Wang Lei, Xiao Zhibo, Yue Zhendong, Zhao Hongwei, Fan Zhenhua, Zhao Mengfei, He Fuliang, Dai Shan, Qiu Bin, Yao Jiannan, Lin Qiushi, Dong Xiaoqun, Liu Fuquan
Department of Interventional Therapy, Beijing Shijitan Hospital, Capital Medical University, P.R., China.
Department of Plastic Surgery, The Second Affiliated Hospital of Harbin Medical University, P.R., China.
Sci Rep. 2016 Feb 15;6:21011. doi: 10.1038/srep21011.
We conducted a single-center randomized trial to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for cirrhotic portal hypertension. From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding (18.3% vs. 33.9%, P = 0.004) and refractory hydrothorax/ascites (6.9% vs. 16.5%, P = 0.019) in the experimental group were significantly lower than those in the control group. The cumulative restenosis rates in 1, 2, 3, 4, and 5-years in the experimental group (6.9%, 11.5%, 19.1%, 26.0%, and 35.9%, respectively) were significantly lower (P < 0.001) than those in the control group (27.6%, 37.0%, 49.6%, 59.8%, 74.8%, respectively). Importantly, the 4 and 5-year survival rates in the experimental group (83.2% and 76.3%, respectively) were significantly higher (P = 0.001 and 0.02) than those in the control group (71.7% and 62.2%, respectively). The rate of secondary interventional therapy in the experimental group was significantly lower than that in the control group (20.6% vs. 49.6%; P < 0.001). Therefore, Fluency covered stent has advantages over the bare stent in terms of reducing the restenosis, recurrence, and secondary interventional therapy, whereas improving the long-term survival for post-TIPS patients.
我们开展了一项单中心随机试验，比较8毫米Fluency覆膜支架与裸支架在经颈静脉肝内门体分流术（TIPS）治疗肝硬化门静脉高压中的疗效。2006年1月至2010年12月，分别对131例和127例患者使用了覆膜支架（试验组）或裸支架（对照组）。试验组胃肠道出血（18.3%对33.9%，P = 0.004）和难治性胸腔积液/腹水（6.9%对16.5%，P = 0.019）的复发率显著低于对照组。试验组1年、2年、3年、4年和5年的累积再狭窄率（分别为6.9%、11.5%、19.1%、26.0%和35.9%）显著低于对照组（分别为27.6%、37.0%、49.6%、59.8%、74.8%，P < 0.001）。重要的是，试验组4年和5年生存率（分别为83.2%和76.3%）显著高于对照组（分别为71.7%和62.2%，P = 0.001和0.02）。试验组二次介入治疗率显著低于对照组（20.6%对49.6%；P < 0.001）。因此，Fluency覆膜支架在降低再狭窄、复发和二次介入治疗方面优于裸支架，同时提高了TIPS术后患者的长期生存率。
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