title: Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study.
abstract: BACKGROUND
  Chronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion.
  
  
  METHODS
  We included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed.
  
  
  RESULTS
  The recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction.
  
  
  CONCLUSIONS
  Drug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.
authors.affiliation: Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Philine J
authors.initials: PJ
authors.lastname: Köln
authors.affiliation: Universitätsklinikum des Saarlandes, Homburg, Germany.
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.affiliation: Sabah Heart Centre, Kota Kinabalu, Malaysia.
authors.forename: Houng Bang
authors.initials: HB
authors.lastname: Liew
authors.affiliation: North Karelia Central Hospital, Joensuu, Finland.
authors.forename: Tuomas T
authors.initials: TT
authors.lastname: Rissanen
authors.affiliation: University of Malaya Medical Center, Kuala Lumpur, Malaysia.
authors.forename: Wan Azman Wan
authors.initials: WA
authors.lastname: Ahmad
authors.affiliation: Evangelisches Krankenhaus Paul Gerhardt Stift, Lutherstadt Wittenberg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Weser
authors.affiliation: Klinikum Ernst von Bergmann, Potsdam, Germany.
authors.forename: Telse
authors.initials: T
authors.lastname: Hauschild
authors.affiliation: National Heart Institute, Kuala Lumpur, Malaysia.
authors.forename: Amin Ariff
authors.initials: AA
authors.lastname: Nuruddin
authors.affiliation: Universitätsklinikum des Saarlandes, Homburg, Germany.
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
authors.affiliation: Tan Tock Seng Hospital, Tan Tock Seng, Singapore, Singapore.
authors.forename: Hee Hwa
authors.initials: HH
authors.lastname: Ho
authors.affiliation: Cardio Centrum Berlin, Academic Teaching Institution, Charité - Universitätsmedizin Berlin, Berlin, Germany. Electronic address: post@fxkleber.de.
authors.forename: Franz X
authors.initials: FX
authors.lastname: Kleber
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D002908:Chronic Disease; D017023:Coronary Angiography / Q000379:methods; D054059:Coronary Occlusion / Q000000981:diagnostic imaging* / Q000601:surgery*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Balloon angioplasty; Chronic coronary total occlusion (CTO); Drug-coated balloon (DCB); Drug-eluting stent (DES); Paclitaxel; Percutaneous coronary intervention (PCI)