Evaluation of Chitosan-Based Axiostat as Hemostatic Dressing for Endovascular Procedures in Patients with Leriche Syndrome on Anticoagulant Therapy

Publication Details:

Perri, P.; Curcio, F.; De Luca, M.; Piro, P.; Trombino, S.; Cassano, R. (2025) Evaluation of Chitosan-Based Axiostat as Hemostatic Dressing for Endovascular Procedures in Patients with Leriche Syndrome on Anticoagulant Therapy. Pharmaceuticals, 18(4), 584.

Access-Site & Patient Cohort

This retrospective, single-center study (Sep 2022–Feb 2024) assessed 60 consecutive patients (mean age 67.4 ± 2.8 yrs; 40% M/60% F) undergoing axillary arterial access for endovascular treatment of Leriche syndrome, all managed with manual compression aided by Axiostat, a 100% chitosan hemostatic dressing.

VariableAll Patients (N = 60)
Age (years)67 ± 2.8 (mean 67.4)
Sex40% M / 60% F
Body Mass Index*27 ± 0.7 (mean 27.1)
aPTT** (seconds)33 ± 0.8 (mean 33.2)
Platelet Count (×10⁶/mL)330 ± 8.7 (mean 330.6)
Diabetes Mellitus40 pts (66%)
Hypertension33 pts (56%)
Coronary Artery Disease8 pts (13%)
Smoking History45 pts (75%)
*Body Mass Index; **activated partial thromboplastin time

Procedural & Pharmacologic Details

All patients underwent axillary access with predominantly 6 Fr or 8 Fr introducer sheaths (mean punctures 1.2 ± 0.2), without suspending pre-existing antithrombotic regimens.Baseline INR averaged 1.3 ± 0.2, confirming safe continuation of anticoagulation during access site management.

Efficacy, Safety & Follow-Up

Primary technical success (hemostasis within 10 min without re-compression) was 100% for antiaggregant‐only patients and 95–98% in anticoagulated cohorts. Secondary technical, clinical and surgical success rates were ≥ 96% across all groups. All patients mobilized within 24 h, and 99.9% achieved complete axillary-site healing by Day 30.
OutcomeMono-Antiagg.Dual-Antiagg.AnticoagulantCombo (Antiagg.+Anticoag.)
Primary Success (%)1001009895.5
Secondary Technical (%)100100100100
Clinical Success (%)1001009896
Ambulation at 24 h (%)100100100100
Healing at 30 days (%)10010098.896

Complication rate was low (1.8% hematoma; 2.9% pseudoaneurysm; 1.2% required surgical repair), with no cases of dissection or arteriovenous fistula formation.

Hemostasis Performance

Hemostatic success at 10 min was 99.5% overall; median time to achieve hemostasis was 5.75 min (range 5–7 min depending on therapy). Failure cases occurred primarily in dual antiplatelet or anticoagulant patients, likely due to higher blood flow delaying clot formation.

Group

Success (%)

Time to Hemostasis (min)

Failure (%)

Mono-antiaggregant therapy

100

5

0

Dual-antiaggregant therapy

100

6

0

Anticoagulant therapy

99.5

5

0

Antiaggregant + anticoagulant

98.2

7

1.8

Effect on Access-Site Management

Axiostat’s cationic chitosan matrix forms an immediate mucoadhesive barrier and promotes rapid fibrin plug formation under manual compression, even in coagulopathic patients. Its porous structure interlocks with tissue, enabling consistent hemostasis without interrupting antithrombotic therapy.

Key Insights:

  • Rapid Hemostasis: Median time < 6 min with > 99% success, minimizing bleeding complications in anticoagulated patients.
  • Therapy Compatibility: Safe application without halting antiplatelets/anticoagulants, preserving therapeutic INR levels.
  • Low Complication Profile: Rare hematomas/pseudoaneurysms and minimal need for surgical intervention.
  • Ease of Use: Simple manual compression protocol with atraumatic removal via saline irrigation.

Axiostat® is a registered medical device of Axio Biosolutions Pvt. Ltd.

Know more

Related Publications

Evaluation of a 100% Chitosan Dressing in the Treatment of Diabetic Foot Ulcers
Endovascular Procedures in Patients with Leriche Syndrome

Chronic Wound Debridement in an Acute Setting

Endovascular Procedures in Patients with Leriche Syndrome

Severe Pressure Ulcer Debridement in the Acute Sector

Endovascular Procedures in Patients with Leriche Syndrome

A Multi-disciplinary Team Approach to the Management

Endovascular Procedures in Patients with Leriche Syndrome