title: Treatment of Small Vessel Disease With the Paclitaxel Drug-Eluting Balloon: 6-Month Angiographic and 1-Year Clinical Outcomes of the Spanish Multicenter Registry.
abstract: BACKGROUND
  Small vessel disease (SMD) remains a major challenge because of the increased risk of restenosis. We sought to assess the efficacy and safety of a paclitaxel-eluting balloon (PEB) in patients with SMD.
  
  
  RESULTS
  One-hundred and four patients with native coronary lesions in small vessels treated by using a PEB were included in this prospective multicenter registry. In each case, after regular balloon dilatation, a larger PEB was inflated for a minimum of 45-60 seconds. Patients were 65 ± 10 years old, 43% diabetic, and 58% presented acutely. Angiographic success was 93% (7% bailout BMS implantation due to coronary dissection). The rate of major adverse cardiac events (MACE) at 12 months was 4.8% (1.9% cardiac death, 1.0% MI, and 2.9% TLR). One definite stent thrombosis was reported at 6 months in a patient with bailout BMS implantation. At 7 months, late loss was 0.31 ± 0.2 mm. Bail-out BMS after DEB use, was an independent predictor of MACE, HR 18.74, 95%CI (2.58-135.84) and TLR, HR 30.99, 95%CI (2.79-344.07).
  
  
  CONCLUSIONS
  The use of this PEB for the treatment of SMD provides excellent 1-year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR.
authors.affiliation: Interventional Cardiology Unit, Hospital Sant Pau, Barcelone, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Vaquerizo
authors.affiliation: Interventional Cardiology Unit, Hospital del Mar, Barcelone, Spain.
authors.forename: Faustino
authors.initials: F
authors.lastname: Miranda-Guardiola
authors.affiliation: Interventional Cardiology Unit, Hospital Trias i Pujol, Barcelone, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Fernández
authors.affiliation: Interventional Cardiology Unit, Hospital Galdakao, Galdakao, Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Rumoroso
authors.affiliation: Interventional Cardiology Unit, Hospital de Bellvitge, Barcelone, Spain.
authors.forename: Josep Antoni
authors.initials: JA
authors.lastname: Gómez-Hospital
authors.affiliation: Interventional Cardiology Unit, Hospital Universitario de Canarias, Tenerife, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Bossa
authors.affiliation: Interventional Cardiology Unit, Hospital Meixoeiro, Vigo, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: Interventional Cardiology Unit, Hospital Vall Hebron, Barcelone, Spain.
authors.forename: Imanol
authors.initials: I
authors.lastname: Oategui
authors.affiliation: Interventional Cardiology Unit, Hospital Sant Pau, Barcelone, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel