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Sided Varizen Early Use of TIPS in Patients with Cirrhosis and Variceal Bleeding — NEJM Sided Varizen


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N Engl J Med ; Patients with cirrhosis in Child—Pugh class C or those in class B who have persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis, even if they have undergone rescue treatment with a transjugular intrahepatic portosystemic shunt TIPS.

This study evaluated the earlier use of TIPS in such patients. Full Text of Background We randomly assigned, within 24 hours after admission, a total sided Varizen 63 patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy to treatment with die beste Behandlung für Krampfadern Rezept polytetrafluoroethylene-covered stent within 72 hours after randomization early-TIPS group, 32 patients or continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation EBLsided Varizen, with insertion of a TIPS if needed as rescue therapy pharmacotherapy—EBL group, sided Varizen, 31 patients.

Full Text of Methods The number of days in the intensive care unit and the sided Varizen of time in the hospital during follow-up were significantly higher in the pharmacotherapy—EBL group than in the early-TIPS group. No significant differences were sided Varizen between the two treatment groups with respect to serious adverse events. Full Sided Varizen of Results In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high sided Varizen for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality.

Full Text of Discussion Variceal bleeding is a severe complication of portal hypertension and a major cause of death in patients with sided Varizen. Advanced liver failure, failure to control variceal bleeding, early rebleeding, and marked elevations in portal pressure are associated with increased mortality.

In a study involving patients at high risk sided Varizen treatment failure, as indicated by a hepatic venous pressure gradient of 20 mm Hg or more, 11 early treatment with TIPS improved the prognosis in comparison with medical treatment sided Varizen a study by Monescillo et al.

We conducted a study to determine whether early treatment with TIPS, with the use of a stent covered with extended polytetrafluoroethylene e-PTFEcan improve outcomes in patients with cirrhosis and variceal bleeding who are at high risk for treatment failure and death. Eligible patients had cirrhosis with acute esophageal variceal bleeding that was sided Varizen treated with a combination of vasoactive drugs, sided Varizen, endoscopic treatment, and prophylactic antibiotics.

Patients had Child—Pugh class C disease a score of 10 to 13 or they had class B disease a score of 7 to 9 but with active bleeding at diagnostic endoscopy. Patients with scores higher than 13 were excluded from the study, sided Varizen. In the Child—Pugh classification of liver disease, class A [a score of 5 or 6] indicates the least severe disease, class B [7 to 9] moderately severe disease, and class C [10 to 15] the most severe disease.

Active variceal bleeding at endoscopy was defined on the basis of the Baveno criteria. Exclusion criteria were an age of more than 75 years, pregnancy, hepatocellular carcinoma that did not meet the Milano criteria for transplantation i. All patients provided written informed consent, sided Varizen. The study protocol was approved by the ethics committees of all participating hospitals and followed the Guidelines for Good Clinical Practice in clinical trials. Randomization was performed within 24 hours after admission.

The randomization sequence was generated by computer with the use of a concealed block size of four. The coded treatment assignments were kept at the sided Varizen center in sealed, consecutively numbered, opaque envelopes, sided Varizen.

Randomized assignments to the study groups were made by contacting the coordinating center available 24 hours a day by telephone or fax. Treatment with vasoactive drugs was continued until patients were free of bleeding for at least 24 hours and preferably up to 5 days, sided Varizen, at which point treatment with a nonselective beta-blocker either propranolol or nadolol was started.

The dose was increased in a stepwise fashion every 2 to 3 days to the maximum tolerated dose or to a maximum of mg twice daily for propranolol and mg per day for nadolol. After these doses were achieved, 10 mg of isosorbidemononitrate was initiated at bedtime, with a stepwise increase in the dose to a maximum of 20 mg twice a day or the maximum tolerated dose.

In addition, within 7 to 14 days after the initial endoscopic treatment, sided Varizen, the second, elective session of EBL was performed. EBL sessions were then scheduled every 10 to 14 days until variceal eradication was achieved i. Patients received proton-pump inhibitors until variceal eradication was accomplished, sided Varizen.

After eradication, endoscopic monitoring was performed at 1-month, 6-month, and month intervals and then annually. If varices reappeared, further EBL sessions were initiated. Treatment failure was defined as one severe rebleeding episode i. TIPS was performed within 72 hours after diagnostic endoscopy sided Varizen, when possible, sided Varizen, within the first 24 hoursand vasoactive drugs were administered until then.

If the portal-pressure gradient the difference between portal-vein pressure and inferior vena caval pressure did not decrease to below 12 mm Hg, the stent was dilated to 10 mm, sided Varizen.

Follow-up visits were scheduled at 1 month, at 3 months, and every 3 months thereafter. Doppler ultrasonography was performed at the first visit, sided Varizen, at 6 months, and every 6 months thereafter, sided Varizen. Patients were followed until death or liver transplantation up to a maximum of 2 years of follow-up or until the end of the study September The primary end point of the study was a composite outcome of failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment.

Secondary end points were mortality at 6 weeks and at 1 year, failure to control acute bleeding, early rebleeding rate of rebleeding at 5 days and at 6 weeksrate of rebleeding between 6 weeks and sided Varizen year, the development of other complications related to portal hypertension on follow-up, sided Varizen, the number of days in the intensive care unit, sided Varizen, the percentage of follow-up days spent in the hospital, and the use of sided Varizen treatments.

In a study by Villanueva et al. Because the only rationale for early use of TIPS would sided Varizen evidence that this approach is better than the current standard treatment, the sample size was calculated with the use of a one-sided test. All data analyses were performed on an intention-to-treat basis according to a preestablished analysis plan. Dichotomous variables were compared by means of Fisher's exact test, and continuous variables were compared by means of the sided Varizen Mann—Whitney rank-sum test, sided Varizen.

The probabilities of reaching the primary end point and of survival were estimated by the Kaplan—Meier method and were compared by means of the log-rank test. A P value of less than 0. The statistical software packages used for the analysis were SPSS version We screened patients with acute variceal bleeding who were admitted to the participating hospitals for study eligibility.

There were no significant differences in baseline characteristics between the two groups at the time of entry into the study Table 1 Table 1 Baseline Characteristics of the Patients. A total of 7 patients 3 in the pharmacotherapy—EBL group and 4 in the early-TIPS group were lost to follow-up after a median of 8 months range, 0. A total of 6 patients 2 in the pharmacotherapy—EBL group and 4 in Prävention von Krampfadern Sauna early-TIPS group underwent liver transplantation during follow-up.

In the pharmacotherapy—EBL group, sided Varizen, 22 patients received propranolol median dose, 55 mg [range, 10 to ]and only 3 received nadolol.

In the remaining 6 patients, nonselective beta-blocker therapy was not initiated because of failure to control bleeding, early rebleeding, or death. In 12 patients, isosorbidemononitrate was added to the nonselective beta-blocker median dose, 25 mg [range, 10 to 40]but it was not added in 13 patients because of arterial hypotension, the treating physician's preference, or early death. Variceal eradication was achieved in 12 patients after a median of 2 EBL sessions range, 1 to 7 without rebleeding; in 4 patients, sided Varizen was achieved after treatment of a rebleeding episode with additional EBL sessions.

In the remaining 15 patients, eradication sided Varizen not achieved in 12 because sided Varizen primary end point was reached [resulting in rescue TIPS in 7 and death in 5], in 2 who were lost to follow-up, and in 1 despite eight EBL sessions.

In the early-TIPS group, all but 1 patient, who withdrew consent, sided Varizen, underwent early shunt placement. There were no technical failures or major complications of the TIPS procedure, sided Varizen. Paroxysmal supraventricular tachycardia occurred in 1 patient and was controlled medically. A total of 27 patients required one stent, and 4 required two stents. The mean portal-pressure gradient dropped from sided Varizen Despite dilation to 10 mm, the portal-pressure gradient after TIPS remained above 12 mm Sided Varizen in sided Varizen patients.

Collateral embolization was performed in 2 patients one of whom had a portal-pressure gradient above 12 mm Hg after TIPS. The probability of remaining free from uncontrolled variceal bleeding or variceal rebleeding is shown in Panel A, sided Varizen, and the probability of survival is shown in Panel B, sided Varizen.

In these patients, the Model for End-Stage Liver Disease MELD score which ranges from 6 to 40, with higher scores indicating more severe disease increased from a mean of In 7 of these patients, TIPS with an e-PTFE—covered stent was used as rescue therapy; although bleeding was controlled, 4 of these patients died within 36 days range, 1 to In 5 patients, no further treatment was considered because of severe liver failure, and all died.

In the 9 patients who died, the mean MELD score was The remaining 2 patients who reached the primary end point underwent additional EBL sessions and were alive at the end of the follow-up period. An additional 4 sided Varizen 3 in the pharmacotherapy—EBL group and 1 in the early-TIPS group had sided Varizen rebleeding episode that was not clinically significant i. Causes of death are summarized in Table sided Varizen. In the pharmacotherapy—EBL group, sided Varizen, 12 patients had a total of 17 episodes of hepatic encephalopathy, whereas in the early-TIPS group, 8 patients had a total of 10 episodes Table 3 Table 3 Adverse Events.

Most of these episodes occurred during the index bleeding, sided Varizen. A total of 3 patients in the pharmacotherapy—EBL group and sided Varizen in sided Varizen early-TIPS group had stage III hepatic encephalopathy, and 1 patient in each group had mild, recurrent hepatic encephalopathy.

Spontaneous bacterial peritonitis developed during the index bleeding in 2 patients in the pharmacotherapy—EBL group, both sided Varizen whom died. In addition, the hepatorenal syndrome developed during the index bleeding in 7 patients: As shown in Sided Varizen 3there were no significant between-group differences in the numbers of patients who had adverse effects.

In the study by Monescillo sided Varizen al. Therefore, sided Varizen, it is difficult to extrapolate the results of this study for application to clinical practice, sided Varizen. Our study was specifically designed to show whether an early decision to use TIPS, with e-PTFE—covered stents and based on clinical criteria, can improve the prognosis for patients with variceal bleeding who are at high risk.

We found that in patients treated early sided Varizen TIPS, the risks of failure to control bleeding and of variceal rebleeding were reduced. In addition, and even more important, the early use of TIPS was associated with a reduction in mortality.

This beneficial effect on survival was observed even though rescue TIPS was sided Varizen in patients sided Varizen whom medical treatment failed, sided Varizen. Mortality was very sided Varizen among the patients who underwent rescue TIPS after treatment failure, a result that sided Varizen consistent with the findings in previous studies. Previous studies evaluating sided Varizen role of TIPS in the prevention of recurrent variceal bleeding clearly showed that TIPS reduces the rebleeding rate but increases hepatic encephalopathy without improving survival.

It should be noted that previous studies of TIPS differed from our study in that they used bare stents or did not limit enrollment to patients at high risk for treatment failure.

In the study by Escorsell et al. Therefore, sided Varizen study design precluded the possibility of demonstrating a benefit of TIPS in these high-risk patients, sided Varizen. In high-risk patients, the potentially deleterious effects of e-PTFE—covered TIPS appear to be counterbalanced by its high efficacy in controlling bleeding and thus preventing further clinical deterioration.

In contrast, sided Varizen, TIPS should not be used as the initial treatment in patients with Child—Pugh class A disease, since the rates of medical-treatment failure and mortality are low among such patients.

Although the risks of treatment failure and death were higher in patients with Child—Pugh class C disease than in those with class B disease, our trial was not powered to conduct appropriate subgroup analyses, sided Varizen. Therefore, further evaluation will be needed to sided Varizen whether the early use of TIPS equally benefits these two subgroups of patients.

The early use of TIPS was not associated with an increase in the number or severity of episodes of hepatic encephalopathy. In conclusion, in patients with Child—Pugh class C disease or class B disease with active bleeding who were admitted for acute variceal bleeding, the early use of TIPS with an e-PTFE—covered stent was associated with significant reductions in the failure to control bleeding, in rebleeding, and in mortality, with no increase in the risk of hepatic encephalopathy.

Lalemanand an educational grant from Gore, sided Varizen. Caca, receiving lecture fees and reimbursement for travel expenses from Gore; and Dr.


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