Research ArticleUse of early-TIPS for high-risk variceal bleeding: Results of a post-RCT surveillance study
Introduction
In patients with cirrhosis, acute variceal bleeding (AVB) is one of the most dreadful complications [1]. Over the past decades, improvements in the management of AVB have been associated with a reduction in treatment failure and mortality. However, despite the application of the current gold standard therapy, consisting in the combination of early vasoactive drugs, prophylactic antibiotics, and therapeutic endoscopic procedures [2], [3], there is still a 10–20% treatment failure and approximately 10% mortality. Remarkably, these complications occur mainly in a relatively small group of patients considered as a high-risk population. These patients are usually identified on the basis of clinical and biochemical characteristics (such as the Child-Pugh score, and activity of bleeding despite vasoactive drug infusion) or hemodynamic findings (such as a HVPG over 20 mmHg) [4], [5]. In a recent randomized international clinical trial (RCT), in high-risk patients with cirrhosis and acute variceal bleeding, the early creation of a transjugular intrahepatic portosystemic shunt (TIPS) with the use of stents covered with polytetrafluoroethylene (e-PTFE) is associated with marked and significant reductions in both treatment failure and mortality. In addition, the incidence of other complications of portal hypertension, such as ascites, is also reduced [6]. The aim of the present surveillance study was to assess whether these excellent results are similar in clinical practice outside RCTs.
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Patients
We conducted a retrospective review of all patients admitted for acute variceal bleeding and at high risk of treatment failure (defined by Child C <14 or Child B plus active bleeding at endoscopy despite intravenous vasoactive drug treatment, as in the RCT) at the centers participating in the original RCT on the use of early TIPS. Active variceal bleeding at endoscopy was defined on the basis of the Baveno criteria [7]. The patients included in the study were those hospitalized over a period of
Study patients
A total of 659 patients with acute variceal bleeding were admitted to the participating hospitals, of which 584 had exclusion criteria for the study (Fig. 1). The remaining 75 patients received either the standard medical therapy (30 patients) or early-PTFE–covered TIPS (45 patients). There were no significant differences in baseline characteristics between the two groups at the time of study entry (Table 1). The mean (±SD) follow-up period was 14.6 ± 12 months in the medical group and 13.1 ± 12
Discussion
Variceal bleeding is a deadly complication of cirrhosis, particularly in patients in whom clinical decompensation has already developed. In the last decades, mortality from variceal bleeding has decreased to the current 10–20% [5], [11], mainly due to the implementation of effective treatments. However, when the bleeding occurs in patients with cirrhosis and high risk of treatment failure (assessed by the hepatic venous pressure gradient (HVPG) ⩾20 mmHg or an impaired liver function), the
Financial support
Supported in part by grants from the Ministerio de Educación y Ciencia (SAF-10/17043) and from the Instituto de Salud Carlos III (PI 09/01261). CIBEREHD is funded by the Instituto de Salud Carlos III. F. Nevens and W. Laleman are senior clinical investigators for the Fund for Scientific Research – Flanders (Fundamenteel klinisch mandaat – FWO Vlaanderen).
Conflict of interest
J.C.G.P., J.B. and C.B. invited speakers from GORE; F.N. Research grants from MSD, Roche, Janssens-Cilag, Ipsen, Eumedica and CAF.
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Cited by (0)
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On behalf of the early TIPS cooperative study group.
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These authors contributed equally to this work.