Covered Wallstents for palliation of malignant biliary obstruction: primary stent placement versus reintervention.

BACKGROUND: Covered self-expandable metallic stents (SEMSs) are designed to prevent tumor ingrowth and can be removed if necessary. Only limited comparative data are available on the performance of covered SEMSs after primary placement versus reintervention.
OBJECTIVE: To assess the effectiveness and safety of covered SEMS placement either as primary treatment or reintervention in patients requiring palliation of malignant biliary obstruction.
DESIGN: Retrospective clinical cohort study.
SETTING: Tertiary referral center. PATIENTS: This study involved 104 patients with unresectable malignant biliary strictures. INTERVENTION: Covered biliary SEMS placement. MAIN OUTCOME MEASUREMENTS: Stent patency, technical success, and patient survival.
RESULTS: Covered SEMSs were placed as primary treatment in 48 patients (46%), and reintervention was performed in 56 patients (54%). At 3, 6, and 12 months thereafter, the Kaplan-Meier estimated fractions of all patients with patent stents were 94%, 84%, and 58%, respectively. Covered SEMSs remained patent until the patient's death in 75 of 89 nonsurvivors (84%). Although patency rates 3, 6, and 12 months after primary placement (100%, 93%, and 82%, respectively) were higher than those after reintervention (90%, 78%, and 48%, respectively), the differences were not statistically significant (P = .057). Overall, the most frequent adverse events were cholangitis (7%) and stent migration (4%). LIMITATIONS: The distribution of stricture locations differed among the groups, and survival data suggested the presence of more extensive disease in the primary treatment group at baseline.
CONCLUSION: The clinical utility and safety of primary covered SEMS placement were confirmed. This study provides the most extensive evidence to date that reintervention with a covered SEMS can provide a useful palliative option.