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Mortality Following Treatment with Paclitaxel-Coated Devices in Real World: Correlation to Total Lifetime Dosage?

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Thomas Nührenberg, Franz-Josef Neumann, Thomas Zeller,

<h4>Purpose</h4>To evaluate the all-cause mortality after treatment with paclitaxel-coated devices depending on paclitaxel exposure in real-world practice.<h4>Materials and methods</h4>A retrospective analysis of mortality of patients with at least a 3-year follow-up was performed. Patients were categorized into terciles according to the paclitaxel dosage received during the index procedure and every ... Read more >>

J Vasc Interv Radiol (Journal of vascular and interventional radiology : JVIR)
[2021, :]

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Outcomes of directional atherectomy for common femoral artery disease.

Tanja Böhme, Leonardo Romano, Roland-Richard Macharzina, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Peter-Christian Flügel, Thomas Zeller, Aljoscha Rastan,

<h4>Background</h4>Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard.<h4>Aims</h4>The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions.<h4>Methods</h4>A retrospective analysis of ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2021, 17(3):260-266]

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Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Aljoscha Rastan, Marianne Brodmann, Tanja Böhme, Roland Macharzina, Elias Noory, Ulrich Beschorner, Peter-Christian Flügel, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller,

[Figure: see text]. ... Read more >>

Circ Cardiovasc Interv (Circulation. Cardiovascular interventions)
[2021, 14(6):e010280]

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Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Tanja Böhme, Elias Noory, Ulrich Beschorner, Frederik Lerke, Andrej Schmidt, Dierk Scheinert, Wulf Ito, Thomas Zeller, Aljoscha Rastan,

<i>Background:</i> To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. <i>Patients and methods:</i> The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, 50(5):387-393]

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Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Roland Macharzina, Lisa-Marie Kuhn, Thomas Nührenberg, Franz-Josef Neumann, Thomas Zeller,

<i>Background</i>: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. <i>Patients and ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2021, 50(2):132-138]

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Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

Marc Bosiers, Koen Deloose, Joren Callaert, Jürgen Verbist, Jeroen Hendriks, Patrick Lauwers, Herman Schroë, Wouter Lansink, Dierk Scheinert, Andrej Schmidt, Thomas Zeller, Ulrich Beschorner, Elias Noory, Giovanni Torsello, Martin Austermann, Jeroen Wauters,

<h4>Background</h4>This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE<sup>®</sup> VIABAHN<sup>®</sup> Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. ... Read more >>

J Cardiovasc Surg (Torino) (The Journal of cardiovascular surgery)
[2020, 61(5):617-625]

Cited: 1 time

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Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.

Tanja Böhme, Elias Noory, Klaus Brechtel, Dierk Scheinert, Marc Bosiers, Ulrich Beschorner, Thomas Zeller,

<h4>Purpose</h4>To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries.<h4>Materials and methods</h4>This prospective, multicenter, single-arm trial (<i>ClinicalTrials.gov</i>; identifier NCT01263665) enrolled 71 patients (mean age ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2021, 28(2):222-228]

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Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Roland Macharzina, Thomas Nührenberg, Florian Cheung, Franz-Josef Neumann, Thomas Zeller,

<h4>Objectives</h4>To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice.<h4>Background</h4>A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices.<h4>Methods</h4>Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who ... Read more >>

Catheter Cardiovasc Interv (Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions)
[2020, 96(6):1306-1314]

Cited: 1 time

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The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Roland Macharzina, Thomas Zeller,

Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel ... Read more >>

Future Cardiol (Future cardiology)
[2021, 17(2):257-267]

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Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions.

Thomas Zeller, Klaus Brechtel, Dirk-Roelfs Meyer, Elias Noory, Ulrich Beschorner, Thomas Albrecht,

<b>Purpose:</b> To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. <b>Materials and Methods:</b> Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2020, 27(5):683-690]

Cited: 2 times

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Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World.

Tanja Böhme, Elias Noory, Ulrich Beschorner, Börries Jacques, Karlheinz Bürgelin, Roland Macharzina, Ellen Gebauer, Florian Cheung, Peter Lechner, Thomas Nührenberg, Thomas Zeller,

<h4>Objectives</h4>This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.<h4>Background</h4>A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.<h4>Methods</h4>A retrospective mortality analysis of patients with ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2020, 13(17):2052-2061]

Cited: 5 times

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Outstanding effectiveness of paclitaxel-based technologies for the treatment of femoropopliteal artery occlusive disease on the potential expense of increased late all-cause mortality? No reason to panic.

Thomas Zeller, Elias Noory, Ulrich Beschorner, Tanja Böhme, Michel Mpj Reijnen,

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2019, 48(2):109-111]

Cited: 0 times

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Renal artery anatomy assessed by quantitative analysis of selective renal angiography in 1,000 patients with hypertension.

Lucas Lauder, Sebastian Ewen, Abraham Rami Tzafriri, Elazer Reuven Edelman, Thomas Felix Lüscher, Peter J Blankenstijn, Oliver Dörr, Markus Schlaich, Faisal Sharif, Michiel Voskuil, Thomas Zeller, Christian Ukena, Bruno Scheller, Michael Böhm, Felix Mahfoud, ,

<h4>Aims</h4>With increasing attention to renovascular causes and targets for hypertension there arises a critical need for more detailed knowledge of renal arterial anatomy. However, a standardised nomenclature is lacking. The present study sought to develop a standardised nomenclature for renal anatomy considering the complexity and variation of the renal arterial ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2018, 14(1):121-128]

Cited: 2 times

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Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial.

David E Kandzari, Michael Böhm, Felix Mahfoud, Raymond R Townsend, Michael A Weber, Stuart Pocock, Konstantinos Tsioufis, Dimitrios Tousoulis, James W Choi, Cara East, Sandeep Brar, Sidney A Cohen, Martin Fahy, Garrett Pilcher, Kazuomi Kario, ,

BACKGROUND:Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. METHODS:In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged ... Read more >>

Lancet (Lancet (London, England))
[2018, 391(10137):2346-2355]

Cited: 115 times

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Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial.

Raymond R Townsend, Felix Mahfoud, David E Kandzari, Kazuomi Kario, Stuart Pocock, Michael A Weber, Sebastian Ewen, Konstantinos Tsioufis, Dimitrios Tousoulis, Andrew S P Sharp, Anthony F Watkinson, Roland E Schmieder, Axel Schmid, James W Choi, Cara East, Anthony Walton, Ingrid Hopper, Debbie L Cohen, Robert Wilensky, David P Lee, Adrian Ma, Chandan M Devireddy, Janice P Lea, Philipp C Lurz, Karl Fengler, Justin Davies, Neil Chapman, Sidney A Cohen, Vanessa DeBruin, Martin Fahy, Denise E Jones, Martin Rothman, Michael Böhm, ,

<h4>Background</h4>Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications.<h4>Methods</h4>SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled ... Read more >>

Lancet (Lancet (London, England))
[2017, 390(10108):2160-2170]

Cited: 169 times

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Laser-assisted transprosthesial coil embolization combined with thrombin injection for treatment of an endoleak type II after endovascular aneurysm repair.

Tanja Boehme, Aljoscha Rastan, Elias Noory, Peter-Christian Fluegel, Thomas Zeller,

The treatment of endoleaks type II had to be adapted to the anatomy of each individual patient. The laser-assisted perforation of the prosthesis can be an easier method to reach the aneurysm sac directly than using transarterial or translumbar approaches. ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2018, 47(1):63-67]

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Anatomical and procedural determinants of catheter-based renal denervation.

Sebastian Ewen, Christian Ukena, Thomas Felix Lüscher, Martin Bergmann, Peter J Blankestijn, Erwin Blessing, Bodo Cremers, Oliver Dörr, Dagmara Hering, Lukas Kaiser, Holger Nef, Elias Noory, Markus Schlaich, Faisal Sharif, Isabella Sudano, Britta Vogel, Michiel Voskuil, Thomas Zeller, Abraham R Tzafriri, Elazer R Edelman, Lucas Lauder, Bruno Scheller, Michael Böhm, Felix Mahfoud,

<h4>Background/purpose</h4>Catheter-based renal sympathetic denervation (RDN) can reduce blood pressure (BP) and sympathetic activity in certain patients with uncontrolled hypertension. Less is known about the impact of renal anatomy and procedural parameters on subsequent BP response.<h4>Methods/materials</h4>A total of 564 patients with resistant hypertension underwent bilateral RDN in 9 centers in Europe ... Read more >>

Cardiovasc Revasc Med (Cardiovascular revascularization medicine : including molecular interventions)
[2016, 17(7):474-479]

Cited: 6 times

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To Stent or Not to Stent? Update on Revascularization for Atherosclerotic Renovascular Disease.

Elias Noory, Kaji Sritharan, Thomas Zeller,

Renal artery stenosis (RAS) is increasingly encountered in clinical practice. The two most common etiologies are fibromuscular dysplasia (FMD) and atherosclerotic renal artery disease (ARAS), with the latter accounting for the vast majority of cases. Significant RAS activates the renin-angiotensin-aldosterone system and is associated with three major clinical syndromes: ischemic ... Read more >>

Curr Hypertens Rep (Current hypertension reports)
[2016, 18(6):45]

Cited: 2 times

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Duplex derived intrarenal resistance index correlates with invasive pressure gradient measurements in detecting relevant unilateral renal artery stenosis.

Elias Noory, Aljoscha Rastan, Ulrich Beschorner, Roland Macharzina, Thomas Zeller,

<h4>Background</h4>The purpose of this study was to assess the correlation between the transstenotic pressure gradient as determined by a pressure wire and the decrease in the intrarenal resistance index (RI) > 0.05 measured by duplex ultrasound in significant unilateral renal artery stenosis (RAS). Intravascular ultrasound (IVUS) was correlated to the ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2016, 45(2):175-180]

Cited: 2 times

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History of transient ischaemic attack, myocardial infarction and hyperlipidaemia affects outcome following carotid artery stenting.

Roland Richard Macharzina, Christian Claus, Steven R Messé, Tanja Boehme, Werner Vach, Thomas Winker, Aljoscha Rastan, Ulrich Beschorner, Elias Noory, Franz-Josef Neumann, Thomas Zeller,

<h4>Aims</h4>This prospective registry study was intended to evaluate outcomes and predictors of adverse events following carotid artery stenting (CAS).<h4>Methods and results</h4>Patients received neurological and duplex exams before CAS, prior to discharge and at 30- and 180-day follow-up. Multiple regression analysis included patient- and procedure-related characteristics. The MACCE endpoint comprised stroke, ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2015, 11(7):808-815]

Cited: 2 times

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One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

Aljoscha Rastan, James F McKinsey, Lawrence A Garcia, Krishna J Rocha-Singh, Michael R Jaff, Elias Noory, Thomas Zeller, ,

<h4>Purpose</h4>To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year.<h4>Methods</h4>In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2015, 22(6):839-846]

Cited: 16 times

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Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease: Predictors of Outcome With a Special Emphasis on Calcium.

Gunnar Tepe, Ulrich Beschorner, Charlotte Ruether, Imma Fischer, Peter Pfaffinger, Elias Noory, Thomas Zeller,

<h4>Purpose</h4>To assess the association of patient, lesion, and procedure variables, including calcification, with late lumen loss (LLL) after use of drug-eluting balloon (DEB) therapy in patients with femoropopliteal arterial disease.<h4>Methods</h4>In this retrospective study, 91 patients (mean age 72.0±8.62 years; 50 men) were analyzed at 6 months after DEB treatment. Lesions ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2015, 22(5):727-733]

Cited: 23 times

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Novel Approaches to the Management of Advanced Peripheral Artery Disease: Perspectives on Drug-Coated Balloons, Drug-Eluting Stents, and Bioresorbable Scaffolds.

Thomas Zeller, Aljoscha Rastan, Roland Macharzina, Ulrich Beschorner, Elias Noory,

Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as ... Read more >>

Curr Cardiol Rep (Current cardiology reports)
[2015, 17(9):624]

Cited: 3 times

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Drug-coated balloons: how should we incorporate into our practice in treating superficial femoral artery lesions?

Thomas Zeller, Aljoscha Rastan, Roland Macharzina, Ulrich Beschorner, Elias Noory,

<h4>Opinion statement</h4>Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of ... Read more >>

Curr Treat Options Cardiovasc Med (Current treatment options in cardiovascular medicine)
[2015, 17(5):380]

Cited: 2 times

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Duplex ultrasound assessment of native stenoses in the superficial femoral and popliteal arteries: a comparative study examining the influence of multisegment lesions.

Richard-Roland Macharzina, Simon F Schmid, Ulrich Beschorner, Elias Noory, Aljoscha Rastan, Werner Vach, Uwe Schwarzwälder, Sebastian Sixt, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller,

<h4>Purpose</h4>To evaluate duplex ultrasonography (DUS) in the assessment of femoropopliteal stenoses comparing a single native stenosis (SNS) to multisegmental native stenoses (MNS).<h4>Methods</h4>Among the 1284 patients treated for atherosclerotic occlusive disease involving the femoropopliteal segment between November 2002 and November 2012, 139 patients (97 men; mean age 68±8 years) with 142 ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2015, 22(2):254-260]

Cited: 2 times

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