Gore Launches Study of Early TIPS Therapy for Ascites Patients

November 1, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced a new prospective, randomized, multicenter study of early intervention with the company's Viatorr transjugular intrahepatic portosystemic shunt (TIPS) endoprosthesis to improve transplant-free survival when compared to large-volume paracentesis in patients with cirrhosis and difficult to treat ascites. The Viatorr is a covered stent that is indicated for TIPS creation and revision. 

The Early TIPS for Ascite Study is a multidisciplinary study joining hepatologists and interventional radiologists to look at early TIPS therapy. Gore expects the study to involve 150 subjects at more than 20 sites. Thomas Boyer, MD, and Ziv Haskal, MD, are the lead investigators of the study.

The Early TIPS for Ascite Study follows publication of a study by Juan Carlos García-Pagán, MD, et al in The New England Journal of Medicine that compared early TIPS intervention with the Gore Viatorr TIPS endoprosthesis to pharmacotherapy/endoscopic band ligation in high-risk variceal bleeding patients with positive results (2010;362:2370–2379).

The company stated that with the TIPS procedure, alternative treatments such as medication and paracentesis for ascites and the treatment of varices may not be needed as often.

According to Dr. Haskal, fundamental and significant improvements in TIPS therapy are seen when using a covered stent versus a bare-metal stent. He commented, “Unlike a bare-metal stent, the Gore Viatorr TIPS endoprosthesis improves patency to such a degree that nearly all repeated invasive procedures on TIPS patients have disappeared. New data concerning covered stents forced us to take a fresh look at all earlier randomized studies comparing bare-metal TIPS to other treatments. The possibility that we may prolong patient lives is one of the most exciting new questions in TIPS therapy that we must answer.”

Arun J. Sanyal, MD, a member of the study's steering committee, added, “TIPS therapy studies in the 1990s may have failed to demonstrate increasing life expectancy for patients because only end stage patients were included. Previous trials with bare-metal stents showed TIPS was a bridge to transplant at best. By including patients in earlier stages of the disease course we hope to show there is an improvement in lifespan. By capturing patients a little earlier we may be able to impact their quality of life, as TIPS therapy may improve the ascites and slow the disease progression.”