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Advances in endovascular techniques and devices have improved the outcomes of percutaneous revascularization in what was once considered a primarily surgical disease.
The utilization of drug-covered stents (ICAST) appears to yield improved patency rate than the 85% patency rate demonstrated with the use of bare metal stents (BMS) across TASC A, B, C, and D lesions.
This is a single center prospective trial consisting of patients who underwent aorto-iliac interventions for de novo lesions or ISR (in-stent restenosis) using BMS or ICAST. The patients received routine clinic visits to assess for claudication and an annual vascular ultrasound of the iliac arteries to evaluate for restenosis. The study consisted of 28 limbs with BMS and 26 limbs with ICAST. The study subjects were followed over 3 years. We compared the number of re-intervention, time to re-intervention and number of crossover to ICAST to determine patency rates.
Out of the 28 limbs with BMS, there were 8 ISR compared to only 2 IRS of the 26 limbs in the ICAST arm. There were 6 limbs in the BMS arm that crossed over to the ICAST arm after a period of 1 month to 12 years with a mean duration of five years. There was 1 case in the BMS arm that underwent percutaneous transluminal angioplasty without stenting, 7 years from original stent deployment. There was another case in the BMS arm with ISR after 6 months who did not undergo any intervention. On the other hand, there was one case of thrombosis in the ICAST arm after 2 months of stent deployment that required re-do with a BMS. There has been one re-do case of ICAST using another ICAST after 2.5 years.
This study showed a trend toward improved patency rate with ICAST. There were four times more ISR with BMS when compared to ICAST. Although our result demonstrates improved patency with ICAST, a large randomized study is needed to validate our findings.