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Journal articles on the topic 'Drug eluting balloon'

Author: Grafiati

Published: 9 March 2023

Last updated: 10 March 2023

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1

Ruebben, Alexander, Juergen Boeing, and Norbert Weiss. "Drug-eluting Balloon Analysis." Interventional Cardiology Review 6, no. 1 (2011): 56. http://dx.doi.org/10.15420/icr.2011.6.1.56.

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Although different drug-eluting balloons appear similar in the underlying concept, the technical differences are important. This article takes a closer look at the coating technique and applications of the different products in the market and why different techniques have been used. The main points covered are loading dose, excipient used and homogenous or partial drug coverage of the balloon used.

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2

Lee, Cheol Whan, and Seung-Jung Park. "Drug-eluting balloon." Coronary Artery Disease 27, no. 2 (March 2016): 78–79. http://dx.doi.org/10.1097/mca.0000000000000313.

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3

Waksman, Ron, and Rajbabu Pakala. "Drug-Eluting Balloon." Circulation: Cardiovascular Interventions 2, no. 4 (August 2009): 352–58. http://dx.doi.org/10.1161/circinterventions.109.873703.

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4

Björkman, P., E. Peltola, A. Albäck, and M. Venermo. "Peripheral Vascular Restenosis: A Retrospective Study on the Use of Drug-Eluting Balloons in Native Arteries, Vein Grafts and Dialysis Accesses." Scandinavian Journal of Surgery 106, no. 2 (June 7, 2016): 158–64. http://dx.doi.org/10.1177/1457496916654098.

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Background and Aims: The objective of this study is to analyze outcomes of the first experiences with drug-eluting balloons in native arteries, vein grafts, and vascular accesses. The study is also a pilot for our future prospective, randomized, and controlled studies regarding the use of drug-eluting balloons in the treatment of the stenosis in bypass vein graft and dialysis access. Materials and Methods: A total of 93 consecutive patients were retrospectively analyzed and in the end 81 were included in the study. Inclusion criteria included at least one previous percutaneous angioplasty to the same lesion. Patients were divided into three groups according to the anatomical site of the lesion: native lower limb artery, vein bypass graft, or vascular access. Time from the previous percutaneous angioplasty to the drug-eluting balloon was compared to the time from the drug-eluting balloon to endpoint in the same patient. Endpoints included any new revascularization of the target lesion, major amputation, or new vascular access. Results: The median time from the drug-eluting balloon to endpoint was significantly longer than the median time from the preceding percutaneous angioplasty to drug-eluting balloon in all three groups. This difference was clearest in native arteries and vein grafts, whereas the difference was smaller from the beginning and disappeared over time in the vascular access group. No significant differences were seen between the groups with regard to smoking, antiplatelet regime, diabetes, Rutherford classification, or sex. Conclusion: Although the setup of this study has several limitations, the results suggest that there could be benefit from drug-eluting balloons in peripheral lesions. Very little data have been published on the use of drug-eluting balloons in vein grafts and vascular accesses, and randomized and controlled prospective studies are needed to further investigate this field.

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Papoyan, S. A., A. A. Shchegolev, D. G. Gromov, and K. S. Asaturyan. "Drug-coated balloon angioplasty in peripheral arterial disease." Russian Medical Inquiry 6, no. 4 (2022): 177–81. http://dx.doi.org/10.32364/2587-6821-2022-6-4-177-181.

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The prevalence of peripheral arterial disease requires the search for an optimal solution for preserving blood flow by using devices of various modifications. Drug-coated balloons are widely used in the surgical treatment of peripheral arterial disease. The article aims at the summarization of the study results on the efficacy and safety of the various drug-coated balloons, in particular, with paclitaxel, in the treatment of steno-occlusive lesions in the peripheral arterial disease. Comparing the study results is fraught with certain difficulties, given the differences in the study endpoints, the demographic characteristics of patients and the lesion patterns. Nevertheless, the study results of percutaneous transluminal angioplasty (PTA) with drug-eluting ballons on the femoropopliteal segment are superior to the results obtained using conventional PTA and other endovascular interventions in the same vascular bed. PTA with drug-eluting balloons has a Class 1 recommendation in accordance with the issued recommendations of the SCAI (Society for Cardiovascular Angiography and Interventions). However, conducting PTA with paclitaxel-eluting balloons requires further determination of the possibilities of its use. KEYWORDS: drug-coated balloons, paclitaxel, percutaneous transluminal angioplasty, angioplasty, atherosclerosis, peripheral arterial disease. FOR CITATION: Papoyan S.A., Shchegolev A.A., Gromov D.G., Asaturyan K.S. Drug-coated balloon angioplasty in peripheral arterial disease. Russian Medical Inquiry. 2022;6(4):177–181 (in Russ.). DOI: 10.32364/2587-6821-2022-6-4-177-181.

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Lugenbiel, Ira, Michaela Grebner, Qianxing Zhou, Anna Strothmeyer, Britta Vogel, Rita Cebola, Oliver Müller, et al. "Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon – results from the Heidelberg PANTHER registry." Vasa 47, no. 1 (January 1, 2018): 49–55. http://dx.doi.org/10.1024/0301-1526/a000671.

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Abstract. Background: Treatment of calcified femoropopliteal lesions remains challenging, even in the era of drug-eluting balloon angioplasty. Lesion recoil and dissections after standard balloon angioplasty in calcific lesions often require subsequent stent implantation. Additionally, poor patency rates in calcified lesions despite the use of drug-eluting balloons may be due to the limited penetration depth of the antiproliferative drug in the presence of vascular calcium deposits. Therefore, preparation of calcified lesions with the AngioSculpt™ scoring balloon might be a valuable option either as a stand-alone treatment, followed by drug-eluting balloon angioplasty or prior to subsequent stent deployment. Patients and methods: In this retrospective, single centre registry, 124 calcified femoropopliteal lesions were treated in 101 subsequent patients. All patients were treated with scoring balloon angioplasty, either alone, in combination with drug-eluting balloons, or prior to stent deployment. The primary outcome was safety and technical success during the index procedure as well as patency at six and 12 months, as evaluated by duplex sonography. Results: Successful scoring was safely performed in all 124 lesions with the AngioSculpt™ balloon. Overall primary patency after 12 months was 81.2 %. Patency rates did not differ significantly between the three treatment strategies. Degree of calcification did not predict patency. Improved clinical outcomes (Rutherford-Becker class and ankle-brachial index) were also observed in the study cohort. Conclusions: Preparation with the AngioSculpt™ scoring balloon offers a safe and valuable treatment option for calcified femoropopliteal lesions.

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Ozpak, Berkan, Sahin Bozok, and Mustafa Cagdas Cayir. "Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries." Vascular 26, no. 5 (February 21, 2018): 457–63. http://dx.doi.org/10.1177/1708538118759416.

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Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle–brachial index 0.4–0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle–brachial index and Rutherford class. Results Both ankle–brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle–brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

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Swinnen, Jan “John”, Kerry Hitos, Lukas Kairaitis, Simon Gruenewald, George Larcos, David Farlow, David Huber, et al. "Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses." Journal of Vascular Access 20, no. 3 (September 18, 2018): 260–69. http://dx.doi.org/10.1177/1129729818801556.

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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.

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9

Ruebben, Alexander, Juergen Boeing, and Norbert Weiss. "Drug-eluting Balloon Analysis." Interventional Cardiology Review 5, no. 1 (2010): 74. http://dx.doi.org/10.15420/icr.2010.5.1.74.

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10

Speck, Ulrich, Nicola Kaufels, Dirk Mahnkopf, Michael Kühler, Michael Böhm, Bruno Scheller, and Bodo Cremers. "Drug-eluting balloon: Very short-term exposure and overlapping." Thrombosis and Haemostasis 101, no. 01 (2009): 201–6. http://dx.doi.org/10.1160/th08-06-0387.

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SummaryPaclitaxel balloon coating has shown promising effects in inhibiting restenosis in initial clinical trials. The aim of the present study was to evaluate the influence of two critical features of drug-eluting balloon (DEB) application – inflation time and increased dose due to overlapping balloons. Fifty-six stainless steel stents were implanted in the left anterior descending and circumflex coronary arteries of 28 domestic pigs using a 1.2:1.0 overstretch ratio. Stents were mounted on conventional un-coated and paclitaxel-coated angioplasty balloon catheters. The animals were randomized to five different treatments with a range of short (10 seconds [s] inflation using 1 DEB) to extended (2x60 s inflation using 2 DEB) intima contact time. After 28 days, quantitative angiography and histomorphometry of the stented arteries was performed on a total of 23 pigs. Paclitaxel balloon coating led to a marked reduction of parameters characterizing in-stent stenosis: Late lumen loss was 1.37 ± 0.49 mm for uncoated balloons, 0.23 ± 0.42 mm for one coated balloon 60 s inflation time, 0.37 ± 0.28 mm for 10 s inflation time and 0.30 ± 0.19 mm for the vessel segment treated by two coated balloons with 60 s inflation each. Neointimal areas were 4.26 ± 1.18, 1.68 ± 0.23, 1.83 ± 0.40 and 1.67 ± 0.46 mm², respectively (p=0.001 versus control, p>0.05 between paclitaxel-treated groups). Despite the marked reduction of neointimal proliferation, endothelialization of stent struts was present in all samples. DEB were found to effectively reduce neointimal proliferation regardless of inflation time and dose within the tested range. No adverse reactions were seen as dose was increased to more than three times the clinically tested dose.

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K Ay, Nuray, and Bekir Inan. "Iloprost treatment on top of infrapopliteal angioplasty accelerates wound healing in critical leg ischemia." Vascular 28, no. 1 (July 29, 2019): 74–80. http://dx.doi.org/10.1177/1708538119866608.

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Objectives This study aimed to examine the efficacy of the concomitant use of infrapopliteal drug-eluting balloon angioplasty and a medical treatment (iloprost) in the treatment of critical leg ischemia. Methods Eighty-seven patients that underwent infrapopliteal drug-eluting balloon angioplasty for critical leg ischemia were included in this retrospective study. For analyses, patients were allocated into one of the two groups: 55 patients that underwent drug-eluting balloon angioplasty alone (drug-eluting balloon Group), and 32 patients that received intravenous iloprost for one week after drug-eluting balloon (DEB-I Group). Demographic, perioperative and follow-up clinical data were extracted retrospectively and analyzed. Results Duration of hospitalization was significantly longer in the DEB-I group (9.7 vs. 3.1 days, p < 0.001); however, the two groups were similar in terms of other clinical outcomes including early postoperative mortality, and primary patency, wound healing, reintervention, mortality, and amputation rates at one year ( p > 0.05 for all). Primary patency was similar across groups. Wound healing occurred earlier in the DEB-I group when compared to drug-eluting balloon group, in the subgroup of patients with ischemic wound at baseline. Mean time to wound healing was 3.0 ± 0.6 and 4.4 ± 0.6 months in DEB-I and drug-eluting balloon groups, respectively ( p = 0.037). Conclusions Iloprost add-on treatment in patients undergoing drug-eluting balloon angioplasty for critical limb ischemia seems to have additional benefits, at least in terms of accelerated wound healing. Further large prospective studies are warranted.

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Mallios, Alexandros, Jeffrey Hull, Benoit Boura, Alessandro Costanzo, and Myriam Combes. "Drug eluting balloon angioplasty for assisted maturation of failing fistulae." Journal of Vascular Access 19, no. 2 (February 19, 2018): 184–86. http://dx.doi.org/10.5301/jva.5000819.

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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.

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Teymen, Burak, Suleyman Akturk, Ulku Akturk, and Muhammed Tdjani. "Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions." Vascular 26, no. 1 (July 14, 2017): 54–61. http://dx.doi.org/10.1177/1708538117719580.

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Objective The aim of this study was to compare the drug-eluting balloon with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Methods We retrospectively identified patients at our clinic with complex femoropopliteal artery lesions treated either with self-expanding interwoven nitinol stent or drug-eluting balloon. All patients had ankle-brachial index measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography was performed at six months and one year. Patients underwent peripheral angiography if needed. Results From April 2012 to July 2015, 107 patients with complex femoropopliteal lesions treated with using self-expanding interwoven nitinol stent ( N = 49, mean length 143.5 mm, mean follow-up of 14.1 ± 3.7 months) or drug-eluting balloon ( N = 58, mean length 140.6 mm, mean follow-up of 13.8 ± 4.1 months). The technical success rate was 100% in Supera® and 96.6% in drug-eluting balloon group. There were seven restenosis in self-expanding interwoven nitinol stent (SUS) group (84.8% patency) and 11 restenosis in drug-eluting balloon group (79.2% patency). A significant increase in the ankle-brachial index in both groups after intervention demonstrated a hemodynamic success (SUS group 0.45 ± 0.06, drug-eluting balloon group 0.43 ± 0.07). The mean Rutherford Becker Class significantly decreased in both groups after a follow-up of 12 months (SUS group 0.70 ± 0.73, drug-eluting balloon group 0.74 ± 0.75). Conclusion Deploying drug-eluting balloon or self-expanding interwoven nitinol stent in patients with complex femoropopliteal lesions are both safe and effective with high patency rates with no statistical difference for one-year primary patency rates between them.

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Özpak, Berkan. "Drug-eluting balloon treatment in femoropopliteal in-stent restenosis of different lengths." Turkish Journal of Thoracic and Cardiovascular Surgery 28, no. 3 (August 28, 2020): 460–66. http://dx.doi.org/10.5606/tgkdc.dergisi.2020.18980.

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Background: In this study, we present one-year results of drug-eluting 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 drug-eluting 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; Group/Class 2 (n=22): 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.

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Chen, Yin, Shilian Hu, and Lei Wu. "Drug-eluting balloon for instent restenosis." Heart 99, no. 24 (August 16, 2013): 1874.1–1874. http://dx.doi.org/10.1136/heartjnl-2013-304720.

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Bahl, Rahul, Andreas Indermuehle, Georg M. Froehlich, Alexandra J. Lansky, Guido Knapp, Adam Timmis, and Pascal Meier. "Drug-eluting balloon for instent restenosis." Heart 99, no. 24 (August 19, 2013): 1874.2–1875. http://dx.doi.org/10.1136/heartjnl-2013-304722.

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Eitan, Abergel, Beyar Rafael, and Roguin Ariel. "Re: Drug Eluting Balloon in bifurcation." Cardiovascular Revascularization Medicine 14, no. 3 (May 2013): 182. http://dx.doi.org/10.1016/j.carrev.2013.01.005.

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Liistro, Francesco, Paolo Angioli, Italo Porto, Kenneth Ducci, Giovanni Falsini, Giorgio Ventoruzzo, Lucia Ricci, Alessia Scatena, Simone Grotti, and Leonardo Bolognese. "Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions." Journal of the American College of Cardiology 74, no. 2 (July 2019): 205–15. http://dx.doi.org/10.1016/j.jacc.2019.04.057.

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Brott, Brigitta C., and Arka Chatterjee. "Drug-Eluting Balloon Therapy for In-Stent Restenosis of Drug-Eluting Stents." JACC: Cardiovascular Interventions 11, no. 10 (May 2018): 979–80. http://dx.doi.org/10.1016/j.jcin.2018.03.014.

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V, Voon. "Incidence of symptom-driven Coronary Angiographic procedures post-drug-eluting Balloon treatment of Coronary Artery drug-eluting stent in-stent Restenosis-does it matter?" Journal of Cardiology and Cardiovascular Medicine 2, no. 1 (2017): 035–41. http://dx.doi.org/10.29328/journal.jccm.1001011.

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Velagapudi, Chetan, and Sreekumar Madassery. "Drug-Eluting Stents." Seminars in Interventional Radiology 39, no. 04 (August 2022): 400–405. http://dx.doi.org/10.1055/s-0042-1758078.

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AbstractEndovascular revascularization strategies have advanced tremendously over the years and are now often considered first line for treatment of peripheral arterial disease. Drug-eluting stents (DESs) have been developed as one of the tools to overcome the limitations of elastic recoil and neointimal hyperplasia observed with balloon angioplasty and bare metal stents. While these stents have been extremely successful in coronary revascularization, they have not translated as effectively to the peripheral arteries which differ in their unique mechanical environments and differences in vessel and lesion composition. DESs, through their embedded pharmaceutical agent, seek to inhibit vascular smooth muscle cell (VSMC) proliferation and migration. Paclitaxel, sirolimus, and its derivatives (-limus family) achieve VSMC inhibition through unique mechanisms. Several clinical trials have been performed to evaluate the use of DES in the femoropopliteal and infrapopliteal territory and have demonstrated overall decrease in revascularization rates and improved clinical outcomes.

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Vachiat, Ahmed, Mpiko Ntsekhe, and Farrel Hellig. "Hybrid rotablation and drug-eluting balloon strategy." Cardiovascular Journal of Africa 32, no. 1 (February 26, 2021): 30–34. http://dx.doi.org/10.5830/cvja-2020-050.

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Wang, Guozhong, Quanming Zhao, Qing Chen, Xiaoxia Zhang, Lei Tian, and Xiaojiang Zhang. "Comparison of drug-eluting balloon with repeat drug-eluting stent for recurrent drug-eluting stent in-stent restenosis." Coronary Artery Disease 30, no. 7 (November 2019): 473–80. http://dx.doi.org/10.1097/mca.0000000000000784.

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Rastan, Noory, and Zeller. "Drug-eluting stents for treatment of focal infrapopliteal lesions." Vasa 41, no. 2 (March 1, 2012): 90–95. http://dx.doi.org/10.1024/0301-1526/a000170.

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We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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Rawat, Bharat, PR Poudel, and Smriti Mulmi. "Drug Eluting Stents & Coronary Angiography." Nepalese Heart Journal 4, no. 1 (November 30, 2006): 27–31. http://dx.doi.org/10.3126/njh.v4i1.26153.

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Twenty-five years ago, a young German physician, Andreas Gruentzig, inserted a catheter into a 38-year-old man's coronary artery, inflated a tiny balloon the doctor had fashioned in his own kitchen, successfully opening a blockage and restoring blood flow to a human heart. This event set a cascade of newer invention.

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Lee, Joo Myung, Jonghanne Park, Jeehoon Kang, Ki-Hyun Jeon, Ji-hyun Jung, Sang Eun Lee, Jung-Kyu Han, et al. "Comparison Among Drug-Eluting Balloon, Drug-Eluting Stent, and Plain Balloon Angioplasty for the Treatment of In-Stent Restenosis." JACC: Cardiovascular Interventions 8, no. 3 (March 2015): 382–94. http://dx.doi.org/10.1016/j.jcin.2014.09.023.

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Shintaku, Sadanori, Tomoyasu Sato, Hideki Kawanishi, Misaki Moriishi, and Shinichiro Tsuchiya. "The efficacy of drug-eluting stent for recurrent central venous restenosis in a patient undergoing hemodialysis." Journal of Vascular Access 20, no. 1_suppl (March 26, 2018): 76–79. http://dx.doi.org/10.1177/1129729818763473.

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Introduction: Recurrent central venous restenosis is problematic in patients with ipsilateral arteriovenous fistula. We report our experience using a drug-eluting stent for the treatment of recurrent central vein restenosis. Case report: A 60-year-old man consulted our hospital because of recurrent swelling of his left upper limb with radial-cephalic arteriovenous fistula that originated in the distal forearm. More than 3 years prior, two bare-metal stents were placed for the obstructed lesions in the left subclavian and brachiocephalic venous lesions, and repeated balloon angioplasty for recurrent in-stent stenosis was performed approximately every 3 months. Angiography with iodinated contrast agents revealed an approximately 3-cm-long restenosis at the distal part of the bare-metal stents. One drug-eluting stent (Zilver PTX Drug-Eluting Peripheral Stent; Cook Medical, Bloomington, IN, USA) was deployed at the narrowing lesion, followed by balloon angioplasty. The stenotic lesion was successfully and safely dilated. The patient consulted our hospital 5.5 months after drug-eluting stent placement because of restenosis at the distal part of the drug-eluting stent, but only in a shorter segment than before. Freedom from clinically driven target-lesion revascularization (TLR) extended from 3.1 to 5.5 months after drug-eluting stent placement. Although additional implantation of the second drug-eluting stent was required 14.6 months after the first drug-eluting stent placement, freedom from TLR before/after the second drug-eluting stent placement extended from 4.4 months to more than 8.6 months. Conclusion: Drug-eluting stent placement is an effective strategy for recurrent central venous stenosis in patients with ipsilateral arteriovenous fistula. To our knowledge, this is the first report of drug-eluting stent placement for recurrent venous stenosis in a patient undergoing hemodialysis.

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Lee, Hak-Il, Won-Kyu Rhim, Eun-Young Kang, Bogyu Choi, Jun-Hyeok Kim, and Dong-Keun Han. "A Multilayer Functionalized Drug-Eluting Balloon for Treatment of Coronary Artery Disease." Pharmaceutics 13, no. 5 (April 23, 2021): 614. http://dx.doi.org/10.3390/pharmaceutics13050614.

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Drug-eluting balloons (DEBs) have been mostly exploited as an interventional remedy for treating atherosclerosis instead of cardiovascular stents. However, the therapeutic efficacy of DEB is limited due to their low drug delivery capability to the disease site. The aim of our study was to load drugs onto a balloon catheter with preventing drug loss during transition time and maximizing drug transfer from the surface of DEBs to the cardiovascular wall. For this, a multilayer-coated balloon catheter, composed of PVP/Drug-loaded liposome/PVP, was suggested. The hydrophilic property of 1st layer, PVP, helps to separate drug layer in hydrophilic blood vessel, and the 2nd layer with Everolimus (EVL)-loaded liposome facilitates drug encapsulation and sustained release to the targeted lesions during inflation time. Additionally, a 3rd layer with PVP can protect the inner layer during transition time for preventing drug loss. The deionized water containing 20% ethanol was utilized to hydrate EVL-loaded liposome for efficient coating processes. The coating materials showed negligible toxicity in the cells and did not induce pro-inflammatory cytokine in human coronary artery smooth muscle cells (HCASMCs), even in case of inflammation induction through LPS. The results of hemocompatibility for coating materials exhibited that protein adsorption and platelet adhesion somewhat decreased with multilayer-coated materials as compared to bare Nylon tubes. The ex vivo experiments to confirm the feasibility of further applications of multilayer-coated strategy as a DEB system demonstrated efficient drug transfer of approximately 65% in the presence of the 1st layer, to the tissue in 60 s after treatment. Taken together, a functional DEB platform with such a multilayer coating approach would be widely utilized for percutaneous coronary intervention (PCI).

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IJsselmuiden, Alexander. "Interim Analysis of the Protégé Paclitaxel-Eluting Balloon in Real-World Practice (PEARL) Registry." Clinical Cardiology and Cardiovascular Interventions 4, no. 3 (February 11, 2021): 01–02. http://dx.doi.org/10.31579/2641-0419/133.

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Almalla, Mohammad, Jörg Schröder, Verena Pross, Nikolaus Marx, and Rainer Hoffmann. "Paclitaxel-eluting balloon versus everolimus-eluting stent for treatment of drug-eluting stent restenosis." Catheterization and Cardiovascular Interventions 83, no. 6 (July 3, 2013): 881–87. http://dx.doi.org/10.1002/ccd.25072.

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Rykowska, I., I. Nowak, and R. Nowak. "Drug-Eluting Stents and Balloons—Materials, Structure Designs, and Coating Techniques: A Review." Molecules 25, no. 20 (October 11, 2020): 4624. http://dx.doi.org/10.3390/molecules25204624.

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Controlled drug delivery is a matter of interest to numerous scientists from various domains, as well as an essential issue for society as a whole. In the treatment of many diseases, it is crucial to control the dosing of a drug for a long time and thus maintain its optimal concentration in the tissue. Heart diseases are particularly important in this aspect. One such disease is an obstructive arterial disease affecting millions of people around the world. In recent years, stents and balloon catheters have reached a significant position in the treatment of this condition. Balloon catheters are also successfully used to manage tear ducts, paranasal sinuses, or salivary glands disorders. Modern technology is continually striving to improve the results of previous generations of stents and balloon catheters by refining their design, structure, and constituent materials. These advances result in the development of both successive models of drug-eluting stents (DES) and drug-eluting balloons (DEB). This paper presents milestones in the development of DES and DEB, which are a significant option in the treatment of coronary artery diseases. This report reviews the works related to achievements in construction designs and materials, as well as preparation technologies, of DES and DEB. Special attention was paid to the polymeric biodegradable materials used in the production of the above-mentioned devices. Information was also collected on the various methods of producing drug release coatings and their effectiveness in releasing the active substance.

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Karnabatidis, Dimitrios, and Panagiotis Kitrou. "Drug eluting balloons for resistant arteriovenous dialysis access stenosis." Journal of Vascular Access 18, no. 1_suppl (March 2017): S88—S91. http://dx.doi.org/10.5301/jva.5000663.

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Vascular access maintenance is vital for hemodialysis patients. Conventional balloon angioplasty is the gold standard of treatment in endovascular therapy according to published guidelines, accompanied by bare metal stents as a bail-out method. Several devices have been used so far with a view to improve patency outcomes, but only covered stents have been proposed as a valid alternative and only for venous juxta-anastomotic stenosis of arteriovenous grafts. Paclitaxel-coated balloons (PCBs) have been extensively investigated in the last few years in pilot studies with small numbers of patients in dialysis access. Results from these studies have been promising so far; however, a larger number of subjects is needed to prove outcomes. Aim of this analysis is to discuss current available studies and explore some critical aspects of PCB use in dialysis access treatment.

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Alvarez, William, and Navin K. Kapur. "Drug Eluting Stent Technology." Journal of Pharmacy Practice 18, no. 6 (December 2005): 461–78. http://dx.doi.org/10.1177/0897190005282359.

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The authors discuss the mechanism of action, clinical trial data, and economic impact of both the paclitaxel and sirolimus drug eluting stents (DESs). Both DESs have been approved by the Food and Drug Administration for the treatment of native coronary arteries to prevent in-stent restenosis (ISR), which patients have experienced since the advent of balloon angioplasty and the bare metal stent. In-stent restenosis, which manifests itself as ischemic symptoms in patients, occurs as a result of the healing process after stent implantation. Until now, there has not been an effective method to prevent ISR. The sirolimus and paclitaxel DESs elute agents that act locally by different mechanisms to reduce neointimal hyperplasia, which is primarily responsible for ISR. Both DESs are capable of reducing the rate of ISR. There are certain physical and mechanistic differences between the 2 stents; the stents have not been compared head to head. Currently, they are indicated for uncomplicated native coronary lesions. Further investigation is needed to define their roles in the treatment of more complex lesions.

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van der Linde, Ferry. "Development of a Science-based Drug-eluting Balloon." Interventional Cardiology Review 6, no. 1 (2011): 53. http://dx.doi.org/10.15420/icr.2011.6.1.53.

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The continuous development of medical devices, more specifically devices for interventional cardiology, ensures constant improvement in the treatment of patients with coronary artery diseases (CAD), satisfying the increasing needs and demands of patients and cardiologists. These increased demands combined with expanding regulations have created the necessity to transform standard product development into science-based, evidence-guided projects. Two newly approved drug-eluting balloon (DEB) products, Protégé and Pioneer, developed by Blue Medical, are based on such scientific evidence gathered using new, innovative methods and combining independent science data during all development phases, leading to scientifically supported improved patient care.

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Tawfik, AhmadM, Aymen Salem, and Amr Elboushi. "Role of drug-eluting balloon in infragenicular angioplasty." Egyptian Journal of Surgery 35, no. 4 (2016): 403. http://dx.doi.org/10.4103/1110-1121.194742.

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36

Tepe, Gunnar, Ulrich Beschorner, Charlotte Ruether, Imma Fischer, Peter Pfaffinger, Elias Noory, and Thomas Zeller. "Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease." Journal of Endovascular Therapy 22, no. 5 (August 6, 2015): 727–33. http://dx.doi.org/10.1177/1526602815600156.

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37

Sharma, Sumeet, Neville Kukreja, Christos Christopoulos, and Diana A. Gorog. "Drug-eluting balloon: new tool in the box." Expert Review of Medical Devices 7, no. 3 (May 2010): 381–88. http://dx.doi.org/10.1586/erd.10.5.

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38

Bukka, Meenasree, Poorna Jyothi Rednam, and Mukty Sinha. "Drug-eluting balloon: design, technology and clinical aspects." Biomedical Materials 13, no. 3 (February 23, 2018): 032001. http://dx.doi.org/10.1088/1748-605x/aaa0aa.

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Ibrahim, Tareq, Ralf Dirschinger, Rüdiger Hein, and Juliane Jaitner. "Downstream Panniculitis Secondary to Drug-Eluting Balloon Angioplasty." JACC: Cardiovascular Interventions 9, no. 17 (September 2016): e177-e179. http://dx.doi.org/10.1016/j.jcin.2016.06.017.

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Dhakam, Sajid, and Nasir Rahman. "A journey from CABG to drug-eluting balloon." Catheterization and Cardiovascular Interventions 84, no. 3 (November 30, 2013): E21—E25. http://dx.doi.org/10.1002/ccd.23448.

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41

Zhang, Dai, Yan Sun, Xiaoli Liu, Fang Liu, Yujing Cheng, Xiaoteng Ma, Yingxin Zhao, and Yujie Zhou. "Long-Term Follow-Up After Treatment of Drug-Eluting Stent Restenosis and De Novo Lesions Using SeQuent Please Paclitaxel-Coated Balloons." Angiology 70, no. 5 (November 1, 2018): 414–22. http://dx.doi.org/10.1177/0003319718809423.

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Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.

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Zhang, Dai-Min, and Shaoliang Chen. "In-Stent Restenosis and a Drug-Coated Balloon: Insights from a Clinical Therapeutic Strategy on Coronary Artery Diseases." Cardiology Research and Practice 2020 (October 25, 2020): 1–7. http://dx.doi.org/10.1155/2020/8104939.

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Coronary heart disease is a major cause of death and disability in developed countries. Stent implantation has become an efficacious treatment for a culprit lesion vessel of the coronary artery. However, 10%–20% restenosis is still an important complication that restricts the clinical safety and efficacy of drug-eluting stents. In-stent restenosis may lead to the recurrence of major cardiovascular adverse events, including angina pectoris, acute myocardial infarction, and even sudden cardiac death. These events are currently serious problems that occur after coronary stent implantation. Clinical physicians face a difficult choice for in-stent restenosis treatment. Recent studies indicate that a drug-coated balloon has promising clinical efficacy similar to the drug-eluting stents for treating coronary in-stent restenosis. Therefore, in this study, we highlight the progress of coronary intervention and the use of drug-coated balloons in the treatment of in-stent restenosis (ISR).

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43

Kilic, Ismail Dogu, and Mehmet Cilingiroglu. "Drug‐eluting stent, drug eluting balloon controversy in peripheral artery disease; what is the verdict?" Catheterization and Cardiovascular Interventions 96, no. 6 (November 2020): 1315–16. http://dx.doi.org/10.1002/ccd.29355.

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44

Latsios, George, Antonios Karanasos, Konstantinos Toutouzas, Georgia Vogiatzi, Spyridon Papaioannou, Andreas Synetos, and Dimitris Tousoulis. "Optical coherence tomography guided treatment of recurrent drug-eluting stent failure using drug-eluting balloon." International Journal of Cardiology 221 (October 2016): 32–33. http://dx.doi.org/10.1016/j.ijcard.2016.07.007.

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45

Bong, Tiffany SH, Charyl JQ Yap, Shereen XY Soon, and Tjun Y. Tang. "Combination therapy using scoring and sirolimus drug-coated balloons during lower limb endovascular revascularization for chronic limb threatening ischaemia: A case series." SAGE Open Medical Case Reports 10 (January 2022): 2050313X2210858. http://dx.doi.org/10.1177/2050313x221085859.

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The aim of this case series was to document our early experience using combination therapy with UltraScore™ Focused Force percutaneous transluminal angioplasty balloon (BD Interventional, New Jersey, US) and Selution Sustained Limus Release (SLR)™ (M.A. MedAlliance SA, Nyon, Switzerland) sirolimus-coated balloon catheter for anti-restenotic drug elution, in the setting of multifocal high-grade stenosis for chronic limb threatening ischaemia. Our anecdotal experience was that preparing the lesion with scoring balloon and then using sirolimus drug-eluting balloon may have synergistic effect when used in tandem, especially in the setting of calcified arterial lesions, where the scoring wires may achieve deeper clefts within the atheromatous plaque to allow better drug absorption into the arterial wall. We report two cases with high-grade multifocal stenosis affecting the superficial femoral and anterior tibial arteries, respectively. Combination therapy using the scoring balloon to first prepare the lesion followed by sirolimus elution achieved technical and procedural success in both cases and a 100% 30-day primary patency. There were no complications related to flow-limiting dissections, vessel perforation or acute recoil. However, whether this combination therapy leads to better primary vessel patency with longer freedom from target lesion revascularization in the medium term remains to be determined.

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46

Hu, Patrick P., and Ehtisham Mahmud. "Sirolimus Eluting Stents." Clinical Medicine Insights: Therapeutics 2 (January 2010): CMT.S2094. http://dx.doi.org/10.4137/cmt.s2094.

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The sirolimus-eluting stent (SES) Cypher was the first commercially available drug-eluting stent. The use of this stent has resulted in significantly lower rates of restenosis and lesion revascularization compared to bare metal stents and balloon angioplasty. In this review, angiographic and clinical outcomes in patients treated with SES are compared to those treated with bare metal stents and other drug-eluting stents. Furthermore, efficacy and safety outcomes of SES in complex lesions (left main stenosis, bifurcation lesions, chronic total occlusions, long lesions and small vessels) and high risk populations (diabetes and acute myocardial infarction) are presented.

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47

Torella, Daniele, Antonio Curcio, Cosimo Gasparri, Valentina Galuppo, Daniela De Serio, Francesca C. Surace, Anna Lucia Cavaliere, et al. "Fludarabine prevents smooth muscle proliferation in vitro and neointimal hyperplasia in vivo through specific inhibition of STAT-1 activation." American Journal of Physiology-Heart and Circulatory Physiology 292, no. 6 (June 2007): H2935—H2943. http://dx.doi.org/10.1152/ajpheart.00887.2006.

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Drug-eluting stents are increasingly used to reduce in-stent restenosis and adverse cardiac events after percutaneous coronary interventions. However, the race for the ideal drug-eluting stent is still on, with special regard to the best stent-coating system and the most effective and less toxic drug. Fludarabine, a nucleoside analog, has both anti-inflammatory and antiproliferative cellular effects. The aim of the present study was to assess the cellular and molecular effects of fludarabine on vascular smooth muscle cell (VSMC) growth in vitro and in vivo and the feasibility and efficacy of a fludarabine-eluting stent. To study the biomolecular effects of fludarabine on VSMC proliferation in vitro, rat VSMCs were grown in the presence of 50 μM fludarabine or in the absence of the same. To evaluate the in vivo effect of this drug, male Wistar rats underwent balloon injury of the carotid artery, and fludarabine was locally delivered at the time of injury. Finally, fludarabine-eluting stents were in-laboratory manufactured and tested in a rabbit model of in-stent restenosis. Fludarabine markedly inhibited VSMC proliferation in cell culture. Furthermore, fludarabine reduced neointimal formation after balloon angioplasty in a dose-dependent manner, and fludarabine-eluting stents reduced neointimal hyperplasia by ∼50%. These in vitro and in vivo cellular effects were specifically associated with the molecular switch-off of signal transducer and activator of transcription (STAT)-1 activation, without affecting other STAT proteins. Fludarabine abolishes VSMC proliferation in vitro and reduces neointimal formation after balloon injury in vivo through specific inhibition of STAT-1 activation. Fludarabine-eluting stents are feasible and effective in reducing in-stent restenosis in rabbits.

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48

Eraliev, T. K., D. A. Khelimskii, A. G. Badoian, O. V. Krestyaninov, A. A. Baranov, and A. P. Gorgulko. "Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions." Patologiya krovoobrashcheniya i kardiokhirurgiya 26, no. 4 (December 29, 2022): 7–18. http://dx.doi.org/10.21688/1681-3472-2022-4-7-18.

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Background: Bifurcation treatments make up ca. 15–20% of coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions, especially with side branches involved, remains a challenge.Objective: To evaluate long-term clinical and angiographic outcomes after using a paclitaxel-coated balloon for the treatment of side branches in patients with true bifurcation lesions.Methods: Eighty patients with coronary artery disease were enrolled after true bifurcation lesion stenting. All patients were randomized at the 1:1 ratio to the group of main branches stenting followed by the dilatation of side branches with drug-eluting balloons and provisional stenting group.Results: Long-term results were analyzed after 12 months. The most common bifurcation lesion involved the left anterior descending artery and diagonal branch (57.5%). Late lumen loss in the side branch (0.51 ± 0.22 vs 0.33 ± 0.24 mm) and in both the bifurcation branches (main branch + side branch) (1.06 ± 0.29 vs 0.79 ± 0.27 mm) was significantly higher in the patients after provisional stenting.Overall postoperative incidence of major adverse cardiovascular events was 17.5% and 7.5% (p = 0.31) in the provisional stenting and drug coated balloon groups, respectively. Patients with drug-eluting balloons for the treatment of side branches had a more pronounced decrease in angina symptoms after 12 months. Multivariate analysis showed that diabetes mellitus (OR: 10.9) and glomerular filtration rate (OR: 0.95) were independent predictors of major adverse cardiovascular events in bifurcation interventions.Conclusion: Drug-eluting balloons for the dilatation of side branches after the stenting of main branches are superior to provisional stenting in terms of the late lumen loss. Received 31 August 2022. Revised 17 November 2022. Accepted 18 November 2022. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovData collection and analysis: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoStatistical analysis: T.K. Eraliev, D.A. Khelimskii, A.G. BadoianDrafting the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoCritical revision of the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovFinal approval of the version to be published: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. Gorgulko

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Geng, Baoyu, Zhe Liu, Guangzhi Feng, and Jun Jiang. "Drug-coated balloon versus drug-eluting stent in acute myocardial infarction." Medicine 100, no. 44 (November 5, 2021): e27259. http://dx.doi.org/10.1097/md.0000000000027259.

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50

Lee, KangJu, JiYong Lee, Seul Gee Lee, SeungHyun Park, Da Som Yang, Jung-Jae Lee, Ali Khademhosseini, Jung Sun Kim, and WonHyoung Ryu. "Microneedle drug eluting balloon for enhanced drug delivery to vascular tissue." Journal of Controlled Release 321 (May 2020): 174–83. http://dx.doi.org/10.1016/j.jconrel.2020.02.012.

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