longterm success of this procedure. In recently published se-Development of stenosis or occlusion of the transjuguries, rates of stenosis and occlusion 1 to 2 years after TIPSS lar intrahepatic portosystemic stent shunt (TIPSS) is placement were on average 47% and 12%, respectively. 5,9,10 one of the major limiting factors in the long-term viabil-Attempts to preserve early shunt patency by anticoagulation ity of this procedure. The efficacy of anticoagulation with heparin for as long as 4 weeks so far have led to no with heparin which is used in different centers is still conclusive results. 10 In our patients, shunt stenosis within 3 unclear. In the present study, we evaluated the effect of months was mostly observed in patients with relatively norphenprocoumon on shunt patency after TIPSS placemal prothrombin time. 11 Therefore, we conducted a randomment using Palmaz stents; 49 patients with Child's A and ized trial to evaluate the effect of phenprocoumon on stenosis B cirrhosis, who underwent successful TIPSS placement and occlusion after TIPSS placement. were randomized into the treatment group (n Γ
24) who received phenprocoumon and a control group (n Γ
25).
PATIENTS AND METHODS
After 11 to 13 weeks, all patients were admitted and had a reevaluation that included control angiography by
The study was designed to determine the effect of phenprocoumon transjugular approach. Phenprocoumon treatment was treatment on the prevention of TIPSS occlusion or stenosis. The series included 49 consecutive patients admitted between September stopped after the first reevaluation and both groups 1993 and November 1994 to the Department of Internal Medicine, were followed for 1 year after randomization. During University of Heidelberg. In all patients, indication for TIPSS was the 3-month treatment period 11 of 22 patients of the recurrent variceal bleeding with at least three bleeding episodes, treatment group and 12 of 23 patients of the control despite endoscopic sclerotherapy and medical treatment. The characgroup required reintervention because of an increased teristics and data of patients entering the study are shown in Table portosystemic gradient. Five of the 12 patients in the 1. control group showed complete occlusion of the shunt, TIPSS was performed as described previously 12,13 by insertion of whereas no occlusion in the treatment group was obas many Palmaz stents (Johnson & Johnson Interventional Systems, served (P Γ΅ .05). During the mean follow-up of 8 months Warren, NJ) as needed to cover a shunt tract measuring between 4 and 6 cm. Expansion of the stent from 8 to 12 mm in diameter was after the treatment was stopped, in both groups stenosis performed to reduce portosystemic gradients to 10 to 15 mm Hg. All occurred in 50% of patients, but no further occlusion of patients received continuous heparin for the first 3 days in a dose the stent was observed. These data indicate that occluthat raised partial prothrombin time to 2.5 times the upper limit sion of the stent is related to thrombosis, whereas stenoof normal and also prophylactic broad-spectrum antibiotic therapy sis does not appear to be dependent on blood coagula-(mezlocillin and metronidazole). Patients with Child A and B cirrho- tion. In patients with preserved liver function occlusion sis, who underwent successful TIPSS placement were included in of the shunt may be prevented by phenprocoumon treatthe trial. Child C patients (n Γ
27 during the same time period) were ment in the first 3 months after TIPSS placement. not included in the trial, as stenosis and occlusion in these patients Thereafter shunt occlusion was not observed and furare rare. 11 Patients were randomized on the third day after TIPSS placement into a treatment (n Γ
24) and into a control group (n Γ
ther phenprocoumon treatment seemed unnecessary. 25). The treatment group received phenprocoumon to maintain the (HEPATOLOGY 1996;24:1433-1436.) prothrombin time at an INR of 1.7 to 2.1. Coagulation status was monitored once or twice weekly in both groups. Informed consent
The transjugular intrahepatic portosystemic stent shunt was obtained from each patient, and the study protocol, conformed (TIPSS) is being increasingly used in cirrhotic patients with to the ethical guidelines of the 1975 Helsinki declaration, was ap- complications of portal hypertension. Clinical trials using proved by the ethical review committee of Heidelberg University.
Evaluation of patients was performed before TIPSS placement and this nonsurgical method of decompressing the portal venous every 11 to 13 weeks thereafter, and consisted of clinical assessment, system have been shown to lead to control of acute variceal upper gastrointestinal endoscopy with grading of varices, 14 examinableeding, prevention of recurrent hemorrhage, 1-5 and imtion of the abdomen by ultrasonography, and investigation of the provement of ascites, refractory to medical treatment. [6][7][8] shunt flow by color duplex sonography. The presence of encephalopa-Development of shunt stenosis or occlusion with recurrence thy was evaluated by clinical examination and a number connection of portal hypertension, is still a major limiting factor in the test. 15 All patients underwent control angiography by a transjugular approach to visualize stent patency and to determine the portosystemic pressure gradient. The terms stenosis and occlusion were based on the angiographic findings. Shunt stenosis was defined as Abbreviation: TIPSS, transjugular intrahepatic portosystemic stent shunt.