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. .

A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions:Study protocol for a prospective,multicenter,single-arm,target-value clinical trial

Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.However,currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis(ICAS).This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.Methods:This prospective,multicenter,single-arm,target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS.Primary metrics and other indicators were collected and analyzed using SAS version 9.4(SAS Institute,Cary,NC,USA).Results:A total of 155 patients were enrolled in this study.The preliminary collection of follow-up data has been completed,while data quality control is ongoing.Conclusion:Results of this study demonstrated the patency rate,safety,and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.Ethics and dissemination:This study,involving human participants,was reviewed and approved by the Ethics Committee of Drugs(Devices)Clinical Experiment at Henan Provincial People’s Hospital(reference number:2020-145-03)and other research centers participating in the clinical trial.The results of this study will be presented at international conferences and sent to peer-reviewed journals for publication.Standard protocol items:The Recommendations for Interventional Trials checklist was used when drafting the study protocol.Trial registration number:Registered with the Chinese Clinical Trial Registry on June 11,2021(Chi CTR2100047223).

Drug-coated balloons for treating de novo lesions in large coronary vessels:A case report

BACKGROUND Percutaneous transluminal coronary angioplasty,while an effective intervention,can frequently lead to acute occlusion with severe consequences.Although clinical trials have demonstrated the efficacy of drug-coated balloons(DCB)in treating acute coronary artery occlusion and in preventing restenosis,there has been limited exploration on the use of DCB in treating de novo lesions in large vessels.Currently,DCB are only recommended for patients with small vessel lesions and in-stent restenosis lesions,those at high risk of bleeding,and other special groups of patients.CASE SUMMARY This report presents a case of successful drug-coated balloon treatment of de novo lesions in large coronary vessels.Postoperatively,the patient demonstrated favorable recovery,with subsequent examination results revealing no significant differences from the previous examination.CONCLUSION The successful treatment of the patient in our case highlights the potential of DCB in the treatment of de novo lesions in large coronary vessels.

Restenosis of a drug eluting stent on the previous bioresorbable vascular scaffold successfully treated with a drug-coated balloon: A case report

BACKGROUND The in-stent restenosis(ISR)rates are reportedly inconsistent despite the increased use of second-generation drug eluting stent(DES).Although bioresorbable vascular scaffold(BVS)have substantial advantages with respect to vascular restoration,the rate of scaffold thrombosis is higher with BVS than with DES.Optimal treatment strategies have not been established for DES-ISR to date.CASE SUMMARY We report on a case of a 60-year-old man patient with acute coronary syndrome.He had a history of ST-segment elevation myocardial infarction associated with very late scaffold thrombosis and treated with a DES.Coronary angiography revealed significant stenosis,suggesting DES-ISR on the previous BVS.Optical coherence tomography(OCT)identified a plaque rupture and a disrupted scaffold strut in the neointimal proliferation of DES.To treat the DES-ISR on the previous BVS,we opted for a drug-coated balloon(DCB)after a balloon angioplasty using a semi-compliant and non-compliant balloon.The patient did not experience adverse cardiovascular events on using a DCB following the use of intensive dual antiplatelet therapy and statin for 24 mo.CONCLUSION This case highlights the importance of OCT as an imaging modality for characterizing the mechanism of target lesion failure.The use of a DCB following the administration of optimal pharmacologic therapy may be an optimal strategy for the treatment and prevention of recurrent BVS thrombosis and DES-ISR.

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.

Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Cut-off values of lesion and vessel quantitative flow ratio in de novo coronary lesion post-drug-coated balloon therapy predicting vessel restenosis at mid-term follow-up

Background:Drug-coated balloons(DCBs)have emerged as potential alternatives to drug-eluting stents in specific lesion subsets for de novo coronary lesions.Quantitative flow ratio(QFR)is a method based on the three-dimensional quantitative coronary angiography and contrast flow velocity during coronary angiography(CAG),obviating the need for an invasive fractional flow reserve procedural.This study aimed to assess the serial angiographic changes of de novo lesions post-DCB therapy and further explore the cut-off values of lesion and vessel QFR,which predict vessel restenosis(diameter stenosis[DS]≥50%)at mid-term follow-up.Methods:The data of patients who underwent DCB therapy between January 2014 and December 2019 from the multicenter hospital were retrospectively collected for QFR analysis.From their QFR performances,which were analyzed by CAG images at follow-up,we divided them into two groups:group A,showing target vessel DS≥50%,and group B,showing target vessel DS<50%.The median follow-up time was 287 days in group A and 227 days in group B.We compared the clinical characteristics,parameters during DCB therapy,and QFR performances,which were analyzed by CAG images between the two groups,in need to explore the cut-off value of lesion/vessel QFR which can predict vessel restenosis.Student's t test was used for the comparison of normally distributed continuous data,Mann-Whitney U test for the comparison of non-normally distributed continuous data,and receiver operating characteristic(ROC)curves for the evaluation of QFR performance which can predict vessel restenosis(DS≥50%)at mid-term follow-up using the area under the curve(AUC).Results:A total of 112 patients with 112 target vessels were enrolled in this study.Group A had 41 patients,while group B had 71.Vessel QFR and lesion QFR were lower in group A than in group B post-DCB therapy,and the cut-off values of lesion QFR and vessel QFR in the ROC analysis to predict target vessel DS≥50%post-DCB therapy were 0.905(AUC,0.741[95%confidence interval,CI:0.645,0.837];sensitivity,0.817;specificity,0.561;P<0.001)and 0.890(AUC,0.796[95%CI:0.709,0.882];sensitivity,0.746;specificity,0.780;P<0.001).Conclusions:The cut-off values of lesion QFR and vessel QFR can assist in predicting the angiographic changes post-DCB therapy.When lesion/vessel QFR values are<0.905/0.890 post-DCB therapy,a higher risk of vessel restenosis is potentially predicted at follow-up.

Drug-coated balloons are not inferior to drug-coated stents in the treatment of acute myocardial infarction and shorten the duration of dual antiplatelet treatment

Background:Drug-coated balloons(DCBs)are an up-and-coming tactic in treating in-stent restenosis and coronary artery small vessel disease,but their efficacy in treating acute myocardial infarction needs to be further explored.Methods:A meta-analysis of 7 studies was conducted to make a comparison with the results of DCB and drug-eluting stent implantation after a median follow-up of 15 months.Results:A total of 922 patients were included in this analysis in total,including 375 patients in the DCB group and 547 patients in the stent group.A total of 962 vascular diseases were manifested in the 2 groups.After 6 to 24 months of follow-up,there was no statistically significant difference with respect to major adverse cardiovascular events(odds ratio[OR]:0.82;95%confidence interval[CI]:0.52–1.29;Z=0.85;P=0.39),cardiac death(OR:0.92;95%CI:0.39–2.12;Z=0.21;P=0.84),target lesion revascularization(OR:1.09;95%CI:0.53–2.25;Z=0.24;P=0.81),late lumen loss(MD:−0.05;95%CI:−0.15 to 0.06;Z=0.85;P=0.40),or dual antiplatelet therapy(DAPT)(OR:1.04;95%CI:0.53–2.05;Z=0.11;P=0.91)between the 2 groups.In the DCB group,persistent residual stenosis or C-F dissection occurrence necessitated that a total of 30 patients receive extra bailout implantations.The rate of bailout stenting was 11.8%(95%CI:7.1–16).Moreover,the DCB group had a shorter DAPT duration compared with the stent group.Conclusion:Drug-coated balloons with shorter DAPT durations may be as effective and safe as stent therapy in treating acute myocardial infarction.

Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment

Objective To evaluate the impact of run-off vessels number on the outcomes of Supera stent(Abbott Vascular,Santa Clara,Calif,USA)for treatment of femoropopliteal occlusive disease.Methods We retrospectively evaluated the medical records of 188 consecutive patients(mean age 68.2±9.6 years,100 males)undergone angiography and woven mesh stent implantation in femoral or popliteal arteries or both arterial segments,in our institution between January 12014 and January 12018.Target lesion revascularization and major adverse limb events at 12-month were evaluated comparing patients with 1-,2-or 3-run-off vessels in the foot.Results Interventional success was achieved in 100%.Stent implantation involved in the femoral site in 56 patients(30.3%),the femoropopliteal in 92 patients(48.9%)and the popliteal site in 40 patients(21.3%).A significant improvement of ankle-brachial index(0.29±0.6 vs.0.88±0.3,P<0.001)and Rutherford class(5.3±0.8 vs.0.7±1.9,P<0.01)were observed before discharge.The median follow-up duration was 12.3 months(inter quartile range:11.0 to 13.9).During the follow-up period,52 patients(27.6%)had clinical events.Primary patency at 12 months was 72.4%.The primary patency significantly increased when the runoff status.Comparing the number of events among patients with different number of run-off vessels,a significant difference(P<0.001)was observed for patients having one(24.0%)and two run-off vessels(15.0%).Conclusions The outcomes of Supera stent in femoropopliteal occlusive disease depend strictly on the number of run-off vessels.

Endoscopic retrograde cholangiopancreatography,lights and shadows:Handle with care

The role of endoscopic retrograde cholangiopancreatography(ERCP) has dramatically changed in the last years, mainly into that of a therapeutic procedure. The treatment of benign biliary disease, like "difficult"choledocolithiasis, with endoscopic papillary large balloon dilation combined with endoscopic sphinterotomy has proven an effective and safe technique.Moreover, safety in ERCP has improved as well, with the prevention of postERCP pancreatitis and patient-to-patient transmission of infections. The advent of self-expandable metal stenting has radically changed the management of biliopancreatic malignant strictures, while the role for therapy of benign strictures is still controversial. In addition, cholangioscopy(though the direct visualization of the biliopancreatic ductal system) has allowed for characterization of indeterminate biliary strictures and facilitated rescue therapy of large biliary stones deemed removable. Encouraging data from tissue ablation techniques, such as photodynamic therapy and radiofrequency ablation, need to be confirmed by large sample size clinical controlled trials. On the other hand, we have no drug-coated stents yet available to implant and evidence for the use of biodegradable stents is still weak. The competency and privileging of ERCP and endoscopic ultrasonography have been analyzed longer but the switch between the two procedures, at the same time, is becoming ordinary; as such, the endoscopist interested in this field should undergo parallel edification through training plans. Finally, the American Society for Gastrointestinal Endoscopy's statement on non-anesthesiologist administration of propofol for gastrointestinal endoscopy is not actually endorsed by the European Society of Anaesthesiology,having many medical-legal implications in some European countries.

Structural and temporal dynamics analysis on drug-eluting stents: History, research hotspots and emerging trends

Purpose:This review aims to explore the history,research hotspots,and emerging trends of drug-eluting stents(DES)in the last two decades from the perspective of structural and temporal dynamics.Methods:Publications on DES were retrieved from WoSCC.The bibliometric tools including CiteSpace and HistCite were used to identify the historical features,the evolution of active topics,and emerging trends on the DES field.Results:In the last 20 years,the field of DES is still in the hot phase and there is a wide range of extensive scientific collaborations.In addition,active topics emerge in different periods,as evidenced by a total of 41 disciplines,511 keywords,and 1377 papers with citation bursts.Keyword clustering anchored five emerging research subfields,namely#0 dual antiplatelet therapy,#3 drug-coated balloon,#4 bifurcation,5#rotational atherectomy,and 6#quantitative flow ratio.The keyword alluvial map shows that the most persistent research concepts in this field are thrombosis,restenosis,etc.,and the emerging keywords are paclitaxel eluting balloon,coated balloon,drug-eluting balloon,etc.There are 7 recent research subfields anchored by reference clustering,namely#2 dual antiplatelet therapy,#4 drug-coated balloon,#5 peripheral artery disease,#8 fractional flow reserve,#10 bioresorbable vascular scaffold,#13 intravascular ultrasound,#14 biodegradable polymer.Conclusion:The findings based on the bibliometric studies provide the current status and trends in DES research and may help researchers to identify hot topics and explore new research directions in this field.