title: Paclitaxel-coated balloons for failing peripheral bypass grafts: the BYPACS study.
abstract: OBJECTIVE
  Aim of the present study was to report the imaging and clinical outcomes of a prospective single-center study investigating paclitaxel-coated balloons (PCB) for the treatment of failing peripheral bypass grafts (BYPACS study).
  
  
  METHODS
  In total, 32 patients had their failing peripheral native or synthetic bypass graft treated with PCB angioplasty (Group PCB). Basic inclusion criteria were any significant proximal or distal anastomotic stenosis confirmed by Duplex ultrasound (DUS; PSVR>2.5) associated with significantly reduced in-graft velocities (<45 cm/s) putting the graft at risk of thrombosis. Results were compared with a similar historical control group of 24 patients who had their failing peripheral bypass treated with plain uncoated balloon angioplasty (Group PTA). Primary endpoint was binary lesion restenosis defined as >50% stenosis of the treated lesion on DUS. Secondary endpoints included freedom from target lesion revascularization (TLR) defined as a patent peripheral bypass graft regardless of restenosis but without any repeat intervention (driven by reduced in-graft velocities <45 cm/s), major amputations and graft thrombosis. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. Results are reported as Cox-adjusted hazard ratios (HR and 95% CI).
  
  
  RESULTS
  Baseline variables were equally distributed between the two groups. Median follow-up was 7 months in group PCB and 8 months in group PTA. Rates of binary restenosis were similar between the 2 groups (HR=1.08, 95% CI=0.49-2.40; P=0.84). Freedom from TLR was also similar (HR=0.97, 95% CI=0.36-2.66; P=0.88). One amputation occurred in the PCB group and 2 in the PTA (P=0.58). Four events of bypass thrombosis occurred in each group (P=0.71).
  
  
  CONCLUSIONS
  PCB does not significantly inhibit restenosis or improve freedom from repeat angioplasty after treatment of failing peripheral arterial vein or synthetic bypass grafts.
authors.affiliation: Department of Interventional Radiology Guy's and St. Thomas' Hospitals, NHS Foundation Trust King's Health Partners, London, UK - konstantinos.katsanos@gstt.nhs.uk.
authors.forename: P
authors.initials: P
authors.lastname: Kitrou
authors.forename: A
authors.initials: A
authors.lastname: Parthipun
authors.forename: A
authors.initials: A
authors.lastname: Diamantopoulos
authors.forename: S
authors.initials: S
authors.lastname: Padayachee
authors.forename: N
authors.initials: N
authors.lastname: Karunanithy
authors.forename: I
authors.initials: I
authors.lastname: Ahmed
authors.forename: H
authors.initials: H
authors.lastname: Zayed
authors.forename: K
authors.initials: K
authors.lastname: Katsanos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D004337:Drug Carriers; D004867:Equipment Design; D005260:Female; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008131:London; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011475:Prosthesis Failure; D012039:Regional Blood Flow; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D017211:Treatment Failure; D018616:Ultrasonography, Doppler, Duplex; D062666:Vascular Access Devices; D014680:Veins / Q000503:physiopathology / Q000637:transplantation*
chemical_list: D002317:Cardiovascular Agents; D004337:Drug Carriers; D017239:Paclitaxel