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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.

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

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.

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 Many clinical trials have demonstrated the value of drug-eluting balloon (DEB) for in-stent restenosis. Recently, DEB for de novo lesions has also attracted more attention. There have been promising results of PCI using DEB alone in selected de novo coronary diseases (small vessels, bifurcating lesions, acute myocardial infarction). However, the application of DEB for patients with de novo coronary artery disease remains controversial due to relatively limited evidence. Purpose The purpose of this study was to evaluate the efficacy and safety DEB-only strategy (bail-out stents were allowed when required) compared with other modalities for the treatment of de novo coronary lesions. Methods We searched PubMed, Embase, Web of Science and Cochrane Library Central Register of Controlled Trials (CENTRAL) electronic databases for randomized controlled trials as well as observational studies published up to Jan 22, 2020. Studies which compared DEB-only approach with other PCI strategies for treatment of any type of de novo coronary lesions were identified. The primary outcome was late lumen loss (LLL) during angiographic follow up. The secondary outcomes were major adverse cardiac events (MACE), target lesion revascularisation (TLR) and binary in-segment restenosis. Results Nineteen studies (eleven randomised controlled trials and eight observational studies) with a total of 3,356 patients were included in this meta-analysis. Angiographic observations were obtained at 6 or 9 months and clinical follow-up duration ranged from 6 months to 36 months. Among the overall studies, the results indicated that DEB-only strategy was superior to the control groups for LLL (mean difference (MD) = −0.30mm; 95% confidence interval (CI), −0.41 to −0.19; P Conclusion DEB-only intervention is an effective treatment associated with a significant reduction in late loss late lumen loss compared to other options. The efficacy and safety of DEB alone are comparable to those of DES and superior to POBA for treatment of selected de novo coronary lesions. Additional evidence is still warranted to confirm value of DEB before a widespread clinical utilization can be recommended. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Beijing Lab for Cardiovascular Precision Medicine

Erectile dysfunction (ED) is defined as the inability to attain or maintain penile erection sufficient for successful sexual intercourse. ED carries a notable influence on quality of life, with significant implications for family and social relationships. Because atherosclerosis of penile arteries represents one of the most frequent causes of ED, patients presenting with it should always be investigated for potential coexistent coronary or peripheral disease. Up to 75% of patients with ED have a stenosis of the iliac-pudendal-penile arteries, supplying perfusion of the male genital organ. Recently the potential treatment of this pathological condition by percutaneous approaches has emerged with good angiographic results and with a significant improvement in symptoms and quality of life. This review will focus on the normal anatomy and physiology of erection, the pathophysiology of ED, the relation between ED and cardiovascular diseases and, lastly, on new treatment modalities aimed at restoration of normal erectile function.

We used a paclitaxel-coated drug-eluting balloon (DEB) for pulmonary vein stenosis (PVS) after repair of total anomalous pulmonary venous return with asplenia. No adverse effect of paclitaxel was revealed and plasma concentration of paclitaxel was not elevated after intervention. Although progression of PVS slowed after dilatation with the DEB, stenosis recurred relentlessly, resulting in patient demise. This strategy may be safe for infantile cases, but requires further effective strategy, such as usage of larger sizes of DEBs.

Background: In this study, we present one-year results of drugeluting balloon treatment of femoropopliteal in-stent restenosis. Methods: A total of 62 patients (48 males, 14 females; mean age 64.2±9.1 years; range, 54 to 81 years) who underwent drugeluting balloon stenting for femoropopliteal in-stent restenosis between August 2013 and October 2017 were included in the study. The patients were classified into three groups based on the narrowing length of stenosis in the stents. Group/Class 1 (n=17): narrowing 1/2 of the stent length, not totally occluded; and Group/Class 3 (n=23): totally occluded. In-stent restenosis was treated with drug-eluting balloon treatment. Results: There was a significant difference among all classes in terms of in-stent restenosis. The length of stenosis was a predictor for in-stent restenosis. The mean stent length was 107.7±24.6 mm in Group 1, 164.6±17.9 mm in Group 2, and 180±19.3 mm in Group 3. For non-occluded in-stent restenosis, restenosis rate at one year after balloon angioplasty was 47.1% in Group 1, 86.4% in Group 2, and 95.7% in Group 3. Femoropopliteal bypass was performed in five patients in whom treatment failed. None of the patients required amputation. Conclusion: The length of in-stent restenosis in the femoropopliteal arterial stents is an important predictor for recurrent stenosis, when re-flow is achieved with drug-eluting balloons. © 2020 Turkish Society of Cardiovascular Surgery.

High rates of restenosis and neointimal formation have driven increasing interest in the application of drug eluting balloons (DEB) as counteractive measures for intraluminal drug delivery. The use of DEBs eliminates the need for stents so that serious side effects including in-stent restenosis and stent thrombosis can be avoided and long-term medication of anti-platelet agent is not needed. Despite their benefits, DEBs have poor drug delivery efficiency due to short balloon inflation times (30–60 s) that limit the passive drug diffusion from the balloon surface to the luminal lesion. To increase drug delivery efficiency, a microneedle DEB (MNDEB) was developed by a conformal transfer molding process using a thin polydimethylsiloxane mold bearing a negative array of MNs of 200 μm in height. A MN array composed of UV curable resin was formed onto the surface of DEB, and drugs were coated onto the structure. The mechanical properties of the MN array were investigated and MN penetration into luminal vasculature was confirmed in vivo. An increase in drug delivery efficiency compared to a standard DEB was demonstrated in an in vivo test in a rabbit aorta. Finally, the superior therapeutic efficacy of MNDEBs was evaluated using an atherosclerosis rabbit model.

Despite the improvement of outcomes after the introduction of bare metal and drug eluting stents for the treatment of CAD, certain type of patients have still an increased risk of stent failure. An alternative is represented by drug-eluting balloons (DEB). This innovation could give potential benefits in particular for the in-stent restenosis (ISR) and the de-novo lesions. In the first setting DEB have shown results superior to those with plain-balloon angioplasty and similar to those with first generation DES. Their performance seems to be more evident in BMS-ISR than in DES-ISR, showing a reliable effectiveness in those cases of recalcitrant ISR or when dual antiplatelet therapy is not indicated. In the context of de-novo lesions the use of DEB as unique strategy results more safe and feasible than a strategy with combined BMS implantation. The results are comparable to DES in lesions limited to small coronary vessels. Other particular scenarios, like bifurcations, acute myocardial infarction and diffuse disease, have been approached with DEB resulting in very heterogeneous outcomes. At present, given the high efficacy of last generation DESs, DEBs should be considered where clinical and angiographic conditions require the avoidance of stent implantation.

Introduction The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. Methods The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. Results A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation). Conclusion This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

Background: The treatment options for cephalic arch stenosis are limited and standard of care remains at crossroads – none are ideal and there is currently no gold standard. Endovascular techniques are now the preferred primary therapeutic option because they are minimally invasive and better tolerated by haemodialysis patients who have multiple comorbidities. However, conventional plain old balloon angioplasty, bare metal stenting and stent grafts all have their limitations. The aim of this trial is to evaluate whether the helical SUPERA™ stent (Abbott Vascular, Santa Clara, CA, USA), which has a higher degree of flexibility and resistance to compressive forces compared to traditionally laser-cut nitinol stents, combined with a drug-coated balloon (Biotronik Passeo-18 Lux™) to minimize the neointimal hyperplasia effect, can improve patency and reduce reintervention rates. Methods and results: Arch V SUPERA-LUX is a pilot investigator-initiated single-centre, single-arm prospective study. Twenty patients with a brachiocephalic fistula within 6 months of initial plain old balloon angioplasty for significant cephalic arch stenosis will be recruited for treatment with SUPERA and drug-coated balloon. The primary objectives are immediate angiographic and procedural success, primary patency and functional fistula at 1 week, 8 weeks, 6 and 12 months. The results from eight patients treated prospectively as proof of concept have shown primary patency of 83.3% at 1 year with 100% technical and procedural success rates. Enrolment for the Arch V SUPERA-LUX study is expected to be completed at the end of 2019. Conclusion: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique. Trial registration: This study is registered on ClinicalTrials.gov NCT03891693.

The use of drug eluting stents (DES) remains state-of-the-art for percutaneous coronary intervention (PCI), because it drastically reduces the rate of in-stent restenosis (ISR) compared with bare metal stents (BMS) [1,2]. However, DES-ISR still develops in 5–10% of patients after DES deployment [3,4], and DES-ISR has become a common clinical challenge even with the widespread application of new-generation DES [5,6]. Moreover, in comparison with BMS ISR, DES-ISR treatment is associated with worse long-term outcomes; current data suggest that 10–20% of these patients will go on to develop recurrent ISR after repeated stenting [7,8]. Recurrent DES-ISR poses a significant clinical challenge for interventional cardiologists. There are many different therapeutic modalities [such as new DES repeated implantation, drug eluting balloon (DEB) dilation, excimer laser angioplasty, and brachytherapy] that have been used in patients presenting with recurrent DES-ISR [5,9]; however, the optimal management of these patients remains undefined. Repeated additional DES implantation for recurrent DES-ISR is performed as a default option by many operators, but it is worrisome that multiple metal layers can themselves result in luminal narrowing and stent thrombosis [10]. A new strategy for BMS-ISR and DES-ISR treatment is DEB angioplasty; research has demonstrated that the DEB is associated with more favorable outcomes compared with other conventional treatment modalities [8,9]. DEB is an attractive strategy for recurrent DES-ISR because it can avoid additional metal layers and long duration dual antiplatelet therapy (DAPT). However, there are few studies on recurrent DES-ISR treated with DEB, and the results are controversial [10–12]. The aim of this study was to investigate the clinical outcomes of recurrent DES-ISR treatment with DEB compared with repeated new-generation DES implantation.

Endovascular recanalization of occluded venous femoropopliteal bypass grafts is widely used because of easy access. This case report describes pseudoaneurysm developing 4 weeks after endovascular recanalization of an occluded in situ venous femoropopliteal graft. The patient was treated for a popliteal aneurysm with a venous femoropopliteal bypass graft, which subsequently occluded. Four weeks after DEB PTA, the occluded graft developed 3 pseudoaneurysms. Impaired vessel wall healing after intraluminal paclitaxel administration could have contributed to this. This case adds a perspective to the choice of treatment of occluded venous femoropopliteal bypass grafts.

We report a case of a 65-year-old female patient treated with an everolimus-eluting bioresorbable scaffold (BRS) after rotational atherectomy of a severely calcified lesion of the left anterior descending coronary artery. The implanted BRS restenosed 10 months after implantation and was treated with a scoring balloon followed by drug-eluting balloons with good immediate and long-term results. To the best of our knowledge, this is the first report of a balloon-only treatment of a restenosis occurring more than 6 months after BRS implantation; angiographic and optical coherence tomography images after treatment and at two-year follow-up are presented.

Aims The management of ostial lesions is one of the challenges of percutaneous coronary intervention (PCI) in recent medicine. Although stent implantation has increased the accuracy of the results and improved long-term outcomes, in-stent restenosis (ISR) occurs more frequency following the treatment of ostial lesions than the treatment of non-ostial lesions. When additional stenting is not desirable, PCI with drug-eluting balloons (DEBs) has emerged as an adjunctive strategy. However, little data regarding the effects of DEBs in ostial ISR lesions are available. Our study aimed to assess the efficacy of the use of DEBs in coronary ostial instent restenotic lesions. Methods and results From November of 2011 to May of 2014, 85 patients were diagnosed with coronary ostial ISR in our hospital. A total of 93 coronary ostial ISR lesions were treated with DEBs. More than half of the study patients had comorbidities, including hypertension, diabetes, and hyperlipidemia, 77.6% of the study patients had triple vessel coronary artery disease, and 54.1% of the study patients had left main coronary artery disease. In our study, target lesion revascularization were performed in 19.2% in all groups; 11.5% were in the ostial left anterior descending artery, 29.0% were in the ostial left circumflex artery, and 21.4% were in the ostial right coronary artery. Across all of the groups, 24.4% of the patients experienced major adverse cardiac cerebral events. Conclusion Percutaneous coronary intervention with drug-eluting balloons is an alternative strategy for coronary ostial instent restenosis when additional stenting is not desirable.

Highlights • The management of carotid in-stent restenosis remains challenging, with several potential management strategies available, but none clearly best. • Bioresorbable vascular scaffolds have proved safe and effective in patients with coronary artery disease, but their use for carotid in-stent restenosis is unprecedented, yet promising. • Bioresorbable vascular scaffolds could become a useful adjunct to the armamentarium of endovascular specialists, including those managing patients with carotid in-stent restenosis, especially if further refinements in sizes and designs are achieved., Introduction Carotid in-stent restenosis is associated with substantial risk of recurrent restenosis, even after drug-eluting balloon usage. Presentation of case We hereby report the case of a patient with recurrent carotid in-stent restenosis and drug-eluting balloon failure treated with a coronary bioresorbable vascular scaffold, achieving a satisfactory acute and long-term result, as disclosed by duplex ultrasound scan performed more than 1 year after the procedure. Discussion/conclusion While awaiting for external validation, this clinical vignette supports expanding the armamentarium of endovascular specialists focusing on carotid artery disease, while providing further proof of the safety and efficacy of current bioresorbable vascular scaffolds.

Rationale: Recent research shows that in-stent restenosis (ISR) occurs in half of the patients treated with stenting of femoral and popliteal artery for lower extremity arteriosclerotic occlusive disease (LEASO). Combined therapy is mainly used clinically to obtain better medium- and long-term treatment outcomes and reduce the occurrences of reintervention, among which, the combination of excimer laser ablation (ELA) and drug eluting balloon (DEB) is a new and effective choice. Patient concerns: A 76-year-old male patient with ISR of right superficial femoral artery after stent implantation was reported. Diagnosis: Rechecking angiography indicated severe occlusion of the right superficial femoral artery. The physical examination showed that bilateral femoral and popliteal arteries were accessible whereas right dorsalis and posterior tibial arteries are unaccessible. Ankleolus brachial index (ABI) was 0.92 for left and 0.58 for right. Interventions: We performed the operation with ELA and drug balloon DEB on the right superficial femoral artery under local anesthesia and treated with oral antiplatelet drugs after operation. Outcomes: The combination treatment was very successful, and postoperative lower extremity arteriogram showed the blood flow was fluent and fast. No recurrence was discovered 3 months after the operation and he had no obvious symptom of claudication. Lessons: The combination of ELA and DEB is useful and effective for ISR of peripheral vessel after stent implantation, and this surgical method is worthwhile but need further clinical research for safety confirmation.

Background: Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis. Methods: This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness). Results: Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44). Conclusion: Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas.

Background: This study assesses clinical outcomes after drug-eluting balloon treatment for recurrent in-stent restenosis lesions based on the number of metallic layers. Methods and Results: We enrolled 304 consecutive patients (333 lesions) treated with percutaneous coronary intervention using drug-eluting balloon for in-stent restenosis lesions between March 2014 and June 2015. Per the number of stent layers previously implanted to the lesion, the patients were categorized into 3 groups, 1 stent layer (1L), 166 patients; 2 stent layers (2L), 87 patients; and ≥3 stent layers (≥3L), 51 patients. The end points were major adverse cardiovascular events (MACE), including cardiac death, target lesion revascularization, myocardial infarction, and definite or probable stent thrombosis. No significant differences were observed in patients’ baseline characteristics among the groups. The 1-year MACE and target lesion revascularization rates were significantly higher in the ≥3L group than those in the 1L and 2L groups (MACE: 1L, 16.9%; 2L, 16.1%; and ≥3L, 43.1%, P P P P =0.02]) were independent predictors for MACE. No significant differences were observed in the occurrence of cardiac death among the groups ( P =0.34). Conclusions: Seemingly, drug-eluting balloon is less effective for ≥3L in-stent restenosis lesions. Hemodialysis and in-stent restenosis with the number of metallic layers are independent predictors for MACE.

Objectives to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. Background BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. Methods We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. Results At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%). Conclusion At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

We thank Dr. Alfonso and colleagues for their interest in the recently published DARE (Drug Eluting Balloon for In-Stent Restenosis) trial [(1)][1] and for the opportunity to better elucidate the apparent differences in angiographic and clinical outcomes compared with the RIBS IV (Restenosis Intra

Objective: To present our experience of balloon-assisted maturation with drug-eluting balloon dilation in patients with recurrent failing arteriovenous fistulae. Case series: Three patients (all males, mean age 71 years) with a complex history of failed attempts at native fistula creation underwent surgical creation of arteriovenous fistulae. Two patients had a two-stage brachio-brachial fistula and 1 had a brachio-cephalic fistula that also required subsequent elevation. After a few weeks of preserved patency with a thrill detected clinically, all patients had a gradual deterioration of flow manifested with loss of thrill and multiple severely stenotic lesions of neo-intimal hyperplasia seen on duplex ultrasound. All 3 non-maturing native arteriovenous fistulae had 1 or more angioplasties with regular balloons that were initially successful; however, they rapidly deteriorated with a loss of thrill and a recurrence of multiple stenosis. Drug-eluting balloon dilation was used subsequently as a last resort to save these failing fistulae. All procedures were successful with the preservation of patency and adequate fistula flow (>600 mL/min) during the follow-up period (4-8 months, mean 6 months), and all patients received successful dialysis with 2-needle cannulation of their fistulae. There were no adverse events during the study period. Conclusions: Drug-eluting balloon angioplasty was to salvage nonmaturing fistulae with durable results in complex patients where conventional treatment had previously failed. Drug-eluting balloons may provide a useful treatment option for patients prone to multiple access failures due accelerated neo-intimal hyperplasia.

Carotid artery stenting is commonly used to treat carotid artery stenosis. However, carotid in-stent restenosis remains a challenging problem. Herein, we report a difficult case of recurrent severe carotid in-stent restenosis with total contralateral internal carotid artery occlusion treated with repeat drug-eluting balloon inflations. The outcome after one year of follow-up showed a good result.

Background— Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. Methods and Results— DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB ( P =0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P =0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB ( P =0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB ( P =0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB ( P =0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB ( P =0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB ( P =0.86). Conclusions— DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique Identifier: NCT01366482.

We report about a 12-year-old girl who presented with a blood pressure difference between the extremities with the suspicion of an aortic coarctation. After imaging and laboratory tests, the diagnosis of Takayasu arteritis was made. Owing to persistent arterial hypertension despite medical treatment, we initiated a treatment with a balloon angioplasty of the renal arteries with an eluting balloon.

In-stent restenosis is the most important limitation of modern coronary angioplasty. Drug-eluting stents solve this problem but at the cost of late stent thrombosis and longer duration of dual-antiplatelet therapy. Drug-eluting balloon (DEB) technology is now available and offers an attractive option for treatment of restenosis.A cohort of 20 patients with in-stent restenosis after stenting were treated with a drug-eluting balloon and were followed up clinically and angiographically for 6 months.Procedural success was achieved in all patients. 6 month clinical follow-up was available for all and 6 month angiographic follow up for 17 patients. On 6 month follow-up, 5 of the 20 patients had recurrence of angina and 4 patients had angiographic restenosis (2 focal, 2 diffuse). The mean Canadian Cardiovascular Society angina score improved significantly from 3.1 to 1.1. DEB offers a novel method of treatment for patients with in-stent restenosis with a good safety and efficacy profile.

Using optical coherence tomography (OCT), the mechanisms of postintervention and 9-month luminal enlargement in drug-eluting stent in-stent restenosis (ISR) lesions treated with a drug-eluting balloon (DEB) were evaluated. A total of 42 patients with DEB-treated drug-eluting stent ISR lesions underwent serial OCT examination before intervention, after intervention, and at 9-month follow-up. Preintervention OCT-derived neointima was classified as either a homogeneous or nonhomogeneous pattern. Ten ISR lesions with homogeneous neointima were identified and compared with 32 ISR lesions with nonhomogeneous neointima. When comparing pre- and postintervention evaluations, changes in luminal cross-sectional area (CSA) were 3.4 mm 2 in ISR lesions with homogeneous neointima and 3.7 mm 2 in those with nonhomogeneous neointima, respectively (p = 0.529); changes in stent CSA were 2.5 mm 2 and 1.4 mm 2 , respectively, p = 0.004; and changes in neointimal CSA were −0.9 mm 2 and −2.3 mm 2 , respectively, p = 0.001. At 9-month follow-up, changes in luminal CSA were −2.0 mm 2 and −0.9 mm 2 in ISR lesions with homogeneous and nonhomogeneous neointima, respectively (p = 0.021); in stent CSA changed by −0.2 mm 2 in both groups (p = 0.851) and changes in neointimal CSA was 1.8 mm 2 and 0.7 mm 2 , respectively (p = 0.003). At the 9-month follow-up, >50% neointimal CSA stenosis was observed in 60% and 19% of the ISR lesions with homogeneous and nonhomogeneous neointima, respectively (p = 0.020). In conclusion, the mechanism of postintervention luminal enlargement by DEB varied with the preintervention OCT-based neointimal characteristics. ISR lesions with homogeneous neointima determined by OCT were associated with greater subsequent regrowth of neointima after DEB treatment.

This is a case report of drug-eluting balloon as a new treatment option for cardiac allograft vasculopathy.

We report a case of left anterior descending coronary artery to left upper lobe bronchus fistula arising out of the coronary artery aneurysm, secondary to drug eluting balloon angioplasty done for in-stent restenosis in the left anterior descending coronary artery in a 54-year-old male. This is an unreported entity yet.

PurposeTo evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS).MethodsAmong 830 consecutive patients un...

A 72-year-old woman with peripheral arterial disease presented with a 5-day history of rest pain of the left lower leg. Nine years earlier, she had undergone left-sided femoropopliteal bypass surgery, with multiple endovascular procedures thereafter. Examination revealed absent popliteal and pedal

In-stent restenosis (ISR) remains an important concern despite the recent advances in the drug-eluting stent (DES) technology. The introduction of drug-eluting balloons (DEB) offers a good solution to such problem.We performed a meta-analysis to assess the clinical efficiency and safety of DEB compared with DES in patients with DES-ISR.A systematic search was conducted and all randomized and observational studies which compared DEB with DES in patients with DES-ISR were included. The primary outcome measure-major adverse cardiovascular events (MACE)-as well as individual events as target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI), cardiac death (CD) and all-cause mortality, were analyzed.Three randomized and 4 observational studies were included with a total of 2052 patients. MACE (relative risk [RR]=1.00, 95% confidence interval (CI) 0.68 to 1.46, P=0.99), TLR (RR=1.15 [CI 0.79 to 1.68], P=0.44), ST (RR=0.37[0.10 to 1.34], P=0.13), MI (RR=0.97 [0.49 to 1.91], P=0.93) and CD (RR=0.73 [0.22 to 2.45], P=0.61) were not different between patients treated with DEB and with DES. However, all-cause mortality was lower in patients treated with DEB (RR=0.45 [0.23 to 0.87, P=0.019) and in particular when compared to only first generation DES (RR 0.33 [0.15-0.74], P=0.007). There was no statistical evidence for publication bias.The results of this meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of DES-ISR.

The idea of adding another metallic layer to correct a failed stent is not so appealing; therefore, any attempt to propose a metal-free strategy is laudable. The initial strategy to perform plain balloon angioplasty to treat bare-metal in-stent restenosis (ISR) was inadequate, leaving the remaining options of implanting a drug-eluting stent or using a drug-eluting balloon (DEB).1–4 Pleva et al5 report, in this issue of Circulation: Cardiovascular Interventions , the results of a study randomizing 136 patients with bare-metal ISR to treatment with a DEB (Sequent Please; B. Braun AG, Melsungen, Germany) or an everolimus-eluting stent (EES; Promus Element; Boston Scientific, Marlborough, MA.) See Article by Pleva et al There were 74 ISR lesions (>50% diameter stenosis) in each group. The primary end point was in-segment late lumen loss at 12 months measured by quantitative control angiography. The decision to evaluate late lumen loss as an end point is open to debate because the acute gain, and therefore late loss, is lower with DEB compared with EES. The selection of minimal lumen diameter at follow-up …