title: The safety and efficacy of a paclitaxel-eluting wrap for preventing peripheral bypass graft stenosis: a 2-year controlled randomized prospective clinical study.
abstract: OBJECTIVE
  To compare the safety and efficacy of a bioresorbable paclitaxel-eluting wrap implanted with a synthetic vascular graft (treatment) versus the graft implanted alone (control).
  
  
  METHODS
  Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft.
  
  
  METHODS
  Hundred and nine subjects were randomized 2:1 to treatment or control. All subjects were implanted with a 6mm expanded PTFE vascular graft; in addition, treated subjects had a 2.5 cm x 4 cm paclitaxel-eluting wrap (1.6 microg/mm(2)) placed around the distal graft anastomosis.
  
  
  RESULTS
  The overall incidence of adverse events was similar in both groups. Treated subjects required fewer limb amputations than controls (15.5% vs 18.4%) and time to amputation for those that required amputation was twice as long (153 days vs 76 days). Among diabetics, this effect was pronounced with 13.8% of treated subjects requiring limb amputations compared with 23.5% of controls. Over the course of study, the diameter at the distal graft anastomosis was greater in treated subjects than in controls (difference of 2.1mm at 2 yr, p=0.03).
  
  
  CONCLUSIONS
  The paclitaxel-eluting wrap maintained graft patency at the distal anastomosis and was safe to use in patients who had received a peripheral bypass PTFE graft.
authors.affiliation: University Teaching County Hospital, Miskolc, Hungary.
authors.forename: L
authors.initials: L
authors.lastname: Mátyás
authors.forename: M
authors.initials: M
authors.lastname: Berry
authors.forename: G
authors.initials: G
authors.lastname: Menyhei
authors.forename: L
authors.initials: L
authors.lastname: Tamás
authors.forename: G
authors.initials: G
authors.lastname: Acsády
authors.forename: P
authors.initials: P
authors.lastname: Cuypers
authors.forename: F
authors.initials: F
authors.lastname: Halmos
authors.forename: A C
authors.initials: AC
authors.lastname: de Vries
authors.forename: V
authors.initials: V
authors.lastname: Forgacs
authors.forename: G
authors.initials: G
authors.lastname: Ingenito
authors.forename: R
authors.initials: R
authors.lastname: Avelar
mesh_terms: D000671:Amputation, Surgical; D000714:Anastomosis, Surgical; D001458:Bandages; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009427:Netherlands Antilles; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016491:Peripheral Vascular Diseases / Q000503:physiopathology / Q000601:surgery*; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D011138:Polytetrafluoroethylene; D017239:Paclitaxel