Treatment of small coronary arteries with a paclitaxel-coated balloon catheter

Unverdorben, Martin; Kleber, Franz X.; Heuer, H.; Figulla, Hans‐Reiner; Vallbracht, C.; Leschke, Matthias; Cremers, Bodo; Hardt, Stefan E.; Buerke, Michael; Ackermann, Hanns; Boxberger, Michael; Degenhardt, Ralf; Scheller, Bruno

doi:10.1007/s00392-009-0101-6

Cited by 165 publications

(134 citation statements)

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“…Again, this finding might be related to the small number of patients analyzed in this study undergoing DEB for de novo lesions. In 2010, Unverdorben et al 23 reported the results of a non-randomized cohort of 118 patients undergoing PCI of small coronary vessels using a paclitaxel-coated balloon. The trial showed a TLR rate of 12% at 12 months after the DEB intervention.…”

Section: Disclosuresmentioning

confidence: 99%

The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Uhlemann

Möbius‐Winkler

Adam

et al. 2016

Circ J

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Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp in DES is associated with worse outcomes than with ISR in BMS. 13 Currently, there is no clear consensus about the optimal management of ISR. Intracoronary stenting is still the preferred treatment in patients with ISR after DES or BMS implantation. 9,14-16 However, drug-eluting balloons (DEB) provide potential advantages: 17 rapid release of high drug concentrations and homogeneous drug delivery to the vessel wall, absence of stent and polymer, reduced chronic inflammation and shorter duration of antiplatelet therapy. The recently published SeQuent Please World Wide Registry 18 confirmed a low TLR rate of 5.2% at 9.4 months' follow-up in patients treated with a DEB for BMS restenosis.The ISAR-DESIRE 3 trial showed non-inferiority of the he introduction of drug-eluting stents (DES) significantly reduced the rates of restenosis and target lesion revascularization (TLR), because of inhibition of cellular proliferation as compared with bare-metal stents (BMS). 1 Despite advances in treatment, in-stent restenosis (ISR) still remains the primary concern after percutaneous coronary intervention (PCI) using DES 2-7 and is surprisingly high ranging from 3% to 20%, especially in an all-comers scenario.

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Section: Disclosuresmentioning

confidence: 99%

The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Uhlemann

Möbius‐Winkler

Adam

et al. 2016

Circ J

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“…Drug-coated balloons (DCB) haven proven ef--gioplasty of de novo lesions in small vessels [1,2]. Most DCBs are coated with the mitotic inhibitor -paclitaxel.…”

Section: Introductionmentioning

confidence: 99%

Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

et al. 2016

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“…However, clinical information on the efficacy and safety in de novo coronary lesions is limited. Moreover, several studies and trials have produced conflicting results in patients with a stable coronary artery disease [8,9,10,11,12,13]. Therefore, we hypothesize that DEB may also be safe for the treatment of non-small coronary artery lesions.…”

Section: Introductionmentioning

confidence: 99%

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Ding²,

Tian³

et al. 2016

Cardiology

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Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

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Treatment of small coronary arteries with a paclitaxel-coated balloon catheter

Abstract: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).

Cited by 165 publications

References 32 publications

The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

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Treatment of small coronary arteries with a paclitaxel-coated balloon catheter

Abstract: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).

Cited by 165 publications

References 32 publications

The Leipzig Prospective Drug-Eluting Balloon-Registry – Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

The Leipzig Prospective Drug-Eluting Balloon-Registry – Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

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The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

The Leipzig Prospective Drug-Eluting Balloon-Registry　– Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –