A Real-World Experience of Drug-Eluting and Nondrug-Eluting Stents in Lower Extremity Peripheral Arterial Disease

Abstract

Drug-eluting stents (DESs) have been promoted as an alternative to the traditional nondrug-eluting stents (nDESs) and offer the potential for improved patency rates. However, DESs are more expensive than nDESs, and results comparing these stents outside of clinical trials have been limited. A retrospective review was performed of all inpatient infrainguinal lower extremity endovascular procedures between January 2014 and September 2016 that involved stent implantation. Procedures involving the common femoral artery, superficial femoral artery, and above-knee popliteal artery were included. The type of stent, number of stents, length of each stent, and location of stent were recorded for each procedure. End points included stent thrombosis, restenosis, reintervention, and limb loss. Postoperative arterial duplex ultrasound examinations were performed every 3 months to determine stent patency during follow-up visits through the end of the study period. In-stent stenosis was defined as >60% narrowing on arterial duplex ultrasound. Thrombosis was defined as in-stent occlusion, and limb loss involved only major amputations in the treated extremity. Multivariate analysis, bivariate analysis, and Student two-sample t-test were used to analyze the data. During the study period, 212 patients underwent a total of 252 procedures. Of this group, 191 procedures met inclusion criteria. The average age of the patients was 73.2 ± 11.6 years; 68.6% had hypertension, and 58.1% had diabetes. The most common indication for intervention was claudication (53%), followed by critical limb ischemia (47%). There were 124 procedures that involved only nDES (Lifestent; Bard Peripheral Vascular, Tempe, Ariz), 46 procedures that involved only DES (Zilver; Cook Medical, Bloomington, Ind), and 21 procedures that involved both DES and nDES (mixed). Comparison of nDES and DES showed that the rate of thrombosis (11.1% vs 16.7%; P = .81), reintervention (13.7% vs 14.3%; P = 1.0), and limb loss (9.7% vs 0.0%; P = .38) was equivalent between the groups. The 6-month primary patency rates for nDES and DES (41.9% vs 40.0%; P = 1.0) were also equivalent. On average, the average lengths of nDESs were longer than those of DESs (19.2 ± 14.3 cm vs 11.4 ± 5.7 cm; P < .0001). Mixed nDES and DES results showed a 33% restenosis rate, 7.1% thrombosis rate, and no limb loss. The mixed stent patency rate at 6 months was 28.6%. There were no statistical differences between the nDES and DES groups with respect to sex, age, laterality, diabetes mellitus, coronary artery disease, gangrene, ulcers, hyperlipidemia, atrial fibrillation, deep venous thrombosis, claudication, ipsilateral bypass, restenosis, thrombosis, limb loss, or ipsilateral amputation. Bivariate analysis showed a higher incidence of hypertension for nDES patients (P = .001). 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, restenosis, ipsilateral reintervention, or ipsilateral amputation during a 2-year period in the common femoral artery, superficial femoral artery, and above-knee popliteal artery.