title: Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial.
abstract: BACKGROUND
  Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty.
  
  
  RESULTS
  Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0 ± 5.3 and 6.6 ± 5.5 cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01 mm [95% CI, -0.29; 0.26] versus 0.65 mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02).
  
  
  CONCLUSIONS
  Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up.
  
  
  BACKGROUND
  URL http://www.clinicaltrials.gov. Unique identifier: NCT01083030.
authors.affiliation: Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany. m.werk@mlk-berlin.de
authors.forename: Michael
authors.initials: M
authors.lastname: Werk
authors.forename: Thomas
authors.initials: T
authors.lastname: Albrecht
authors.forename: Dirk-Roelfs
authors.initials: DR
authors.lastname: Meyer
authors.forename: Mohammed Nabil
authors.initials: MN
authors.lastname: Ahmed
authors.forename: Andrea
authors.initials: A
authors.lastname: Behne
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dietz
authors.forename: Götz
authors.initials: G
authors.lastname: Eschenbach
authors.forename: Holger
authors.initials: H
authors.lastname: Hartmann
authors.forename: Christian
authors.initials: C
authors.lastname: Lange
authors.forename: Beatrix
authors.initials: B
authors.lastname: Schnorr
authors.forename: Heiner
authors.initials: H
authors.lastname: Stiepani
authors.forename: Giuseppe Biondi
authors.initials: GB
authors.lastname: Zoccai
authors.forename: Enrique Lopez
authors.initials: EL
authors.lastname: Hänninen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D004337:Drug Carriers; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D016013:Likelihood Functions; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D016016:Proportional Hazards Models; D011859:Radiography; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D004337:Drug Carriers; D017239:Paclitaxel