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.

OBJECTIVES: 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).