title: Wound Healing Outcomes and Health-Related Quality-of-Life Changes in the ACHILLES Trial: 1-Year Results From a Prospective Randomized Controlled Trial of Infrapopliteal Balloon Angioplasty Versus Sirolimus-Eluting Stenting in Patients With Ischemic Peripheral Arterial Disease.
abstract: OBJECTIVE
  The authors sought to report the wound healing outcomes, health-related quality-of-life changes and quality-adjusted life-years (QALYs) gain in the 2 treatment arms of the ACHILLES (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease) multicenter randomized trial.
  
  
  BACKGROUND
  The ACHILLES randomized trial has previously shown that sirolimus-eluting stents (SES) may achieve lower vessel restenosis and higher event-free survival rates compared with plain balloon angioplasty (PTA) for infrapopliteal lesions.
  
  
  METHODS
  A total of 200 patients were randomly assigned between SES and PTA for the treatment of infrapopliteal arterial occlusive lesions. Progression of wound healing was serially assessed by digital photography. Health-related quality-of-life scores were assessed with the self-administered EQ-5D questionnaire up to 1 year from randomization. QALYs gained were calculated with a standard multiplicative model using distribution-free Bayesian modeling.
  
  
  RESULTS
  In total, 109 open wounds (n = 54 in SES; n = 55 in PTA) were documented at baseline. At 6 months, wound volume reduction (%) was significantly higher in the SES group (95% healing [95% confidence interval (CI): 80% to 99%] compared with 60% healing [95% CI: 13% to 90%] in the PTA group; p = 0.048). At 1 year, rates of complete wound closure were higher in the case of SES (72.9% vs. 55.6% closed wounds in PTA; p = 0.088). The recorded weighted EQ-5D score improved significantly up to 1 year in case of SES (p < 0.0001), but not in case of PTA. There was a trend of more QALYs gained with SES compared with PTA up to 1 year after randomization. Relative QALY gain was 0.10 (95% CI: -0.01 to 0.21; p = 0.08) in the whole study and 0.17 (95% CI: -0.03 to 0.35; p = 0.09) in the wound subgroups comparison.
  
  
  CONCLUSIONS
  Infrapopliteal SES accelerates wound healing and may improve quality of life compared with PTA. (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease [ACHILLES]; NCT00640770).
authors.affiliation: Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, United Kingdom; Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece. Electronic address: konstantinos.katsanos@gstt.nhs.uk.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.affiliation: Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
authors.forename: Stavros
authors.initials: S
authors.lastname: Spiliopoulos
authors.affiliation: Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, United Kingdom.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Diamantopoulos
authors.affiliation: Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
authors.affiliation: Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Karnabatidis
authors.affiliation: Department of Angiology, Park Hospital and Universitätsklinikum, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007511:Ischemia / Q000628:therapy; D007866:Leg / Q000098:blood supply; D008297:Male; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011150:Popliteal Artery; D011446:Prospective Studies; D011788:Quality of Life; D020123:Sirolimus / Q000008:administration & dosage; D014945:Wound Healing
chemical_list: D020123:Sirolimus
keywords: balloon angioplasty; critical limb ischemia; infrapopliteal; quality-of-life; sirolimus-eluting stent(s); wound healing