title: Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.
abstract: BACKGROUND
  There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions.
  
  
  METHODS
  A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients.
  
  
  RESULTS
  The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P(non-inf)  < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38).
  
  
  CONCLUSIONS
  Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Aleksander
authors.initials: A
authors.lastname: Żurakowski
authors.affiliation: American Heart of Poland, Katowice, Poland.|Silesian Center for Heart Diseases, Zabrze, Poland.
authors.forename: Piotr P
authors.initials: PP
authors.lastname: Buszman
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Krzysztof P
authors.initials: KP
authors.lastname: Milewski
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Janas
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Gorycki
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Kondys
authors.affiliation: Silesian Center for Heart Diseases, Zabrze, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Gąsior
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Michalak
authors.affiliation: B.Braun, Melsungen AG, Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Boxberger
authors.affiliation: Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Peppas
authors.affiliation: Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
authors.affiliation: American Heart of Poland, Katowice, Poland.
authors.forename: Paweł E
authors.initials: PE
authors.lastname: Buszman
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy; D023921:Coronary Stenosis / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D015607:Stents
chemical_list: D017239:Paclitaxel