■经颈静脉肝内门体分流术(TIPS)是高危急性静脉曲张破裂出血的首选治疗方法(AVB;即Child-Turcotte-Pugh[CTP]B8-9+活动性出血/C10-13)。然而,尽管联合使用非选择性β受体阻滞剂(NSBB)和内镜下静脉曲张结扎术(EVL)进行二级预防,但预后较差的“非高危”患者仍然存在。我们调查了非高风险AVB中再出血和死亡率的预后因素,以确定可能从更有效的治疗中受益的亚组(即,TIPS)以防止进一步的代偿失调和死亡。
方法:在2011-2015年间,在34个中心前瞻性招募了2225名患有肝硬化和静脉曲张破裂出血的成年人;为了本研究的目的,低危患者在AVB指数和第5日的病例定义和预后指标信息得到进一步细化.最终纳入由NSBB/EVL管理的581名特征良好的无出血控制或TIPS禁忌症的低风险患者。患者随访一年。
结果:总体而言,90例(15%)患者再次出血,70例(12%)患者在随访期间死亡。使用临床常规数据,没有发现有意义的再出血预测因子.然而,再出血(作为时间依赖性协变量)增加死亡率,即使考虑了患者特征的差异(调整后的病因特异性风险比:2.57[95CI:1.43-4.62];p=0.002).包括CTP的列线图,肌酐,和钠在基线测量准确(一致性:0.752)分层死亡风险。
结论:大多数“非高危”AVB患者的预后良好,如果根据目前的建议进行治疗。然而,大约五分之一的病人,即,那些CTP≥8和/或高肌酐水平或低钠血症,在索引出血的1年内有相当大的死亡风险。未来的临床试验应调查选择性TIPS放置是否降低这些患者的死亡率。
Pre-emptive transjugular intrahepatic portosystemic shunt (TIPS) is the treatment of choice for high-risk acute variceal bleeding (AVB; i.e., Child-Turcotte-Pugh [CTP] B8-9+active bleeding/C10-13). Nevertheless, some \'non-high-risk\' patients have poor outcomes despite the combination of non-selective beta-blockers and endoscopic variceal ligation for secondary prophylaxis. We investigated prognostic factors for re-bleeding and mortality in \'non-high-risk\' AVB to identify subgroups who may benefit from more potent treatments (i.e., TIPS) to prevent further decompensation and mortality.
A total of 2,225 adults with cirrhosis and variceal bleeding were prospectively recruited at 34 centres between 2011-2015; for the purpose of this study, case definitions and information on prognostic indicators at index AVB and on day 5 were further refined in low-risk patients, of whom 581 (without failure to control bleeding or contraindications to TIPS) who were managed by non-selective beta-blockers/endoscopic variceal ligation, were finally included. Patients were followed for 1 year.
Overall, 90 patients (15%) re-bled and 70 (12%) patients died during follow-up. Using clinical routine data, no meaningful predictors of re-bleeding were identified. However, re-bleeding (included as a time-dependent co-variable) increased mortality, even after accounting for differences in patient characteristics (adjusted cause-specific hazard ratio: 2.57; 95% CI 1.43-4.62; p = 0.002). A nomogram including CTP, creatinine, and sodium measured at baseline accurately (concordance: 0.752) stratified the risk of death.
The majority of \'non-high-risk\' patients with AVB have an excellent prognosis, if treated according to current recommendations. However, about one-fifth of patients, i.e. those with CTP ≥8 and/or high creatinine levels or hyponatremia, have a considerable risk of death within 1 year of the index bleed. Future clinical trials should investigate whether elective TIPS placement reduces mortality in these patients.
Pre-emptive transjugular intrahepatic portosystemic shunt placement improves outcomes in high-risk acute variceal bleeding; nevertheless, some \'non-high-risk\' patients have poor outcomes despite the combination of non-selective beta-blockers and endoscopic variceal ligation. This is the first large-scale study investigating prognostic factors for re-bleeding and mortality in \'non-high-risk\' acute variceal bleeding. While no clinically meaningful predictors were identified for re-bleeding, we developed a nomogram integrating baseline Child-Turcotte-Pugh score, creatinine, and sodium to stratify mortality risk. Our study paves the way for future clinical trials evaluating whether elective transjugular intrahepatic portosystemic shunt placement improves outcomes in presumably \'non-high-risk\' patients who are identified as being at increased risk of death.