NDLI: 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.

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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.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Uhlemann, Madlen Möbius-Winkler, Sven Adam, Jennifer Erbs, Sandra Mangner, Norman Sandri, Marcus Boudriot, Enno Woinke, Michael Schuler, Gerhard C. Linke, Axel
Spatial Coverage	Germany
Description	Author Affiliation: Uhlemann M ( Heart Centre, Department of Internal Medicine/Cardiology, University of Leipzig, University of Leipzig.)
Abstract	BACKGROUND: Drug-eluting balloons (DEB) are an alternative treatment of in-stent restenosis (ISR), but data regarding outcomes of DEB in de novo lesions are lacking. METHODSâ ANDâ RESULTS: We investigated the effect of DEB on target lesion revascularization (TLR), procedural complications (coronary dissection/rupture, pericardial effusion, stent thrombosis, peri-interventional NSTEMI, stroke), major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction, TLR, stroke) in patients with ISR and de novo lesions in an all-comers setting. Between April 2009 and October 2013, 484 consecutive patients (mean age 68.4 years; 77.9% male) were enrolled in a prospective registry. TLR rate was 4.9% at 12 months and 8.7% at long-term follow-up of 2.3 years. Subgroup analysis confirmed a TLR rate of 8.9% after DEB treatment of ISR in bare-metal stents (21/235 lesions), 13.0% in drug-eluting stents (21/161 lesions) and 0% for de novo lesions (0/76 lesions). At long-term follow-up, all-cause mortality/cardiac mortality was 8.7% (42/484)/3.3% (16/484) and MACCE rate was 18.4% (89/484 patients), with no differences between DEB for ISR compared with de novo lesions. CONCLUSIONS: DEB for ISR resulted in a low rate of TLR. Our data support DEB in ISR as an effective treatment option. DEB in small coronary vessels in our limited cohort appeared to be safe. Larger, randomized trials in small coronary vessels should be undertaken to verify the long-term results of the current trial.
File Format	HTM / HTML
ISSN	13469843
e-ISSN	13474820
Journal	Circulation Journal
Issue Number	2
Volume Number	80
Language	English
Publisher	The Japanese Circulation Society
Publisher Date	2016-01-01
Publisher Place	Japan
Access Restriction	Open
Subject Keyword	Discipline Cardiology Angioplasty, Balloon, Coronary Graft Occlusion, Vascular Mortality Surgery Paclitaxel Administration & Dosage Registries Coronary Artery Disease Germany Myocardial Infarction Prospective Studies
Content Type	Text
Resource Type	Article
Subject	Cardiology and Cardiovascular Medicine

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