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Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
by
Hehrlein, Christoph
, Scheller, Bruno
, Bocksch, Wolfgang
, Haghi, Dariush
, Rutsch, Wolfgang
, Böhm, Michael
, Dietz, Ulrich
, Speck, Ulrich
in
Aged
/ Cardiology
/ Catheterization - methods
/ Clinical trials
/ Coronary Restenosis - drug therapy
/ Coronary Restenosis - etiology
/ Double-Blind Method
/ Drug-Eluting Stents - adverse effects
/ Female
/ Follow-Up Studies
/ Germany
/ Graft Occlusion, Vascular - drug therapy
/ Graft Occlusion, Vascular - etiology
/ Humans
/ Male
/ Medical imaging
/ Medicine
/ Medicine & Public Health
/ Original Paper
/ Paclitaxel - administration & dosage
/ Placebo Effect
/ Stents
/ Stents - adverse effects
/ Treatment Outcome
/ Tubulin Modulators - administration & dosage
2008
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Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
by
Hehrlein, Christoph
, Scheller, Bruno
, Bocksch, Wolfgang
, Haghi, Dariush
, Rutsch, Wolfgang
, Böhm, Michael
, Dietz, Ulrich
, Speck, Ulrich
in
Aged
/ Cardiology
/ Catheterization - methods
/ Clinical trials
/ Coronary Restenosis - drug therapy
/ Coronary Restenosis - etiology
/ Double-Blind Method
/ Drug-Eluting Stents - adverse effects
/ Female
/ Follow-Up Studies
/ Germany
/ Graft Occlusion, Vascular - drug therapy
/ Graft Occlusion, Vascular - etiology
/ Humans
/ Male
/ Medical imaging
/ Medicine
/ Medicine & Public Health
/ Original Paper
/ Paclitaxel - administration & dosage
/ Placebo Effect
/ Stents
/ Stents - adverse effects
/ Treatment Outcome
/ Tubulin Modulators - administration & dosage
2008
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Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
by
Hehrlein, Christoph
, Scheller, Bruno
, Bocksch, Wolfgang
, Haghi, Dariush
, Rutsch, Wolfgang
, Böhm, Michael
, Dietz, Ulrich
, Speck, Ulrich
in
Aged
/ Cardiology
/ Catheterization - methods
/ Clinical trials
/ Coronary Restenosis - drug therapy
/ Coronary Restenosis - etiology
/ Double-Blind Method
/ Drug-Eluting Stents - adverse effects
/ Female
/ Follow-Up Studies
/ Germany
/ Graft Occlusion, Vascular - drug therapy
/ Graft Occlusion, Vascular - etiology
/ Humans
/ Male
/ Medical imaging
/ Medicine
/ Medicine & Public Health
/ Original Paper
/ Paclitaxel - administration & dosage
/ Placebo Effect
/ Stents
/ Stents - adverse effects
/ Treatment Outcome
/ Tubulin Modulators - administration & dosage
2008
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Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
Journal Article
Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
2008
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Overview
Background
We are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years.
Methods
Hundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 µg/mm
2
balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30 mm length with a vessel diameter of 2.5–3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE).
Results
Quantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 ± 0.79 mm in the uncoated balloon group vs. 0.11 ± 0.45 mm (
P
< 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (
P
< 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (
P
= 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group.
Conclusion
Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).
Publisher
D. Steinkopff-Verlag,Springer Nature B.V
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