Novel Biliary Stent Proves Long-Term Mettle

SAN DIEGO -- Three years of follow-up in patients receiving a self-expanding metal stent to relieve benign biliary strictures showed the devices had durable efficacy, a researcher said here.

In an intent-to-treat analysis of 127 patients who had received the stents in a global trial, 60% remained free of strictures at 3-year follow-up, said Guido Costamagna, MD, of Universitá Cattolica del Sacro Cuore in Rome, at the Digestive Disease Week meeting.

Three-year stricture freedom was observed in more than 80% of those who had kept the stents in place as planned, he added, calling it "really an excellent result."

Mark Callery, MD, of Beth Israel Deaconess Medical Center in Boston, who was not involved with the study, said it represented an important advance in treatment of benign biliary strictures.

These follow-up data are "very significant," he said during a press briefing at which the study was discussed.

If this degree of long-term efficacy is maintained at a planned 5-year follow-up, Costamagna told MedPage Today, the stent could become the standard of care as first-line treatment.

Produced by Boston Scientific, the WallFlex Biliary RX stent is currently approved in Europe but not yet in the U.S. for treatment of benign strictures. It does have an FDA 510(k) clearance for biliary strictures produced by malignant neoplasms.

The alternative for stenting of benign strictures is plastic stents, Costamagna explained. These typically "occlude after a few months" and have to be replaced he said.

In contrast, the WallFlex product is covered to prevent tissue in-growth, allowing it to stay in place longer while remaining patent and also allowing for removal, considered a critical property for biliary stricture stenting.

The current analysis reflects follow-up of patients in a major international trial, short-term results of which were published in 2014. A total of 187 patients had received the device in the trial, which was conducted at 13 centers in 11 countries in Europe, Latin America, Canada, India, and Australia.

Most patients had developed strictures as a complication of chronic pancreatitis. The protocol specified that stents would be removed after 10-12 months in patients with this diagnosis; removal was scheduled at 4-6 months in patients with strictures related to liver transplantation.

Of the 127 patients available for follow-up, nine had died of causes unrelated to the biliary strictures or treatment and were excluded from the per-protocol analysis.

Fifteen patients were restented due to recurrent strictures. The total recurrence rate after median follow-up of 3 years is 17%, Costamagna said.

Costamagna said patients will be followed for 5 years after stent placement.

The study was supported by Boston Scientific. Several investigators reported relationships with this and other device companies.

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Novel Biliary Stent Proves Long-Term Mettle