Patients with infrapopliteal lesions treated with sirolimus-eluting stents experienced faster wound healing and greater improvements to quality of life compared with those who underwent percutaneous transluminal balloon angioplasty, according to new data from the ACHILLES study.
The analysis included data collected from patients enrolled in the multicenter ACHILLES trial. In this study, patients with ischemic peripheral artery disease were randomly assigned to undergo treatment with sirolimus-eluting stents (SES; n = 99; Cypher Select, Cordis/Johnson & Johnson) or percutaneous transluminal balloon angioplasty (PTA; n = 101).
For the current analysis, researchers evaluated data from 41 patients with 54 open wounds at baseline in the SES group, and 37 patients with 55 wounds in the PTA group. They assessed wound status in the index limb at baseline and then at 6 weeks, 6 months and 12 months after treatment. The healing process was documented in each patient, and health-related quality of life was determined via patient responses to the self-administered EQ-5D questionnaire.
Patients in the SES group with wounds at baseline exhibited a greater reduction in would volume at 6 months compared with the PTA group (95% reduction vs. 60%; P = .048), with similar results between the groups at 1 year. The researchers observed numerically higher rates of wound closure in the SES group compared with the PTA group at 6 weeks (25.9% vs. 20%; P = .501), 6 months (54.2% vs. 46.9%; P = .544) and 1 year (72.3% vs. 56.5%; P = .132) in the intention-to-treat analysis. Results from the per-protocol analysis more strongly favored the SES group at 1 year, but the difference did not achieve statistical significance (72.9% vs. 55.6%; P = .088).
Across the entire population, both treatment groups exhibited improvements to quality of life during follow-up. The difference in quality of life at up to 1 year achieved statistical significance in the SES group (P < .0001), but not the PTA group. Analysis of patients with wounds at baseline yielded similar results.
Quality-adjusted life-years increased significantly at all evaluated time points among patients in the SES group, and at 6 weeks and 6 months among patients in the PTA group. At 1 year, those in the SES group had gained 0.13 quality-adjusted life-years vs. 0.03 in the PTA group, with a relative gain of 0.1 years favoring SES (P = .08). Among patients with open wounds at baseline, those in the SES group gained 0.22 quality-adjusted life-years at 1 year vs. 0.06 in the PTA group, with a relative gain of 0.17 years favoring SES (P = .09).
“We have demonstrated that infrapopliteal [SES] accelerate wound healing and may improve quality of life metrics compared to plain balloon angioplasty,” Konstantinos Katsanos, MSc, MD, PhD, EBIR, from Guy’s and St. Thomas’ Hospitals, London, and Patras University Hospital, Greece, and colleagues wrote.
According to Beau M. Hawkins, MD, FACC, of the cardiovascular diseases section at University of Oklahoma Health Sciences Center, Oklahoma City, the study “undoubtedly represents some progress for [peripheral vascular intervention] research,” and the results “represent a unique inclusion of patient-centric outcomes with traditional PAD trial endpoints such as restenosis, patency and target vessel revascularization,” he wrote in a related editorial. However, he noted that significant changes to quality of life such as those observed in the present analysis “may not always correlate with patient benefit,” and that information on other factors potentially related to wound closure, such as the use of an angiosome-guided revascularization strategy, medical therapy and wound-care techniques, were not accounted for.
“While the ACHILLES trial has demonstrated benefits in terms of restenosis and patency with SES use in infrapopliteal arteries, it remains unclear if this translates into meaningful clinical benefit for patients,” he wrote. “[Peripheral vascular intervention] research is moving in the right direction by beginning to focus on the right questions, but there is obviously much more to be learned.” – by Adam Taliercio
Disclosure: The researchers and Hawkins report no relevant financial disclosures.