Authors: Norio Hongo, MD, Hiro Kiyosue, Shinichi Ota, MD, MD, Norihisa Nitta, MD, Masamichi Koganemaru, MD, Masanori Inoue, MD, Seishi Nakatsuka, MD, Keigo Osuga, MD, Hiroshi Anai, MD, Taku Yasumoto, MD, Shuichi Tanoue, MD, Miyuki Maruno, MD, Noritaki Kamei, MD, Kimihiko Kichikawa, MD, Toshi Abe, MD, Terumitsu Hasebe, MD and Yoshiki Asayama, MD

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To evaluate the safety and effectiveness of hydrogel-coated coils for vessel occlusion in the body trunk.

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A total of 77 patients with various peripheral vascular lesions, tratable 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 bare platinum coils and fibered coils without the use of hydrogel-coated coils.

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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/vessels 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 (31.95mm) 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%

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In the largely unselected population of patients at high bleeding risk after coronary stenting with an Ultimaster™ family DES, stopping DAPT 1 month after the procedure was associated with lower bleeding risk, without additional ischaemic risk, both in patients who received OAC therapy and in those who did not. Further research is required to explore the effect of stopping all DAPT after 6 months in patients requiring OAC.

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