Author + information
- Noor A. Al-Asady,
- Ashwat S. Dhillon,
- David M. Shavelle,
- Vincent L. Rowe and
- Leonardo C. Clavijo
Randomized studies and registries have shown that drug-eluting stenting (DES) of infra-popliteal arteries (IPA) is an excellent revascularization strategy in patients with critical limb ischemia (CLI) Rutherford class IV and V. There is no available data for RC VI patients because they were excluded from DES trials due to poor outcomes. CLI RC class VI is associated with unplanned amputation rates of up to 87% at 6 months. The goal of this pilot study is to evaluate limb-related outcomes in patients with CLI RC VI treated with IPA DES.
This is a prospective study of 300 patients admitted to LAC+USC Hospital from 2011-2016 with CLI. We identified 28 subjects with 39 lesions treated with IPA DES. Patients were divided in two groups for comparison, RC IV+V and RC VI, both groups with 14 patients each. Data collected included demographic, clinical and procedural characteristics. Patients were followed for 2 years, myocardial infarction (MI), stroke, death, unplanned amputation, and repeated revascularization were recorded.
Overall mean age was 66.3±9 years and 60.7% were male; 71% diabetic, 17.8% dialysis dependent and 89% had hypertension. Mean stent diameter, stented segment length and number of stents were 2.56mm±0.28 vs. 2.29mm±0.45, 79.6mm vs. 80.5mm, and 2.5±1.5 vs 2.79±2.0, in RC IV+V and RC VI groups, respectively. Unplanned amputations occurred in 28.6% of RC IV+V patients and 21.4% of RC VI patients (p=0.8). Repeated revascularization occurred in 14.3% for both groups. Death and MI rates were 7.14% in both groups.
In this pilot study, the use of infra-popliteal drug-eluting stents in patients with CLI RC VI was safe and associated with similar limb-related outcomes to RC IV and V patients. Large studies are necessary to further define the role of IPA DES in CLI RC VI patients.