title: Treatment of small coronary arteries with a paclitaxel-coated balloon catheter.
abstract: BACKGROUND
  Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication.
  
  
  METHODS
  One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)). The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length with a vessel diameter of 2.25-2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss.
  
  
  RESULTS
  Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 +/- 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 +/- 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 +/- 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Unverdorben
authors.forename: Franz X
authors.initials: FX
authors.lastname: Kleber
authors.forename: Hubertus
authors.initials: H
authors.lastname: Heuer
authors.forename: Hans-Reiner
authors.initials: HR
authors.lastname: Figulla
authors.forename: Christian
authors.initials: C
authors.lastname: Vallbracht
authors.forename: Matthias
authors.initials: M
authors.lastname: Leschke
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Stefan
authors.initials: S
authors.lastname: Hardt
authors.forename: Michael
authors.initials: M
authors.lastname: Buerke
authors.forename: Hanns
authors.initials: H
authors.lastname: Ackermann
authors.forename: Michael
authors.initials: M
authors.lastname: Boxberger
authors.forename: Ralf
authors.initials: R
authors.lastname: Degenhardt
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000368:Aged; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D012008:Recurrence; D015607:Stents; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel