Infrapopliteal sirolimus-eluting stenting (SES) is more effective for wound healing and could help improve quality of life for patients when compared with plain balloon angioplasty (PTA), according to 1-year results from the ACHILLES trial.
Initially, the ACHILLES trial compared SES and PTA methods on infrapopliteal lesions and found that SES may result in lower vessel restenosis and higher event-free survival rates when compared with PTA.
The trial included 200 patients who were randomly assigned to receive SES or PTA treatment of infrapopliteal arterial occlusive lesions. Researchers took digital photos to assess wound healing and health-related quality of life (HRQOL) scores were calculated based on patient responses to a self-administered questionnaire. Researchers also calculated quality-adjusted life years (QUALYs) gained with a standard multiplicative model.
“Typically, quality of life is depressed in diabetes and further impaired by the presence of diabetic foot ulcers. On the other hand, successful wound healing is associated with improvements in HRQOL,” the authors wrote in their study, published in JACC: Cardiovascular Interventions.
Researchers noted 54 wounds in the SES group and 55 wounds from the PTA group at the start of the study. The wound volume reduction was 95% in the SES group (95% confidence interval [CI]: 80% to 99%) at 6 months, compared to 60% in the PTA group (95% CI: 13% to 90%). After 1 year, 72.9% of patients in the SES group had complete wound closure, compared to 55.6% in the PTA group, though technically not statistically significant (P=.088).
The researchers also found more QUALYs gained in the SES group than with PTA. Head-to-head comparisons between the 2 groups revealed relative QUALY gain of 0.10 (95% CI: -0.01 to 0.21; P=.08) for the overall study and 0.17 (95% CI: -0.3 to 0.35; P=.09) for the head-to-head subgroup comparisons. At 1 year after randomization, the SES group gained QALYs of 0.13 (95% CI: 0.05-0.21) compared with 0.03 (95% CI; -0.06 to 0.11) in the PTA control group.
The authors noted that, “future randomized trials should include patient reported outcome measures, especially in the case of critical limb ischemia patients. Quality of life metrics and cost-utility analyses will be important in demonstrating a more pragmatic clinically relevant benefit in this very morbid patient population.”
Katsanos K, Spiliopoulos S, Diamantopoulos A, et al. 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. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2015.10.038.