Comparison of the efficacy of drug-eluting balloon for de novo lesions and in-stent restenosis lesions of the femoropopliteal arteries

Objective:To compare the efficacy of drug-eluting balloons for de novo and in-stent restenosis(ISR)for lesions of the femoropopliteal arteries during 12-month follow-up.Materials and methods:A retrospective analysis of 66 patients was performed.These patients had lower extremity atherosclerosis obliterans and were treated with drug-eluting balloons from June 2016 to June 2017.All the lesions were femoropopliteal,including 47 de novo lesions and 19 ISR lesions.Clinical results were followed up at 6 months and 12 months postoperatively.The primary patency rate,target lesion revascularization,Rutherford classification,ankle-brachial index,amputation rate and mortality were compared between the two groups.Results:All the 66 patients underwent the treatment of femoropopliteal artery lesions with unilateral limbs.The surgical success rates were 100%.No adverse events such as acute ischemia or amputation occurred in the hospital.There was no difference between the two groups'Rutherford classification and the ankle-brachial index at the 6-month follow-up(p>0.05).At the 12-month follow-up,the de novo group's Rutherford classification was lower than the ISR group(p=0.026),and the ankle-brachial index of the ISR group was lower(0.66±0.033 vs 0.52±0.056,p=0.036).There was no difference between the patency rate of the de novo group and the ISR group(93.6%vs 84.2%,p=0.229)at the 6-month follow-up.However,the ISR group patency rate was lower at the 12-month follow-up(63.2%vs 85.1%,p=0.048).As for revascularization there was no significant difference between the two groups at the 6-month follow-up(4.2%vs 10.5%,p=0.334),but a higher rate occurred in the ISR group at the 12-month follow-up(26.3%vs 6.4%,p=0.025).There were no significant differences in the mortality or amputation rate between the two groups(p>0.05).Conclusions:Drug-eluting balloons were effective in treating both de novo lesions and ISR lesions in the atherosclerotic femoropopliteal artery,but the 12-month follow-up results of ISR lesions were less favorable than the de novo lesions.

Comparison of the safety and efficacy of two types of drug-eluting balloons （RESTORE DEB and SeQuent Please） in the treatment of coronary in-stent restenosis： study protocol for a randomized controlled trial （RESTORE ISR China）

1 Introduction In-stent restenosis （ISR）, characterized by neointimal proliferation and/or neoatherosclerosis in the vessel of the stent, can cause a reduction in lumen diameter after stent implantation, which can directly induce the recurrence of angina symptoms or an acute coronary syndrome in patients and is usually life-threatening.

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.

The effectiveness and safety of the RESTORE R drug-eluting balloon versus a drug-eluting stent for small coronary vessel disease： study protocol for a multi-center, randomized, controlled trial

bjective Small coronary vessel disease （disease affecting coronary vessels with main branch diameters of 〈 2.75 mm） is a common and intractable problem in percutaneous coronary intervention （PCI）. This study was designed to test the theory that the effectiveness and safety of drug-eluting balloons for the treatment of de novo lesions in small coronary vessels are non-inferior to those of drug-eluting stents. Methods We designed a prospective, multicenter, randomized, controlled clinical trial aiming to assess the effectiveness and safety of the RESTORE R （Cardionovum, Bonn, Germany） drug-eluting balloon （DEB） versus the RESOLUTE R （Medtronic, USA） drug-eluting stent （DES） in the treatment of small coronary vessel disease. This trial started in August 2016. A total of 230 patients with a reference vessel diameter （RVD） 〉 2.25 mm and 〈 2.75 mm were randomly assigned to treatment with a DEB or a DES at a 1：1 ratio. The study was also designed to enroll 30 patients with an RVD 〉 2.00 mm and 〈 2.25 mm in the tiny vessel cohort. Results The key baseline data include demographic characteristics, relative medical history, baseline angiographic values and baseline procedural characteristics. The primary endpoint is in-segment diameter stenosis at nine months after the index procedure. Secondary endpoints include acute success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis. Conclusions The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEBs compared to DESs in the treatment of de novo coronary artery lesions in small vessels.

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.

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.

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.

Drug-eluting beads chemoembolization combined with programmed cell death 1 inhibitor and lenvatinib for large hepatocellular carcinoma

BACKGROUND The combination of transarterial chemoembolization(TACE),lenvatinib,and programmed cell death 1(PD-1)inhibitor has been widely used in the treatment of advanced hepatocellular carcinoma(HCC)and has achieved promising results.However,there are few studies comparing whether drug-eluting beads TACE(DTACE)can bring more survival benefits to patients with large HCC compared to conventional TACE(C-TACE)in this triplet therapy.AIM To compare the efficacy and adverse events(AEs)of triple therapy comprising DTACE,PD-1 inhibitors,and lenvatinib(D-TACE-P-L)and C-TACE,PD-1 inhibitors,and lenvatinib(C-TACE-P-L)in patients with large HCC(maximum diameter≥5 cm),and analyze the prognostic factors.METHODS Following a comprehensive review of our hospital’s medical records,this retrospective study included 104 patients:50 received D-TACE-P-L,and 54 received CTACE-P-L.We employed Kaplan-Meier estimation to assess the median progression-free survival(PFS)between the two groups,utilized Cox multivariate regression analysis to identify prognostic factors,and applied theχ2 test to evaluate AEs.RESULTS The objective response rate(ORR)and median PFS were significantly higher in the D-TACE-P-L group compared to the C-TACE-P-L group(ORR:66.0%vs 44.4%,P=0.027;median PFS:6.8 months vs 5.0 months,P=0.041).Cox regression analysis identified treatment option,portal vein tumor thrombus,and hepatic vein invasion as protective factors for PFS.AEs were comparable between the two CONCLUSION D-TACE-P-L may have significantly better PFS and ORR for large HCC,while exhibiting similar AEs to C-TACE-PL.

A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch:a prospective multicenter ranDomized (BEYOND)clinical trial in China

Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported.This prospective,multicenter,randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon(PEB)compared with regular balloon angioplasty(BA)in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers.Patients were randomly allocated at a 1:1 ratio to a PEB group(n=113)and a BA group(n=109).The primary efficacy endpoint was angiographic target lesion stenosis at 9 months.Secondary efficacy and safety endpoints included target lesion revascularization,target vessel revascularization,target lesion failure,major adverse cardiac and cerebral events(MACCEs),all-cause death,cardiac death,non-fatal myocardial infarction,and thrombosis in target lesions.The main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety analysis.SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up,the difference in the primary efficacy endpoint of target lesion stenosis between the PEB(28.7%±18.7%)and BA groups(40.0%±19.0%)was-11.3%(95%confidence interval:-16.3%to-6.3%,Psuperiority<0.0001)in the intention-to-treat analysis,and similar results were recorded in the per-protocol analysis,demonstrating the superiority of PEB to BA.Late lumen loss was significantly lower in the PEB group than in the BA group(-0.06±0.32 vs.0.18±0.34 mm,P<0.0001).For intention-to-treat,there were no significant differences between PEB and BA in the 9-month percentages of MACCEs(0.9%vs.3.7%,P=0.16)or non-fatal myocardial infarctions(0 vs.0.9%,P=0.49).There were no clinical events of target lesion revascularization,target vessel revascularization,target lesion failure,all-cause death,cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting,SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov,NCT02325817;https://clinicaltrials.gov.

Drug-Eluting Balloon versus New-Generation Drug-Eluting Stent for the Treatment of In-Stent Restenosis： An Updated Systematic Review and Meta-Analysis

Background： Currently, drug-eluting balloon （DEB） appears to be an attractive alternative option for the treatment of in-stent restenosis （ISR）. Nevertheless, the clinical outcomes of DEB have seldom been compared to those of new-generation drug-eluting stent （DES）. Thus, this meta-analysis aimed to evaluate the safety and efficacy of DEB compared to those of new-generation DES in the treatment of ISR. Methods： A comprehensive search of electronic databases including PubMed, EMBASE, and Cochrane Library up to November 2, 2017 was performed to identify pertinent articles comparing DEB to new-generation DES for the treatment of ISR. In addition, conference proceedings for the scientific sessions of the American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and EuroPCR were also searched. The primary endpoint was target lesion revascularization （TLR） at the longest follow-up. Dichotomous variables were presented as risk ratios （RRs） with 95% confidence intervals （C/s）, while the overall RRs were estimated using the Mantel-Haenszel random-effects model. Results： Five randomized controlled trials （RCTs） and eight observational studies involving 2743 patients were included in the present meta-analysis. Overall, DEB was comparable to new-generation DES in terms ofTLR （RR = 1.24, 95% CI： 0.89-1.72, P = 0.21 ）, cardiac death （RR = 1.55, 95% CI： 0.89-2.71, P= 0.12）, major adverse cardiovascular event （RR = 1.21,95% CI： 0.98-1.48, P = 0.07）, myocardial infarction （RR = 1.12, 95% CI： 0.72-1.76, P = 0.62）, and stent thrombosis （RR = 0.95, 95% CI： 0.38-2.42, P associated with higher risk of all-cause mortality than new-generation DES （RR = 1.65, 95% CI： 1.09-2.50, P = true in the real-world observational studies （RR = 1.79, 95% CI： 1.12-2.88, P = 0.02）. In RCTs, however, no found between the two treatment strategies in the risk of all-cause mortality. 0.92）. However, DEB was 0.02）. This was especially significant difference was Conclusions： The current meta-analysis showed that DEB and new-generation DES had comparable safety and efficacy for the treatment of ISR in RCTs. However, treatment with DEB was associated with higher risk of all-cause mortality in the real-world nonrandomized studies.

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.

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.

Chinese expert consensus on the clinical application of drugcoated balloon(2^(nd) Edition)

Percutaneous coronary interventions have progressed through the era of plain balloon dilation, bare-metal stent insertion to drug-eluting stent treatment, which has significantly reduced the acute occlusion and restenosis rates of target vessels and improved patient prognosis, making drug-eluting stents the mainstream interventional treatment for coronary artery disease. In recent years, drug-coated balloons(DCBs) have become a new treatment strategy for coronary artery disease, and the drugs used in the coating and the coating technology have progressed in the past years. Without permanent implant, a DCB delivers antiproliferative drugs rapidly and uniformly into the vessel wall via the excipient during a single balloon dilation. Many evidence suggests that DCB angioplasty is an effective measure for dealing with in-stent restenosis and de novo lesions in small coronary vessels.As more clinical studies are published, new evidence is emerging for the use of DCB angioplasty in a wide range of coronary diseases, and the indications are expanding internationally. Based on the latest research from China and elsewhere, the Expert Writing Committee of the Chinese Expert Consensus on Clinical Applications of Drug-Coated Balloon has updated the previous DCB consensus after evidence-based discussions and meetings in terms of adequate preparation of in-stent restenosis lesions, expansion of the indications for coronary de novo lesions, and precise guidance of DCB treatment by intravascular imaging and functional evaluation.

Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions

Background Severely calcified coronary lesions respond poorly to balloon angioplasty, resulting in incomplete and asymmetrical stent expansion. Therefore, adequate plaque modification prior to drug-eluting stent （DES） implantation is the key for calcified lesion treat- ment. This study was to evaluate the safety and efficacy of cutting balloon angioplasty for severely calcified coronary lesions. Methods Ninety-two consecutive patients with severely calcified lesions （defined as calcium arc 〉 180% calcium length ratio 〉 0.5） treated with bal- loon dilatation before DES implantation were randomly divided into two groups based on the balloon type： 45 patients in the conventional balloon angioplasty （BA） group and 47 patients in the cutting balloon angioplasty （CB） group. Seven cases in BA group did not satisfactorily achieve dilatation and were transferred into the CB group. Intravascular ultrasound （IVUS） was performed before balloon dilatation and after stent implantation to obtain qualitative and quantitative lesion characteristics and evaluate the stent, including minimum lumen cross-sectional area （CSA）, calcified arc and length, minimum stent CSA, stent apposition, stent symmetry, stent expansion, vessel dissection, and branch vessel jail. In-hospital, 1-month, and 6-month major adverse cardiac events （MACE） were reported. Results There were no statistical differences in clinical characteristics between the two groups, including calcium arc （222.2° ± 22.2° vs. 235.0° ± 22.1 °, p=0.570）, calcium length ratio （0.67 ± 0.06 vs. 0.77± 0.05, P = 0.130）, and minimum lumen CSA before PCI （2.59 ±0.08 mm2 vs. 2.52 ± 0.08 mm2, P = 0.550）. After stent implantation, the final minimum stent CSA （6.26 ± 0.40 mm2 vs. 5.03 ± 0.33 mm2; P = 0.031） and acute lumen gain （3.74 ±0.38 mm2 w. 2.44 ± 0.29 mm2, P = 0.015） were significantly larger ila the CB group than that of the BA group. There were not statis tically differences in stent expansion, stent symmetry, incomplete stent apposition, vessel dissection and branch vessel jail between two groups. The 30-day and 6-month MACE rates were also not different. Conclusions Cutting balloon angioplasty before DES implantation in severely calcified lesions appears to be more efficacies including significantly larger final stent CSA and larger acute lumen gain, without increasing complications during operations and the MACE rate in 6-month.

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.

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. .

Significance of balloon aortic valvuloplasty as palliative procedure for symptom benefit in patients with severe aortic stenosis

Aortic stenosis(AS)stands out as the most prevalent individual valvular defect globally.The onset and progression of AS mirror an active process akin to atherosclerosis,and the traditional triad of symptoms includes chest pain,breathlessness,and loss of consciousness.Prognosis takes a significant downturn when symptoms manifest,with mortality reaching approximately 50%-85% within the subsequent 5 years after symptom onset.

Study of Secondary Cosmic Rays and Astronomical X-Ray Sources using Small Stratospheric Balloons

The X-ray sources of the universe are extraterrestrial in nature which emit X-ray photons.The closest strong X-ray source is the Sun,which is followed by various compact sources such as neutron stars,black holes,the Crab pulsar,etc.In this paper,we analyze the data received from several low-cost lightweight meteorological balloon-borne missions launched by the Indian Centre for Space Physics.Our main interest is to study the variation of the vertical intensity of secondary cosmic rays,the detection of strong X-ray sources,and their spectra in the energy band of^(1)0–80 keV during the complete flights.Due to the lack of an onboard pointing system,low exposure time,achieving a maximum altitude of only~42 km,and freely rotating the payload about its axis,we modeled the background radiation flux for the X-ray detector using physical assumptions.We also present the source detection method,observation of the pulsation of the Crab(^(3)3 Hz),and spectra of some sources such as the quiet Sun and the Crab pulsar.

Long-term outcomes of urethral balloon dilation for anterior urethral stricture: A prospective cohort study

Objective:To prospectively follow up a cohort of anterior urethral stricture disease patients managed with balloon dilation(BD)for 3 years to evaluate the long-term outcomes and to study factors that contribute to recurrence.Methods:This study included men who had urethral BD for significant anterior urethral stricture disease between January 2017 and March 2019.Data about the patient age,stricture characteristics,and recurrence date were recorded,along with information on postoperative indwelling catheter use and operative complications.Furthermore,information about the self-calibration procedure was collected and where available,free flow(FF)measurements during the follow-up period were recorded and analyzed.Success was defined as a lack of symptoms and acceptable FF rates(maximum flow rate>12 mL/s).Results:The final analysis was conducted on 187 patients.The mean follow-up period was 37 months.The long-term overall success rate at the end of our study was 66.8%.Our recurrence rate was 7.4%at 12 months,24.7%at 24 months,and reached 33.2%at the end of our study.The time to recurrence ranged from 91 days to 1635 days,with a mean of 670 days.The stricture-free survival was significantly shorter with lengthy peno-bulbar(p=0.031)and multiple strictures(p=0.015),and in the group of patients who were not committed to self-calibration protocol(p<0.011).However,post-procedural self-calibration was the most important factor that may have decreased the incidence of recurrence(odds ratioZ5.85).Adjuvant self-calibration after BD not only reduced the recurrence rate from 85.4%in the non-self-calibration group to 15.1%in the self-calibration one(p<0.001),but also improved the overall stricture-free survival and FF parameters.

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

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.