Wound Healing and Quality-of-Life Outcomes Reported From the ACHILLES Trial

February 3, 2016—One-year wound healing outcomes and health-related quality-of-life (QoL) changes from the ACHILLES trial were published by Konstantinos Katsanos, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:259–267). 

ACHILLES is a prospective, randomized, controlled trial of infrapopliteal percutaneous transluminal balloon angioplasty (PTA) versus sirolimus-eluting stent (SES) placement in patients with ischemic peripheral arterial disease.

The investigators sought to report the wound healing outcomes, health-related QoL changes, and quality-adjusted life-years (QALYs) gains in the two treatment arms of the ACHILLES multicenter, randomized trial. The ACHILLES randomized trial has previously shown that SES may achieve lower vessel restenosis rates and higher event-free survival rates compared with PTA for infrapopliteal lesions, noted the investigators in the background to the study.

As summarized in JACC: Cardiovascular Interventions, a total of 200 patients were randomly assigned to either SES or PTA for the treatment of infrapopliteal arterial occlusive lesions. Progression of wound healing was serially assessed by digital photography. Health-related QoL 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.

At baseline, the investigators documented 109 open wounds (SES, n = 54; PTA, n = 55). 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 = .048). 

At 1 year, rates of complete wound closure were higher for SES patients (72.9% vs 55.6% closed wounds in PTA; P = .088). The recorded weighted EQ-5D score improved significantly up to 1 year for SES (P < .0001), but not for 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 = .08) in the whole study and 0.17 (95% CI, −0.03 to 0.35; P = .09) in the wound subgroups comparison.

The investigators concluded that infrapopliteal SES accelerates wound healing and may improve QoL compared with PTA.