title: Influence of a paclitaxel coated balloon in combination with a bare metal stent on restenosis and endothelial function: comparison with a drug eluting stent and a bare metal stent.
abstract: OBJECTIVE
  Different approaches of local intravascular drug delivery may influence endothelial and microvascular function. The aim of this trial was to study the influence of a paclitaxel coated balloon in combination with a bare metal stent (DCB + BMS) versus a bare metal stent (BMS) or a sirolimus-eluting stent (DES) on coronary restenosis and endothelial function.
  
  
  RESULTS
  This prospective trial included 77 patients with coronary de novo lesions. The patients were assigned to either one of the treatment groups. After 9 months, patients underwent angiographic follow-up including invasive measurement of coronary endothelial function. After 9 months, late lumen loss in-stent was highest in the BMS group (0.85 ± 0.73 mm), lower in DCB + BMS (0.36 ± 0.46 mm); and lowest in the DES group (0.25 ± 0.34 mm; P = 0.001 [ANOVA]). When compared to the BMS group, in-segment late lumen loss was significantly reduced in the DCB + BMS group (0.27 ± 0.43 mm vs. 0.60 ± 0.55 mm, P = 0.029) and the DES group (0.28 ± 0.40 mm, P = 0.045). Coronary flow reserve was significantly higher with the DCB + BMS treatment (3.16 ± 0.97 vs. 2.42 ± 0.99 [BMS], P = 0.036) whereas the increase in the DES group did not reach the significance level (3.06 ± 1.39, P = 0.144 vs. BMS). Parameters of endothelial function like intracoronary flow velocity and vessel diameter distal to the stented area showed similar patterns of response to adenosine, acetylcholine, and nitro in all groups.
  
  
  CONCLUSIONS
  DES and the combination of DCB + BMS showed a significant reduction of late lumen loss as compared to a BMS alone. Furthermore, both types of local drug delivery were not associated with a deterioration of microvascular function at 9 months [ClinicalTrials.gov Identifier: NCT00473499].
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dietz
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003326:Coronary Circulation / Q000187:drug effects; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D004730:Endothelium, Vascular / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D008670:Metals; D008833:Microcirculation / Q000187:drug effects; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D014665:Vasodilator Agents
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D014665:Vasodilator Agents; D017239:Paclitaxel; D020123:Sirolimus
keywords: drug coated balloon; drug eluting stent; endothelial function