Clinical

Plastic stent reduces 6-month TIPS revision rate

Last Updated: 2004-03-30 12:30:47 -0400 (Reuters Health)

By Peggy Peck

PHOENIX, Arizona (Reuters Health) - The 6-month results of a randomized, multicenter study suggest that the use of a plastic transjugular intrahepatic portosystemic stent (TIPS) reduces the TIPS revision rate by a factor of three compared with the use of a bare metal stent.

The Viatorr Polytetrafluoroethylene (ePTFE) TIPS stent was superior to the bare metal WallStent, principal investigator Dr. Ziv J. Haskel, of New York Presbyterian Hospital-Columbia University, reported at the 29th Annual Meeting of the Society of Interventional Radiology.

The initial analysis of the 253-patient trial was "just given to us a week ago so the data are very raw and more analysis will need to be done," Dr. Haskel told Reuters Health. "Nonetheless, venographic and clinical patency at 6 months indicate this three-fold advantage. Moreover, if the stents could have been placed more precisely, by that I mean if the entire hepatic vein had been covered, there would have been a 10-fold improvement."

One hundred and twenty-five patients were randomized to the Viatorr TIPS stent and 128 to the bare metal stent. The mean age of patients in the Viatorr arm was 53 years versus 54 years in the bare metal arm. Seventy-four percent of patients in the Viatorr arm were men, while 56 men were in the bare metal arm.

The breakdown for hepatitis C was 47% and 44% in Viatorr and Wallstent, respectively. Sixty-three percent of the Viatorr patients had alcoholic liver disease, compared with 47% of the patients in the Wallstent arm.

At 6 months, there were 12 revisions in the Viatorr arm and 31 revisions in the bare metal arm, he reported.

Dr. Haskel said the trial is "really unique in that this is the largest-ever randomized trial in TIPS." He added that the results of this pivotal trial will be presented to the Food and Drug Administration to obtain labeling approval for use of Viatorr ePTFE in TIPS.