title: The Valentines Trial: results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation DIOR paclitaxel drug-eluting balloon for in-stent restenosis treatment.
abstract: OBJECTIVE
  To assess the safety and efficacy of the second generation DIOR paclitaxel drug-eluting balloon (DEB) for in-stent restenosis in a real world setting in a prospective single-arm registry with 8-month clinical outcomes.
  
  
  RESULTS
  In this "real world", international prospective registry, patients with in-stent restenosis (bare-metal stent and drug-eluting stent) were enrolled- in a unique study design- with a one week enrolment period, spread over 104 centres worldwide. Patients underwent predilatation with a regular balloon, with subsequent DEB inflation in the target lesion. Additional stenting of the target lesion was left to the operators discretion in case of suboptimal angiographic success (TIMI flow <3 and/or residual stenosis >30%). The primary endpoint was 6-9-month major adverse cardiac events (MACE: all cause death, myocardial infarction, and target vessel revascularisation). A total of 250 evaluable patients were enrolled in a large web-based clinical research form and treated with the second generation DIOR DEB. Of these, 244 had 6-9 month clinical follow-up, with a mean follow-up time of 7.5 months. The cumulative MACE rate at follow-up was 11.1%, with 3 (1.2%) cardiac deaths, 1 (0.4%) non-cardiac death, 5 (2.0%) myocardial infarctions of which 2 (0.8%) periprocedural, 21 (8.6%) target vessel revascularisations, of which 18 (7.4%) target lesion revascularisations.
  
  
  CONCLUSIONS
  In-stent restenosis treatment with the second generation DIOR DEB is safe and feasible, with high angiographic success and low target lesion revascularisation and overall MACE rates. Moreover this new and unique method of high speed and short duration multicentre study enrolment was very successful.
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. P.Stella@umcutrecht.nl
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
authors.forename: Anouar
authors.initials: A
authors.lastname: Belkacemi
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Stefanie
authors.initials: S
authors.lastname: Stahnke
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Rembert Pogge
authors.initials: RP
authors.lastname: von Strandmann
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sangiorgi
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D018579:Patient Selection; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel