A real-world experience of drug eluting and non-drug eluting stents in lower extremity peripheral arterial disease

Abstract

Objectives

Drug-eluting stents (DES) have been promoted as an alternative to the traditional non-drug eluting stents (nDES), and offer the potential for improved patency rates. However, DES are more expensive than nDES, and results comparing these stents outside of clinical trials have been limited.

Materials and methods

A retrospective review was performed on all in patient infrainguinal lower extremity endovascular procedures between January 2014 and September 2016, which involved stent implantation. Procedures involving the common femoral artery, superficial femoral artery, and above knee popliteal artery were included. Procedures involving iliac, below knee popliteal, tibial, peroneal, and pedal arteries were excluded. The type of stent, number of stents, length of each stent, and location of stent were recorded for each procedure. Data on each patients Trans-Atlantic Inter Society Consensus II class were collected. End-points included stent thrombosis, restenosis, re-intervention, and limb loss. Post-operative arterial duplexes were obtained every three months to determine stent patency during follow-up visits. In-stent stenosis was defined as >60% narrowing on arterial duplex. Thrombosis was defined as in-stent occlusion, and limb loss involved only major amputations in the treated extremity. Bivariate analysis and Students two-sample T-test were used to analyze the data. IBM-SPSS – 22 was used for all analyses.

Results

Two hundred and twelve patients underwent at total of 252 procedures during the study period. Of this group, 191 procedures met inclusion criteria. There were 21 lesions that were treated with both nDES and DES and they were excluded from further analysis. The average patient age was 73.2 ± 11.6 years; 68.6% had hypertension, and 58.1% had diabetes. Mean follow-up was 7.18 ± 7.96 months. The most common indication for intervention was claudication (53%), followed by critical limb threatening ischemia (47%); 124 procedures involved only nDES (Lifestent®)(Bard, Tempe, AZ), 46 procedures involved only DES (Zilver®) (Cook, Bloomington, IN). Comparison of nDES and DES showed the overall rate of thrombosis (11.1% vs. 16.7%, p = 0.81), overall rates of re-stenosis (48.2% vs. 46%, p = 1.0), re-intervention (13.7% vs. 14.3%, p = 1.0), and limb loss (9.7% vs. 0.0%, p = 0.38) was equivalent between the groups. The six-month primary patency rate for nDES and DES (41.9% vs. 40.0%, p = 1.0) was also equivalent. On average, the average lengths of nDES were longer than DES (19.2 ± 14.3 cm vs.11.4 ± 5.7 cm) (p < .0001). DES results showed overall rates of 33% re-stenosis, 7.1% thrombosis, and no limb loss. There were no statistical differences between the nDES or DES groups with respect to gender, age, laterality, diabetes mellitus, coronary artery disease, gangrene, ulcers, hyperlipidemia, atrial fibrillation, deep vein thrombosis, claudication, critical limb-threatening ischemia, ipsilateral bypass, re-stenosis, thrombosis, limb loss, or ipsilateral amputation. Bivariate analysis showed a higher incidence of hypertension for nDES patients (p = .001). There was no statistical difference between Trans-Atlantic Inter Society Consensus II classes and type of stent used (p = .95).

Conclusions

In this retrospective analysis from one institution, the use of an nDES or DES did not result in a statistically significant difference in the rate of thrombosis, re-stenosis, ipsilateral re-intervention, or ipsilateral amputation over a two-year period when involving the CFA, SFA, and above knee popliteal artery.