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Introduction and objectives: Drug-eluting balloon (DEB) angioplasty is an effective technique to treat in-stent restenosis (ISR). Neointimal modification with cutting balloon (CB) or scoring balloon (SB) enhances the angiographic results of DEB, but with no benefits have been reported in the clinical endpoints at the mid-term. There is lack of information on the clinical long-term results of this strategy. We aim to compare very long-term results of CB before DEB vs standard DEB to treat real-world patients with ISR. Methods: Retrospective cohort registry of DEB PCIs to treat ISR defined by the use of CB. The primary endpoint was clinically driven target lesion revascularization (TLR) at 5 years. The secondary endpoints were based on the ARC-2 criteria. Results: From January 2010 to December 2015, 107 ISRs were treated with DEB in 91 patients. CBs were used in 51 lesions (46 patients). Both cohorts were well balanced regarding clinical, lesion, and procedural characteristics. Compared to standard DEBs, CBs showed lower, although statistically non-significant rates, of TLR at 5 years (9.8% vs 23.6%, OR, 0.36; 95% confidence interval 0.19 to 1.09 P = .05). The Kaplan-Meier cumulative incidence of time until TLR showed similar results (log-rank test P value = .05) with similar rates of TLR at 1 year (3.9% vs 7.1%, P = .68) as curve separation in the long-term. There were no differences in the secondary endpoints. No stent thrombosis was reported. Conclusions: In a real-world setting, neointimal modification with CB before DEB vs standard DEB to treat ISR shows lower, although statistically non-significant rates of TLR at 5 years. This benefit has been confirmed in the long-term and is consistent with bare-metal and drug-eluting stents.

There are few studies on excimer laser (308 nm) atherectomy in the treatment of infrapopliteal artery disease. The purpose of this retrospective clinical study was to assess the efficacy and safety of excimer laser atherectomy (ELA) in combination with adjuvant drug-coated balloon angioplasty (DCB) compared to DCB for infrapopliteal arterial revascularization in patients with ischemic diabetic foot. From September 2018 to February 2019, a total of 79 patients with diabetic foot were treated for infrapopliteal arterial revascularization at Tianjin First Central Hospital (Tianjin, China). In this project, 35 patients were treated with ELA combined with DCB angioplasty, and 44 patients were treated with DCB angioplasty. The patients' baseline characteristics were similar between the 2 groups. The primary efficacy endpoints through 24 months were clinically driven target lesion revascularization (CD-TLR), wound healing rate, major amputation rate, and target vessel patency rate. The primary safety endpoint through 24 months was all-cause mortality. The primary efficacy results at 24 months of ELA + DCB versus DCB were CD-TLR of 14.3% versus 34.1% (p = 0.044), wound healing rate of 88.6% versus 65.9% (p = 0.019), target vessel patency rate of 80.0% versus 52.3% (p = 0.010), and major amputations rate of 5.7% versus 22.7% (p = 0.036). The safety signal at 24 months of all-cause mortality rate was 2.9% for ELA + DCB group and 4.5% for DCB group (p = 0.957). ELA combined with DCB angioplasty is more effective than DCB in the treatment of infrapopliteal artery disease in patients with ischemic diabetic foot, which can improve the wound healing rate and target vessel patency rate. There was no statistical difference in the safety results between the two groups.

Aim The aim was to assess the safety and efficacy of rotational atherectomy followed by drug-eluting balloon (DEB) in patients with a high risk of bleeding. Methods A retrospective review was carried out of hospital records of consecutive patients who underwent the hybrid procedure. Results The average age of the 23 patients was 74 years. Risk factors for bleeding included renal failure (35%), oral anticoagulation use (26%) and peptic ulcer disease (35%). All patients had procedural success. No bleeding was reported over the 24-month follow-up period. Dual antiplatelet therapy was stopped successfully in six patients (26%) at three months. Two patients had confirmed target-lesion failure (restenosis). Two patients died over the study period but the cause of death was not known to be cardiovascular disease related. Conclusions For patients at high risk of bleeding who require rotablation, the use of a drug-eluting balloon may be a safe, effective alternative.

Background Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. Purpose The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. Method We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). Results A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). Conclusion The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

Ziel: Das Ziel der Arbeit ist es die unterschiedlichen Medikamentenbeschichtungen bei Ballonen und Stents in der interventionellen Angiographie sowie deren Wirkweise zu erarbeiten. Weiters sollen die Einführungssysteme Monorail und Over-the-wire, die bei der Applikation von Drug eluting Stents (DES) und Drug eluting Ballonen (DEB) ihre Anwendung finden, in ihrem Aufbau, deren Anwendung und deren Vor- und Nachteilen beschrieben werden. Einen weiteren Aspekt der Arbeit soll die Handhabung der DEB und DES bei der sterilen Arbeit darstellen. Methode: Bei dieser Arbeit handelt es sich um eine theoretische Arbeit. Für das Erstellen der Arbeit wurden medizinische Fachbücher und Datenbanken in deutscher und englischer Sprache herangezogen. Für die Recherche in den Datenbanken wurden primär folgende Keywords verwendet: „Drug Eluting Stent“, „Drug Eluting Balloon“, „Paclitaxel“, „Sirolimus“, „Everolimus“, „Biolimus“ „Over-the-wire“, „Monorail“, „Handling“. Ergebnisse: Medikamentenbeschichtete Devices erzielen bei Lumenverlust und Target Lesion Revascularisation (TLR) bessere Ergebnisse als unbeschichtete Devices. Weiters müssen weniger Reinterventionen durchgeführt werden. Sirolimus und seine Analoga konnten eine bessere primäre Offenheitsrate und Freiheit von TLR erreichen als Paclitaxel beschichtete Devices. Monorail Systeme werden fast ausschließlich in der kardiologischen Angiographie verwendet. In der peripheren Angiographie werden hauptsächlich Over-the-wire Systeme verwendet. Bei einem fehlerhaften Handling in der sterilen Assistenz kann es zu einem Abtragen des Wirkstoffes kommen, wodurch der Ballon beziehungsweise Stent an seiner Wirkung verliert. Diskussion: Die Forschungsfragen konnten im Rahmen der Arbeit beantwortet werden. Es fanden sich jedoch keine Studien zur Handhabung der Devices oder den Einführungssystemen. Aim: The goal of this senior thesis is to discuss the different approaches of drug eluting balloons and stents used in interventional angiography as well as explaining their mode of action. Furthermore this paper explains the structure, advantages, disadvantages and the use of the application systems monorail and over-the-wire, both of which are used in application of Drug eluting Stents (DES) and Drug eluting Balloons (DEB). Another aspect of this paper will discuss the handling of DEB and DES in the sterile operating environment. Methods: The research design used in this paper is the theoretical work. Relevant specialist literature, research studies and research papers in German and English language are used. For database enquiries the main keywords searched for were: „Drug Eluting Stent“, „Drug Eluting Balloon“, „Paclitaxel“, „Sirolimus“, „Everolimus“, „Biolimus“ „Over-the-wire“, „Monorail“, „Handling“. Results: Drug eluting devices show better results in late lumen loss and target lesion revascularisation (TLR) than non-drug eluting devices. Additionally, fewer Repeat Revascularization are needed. Sirolimus and analogs have proven better primary patency rates and freedom from TLR than Paclitaxel eluting devices. Monorail Systems are almost exclusively used in angiocardiography, whereas Over-the-wire systems are mainly used in peripheral angiography. Incorrect sterile handling can lead to the loss of the active ingredient which results in the balloon or stent losing its effect. Discussion: This paper answers the research questions. There were no studies available concerning the handling of the devices and the application systems.

Ziel: Das Ziel der Arbeit ist es die Therapie von akuten Myokardinfarkten mittels drug coated balloon (DCB) und drug eluting stent (DES) in Bezug auf postinterventionelle kardiale Komplikationen (MACE: cardiac death, myocardial infarction, target lesion revascularisation (TLR) und target vessel revascularisation(TVR)) zu vergleichen. Methode: Bei dieser Arbeit handelt es sich um eine theoretische Arbeit, welche auf Grundlage einer systematischen Literatur- und Internetrecherche basiert. Für das Erstellen der Arbeit wurden medizinische Fachbücher und Datenbanken, wie PubMed und Google Scholar, in deutscher und englischer Sprache herangezogen. Der Publikationszeitraum wurde von 2015-2021 gewählt. Für die Recherche in den Datenbanken wurden folgende Keywords verwendet: „Drug Eluting Stent“, Drug Coated Balloon“, „Acute Myocardial Infarction“, „STEMI“, „NSTEMI“, „MACE“. Ergebnisse: Die für die BAC-Arbeit ausgewerteten Studien zeigen, dass sowohl DCB als auch DES ähnliche Ergebnisse bei MACE erzielten. Um jedoch ein ideales Ergebnis mittels DCB zu erzielen ist eine entsprechende Gefäßvorbereitung mittels Thrombusaspiration und Prädilatation unumgänglich. Der Einsatz von DCB bei Patient*innen mit akutem Myokardinfarkt könnte eine potentielle Therapieform darstellen. Besonders für Patient*innen mit erhöhtem Blutungsrisiko, Kontraindikationen für Stents und DAPT könnte dies eine Alternative sein. Diskussion: Die Forschungsfrage konnte im Rahmen der Arbeit beantwortet werden. Es fanden sich jedoch keine Studien, die die Anwendung von DCB und DES in Bezug auf MACE über einen längeren Zeitraum als 24 Monate vergleichen. Aim: The goal of this senior thesis is to compare the therapy strategy of drug coated balloon (DCB) and drug eluting stent (DES) in myocardial infarction with regard to major adverse cardiac events (MACE). MACE events are defined as : cardiac death during follow up, myocardial infarction, target lesion revascularisation (TLR) and target vessel revascularisation(TVR). Methods: The research design used in this paper is the theoretical work. It is based on a systematic research of literature and the internet in german and english language. Medical databases such as PubMed and Google Scholar were used to search for literature. Medical textbooks were also used. The publication year of the literature ranges from 2015 to 2021. The primary keywords for the research were „drug eluting stent“, „drug eluting balloon“, „acute myocardial infarction“, „STEMI“, „NSTEMI“ and „MACE“. Results: The for the work evaluated studies show, that DCB and DES have similar results by the MACE-rate. To achieve good results with DCB vacsular pretreatment such as the removal of the thrombus and predilatation is necessary The usage of DCB represents a potential treatment by patients with acute myocardial infarction. Espacially for patients with high risk of bleeding, contraindications for a stent or a DAPT, DCB could be a great alternative. Discussion:This paper answers the research question. There were no studies available which compared DCB and DES in the treatment of acute myocardial infarction with regard on MACE during a longer follow up than 24 months.

Aim To evaluate the long-term results of the use of drug-eluting balloon catheters in patients with Left Main (LM) bifurcation stenosis. Methods The analysis involved 142 patients with true bifurcations of the Left Main. Randomization in 2 main groups: Group I (n=52) included patients, who received kissing- dilatation with traditional NC balloon catheters and Group II (n=52), who had a kissing-dilatation of the main bifurcation artery with a traditional NC balloon catheters, and a side branch - with drug-eluting balloon catheters. In retrospectively, the third (III) control group (n=38) was formed, where the two-stent technique was performed. All patients from main groups had previously performed “Provisional T” stenting and final “kissing balloons” dilation technique. Coronary angiography and OCT were performed to evaluate the results of all patients. Inclusion criteria: true LM bifurcation stenoses according to QCA and OCT; SYNTAX score Results The long-term results after 4-years were observe in 46 patients from Group I and 48 patients from Group II. Restenosis of the side branch of more than 50% according to QCA was detected in 12 patients (26.0%) from Group I and in 5 patients (10.4%) from Group II (p0.05). In patients from Group II, the average MLA were, respectively, 5.38±1.24 and 5.01±1.14 mm2 in side branch (p>0.05) and 6.68±1.75 and 6.36±1.22 mm2 in main branch (p>0.05). When comparing the data of MLA in the side branch in groups I and II, there was a significant difference (4.12±1.21 vs. 5.01±1.14 mm2; p Conclusions The use of dug-eluting balloon catheters for the “Provisional T” stenting in patients with true LM bifurcation stenosis, associated with good prognosis and demonstrated significantly lower frequency of MACE and side branch restenosis, according to OCT data, compared with patients who used traditional NC balloon catheters for “kissing-dilatation” and two-stent technique strategy. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Russian academic excellence project 5-100

Objectives The aim of the DAPT-DRAGON registry was to asses long-term outcomes and the length of dual antiplatelet therapy (DAPT) in patients treated with percutaneous coronary intervention (PCI) due to drug-eluting stent in stent restenosis (DES-ISR) with drug-eluting balloons (DEB) or thin-DES. Background Data regarding the duration of DAPT in patients with DES-ISR treated with PCI is still undergoing research and observation, and the adequate duration of DAPT in this group of patients is not unambiguously sanctioned. Methods Overall, 1,367 consecutive patients with DES-ISR who underwent PCI with DEB or DES, were entered into the multi-center DAPT-DRAGON Registry (Fig. 1). The mean age was 66.7±9 years (70.5% males). The median follow-up was 3.3 years. There were 34.1% patients with chronic coronary syndrome, 35.2% with unstable angina, 2.9% with ST segment elevation myocardial infarction and 27.7% with non-ST segment elevation myocardial infarction (MI). We assessed selected study endpoints according to the duration of DAPT (≤3 vs. >3 months and ≤6 vs. >6 months), before and after propensity score matching (PSM): stroke, target lesion revascularization (TLR), target vessel revascularization (TVR), MI, death and device-oriented composite endpoints (DOCE). Results Among predictors of increased DOCE rate before PSM, we demonstrated: PCI with DEB vs. DES (p6 months) before PSM revealed superiority of thin-DES+DAPT >6 months vs. DEB+DAPT >6 months for DOCE (p3 months) had no significant influence on assessed long-term outcomes, while the percentage of stroke free survival was significantly lower in the group of patients with DAPT ≤6 months vs. >6 months (p=0.01; Fig. 2). Conclusions Long-term treatment with DAPT (>6 months) in patients with DES-ISR with DES implantation is related to better long-term outcomes in terms of lower rate of DOCE, TVR and TLR compared to PCI with DEB. DAPT >6 months is related to a greater rate of strokes, independently of the type of treatment (thin-DES and DEB) compared to DAPT ≤6 months. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Background End stage renal disease is on increasing trend and haemodialysis is the main dialysis modality among these patients. Thus, a functioning dialysis vascular access is critical to the delivery of life-saving haemodialysis treatment to these patients. Conventional angioplasty is the first line of treatment; with a 50% of permeability rate (6 months). For this reason, new alternatives are necessary to maintain the access permeability.Hypothesis: Paclitaxel coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target lesion patency, and decreased number of interventions needed to maintain patency. Methods A total of 39 patients were randomized to receive a paclitaxel-coated balloon (n=15) or plain angioplasty balloon (n=24) after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 3, 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival. Results We recruited 39 patients with dysfunctional vascular accesses; 24 were assigned to the conventional balloon angioplasty group and 15 drug-eluting balloon angioplasty (paclitaxel). With demographic characteristics in Table I. In group A, all were autologous acces. Group B 16% (4) of the accesses were prosthetic and 84% (20) autologous. In relation to the type and length of stenosis, group A was more frequent at the level and longer, whereas in group B it predominated in the central type and less than 20 mm.In our study, we also observed a high rate of total occlusions, frequently in central vessels in group B, while in group A, where peripheral vessels were predominant, total occlusion was less frequent. Table II. We had no complications in either group, and dialysis was immediate at the end of the procedure. Group A did not present restenosis. Table III. Table III shows DEB group (15p) with 100% of permeability according to follow-up and only one (1/15) of patients died due to myocardial infarction and cerebrovascular accident and this patient kept lasted 9 months without restenosis In Table IV. Group B had 2 (8%) patients with restenosis so it was necessary to reoperate using a drug eluting balloon and until now there is no restenosis. From this group we do not have mortality. One patient 1 (24%) had a recovered infarction. Conclusions Paclitaxel-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 12 meses. Both arms show equivalent complications and similar mortality Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Enrique Garcés Hospital

Introduction and objectives: Coronary in-stent restenosis (ISR) is associated with a high target lesion revascularization rate, while the drug-eluting balloon (DEB) presents IA class level of evidence for its treatment. Nevertheless, very long-term outcomes of DEB for ISR in non-selected populations of patients are unknown. Our goal is to evaluate the very long-term (5 year) effectiveness of DEBs in a real-world registry. Methods: Retrospective registry from an ISR cohort treated with DEB. The primary outcome was the rate of target lesion revascularization (TLR) at 5 years. Secondary outcomes were evaluated according to the ARC-2 criteria. Results: From January 2010 through December 2013, 53 ISRs were treated using DEBs in 48 patients. Patients were old (69.3 ± 11.8 years-old) and 55.8% had diabetes. The rate of TLR at 1 year was 9.4%, and 20.8% at 3 and 5 years, respectively. The rate of late TLR (after the first year) was 11.4%, only after DEB for bare metal ISR. The 5-year TLR was not associated with diabetes (22.7% vs 19.2%; P = .76) and was not significantly lower after cutting-balloon (12.5% vs 24.3%; P = .47) or in bare-metal stent ISR (20.6% vs 21.1%; P = .96). There was no definite/probable stent thrombosis of the lesions treated with DEB at follow-up. Conclusions: In a real-world cohort, the 5-year TLR rate after DEB for ISR was 20.8%. Late TLR accounted for half of the TLR at follow-up (after DEB for bare metal ISR), while the rate of TLR seemed to stabilize at 3 years. There was no stent thrombosis of the lesions treated with DEB.

Background: Glycoprotein IIb/IIIa inhibitors have been reported to cause thrombocytopenia, however, only few case reports exist regarding tirofiban. We report a rare case of tirofiban-induced severe thrombocytopenia and its management. Case Presentation: We present a 51-year-old male who underwent coronary angioplasty with drug eluting balloon for exertional angina. The platelet count dropped from 230 x 109 /L (before angiogram) to 3.8 x 109 /L within 24 hours of intravenous tirofiban infusion without active bleeding. We transfused 4 units of platelets, continued aspirin and clopidogrel and monitored in coronary care unit. Gradually the platelet count improved with no evidence of bleeding, ischemic or thrombotic events. Conclusion: The case highlights the awareness for the dramatic and profound tirofiban-induced thrombocytopenia that may pose a challenge to manage.

La aterosclerosis es una patologia sistemica que afecta a todo el sistema vascular. El tabaquismo, la hiperlipidemia, la diabetes mellitus, la edad avanzada y la hipertension son factores de riesgo conocidos para el desarrollo de aterosclerosis. El tratamiento quirurgico en la enfermedad arterial periferica ha sido reemplazado por opciones de tratamiento endovascular en los ultimos anos debido a la mortalidad y la morbilidad. En nuestro estudio, nuestro objetivo fue presentar la efectividad de la aterectomia, el balon liberador de farmacos y la terapia combinada con valores determinados por espectroscopia de infrarrojo cercano en pacientes con enfermedad arterial periferica aterosclerotica. Material y metodos: Los pacientes con claudicacion intermitente o isquemia critica de la pierna (Rutherford clase 3 o mas) han sido vistos en el estudio. Hubo 30 pacientes masculinos y 9 femeninos. Los pacientes fueron seguidos antes, en la primera hora despues y en el tercer mes despues del procedimiento, con un indice simultaneo de presion tobillo-brazo (ABI), mediciones de la distancia a pie y medicion de la oxigenacion de los tejidos mediante el metodo de espectroscopia de infrarrojo cercano (NIR). Resultado: cuando los pacientes con mediciones similares de ABI postoperatorio se evaluaron con NIR, se observo una mayor oxigenacion venosa en los pacientes que usaron metodos de tratamiento combinados con aterectomia. Segun estos resultados, pensamos que los metodos de tratamiento combinados con aterectomia han aumentado la mirocirculacion y la circulacion colateral mas que otros metodos. Atherosclerosis is a systemic pathology involving the entire vascular system. Smoking, hyperlipidemia, diabetes mellitus, advanced age, and hypertension are known risk factors for the development of atherosclerosis. Surgical treatment in peripheral arterial disease (PAD) has been replaced by endovascular treatment options in recent years due to mortality and morbidity. In our study, we aimed to present the effectiveness of atherectomy, drug-eluting balloon, and combined therapy with values determined by near-infrared spectroscopy (NIRS) in patients they have atherosclerotic PAD. Materials and methods: Patients with intermittent claudication or critical leg ischemia (Rutherford class 3 or more) have been viewed in the study. There were 30 male and 9 female patients. Patients were followed up before, at the 1st h after and at the 3rd month after the procedure, with simultaneous ankle-brachial pressure index (ABPI), walking distance measurements, and measurement of tissue oxygenation by NIRS method. Results: When patients with similar post-operative ABPI measurements were evaluated with NIRS, venous oxygenation was observed higher in patients used treatment methods combined with atherectomy. According to these results, we thought that treatment methods combined with atherectomy have increased microcirculation and collateral circulation more than other methods.

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. Keywords: Lower extremity atherosclerosis obliterans, De novo lesions, In-stent restenosis, Drug-eluting balloon

Background/aims After a study comparing drug-eluting stents (DESs) to sequential treatment with drug-eluting balloons (DEBs) and bare metal stents (BMSs), we retrospectively analysed strut malapposition and neointimal hyperplasia in de novo coronary lesions using optical coherence tomography (OCT) or intravascular ultrasonography (IVUS). Methods We obtained OCT data from 16 patients (eight per group) and IVUS data from 40 patients (20 per group). OCT or IVUS was performed after the index procedure and after 9 months. Parameters including obstruction volume due to neointimal hyperplasia (neointimal hyperplasia volume/stent volume, %), strut malapposition (% of malapposed struts), and intra-individual inhomogeneity of in-stent restenosis were compared. Results Although obstruction volume due to neointimal hyperplasia was significantly higher in the DEB-BMS group (14.90 ± 15.36 vs. DES 7.03 ± 11.39, p = 0.025), there was no difference in strut malapposition between the two groups (DEB-BMS 1.99 ± 5.37 vs. DES 0.88 ± 2.22, p = 0.856). The DEB-BMS group showed greater intra-individual inhomogeneity of in-stent restenosis pattern than the DES group. Conclusion Treatment with DEB followed by BMS failed to improve strut malapposition despite higher in-stent neointimal growth, probably because of the inhomogeneous inhibition of in-stent neointimal hyperplasia by DEB. DEB technology should be improved to obtain even drug delivery to the vessel wall and homogeneous prevention of neointimal growth comparable to contemporary DES.

Background: Re-stenosis following infra-popliteal angi-oplasty could results in many serious consequences like recurrence of ischemic symptoms or break through of wound healing. With the evolving techniques of Paclitaxil release and the rapid advancement in the manufacturing of endovas-cular equipment, drug eluting balloons emerge as a useful option to overcome intimal hyperplasia and subsequent re-stenosis.Aim of Study: To highlight the clinical impact of additional DEB application in patients with CLI attributed to infra-popliteal disease regarding the re-stenosis rate, amputation free survival and limb salvage.Material and Methods: This study is prospective obser-vational study over a period of one year including 33 patients who underwent infra-popliteal angioplasty using DEB.Results: 33 patients (36 limbs) were included in the study, 24 cases (27 limbs) were presented by a re-stenosis or occlusion after previous trial of angioplasty using plain balloon, while 9 patients come with the first presentation (Denovo lesions). Stenotic lesions were found in 21 limbs (58.3%) while occlu-sive lesions were observed in 9 limbs (25%) and combined stenotic and occlusive lesions were found in 6 limbs (16.7%). The mean length of the treated lesions within the tibial arteries using DEB was 7.6±3.4m. Primary patency rate at 3, 6 and 12 months was 91.3%, 82.6% and 70.9%. While limb salvage rate at 3, 6 and 12 months was 91.6%, 81.8% and 72.8% respectively.Conclusion: With the rapid advancement in the endovas-cular tools & equipment, the early results is encouraging and promising with additional application of DEB for patients with infra-popliteal arterial disease in comparison to the traditional use of plain uncoated balloons. However, the mid-term and late results of the IN.PACT DEEP study suggest that an extreme caution is to be considered in this field.

Introduction:The aim of this study was to investigate the safety and efficacy of drug-elicited balloon (DEB) use in the interventional treatment of patients with end-stage renal disease (ESRD) and complex femoropopliteal artery lesions.Methods:A retrospective chart review identified 30 ESRD patients who were treated for symptomatic peripheral artery disease with DEB angioplasty between September 2012 and February 2016. The inclusion criteria were having Rutherford class 2 to 6 symptoms and a critical stenosis or occlusion of the femoropopliteal artery. While restenosis or reocclusion was the primary end point, major or minor amputation was the secondary end point.Results:A total of 36 diabetic patients with complex femoropopliteal lesions who underwent endovascular therapy with DEB were identified. Four patients were lost during follow-up and 30 patients were included in the study. The mean lesion length was 114.6±27.8 mm. Primary patency was 73.1% and the secondary end point was 10.7% at 1-year. After a mean follow-up of 16.0±5.0 months, all-cause mortality was 7.1% (n=2). Ankle-brachial index increased from 0.42±0.04 to 0.88±0.05 postoperatively.Conclusion:DEB angioplasty is efficient and safe even in long and calcified obstructive lesions including the distal superficial femoral and popliteal artery in patients with ESRD.

Objectives To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. Methods This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. Results Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34–0.71, P Conclusions The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.

Purpose: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences. Methods: From January to June 2019, patients’ data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months. Results: Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively. Conclusions: In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.

Background: The efficacy and cost-effectiveness of drug-eluting balloon (DEB) in vascular access for dialysis remain unclear. Methods: Data obtained from using DEB in highly recurrent stenosis were retrospectively analyzed. These data were obtained from procedures performed in the Vascular Access Center, responsible for attending over 3600 patients from 30 dialysis centers. Highly recurrent stenosis is defined as stenosis having three or more previous interventions and/or associated with early recurrence defined as the last procedure in less than 90 days. Patency and cost-effectiveness were evaluated. Patency was defined as the number of days free of interventions after applying DEB. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio (ICER) and an estimation of costs per day/patient/year. Results: Data from 37 consecutive procedures on 32 patients were assessed. The average patency time between interventions was 107.22 ± 104.428 days before DEB intervention. After the procedure, the average patency time intervention was 160.27 ± 96.472 days (ρ=0.001). The cost analysis revealed an ICER of 10.37€/ patency day gained. The costs estimation revealed improved patency of 14.5 days/patient/year, and an increased cost of 1028.4€/patient/year when compared to conventional balloon. Conclusions: This retrospective analysis may suggest a benefit of DEB on this highly recurrent stenosis. Although it appears to be more expensive, the increased patency at long term may be considered encouraging.