Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils in Peripheral Arterial Applications: A Prospective, Multicenter, Randomized Trial.

ABSTRACT

PURPOSE: To evaluate the safety and effectiveness of hydrogel-coated coils for vessel occlusion in the body trunk. MATERIALS AND METHODS: A total of 77 patients with various peripheral vascular lesions, treatable by embolization with coils, were randomized (hydrogel group, n = 38; nonhydrogel group, n = 39). In the hydrogel group, embolization of the target vessel was conducted using 0.018-inch hydrogel-coated coils (AZUR 18; Terumo Medical Corporation, Tokyo, Japan) with or without bare platinum coils. The nonhydrogel group received both bare platinum coils and fibered coils without the use of hydrogel-coated coils. RESULTS: Complete target vessel occlusion was accomplished in 36 patients in the hydrogel group and 37 patients in the nonhydrogel group. No major adverse events were observed in either group. The median number of coils/vessel diameter and the median total coil length/vessel diameter were significantly larger in the nonhydrogel group than in the hydrogel group (P = .005 and P = .004, respectively). The median embolization length was significantly longer in the nonhydrogel group (31.95 mm) than in the hydrogel group (23.43 mm) (P = .002). If no expansion was assumed, the median packing density in the hydrogel group was 44.9%, which was similar to that in the nonhydrogel group (46.5%) (P = .79). With full expansion assumed, the median packing density in the hydrogel group was 125.7%. CONCLUSIONS: Hydrogel-coated coils can be safely used for peripheral vascular coil embolization, and hydrogel-coated and conventional coils in combination allow for a shorter embolization segment and shorter coil length.