Irradiation stents confer better survival, stent patency than uncovered SEMS
Insertion of an irradiation stent leads to longer survival and better patency than uncovered self-expandable metallic stents (SEMS) in patients with unresectable malignant biliary obstruction (MBO), a recent multicentre trial has found.
Stent restenosis was less frequent in patients who received irradiation stents than in those who received uncovered SEMS (21 percent vs 34 percent). Irradiation stents were associated with significantly lower rates of restenosis (cause-specific hazard ratio, 0.479; 95 percent CI, 0.312–0.737).
The rate of stent restenosis was also lower in the irradiation stent vs uncovered SEMS group at 90 days (9 percent vs 15 percent), 180 days (16 percent vs 27 percent) and 360 days (21 percent vs 33 percent; p=0.01).
Moreover, while the median patency time in the uncovered SEMS group was 294 days, the same value could not be determined for the irradiation stents group due to the low rate of restenosis.
Overall survival was likewise better in the irradiation stent group, whose median survival of 202 days was significantly longer than the 140 days in the uncovered SEMS group (p=0.002).
“For patients with unresectable MBO, placement of an SEMS is a recommended palliative modality to relieve pruritus, cholangitis, pain and jaundice. However, restenosis is a main pitfall after stent placement,” said researchers.
“Data from this first multicentre randomized controlled trial showed that insertion of an irradiation stent provided longer patency and better survival compared with a conventional metal stent,” they added.
For the study, researchers randomized 328 participants to receive either irradiation stents (n=164; median age 65 years; 62.8 percent male) or uncovered SEMS (n=164; median age 64 years; 66.5 percent male). Cox regression and Fine-Gray analyses were performed to evaluate the effect of the different interventions on restenosis.