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100037China Department of Cardiology Urumqi Friendship HospitalUrumqiXinjiang 830049China

Background:The mechanism and characteristics of early and late Drug-eluting Stent in-stent restenosis(DES-ISR)have not been fully clarified.Whether there are different outcomes among those patients being irrespective of their repeated treatments remain a knowledge gap.Methods:A total of 250 patients who underwent initial stent implantation in our hospital,and then were readmitted to receive treatment for the reason of recurrent significant DES-ISR in 2016 were involved.The patients were categorized as early ISR(<12 months;E-ISR;n=32)and late ISR(≥12 months;L-ISR;n=218).Associations between patient characteristics and clinical performance,as well as clinical outcomes after a repeated percutaneous coronary intervention(PCI)were evaluated.Primary composite endpoint of major adverse cardiac events(MACEs)included cardiac death,non-fatal myocardial infarction(MI),or target lesion revascularization(TLR).Results:Most baseline characteristics are similar in both groups,except for the period of ISR,initial pre-procedure thrombolysis in myocardial infarction,and some serum biochemical indicators.The incidence of MACE(37.5%vs.5.5%;P<0.001)and TLR(37.5%vs.5.0%;P<0.001)is higher in the E-ISR group.After multivariate analysis,E-ISR(odds ratio[OR],13.267;[95%CI 4.984-35.311];P<0.001)and left ventricular systolic dysfunction(odds ratio[OR],6.317;[95%CI 1.145-34.843];P=0.034)are the independent predictors for MACE among DES-ISR patients in the mid-term follow-up of 12 months.Conclusions:Early ISR and left ventricular systolic dysfunction are associated with MACE during the mid-term follow-up period for DES-ISR patients.The results may benefit the risk stratification and secondary prevention for DES-ISR patients in clinical practice.

关键词： In-stent restenosis Neointimal hyperplasia Risk factors Drug-eluting Stent

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Paclitaxel drug-eluting Tracheal stent Could Reduce Granulation Tissue Formation in a Canine Model

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Chinese Medical Journal 2016年第22期129卷 2708-2713页

作者： Ting Wang Jie Zhang Juan Wang Ying-Hua Pei Xiao-Jian Qiu Yu-Ling Wang Department of Respiratory Beijing Tian Tan Hospital Capital Medical University Beijing 100069 China

Background：Currently available silicone and metallic stents for tracheal stenosis are associated with many problems.Granulation proliferation is one of the main complications.The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model,as well as the pharmacokinetic features and safety profiles of the coated drug.Methods：Eight beagles were randomly divided into a control group （bare-metal stent group,n =4） and an experimental group （paclitaxel-eluting stent group,n =4）.The observation period was 5 months.One beagle in both groups was sacrificed at the end of the 1st and 3rd months,respectively.The last two beagles in both groups were sacrificed at the end of 5th month.The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups.Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent.The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent.Results：Compared with the control group,the proliferation of granulation tissue in the experimental group was significantly reduced.The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation （up to 70.9%）.Then,the release slowed down gradually.By the 54 month,the release reached up to 98.5%.During the observation period,a high concentration of the drug in the trachea （in the stented and adjacent unstented areas） and lung tissue was not noted,and the blood test showed no side effect.Conclusions：The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo,suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

关键词： Canine Drug-eluting Stent Paclitaxel Tracheal Stenosis

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Evaluation of neointimal coverage in patients with coronary artery aneurysm formation after Drug-eluting Stent implantation by optical coherence tomography

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Chinese Medical Journal 2013年第11期126卷 2092-2097页

作者： TIAN Feng CHEN Yun-dai CHEN Lian SUN Zhi-jun GUO Jun JIN Qin-hua LIU Chang-N WANG Jin-da LIU Hong-bin Department of Cardiology Chinese People's Liberation ArmyGeneral Hospital Beijing 100853 China

Background The vessel healing in patients with coronary artery aneurysms （CAA） that form after Drug-eluting Stent （DES） implantation is not clear. This study aims to assess the vessel healing in patients with CAA formation after DES implanation. Methods From June 2008 to August 2011, follow-up coronary angiography was conducted on 1160 patients who underwent percutaneous coronary intervention （PCI）. The average period of follow-up was about （18.95±13.05） months. A total of 175 patients who underwent DES implantation into de novo lesions and who underwent coronary angiography and optical coherence tomography （OCT） examination during follow-up were identified. Patients were divided into the CAA group （n=31） and non-CAA group （n=144） based on the results of the coronary angiography. The cardiac events including angina and acute myocardial infarction were noted; in addition, the neointimal thickness and the frequency of strut malapposition and strut uncoverage were also noted. Results A greater proportion of incomplete neointimal coverage （17.17% vs. 1.90%, P 〈0.001） and strut malapposition （18.20% vs. 1.38%, P 〈0.001） were observed in the CAA group. The neointimal thickness in the CAA group was significantly thinner than that in the non-CAA group （（146.6±94.8） μm vs. （192.5＋97.1）μm, P 〈0.001）, as detected via OCT. Patients with CAA formation had a higher frequency of cardiac events including angina pectoris （25.81% vs. 6.25%, P=0.001） and acute myocardial infarction （9.68% vs. 0.13%, P=0.002） and thrombosis （16.13% vs. 0.69%, P 〈0.001）. The longitudinal length of the CAA in the cardiac event group was significantly longer than in the no cardiac event group （（20.0±9.07） mm vs. （12.05±5.38） ram, P=0.005）. Conclusion CAA formation after DES implantation is frequently associated with cardiac events as a result of stent malapposition and incomplete neointimal coverage.

关键词： optical coherence tomography coronary artery aneurysms Drug-eluting Stent neointimal coverage

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Drug-eluting Stent for the treatment of small coronary lesion:comparison between sirolimus- and paclitaxel-eluting stent

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Chinese Medical Journal 2007年第7期120卷 569-573页

作者： LI Jian-jun XU Bo YANG Yue-Jin CHEN Ji-lin QIAO Shu-bin MA Wei-hua QIN Xue-wen YAO Min LIU Hai-bo WU Yong-jian YUAN Jin-qing CHEN Jue YOU Shi-jie DAI Jun XIA Ran GAO Run-lin Department of Cardiology Fuwai Hospital Chinese Academy of Medical Sciences ＆ Peking Union Medical College Beijing 100037 China

Background Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of Drug-eluting Stents （DES） has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available （sirolimus-eluting stent （SES） and paclitaxel-eluting stent （PES））. However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions. Methods In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES （n=68） and PES （n=83）. Quantitative coronary angiography （QCA） was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 42.5 mm measured by QCA. Major adverse cardiac events （MACE） including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization （TLR） were compared between the two groups. Results Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups （0 vs 1.2%, P〉0.05）. The TLR and in-segment restenosis were not significantly different （19.1% vs 25.3%; 10.3% vs 10.8%, P=0.365 and P=0.913 respectively） between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group （4.4% vs 21.7%; P=0.002）. Similarly, the late loss was significantly higher in the PES group （（0.14±0.38） mm vs （0.49±0.61） mm; P〈0.001）. Conclusions In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.

关键词： Drug-eluting Stent coronary artery disease angiography restenosis small coronary lesion

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Local aneurysmal dilatation mimicking stent malapposition and concurrent vulnerable plaque within neointima of normal lumen after Drug-eluting Stent implantation： primary new findings from optical coherence tomography

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Chinese Medical Journal 2012年第6期125卷 1186-1188页

作者： GUO Yuan-lin YANG Yue-jin GAO Zhan QIAN Jie Clinical and Research Center for Coronary Disease Fu Wai HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100037China

Very late stent thrombosis is a life-threatening complication of implantation of Drug-eluting Stent （DES）. The mechanisms are still unidentified. stent malapposition is supposed to be one debated reason. Here we report a case of 33 months after DES implanted. Observed by optical coherence tomography, we detected a lipid-rich plaque with defective fibrous cap within the neointima and many local aneurysmal dilatations between stent struts, which mimic ＂malapposition＂ on the angiogram. These indicated that vulnerable plaque hidden in the neointima at the stent segment might be a potential mechanism of very late stent thrombosis after DES implantation.

关键词： Drug-eluting Stent stent malapposition vulnerable plaque optical coherence tomography

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