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Pedal artery angioplasty yields higher rate of wound healing in patients with CLI
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Pedal artery angioplasty appears to benefit patients with critical limb ischemia who present with de novo femoropopliteal pedal artery disease, according to findings from the RENDEZVOUS registry.
The results demonstrated a significantly higher rate of wound healing and shorter time to healing in those treated with pedal artery angioplasty (PAA) vs. those not treated with it.
In the multicenter registry, researchers enrolled 317 consecutive patients with CLI who underwent endovascular therapy at one of five CV centers in Japan after presenting with infrapopliteal arterial disease between 2012 and June 2014.
After applying exclusion criteria, the researchers retrospectively evaluated 257 patients (mean age, 73.2 years; 68.1% men) with 257 limbs. The patients were categorized into two groups: those in whom adjunctive PAA was conducted (n = 140) and those who did not undergo adjunctive PAA (n = 117). The indication of adjunctive PAA was decided by a minimum of two endovascular specialists with adequate knowledge and experience in endovascular therapy procedures for CLI.
All patients were seen at 1 week; 1, 2 and 3 months; and every 3 months up to 12 months after the procedure for follow-up, which consisted of duplex ultrasound, and ankle-brachial index and skin perfusion pressure measurements.
The primary efficacy outcomes were the rate of wound healing 1 year after treatment and time to wound healing. Secondary efficacy outcomes included overall survival rate, limb salvage rate, amputation-free survival rate and rate of freedom from reintervention. Secondary safety outcomes included the success rate of adjunctive PAA and the rate of procedure-related complications. The researchers also calculated a delayed wound healing score, which was calculated using the number of independent predictors of delayed wound healing, shown in a multivariate analysis.
The researchers found that the overall rate of limb salvage was 88.5%, and the rate of amputation-free survival was 73.5%. The rate of wound healing was 49.5%.
Healing benefits
Compared with the non-PAA group, the patients in the PAA group had a higher rate of wound healing (59.3% vs. 38.1%; P = .003) and had a shorter time to wound healing (211 days vs. 365 days; P = .008), the researchers wrote.
There were 17 (6.6%) cases of procedure-related complications; of these, three cases (1.2%) were limb-threatening complications. No significant differences were seen between the incidence of complications in PAA-treated patients and those in the non-PAA group. Puncture-site hematoma (2.7%) was the most commonly observed complication.
No significant differences were seen between the groups in overall survival rate (PAA, 85%; non-PAA, 80.2%), amputation-free survival rate (PAA, 76.4%; non-PAA, 70.1%), limb salvage rate (PAA, 88.7%; non-PAA, 88.2%) and rate of freedom from reintervention (PAA, 57.8%; non-PAA, 64.4%).
Univariate and multivariate analyses revealed nonambulatory status, daily hemodialysis and wound depth University of Texas grade ≥ 2 as independent predictors of delayed wound healing.
The treatment effect of PAA on rate of wound healing was significant in moderate-risk patients (PAA, 59.3%; non-PAA, 33.9%; P = .001), but not in high-risk patients, according to the researchers.
Importance of healing
In a related editorial, Jihad A. Mustapha, MD, director of cardiovascular catheterization laboratories at Metro Health Hospital in Wyoming, Michigan, and colleagues wrote that the 88.5% rate of wound salvage and the 49.5% rate of wound healing means that “the limbs are being saved, but the wounds are not healing.
“This ultimately leads to further ancillary tests, follow-up and intervention, keeping patients from returning to their regular lives and jobs, while increasing costs,” they wrote. – by Jennifer Byrne
Disclosure: The researchers and editorial authors report no relevant financial disclosures.
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