Current evidence of drug-elution therapy for infrapopliteal arterial disease

New and sophisticated endovascular devices, such as drug-eluting stents(DES)and drug-coated balloons(DCB), provide targeted drug delivery to affected vessels. The invention of these devices has made it possible to address the reparative cascade of arterial wall injury following balloon angioplasty that results in restenosis. DESs were first used for the treatment of infrapopliteal lesions almost 20 years ago. More recently, however, DCB technology is being investigated to improve outcomes of endovascular below-the-knee arterial procedures, avoiding the need for a metallic scaffold. Today, level IA evidence supports the use of infrapopliteal DES for short to medium length lesions,although robust evidence that justifies the use of DCBs in this anatomical area is missing. This review summarizes and discusses all available data on infrapopliteal drug-elution devices and highlights the most promising future perspectives.

Small particle drug-eluting beads-transarterial chemoembolization combined with targeted therapy in the clinical treatment of unresectable liver cancer

BACKGROUND Liver cancer is a highly malignant tumor with significant clinical impact.Chemotherapy alone often yields suboptimal outcomes in both the short and long term,characterized by high rates of local recurrence and distant metastasis,leading to a poor long-term prognosis.AIM To evaluate the clinical efficacy of small particle drug-eluting beads-transarterial chemoembolization(DEB-TACE)combined with targeted therapy for the treatment of unresectable liver cancer.METHODS We analyzed clinical data from 74 patients with unresectable liver cancer admitted between January 2019 and December 2020.Based on the different treatment regimens administered,patients were divided into the control(36 patients receiving sorafenib alone)and joint(38 patients receiving small particle DEB-TACE combined with sorafenib)groups.We compared liver function indicators[alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),albumin(ALB)]and serum tumor markers[alpha fetoprotein(AFP)]before and after treatment in both groups.Short-term efficacy measures[complete response(CR),partial response,progression disease,stable disease,objective response rate(ORR),and disease control rate(DCR)]were assessed post-treatment.Long-term follow-up evaluated median overall survival(OS),progression-free survival(PFS),and adverse reaction rates between the two groups.RESULTS One month post-treatment,the joint group demonstrated significantly higher rates of CR,ORR,and DCR compared to the control group(P<0.05).Three days after treatment,the joint group showed elevated levels of ALT,AST,and TBIL but reduced levels of ALB and AFP compared to the control group(P<0.05).The median OS was 18 months for the control group and 25 months for the joint group,while the median PFS was 15 months for the control group and 22 months for the joint group,with significant differences observed(log-rank:χ2=7.824,6.861,respectively;P=0.005,0.009,respectively).The incidence of adverse reactions was not significantly different between the groups(P>0.05).CONCLUSION The combination of small particle DEB-TACE and sorafenib significantly improves both short-and long-term outcomes in the treatment of unresectable liver cancer while preserving liver function.

Drug-eluting bead transarterial chemoembolization as neoadjuvant therapy pre-liver transplantation for advanced-stage hepatocellular carcinoma

BACKGROUND The objectives of this study were to assess the safety and efficacy of drug-eluting bead transarterial chemoembolization(DEB-TACE)as neoadjuvant therapy before liver transplantation(LT)for advanced-stage hepatocellular carcinoma(HCC)and to analyze the prognostic factors.AIM To determine whether DEB-TACE before LT is superior to LT for advanced-stage HCC.METHODS A total of 99 individuals diagnosed with advanced HCC were studied retrospectively.The participants were categorized into the following two groups based on whether they had received DEB-TACE before LT:DEB-TACE group(n=45)and control group(n=54).The participants were further divided into two subgroups based on the presence or absence of segmental portal vein tumor thrombus(PVTT).The DEB-TACE group consisted of two subgroups:Group A(n=31)without PVTT and group B(n=14)with PVTT.The control group also had two subgroups:Group C(n=37)without PVTT and group D(n=17)with PVTT.Data on patient demographics,disease characteristics,therapy response,and adverse events(AEs)were collected.The overall survival(OS)and recurrence-free survival(RFS)rates were assessed using Kaplan-Meier curves.Univariate and multivariate Cox regression analyses were conducted to determine the parameters that were independently related to OS and RFS.RESULTS The DEB-TACE group exhibited an overall response rate of 86.6%.Following therapy,there was a significant decrease in the median alpha-fetoprotein(AFP)level(275.1 ng/mL vs 41.7 ng/mL,P<0.001).The main AE was post-embolization syndrome.The 2-year rates of RFS and OS were significantly higher in the DEB-TACE group than in the control group(68.9%vs 38.9%,P=0.003;86.7%vs 63.0%,P=0.008).Within the subgroups,group A had higher 2-year rates of RFS and OS compared to group C(71.0%vs 45.9%,P=0.038;83.8%vs 62.2%,P=0.047).The 2-year RFS rate of group B was markedly superior to that of group D(64.3%vs 23.5%,P=0.002).Results from multivariate analyses showed that pre-LT DEB-TACE[hazard ratio(HR)=2.73,95%confidence interval(CI):1.44-5.14,P=0.04],overall target tumor diameter≤7 cm(HR=1.98,95%CI:1.05-3.75,P=0.035),and AFP level≤400 ng/mL(HR=2.34;95%CI:1.30-4.19,P=0.009)were significant risk factors for RFS.Additionally,pre-LT DEBTACE(HR=3.15,95%CI:1.43-6.96,P=0.004)was identified as a significant risk factor for OS.CONCLUSION DEB-TACE is a safe and efficient therapy for advanced-stage HCC and also enhances patient survival after LT.

Long-term outcomes of titanium-nitride-oxide coated stents and drug-eluting stents in acute coronary syndrome:A systematic review and meta-analysis

BACKGROUND In severe cases of coronary artery disease,percutaneous coronary intervention provide promising results.The stent used could be a drug-eluting stent(DES)or a titanium-nitride-oxide coated stent(TiNOS).AIM To compare the 5-year effectiveness and safety of the two stent types.METHODS The following systematic review and meta-analysis was conducted in accordance with the preferred reporting items for systematic reviews and meta-analysis guidelines,and PubMed/MEDLINE,Scopus,and Cochrane Central were searched from inception till August 2023.Primary outcomes were major adverse cardiac events(MACE),cardiac death,myocardial infarction(MI),cardiac death or MI,and ischemia-driven total lesion revascularization(ID-TLR).RESULTS Four randomized controlled trials(RCT),which analyzed a sum total of 3045 patients with acute coronary syndrome(ACS)after a median follow-up time of 5 years were included.Though statistically insignificant,an increase in the ID-TLR was observed in patients receiving TiNOSs vs DESs.In addition,MI,cardiac death and MI,and definite stent thrombosis(DST)were significantly decreased in the TiNOS arm.Baseline analysis revealed no significant results with meta-regression presenting non-ST elevated MI(NSTEMI)as a statistically significant covariate in the outcome of MACE.CONCLUSION TiNOS was found to be superior to DES in terms of MI,cardiac death or MI,and DST outcomes,however,the effect of the two stent types on ID-TLR and MACE was not significant.A greater number of studies are required to establish an accurate comparison of patient outcomes in TiNOS and DES.

Prolonged dual antiplatelet therapy after drug-eluting stent implantation improves long-term prognosis for acute coronary syndrome:five-year results from a large cohort study

BACKGROUND:To investigate the most appropriate dual antiplatelet therapy(DAPT)duration for patients with acute coronary syndrome(ACS)after drug-eluting stent(DES)implantation in the largest cardiovascular center of China.METHODS:We enrolled 5,187 consecutive patients with ACS who received DES from January to December 2013.Patients were divided into four groups based on DAPT duration:standard DAPT group(11-13 months,n=1,568)and prolonged DAPT groups(13-18 months[n=308],18-24 months[n=2,125],and>24 months[n=1,186]).Baseline characteristics and 5-year clinical outcomes were recorded.RESULTS:Baseline characteristics were similar across the four groups.Among the four groups,those with prolonged DAPT(18-24 months)had the lowest incidence of major adverse cardiovascular and cerebrovascular events(MACCEs)(14.1%vs.11.7%vs.9.6%vs.24.2%,P<0.001),all-cause death(4.8%vs.3.9%vs.2.1%vs.2.6%,P<0.001),cardiac death(3.1%vs.2.6%vs.1.4%vs.1.9%,P=0.004),and myocardial infarction(MI)(3.8%vs.4.2%vs.2.5%vs.5.8%,P<0.001).The incidence of bleeding was not different among the four groups(9.9%vs.9.4%vs.11.0%vs.9.4%,P=0.449).Cox multivariable analysis showed that prolonged DAPT(18-24 months)was an independent protective factor for MACCEs(hazard ratio[HR]0.802,95%confidence interval[CI]0.729-0.882,P<0.001),all-cause death(HR 0.660,95%CI 0.547-0.795,P<0.001),cardiac death(HR 0.663,95%CI 0.526-0.835,P<0.001),MI(HR 0.796,95%CI 0.662-0.957,P=0.015),and target vessel revascularization(HR 0.867,95%CI 0.755-0.996,P=0.044).Subgroup analysis for high bleeding risk showed that prolonged DAPT remained an independent protective factor for all-cause death and MACCEs.CONCLUSION:For patients with ACS after DES,appropriately prolonging the DAPT duration may be associated with a reduced risk of adverse ischemic events without increasing the bleeding risk.

Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries

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%CI:3.56-9.03),respectively].CONCLUSION Compared with traditional treatment modalities(i.e.,PTA with or without BMSI),DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.

Intracoronary thrombolysis combined with drug balloon angioplasty in a young ST-segment elevation myocardial infarction patient:A case report

BACKGROUND The combination of acute ST-segment elevation myocardial infarction(STEMI)and gastric ulcers poses a challenge to primary percutaneous coronary intervention(PPCI),particularly for young patients.The role of drug-coated balloons(DCBs)in the treatment of de novo coronary artery lesions in large vessels remains unclear,especially for patients with STEMI.Our strategy is to implement drug balloon angioplasty following the intracoronary administration of low-dose prourokinase and adequate pre-expansion.CASE SUMMARY A 54-year-old male patient presented to the emergency department due to chest pain on June 24,2019.Within the first 3 minutes of the initial assessment in the emergency room,the electrocardiogram(ECG)showed significant changes.There was atrial fibrillation with ST-segment elevation.Subsequently,atrial fibrillation terminated spontaneously and reverted to sinus rhythm.Soon after,the patient experienced syncope.The ECG revealed torsades de pointes ventricular tachycardia.A few seconds later,it returned to sinus rhythm.High-sensitivity tropon in I was normal.The diagnosis was acute STEMI.Emergency coronary angiography revealed subtotal occlusion with thrombus formation in the proximal segment of the left anterior descending artery.Considering the patient's age and history of peptic ulcer disease,after the intracoronary injection of prourokinase,percutaneous transluminal coronary angioplasty and cutting balloon angioplasty were conducted for thorough preconditioning,and paclitaxel drug-eluting balloon angioplasty was performed without any stents,achieving favorable outcomes.CONCLUSION A PPCI without stents may be a viable treatment strategy for select patients with STEMI,and further research is warranted.

The Efficacy and Safety of Drug-Coated Balloons in the Treatment of Acute Myocardial Infarction

The incidence of acute myocardial infarction (AMI) is increasing year by year, which seriously endangers human health around the world. The preferred treatment strategy for AMI patients is the use of drug-eluting stents (DES), as there is ample evidence to suggest that stent implantation can reduce major adverse cardiovascular events (MACEs). With the application of drug-coated balloons (DCBs) and the enhancement of the concept of interventional without implantation, the question is whether DCBs can be safely and effectively used in patients with AMI? The purpose of this study was to investigate the safety and effectiveness of DCBs in the treatment of AMI. A retrospective review of clinical data was conducted on 55 AMI patients who underwent primary percutaneous coronary intervention (PCI) from January 2020 to December 2021. Of these patients, 25 were treated with DCBs and 30 were treated with DESs. Optical coherence tomography (OCT) was used to measure the minimum lumen diameter, lumen stenosis, and coronary artery dissection before and after surgery, and angina pectoris attacks and various MACEs were recorded at 1, 6, and 12 months after surgery. The results showed that there were no significant differences in clinical baseline data between the two groups. However, the minimum lumen diameter of the DCB group immediately after the operation was smaller than that of the DES group, and the stenosis degree of the lumen in the DCB group was higher than that in the DES group. The incidence of coronary artery dissection in the DCB group was significantly higher than that in the DES group, but the majority of them were type B. At 1, 6, and 12 months after treatment, there was no significant difference in the occurrence of MACEs between the two groups. In conclusion, DCBs is a safe and effective treatment for AMI. However, the incidence of coronary artery dissection in DCB patients is higher than that in DES patients, but the majority of them are type B. .

Drug-eluting fully covered self-expanding metal stent for dissolution of bile duct stones in vitro

BACKGROUND The treatment of difficult common bile duct stones(CBDS)remains a big challenge around the world.Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic retrograde cholangiopancreatography.Fully covered self-expanding metal stent(FCSEMS)has gained increasing attention in the management of difficult CBDS.AIM To manufacture a drug-eluting FCSEMS,which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS.METHODS Customized covered nitinol stents were adopted.Sodium cholate(SC)and disodium ethylene diamine tetraacetic acid(EDTA disodium,EDTA for short)were used as stone-dissolving agents.Three different types of drug-eluting stents were manufactured by dip coating(Stent I),coaxial electrospinning(Stent II),and dip coating combined with electrospinning(Stent III),respectively.The drugrelease behavior and stone-dissolving efficacy of these stents were evaluated in vitro to sort out the best manufacturing method.And the selected stonedissolving stents were further put into porcine CBD to evaluate their biosecurity.RESULTS Stent I and Stent II had obvious burst release of drugs in the first 5 d while Stent III presented controlled and sustainable drug release for 30 d.In still buffer,the final stone mass-loss rate of each group was 5.19%±0.69%for naked FCSEMS,20.37%±2.13%for Stent I,24.57%±1.45%for Stent II,and 33.72%±0.67%for Stent III.In flowing bile,the final stone mass-loss rate of each group was 5.87%±0.25%for naked FCSEMS,6.36%±0.48%for Stent I,6.38%±0.37%for Stent II,and 8.15%±0.27%for Stent III.Stent III caused the most stone mass-loss no matter in still buffer or in flowing bile,which was significantly higher than those of other groups(P<0.05).In vivo,Stent III made no difference from naked FCSEMS in serological analysis(P>0.05)and histopathological examination(P>0.05).CONCLUSION The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro.When conventional endoscopic techniques fail to remove difficult CBDS,SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative.

Efficacy of intra-arterial contrast-enhanced ultrasonography during transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma

AIM To assess the usefulness of intra-arterial contrastenhanced ultrasonography(IAUS) during transarterial chemoembolization(TACE) with drug-eluting beads(DEB) for hepatocellular carcinoma(HCC).METHODS Thirty two patients with 39 HCC underwent DEB-TACE guided with IAUS, and examined by contrast-enhanced ultrasonography(CEUS) or dynamic CT after DEB-TACE were enrolled in this study. CEUS findings before DEBTACE and IAUS findings were compared. Treatments judged to be complete and incomplete for lesions were appropriate and insufficient, respectively. Findings on CEUS and/or dynamic CT performed 1, 3 and 6 mo after DEB-TACE were evaluated using m RECIST(CR/PR/SD/PD).RESULTS The treatments were complete and incomplete in 26 and 13 lesions, respectively. On imaging evaluation using CEUS and/or dynamic CT one month after treatment, 25 and 1 lesions were judged to be CR and PR, respectively, and at 6 mo after treatment, the results were CR, PR, SD and PD for 24, 1, 0 and 1 of these lesions, respectively, in the 26 completely treated lesions. Of the 13 lesions in which treatment was incomplete, the results on imaging at one month after treatment were CR, PR, SD and PD for 0, 6, 4 and 3 lesions, respectively. The overall CR rate at 6 mo after treatment was 61.5%(24/39).CONCLUSION A combination of DEB-TACE with IAUS can improve the therapeutic effects in patients with HCC.

Conventional vs drug-eluting beads transarterial chemoembolization for hepatocellular carcinoma

Transarterial chemoembolization(TACE) is the current standard of therapy for patients with intermediatestage hepatocellular carcinoma(HCC) according to the Barcelona Clinic Liver Cancer classification. The concept of conventional TACE(cTACE) is the selective obstruction of tumor-feeding artery by injection of chemotherapeutic agents, leading to ischemic necrosis of the target tumor via cytotoxic and ischemic effects. Drugeluting beads(DEBs) have been imposed as novel drugdelivering agents for TACE, which allows for higher concentrations of drugs within the target tumor and lower systemic concentrations compared with cTACE. Despite the theoretical advantages of DEB-TACE, it is still controversial in clinical practice as to whether DEBTACE is superior to cTACE in regard to overall survival and treatment response. In this review article, we summarize the clinical efficacy and safety of DEB-TACE for patients with intermediate or advanced stage HCC in comparison with cTACE.

Five-year major clinical outcomes between first-generation ana second- generation drug-eluting stents in acute myocardial infarction patients underwent percutaneous coronary intervention

Background There were limited data comparing the major clinical outcomes between first-generation （1G）-drug eluting stentts （DES） and second-generation （2G）-DES in patients with acute myocardial infarction （AMI） after percutaneous coronary intervention （PCI） during very long follow-up periods. We thought to investigate the comparative efficacy and safety of 2G-DES compared with 1G-DES in AMI patients during 5-year follow-up periods. Method A total of 1016 eligible AMI patients who underwent PCI with 1G-DES [paclitaxel-, sirolimus-, 1G-zotarolimus-eluting stent （endeavor~ or endeavor sprintS）, n = 554] or 2G-DES [2G-zotarolimus （endeavor resolute~）- or everolimus-eluting stent, n = 462] were enrolled. The primary endpoint was the occurrence of major adverse cardiac events （MACE） defined as total death, non-fatal myocardial infarction （MI）, target lesion revascularization （TLR）, target vessel revascularization （TVR）, non-target vessel revascularization （Non-TVR） and the secondary endpoint was stem thrombosis （ST） at 5 years. Results Two propensity score-ma- tched （PSM） groups （232 pairs, n = 464, C-statistic = 0.802） were generated. During the 5-year follow-up period, the cumulative incidence of TLR [hazard ratio （HR）： 3.133; 95% confidence interval （CI）： 1.539-6.376; P = 0.002], TVR （HR： 3.144; 95% CI： 1.59645.192; P = 0.001） and total revascularization rate （FIR： 1.874; 95% CI： 1.086-3.140; P = 0.023） were significantly higher in 1G-DES compared with 2G-DES after PSM. However, the incidence of total death, non-fatal MI and ST were similar between the two groups. Conclusion In this single-center and all-comers registry, 2G-DES＇s superiorities for TLR, TVP, and total revascularization in AMI patients suggested during 5-year clinical follow-up periods.

Transarterial chemoembolization with drug-eluting beads in hepatocellular carcinoma

Transarterial chemoembolization(TACE) is a widely used standard treatment for patients with hepatocellular carcinoma(HCC) who are not suitable candidates for curative treatments. The rationale for TACE is that intra-arterial chemotherapy using lipiodol and chemotherapeutic agents, followed by selective vascular embolization, results in a strong cytotoxic effect as well as ischemia(conventional TACE). Recently, drugeluting beads(DC Beads?) have been developed for transcatheter treatment of HCC to deliver higher doses of the chemotherapeutic agent and to prolong contact time with the tumor. DC Beads? can actively sequester doxorubicin hydrochloride from solution and release it in a controlled sustained fashion. Treatment with DC Beads? substantially reduced the amount of chemotherapeutic agent that reached the systemic circulation compared with conventional, lipiodol-based regimens, significantly reducing drug-related adverse events. In this article, we describe the treatment response, survival, and safety of TACE used with drugeluting beads for the treatment of HCC and discuss future therapeutic possibilities.

Advances in the treatment of hepatocellular carcinoma using drug-eluting beads

Hepatocellular carcinoma(HCC)is one of the most common types of malignant tumor.Although radical surgery and liver transplantation are possible cures for the disease,most patients are beyond the optimum stage for radical treatment at the time of diagnosis.Transarterial chemoembolization(TACE)is the first choice of treatment for advanced HCC.Owing to the widespread use of conventional TACE(cTACE),the problems with this treatment cannot be ignored.Drug-eluting beads(DEBs),a new type of embolization material,appear to overcome the problems of cTACE,and they have other advantages such as synchronous controlled continuous drug release after chemotherapy and embolization and low blood concentrations after treatment.This review summarizes the recent advances in the use of DEB-TACE to treat HCC.

Conventional versus drug-eluting bead transarterial chemoembolization:A better option for treatment of unresectable hepatocellular carcinoma

Transarterial chemoembolization(TACE) is a minimally invasive procedure involving intra-arterial catheter-based chemotherapy to selectively administer high doses of cytotoxic drugs to the tumor bed along with ischemic necrosis induced by arterial embolization.Chemoembolization forms the essential core of management in patients with hepatocellular carcinoma(HCC) who are not suitable for curative therapies such as transplantation,resection,or percutaneous ablation.TACE of hepatic cancer(s) has proven to be helpful in achieving local tumor control,and has supported the ability to prevent tumor progression,prolong patient life,and manage patient symptoms.Recent data have demonstrated that,in patients with single-nodule HCC ≤3 cm without vascular invasion,the 5-year overall survival with TACE was found to be comparable with hepatic resection and radiofrequency ablation.Used for several years,Lipiodol continues to play a vital role as a tumor-seeking and radiopaque drug delivery vector in interventional oncology.Efforts have been made to enhance the administration of chemotherapeutic agents to tumors.Compared with conventional TACE,drug-eluting bead TACE is a fairly new drug delivery embolization technique that permits fixed dosing and has the ability to provide sustained release of anticancer agents over a period of time.The present review discusses the basic procedure of TACE and its properties,and the effectiveness of conventional and drug-eluting bead chemoembolization systems currently available or presently undergoing clinical evaluation.

Drug-eluting balloons versus new generation drug-eluting stents for the management of in-stent restenosis: an updated meta-analysis of randomized studies

Background New-generation drug-eluting stents (DES) was more effective in the treatment of in-stent restenosis (ISR) compared with the first-generation DES. Drug-eluting balloons (DEB) and new-generation DES had been available strategies in treatment of bare-metal stents/DES ISR (BMS/DES-ISR). Six new randomized trials have recently examined the angiographic outcomes and one-year clinical outcomes of DEB and new generation DES in BMS/DES-ISR. However, the optimal management for BMS/DES-ISR lesions remains controversial. Methods We searched the randomized clinical trials evaluating the angiographic outcomes and one-year clinical outcomes of DEB and new-generation DES in patients with BMS/DES-ISR. The primary endpoints were the angiographic outcomes, including the minimal luminal diameter (MLD), diameter stenosis %(DS%), late lumen loss (LLL), and binary restenosis (BR). Results A total of six randomized clinical trials with 1177 BMS/DES-ISR patients were included in our meta-analysis. For angiographic outcomes, there were significantly less MLD and more DS% with DEB compared to new-generation DES (MLD: MD =?0.18, 95% CI:?0.31– ?0.04, P < 0.001;DS%: MD = 5.68, 95% CI: 1.00–10.37, P < 0.001). Moreover, for one-year clinical outcomes, DEB was associated with a significant increase risk in target lesion revascularization (TLR)(RR = 2.93, 95% CI: 1.50–5.72, P = 0.002). However, DEB was associated with higher risks of major adverse cardiac event, target vessel revascularization, TLR, BR, and more DS% only in DES-ISR group. Conclusions DEB and new-generation DES have the similar clinical efficacy for the treatment of BMS-ISR. However, DES showed more MLD, less DS%, and a decreased risk of TLR for the treatment of DES-ISR.

Ureteral stent technology:Drug-eluting stents and stent coatings

Ureteral stents are commonly used following urological procedures to maintain ureteral patency.However,alongside the benefits of the device,indwelling stents frequently cause significant patient discomfort(pain,urgency,frequency)and can become encrusted and infected.The importance of these sequelae is that they are not only bothersome to the patient but can lead to significant morbidity,urinary retention,ureteral damage,recurrent infections,pyelonephritis and sepsis.When these problems occur,stent removal or replacement alongside antibiotic,analgesic and/or other symptom-modifying therapies are essential to successfully treat the patient.In an attempt to prevent such morbidity,numerous approaches have been investigated over the past several decades to modify the stent itself,thereby affecting changes locally within the urinary tract without significant systemic therapy.These strategies include changes to device design,polymeric composition,drug-elution and surface coatings.Of these,drug-elution and surface coatings are the most studied and display the most promise for advancing ureteral stent use and efficacy.This article reviews these two strategies in detail to determine their clinical potential and guide future research in the area.

Drug-eluting beads transarterial chemoembolization sequentially combined with radiofrequency ablation in the treatment of untreated and recurrent hepatocellular carcinoma

BACKGROUND Drug-eluting beads transarterial chemoem-bolization(DEB-TACE)has the advantages of slow and steady release,high local concentration,and low incidence of adverse drug reactions compared to the traditional TACE.DEBTACE combined with sequentially ultrasound-guided radiofrequency ablation(RFA)therapy has strong anti-cancer effects and little side effects,but there are fewer related long-term studies until now.AIM To explore the outcome of DEB-TACE sequentially combined with RFA for patients with primary hepatocellular carcinoma(HCC).METHODS Seventy-six patients with primary HCC who underwent DEB-TACE sequentially combined with RFA were recruited.Forty patients with untreated HCC were included in Group A,and 36 patients with recurrent HCC were included in Group B.In addition,40 patients with untreated HCC who were treated with hepatectomy were included in Group C.The serological examination,preoperative magnetic resonance imaging examination,and post-treatment computed tomography enhanced examination were performed for all patients.The efficacy was graded as complete remission(CR),partial remission(PR),stable disease and progressive disease at the 3rd,6th,and 9th.All patients were followed up for 3 years and their overall survival(OS),disease-free survival(DFS)were assessed.RESULTS The efficacy of Group A and Group C was similar(P>0.05),but the alanine aminotransferase,aspartate aminotransferase and total bilirubin of Group A were lower than those of Group C(all P<0.05).The proportions of CR(32.5%),PR(37.5%)were slightly higher than Group A(CR:27.5%,PR:35%),but the difference was not statistically significant(χ2=0.701,P=0.873).No operationalrelated deaths occurred in Group A and Group C.The OS(97.5%,84.7%,and 66.1%)and the DFS(75.0%,51.7%,and 35.4%)of Group A at the 1st,2nd,and 3rd year after treatment were similar with those of Group C(OS:90.0%,79.7%,and 63.8%;DFS:80.0%,59.7%,and 48.6%;P>0.05).The OS rates in Group A and Group B(90%,82.3%,and 66.4%)were similar(P>0.05).The DFS rates in Group B(50%,31.6%,and 17.2%)were lower than that of Group A(P=0.013).CONCLUSION The efficacy of DEA-TACE combined with RFA for untreated HCC is similar with hepatectomy.Patients with recurrent HCC could get a longer survival time through the combined treatment.

Domestic versus imported drug-eluting stents for the treatment of patients with acute coronary syndrome

BACKGROUND:The application of coronary stents,especially drug-eluting stents(DESs),has made percutaneous coronary intervention(PCI) one of important therapeutic methods for CHD. DES has reduced the in-stent restenosis to 5%–9% and signifi cantly improved the long-term prognosis of patients with CHD. The study aimed to investigate the long-term eff icacy and safety of domestic drugeluting stents(DESs) in patients with acute coronary syndrome(ACS).METHODS:All patients with ACS who had undergone successful percutaneous coronary intervention(PCI) in the First Aff iliated Hospital of Zhengzhou University from July 2009 to December 2010 were included in this study. Patients were excluded from the study if they were implanted with bare metal stents or different stents(domestic and imported DESs) simultaneously. The included patients were divided into two groups according to different stents implanted:domestic DESs and imported DESs.RESULTS:In the 1 683 patients of this study,1 558(92.6%) patients were followed up successfully for an average of(29.1±5.9) months. 130(8.3%) patients had major adverse cardiovascular events(MACEs),including cardiac death in 32(2.1%) patients,recurrent myocardial infarction in 16(1%),and revascularization in 94(6%). The rates of cardiac death,recurrent myocardial infarction,revascularization,in-stent restenosis,stent thrombosis and other MACEs were not signif icantly different between the two groups(all P>0.05). Multivarite logistic regression revealed that diabetes mellitus(OR=1.75,95%CI:1.09–2.82,P=0.021),vascular numbers of PCI(OR=2.16,95%CI:1.22–3.83,P=0.09) and PCI with left main lesion(OR=9.47,95%CI:2.96–30.26,P=0.01) were independent prognostic factors of MACEs. The Kaplan-Meier method revealed that there was no significant difference in cumulative survival rates and survival rates free from clinical events between the two groups(all P>0.05).CONCLUSIONS:The incidences of clinical events and cumulative survival rates are not statistically different between domestic DESs and imported DESs. Domestic DES is effective and safe in the treatment of patients with ACS.

From oral formulations to drug-eluting implants:using 3D and 4D printing to develop drug delivery systems and personalized medicine

Since the start of the Precision Medicine Initiative by the United States of America in 2015,interest in personalized medicine has grown extensively.In short,personalized medicine is a term that describes medical treatment that is tuned to the individual.One possible way to realize personalized medicine is 3D printing.When using materials that can be tuned upon stimulation,4D printing is established.In recent years,many studies have been exploring a new field that combines 3D and 4D printing with therapeutics.This has resulted in many concepts of pharmaceutical devices and formulations that can be printed and,possibly,tailored to an individual.Moreover,the first 3D printed drug,Spritam®,has already found its way to the clinic.This review gives an overview of various 3D and 4D printing techniques and their applications in the pharmaceutical field as drug delivery systems and personalized medicine.