Original Title: Wound Healing Outcomes and Health-Related Quality-of-Life Changes in the ACHILLES Trial1-Year Results From a Prospective Randomized Controlled Trial of Infrapopliteal Balloon Angioplasty Versus Sirolimus-Eluting Stenting in Patients With Ischemic Peripheral Arterial Disease. Reference: Konstantinos Katsanos et al. J Am Coll Cardiol Intv. 2016, online before print.
The ACHILLES study (Comparing Angioplasty and DES in the Treatment of Subjects with Ischemic Infrapopliteal Arterial Disease) was a randomized multicenter study comparing balloon angioplasty vs. sirolimus eluting stenting in infrapopliteal territory.
The study had already reported that sirolimus eluting stenting results in lower restenosis and higher event-free survival rates compared to balloon angioplasty.
This sub study assessed wound healing and quality of life in patients with intermittent claudication and critical ischemia due to infrapopliteal lesions.
A total of 200 patients were randomized to balloon angioplasty vs. sirolimus eluting stenting in infrapatellar occlusive lesions. Wound evolution was assessed by photography and quality of life by standardized questions after one year of randomization.
109 open wounds were documented at baseline (54 received sirolimus eluting stents and 55 balloon angioplasty).
At 6 months, wound volume reduction was significantly higher in patients receiving stents (95% reduction with stents vs. 60% reduction with balloons; p=0.048). At one year, complete wound closure rates were also higher in those receiving sirolimus eluting stents (72.9% vs 55.6%; p=0.088).
Quality of life scored (EQ-5D) significantly higher in those receiving stents (p<0.0001) than those receiving balloons.
Conclusion
Sirolimus eluting stenting in infrapopliteal territory accelerates wound healing and could improve quality of life, compared to balloon angioplasty.