Breaking Strictures: Fully Covered Metal Stents Dominate in Cost and Effectiveness for Post-Liver Transplant Patients

Aims In 2023, the United Network for Organ Sharing (UNOS) reported a record 10,660 liver transplants (LT) in the United States alone. Anastomotic biliary stricture (ABS) is a significant post-LT complication, affecting up to 36% of recipients. Endoscopic retrograde cholangiopancreatography (ERCP) remains the primary treatment for ABS in patients with normal anatomy. While guidelines favor the use of fully covered self-expanding metal stents (Fc-SEMS) over multiple plastic stents (MPS), this recommendation is based on low to moderate evidence. Additionally, no robust cost-effectiveness analysis comparing these strategies in post-LT ABS exists. This study addresses this gap by evaluating the financial and clinical outcomes of Fc-SEMS versus MPS [1] [2].

Methods A decision-tree model was constructed using data from a meta-analysis by Viscoti et al. and recent randomized controlled trials (RCTs) comprising 262 patients in total (129 Fc-SEMS, 133 MPS). Key outcomes included incremental cost, incremental effectiveness, and net monetary benefit (NMB). Cost inputs for ERCP, stents, and adverse event management were derived from CMS Physician Fee Schedules and published data. Utility values, stent usage, and ERCP session frequencies were sourced from the literature. The primary analysis assumed treatment crossover for stricture recurrence or failure, as reported by RCTs. A willingness-to-pay (WTP) threshold of $100,000 per quality-adjusted life year (QALY) was applied. Probabilistic sensitivity analysis (PSA), One Way Sensitivity Analysis and Threshold Analysis were performed to evaluate real-world uncertainty and key cost-effectiveness drivers.

Results Fc-SEMS dominated MPS by yielding lower costs ($26,433 vs. $36,256), higher effectiveness (0.92 vs. 0.89 QALYs), and superior NMB ($65,439 vs. $52,454). Deterministic sensitivity analysis revealed that incremental cost was most sensitive to the number of ERCP sessions in the MPS arm, the probability of stricture resolution and recurrence after Fc-SEMS, and the number of Fc-SEMS stents used. As ERCP sessions in the MPS arm increased from 2 to 4, Fc-SEMS shifted from being $2,500 more costly to $8,000 less costly. Fc-SEMS remained cost-effective when the recurrence rate and the number of stents used were below 50% and 5.65, respectively. Adverse event probabilities and management costs had minimal impact. PSA indicated that Fc-SEMS was the optimal strategy in 92.33% of simulations at the $100,000/QALY threshold.

Conclusions Fc-SEMS is a cost-effective strategy for managing post-LT anastomotic biliary strictures at commonly accepted WTP thresholds. Larger, high-quality prospective studies are warranted to confirm these findings and further refine cost-effectiveness estimates.

Publication History

Article published online:
27 March 2025

• References

• 1 Zeair S, Butkiewicz F, Butkiewicz J, Stasiuk R.. Application of Fully Covered Self-Expandable Metallic Stents with and without Antimigration Waist Versus Repeated Plastic Biliary Stent Placement in Management of Anastomotic Biliary Strictures After Orthotopic Liver Transplantation. Ann Transplant 2017; 22: 719-724 Published 2017 Dec 1
• 2 Visconti TAC, Bernardo WM, Moura DTH. et al. Metallic vs plastic stents to treat biliary stricture after liver transplantation: a systematic review and meta-analysis based on randomized trials. Endosc Int Open 2018; 6 (08): E914-E923