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Sirolimus-eluting stenting (SES) of infrapopliteal lesions was associated with quicker wound healing and improved quality of life when compared with plain balloon angioplasty, a substudy of the ACHILLES trial found.

Patients reported a better quality of life 1 year after receiving SES below the knee for critical limb ischemia (P<0.0001), while balloon angioplasty recipients trended toward a similar improvement that failed to reach statistical significance.

Wounds healed by 95% in volume for patients who received SES as opposed to 60% for the plain balloon angioplasty group (P=0.048) by 6 months. The latter caught up, however, within the year.

The initially-accelerated wound repair in SES patients might nevertheless be associated with "reduced risk of infection" and "reduced healthcare costs," , of Guy's and St. Thomas' Hospitals in London, and colleagues reported in .

They cautioned, though, that whether SES of infrapopliteal arteries is truly cost-effective remains to be seen.

Main results from the ACHILLES trial had previously shown over balloon angioplasty. Compared with bare-metal stents too, SES have improved patency and restenosis in diseased infrapopliteal arteries.

, of University of Oklahoma Health Sciences Center in Oklahoma City, praised the investigators for reporting their "patient-centric outcomes with traditional peripheral artery disease trial endpoints such as restenosis, patency, and target vessel revascularization" in a time when research in peripheral vascular intervention still "has not yet matured in terms of magnitude, quality, or clarity."

But, like the researchers, he was cautious in interpreting the study's results in an accompanying editorial.

"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," wrote Hawkins, who was not involved in the study. "It is also difficult to ascertain if the statistically significant changes in quality of life reported represent any clinical impact, as significant P values in quality of life studies may not always correlate with patient benefit."

ACHILLES was a randomized, multicenter study that included 200 patients randomized to treatment for infrapopliteal lesions with either SES or plain balloon angioplasty.

In the subset of 109 patients with open wounds included in the analysis, rates of complete wound healing improved similarly over time in both groups without significant differences.

At 1 year, restenosis rates favored the SES group (28.0% versus 65.2% for plain balloon angioplasty, P=0.019). The frequencies of major and minor amputations were similar between groups (P=1.000 and P=0.186, respectively).

These results have apparent limitations, according to Hawkins.

"Despite better patency and restenosis rates, the use of SES for infrapopliteal disease did not improve wound closure rates or wound healing at 1 year. If SES accelerate wound healing as the authors suggest, it remains unclear why similar rates of amputation and target vessel revascularization were noted," he wrote.

The authors suggested that their investigation was constrained by the design of the ACHILLES trial itself, which studied restenosis as the primary endpoint and was therefore "not adequately powered for wound healing and quality of life metrics."

Hawkins offered another limitation to the study, writing that "while the improvement in quality of life was significant only in the SES group, the baseline score in the [plain balloon angioplasty] arm was objectively much higher, and this may have minimized the ability to identify a similar, statistically significant improvement."

He also faulted the investigation for not accounting for angiosome-guided revascularization, which emerging data suggests may be tied to "better" limb salvage and wound healing rates. Likewise, "details on medication and wound care algorithms are not available" in the study.

"The achievement of wound closure in patients with critical limb ischemia relies on much more than establishing in-line flow to the foot," Hawkins emphasized.

From the American Heart Association: