title: 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.
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.
  
  
  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.
authors.affiliation: Heart Centre, Department of Internal Medicine/Cardiology, University of Leipzig, University of Leipzig.
authors.forename: Madlen
authors.initials: M
authors.lastname: Uhlemann
authors.forename: Sven
authors.initials: S
authors.lastname: Möbius-Winkler
authors.forename: Jennifer
authors.initials: J
authors.lastname: Adam
authors.forename: Sandra
authors.initials: S
authors.lastname: Erbs
authors.forename: Norman
authors.initials: N
authors.lastname: Mangner
authors.forename: Marcus
authors.initials: M
authors.lastname: Sandri
authors.forename: Enno
authors.initials: E
authors.lastname: Boudriot
authors.forename: Michael
authors.initials: M
authors.lastname: Woinke
authors.forename: Gerhard C
authors.initials: GC
authors.lastname: Schuler
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000401:mortality* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D012042:Registries
chemical_list: D017239:Paclitaxel