Authors' objectives: The academic technology assessment group (ATAG) reviewed a report on the additional benefit and cost-effectiveness of the new aortic stent graft (the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System: the Gore CTAG stent-graft with ACS) compared to conventional aortic stent-grafts in patients with thoracic aortic aneurysm (TAA) and complicated type B aortic dissection (TBAD). The report was submitted by the manufacturer of the Gore CTAG stent-graft with ACS (W. L. Gore & Associates, Inc.). This report summarizes the results of a review and reanalysis conducted by the ATAG. In evaluating additional benefits, the manufacturer selected the outcomes as the number of stent grafts initially implanted, overall survival, reintervention incidence, and deployment with rapid ventricular pacing, and conducted a systematic review. Although two studies of the Gore CTAG stent-graft with ACS were identified, including the SURPASS registry, there were no studies directly comparing the efficacy and safety with the conventional aortic stent-grafts. Therefore, indirect comparisons were conducted to evaluate the additional benefits. For the patients with TAA, although the Gore CTAG stent-graft with ACS was associated with fewer initial device uses and deployment with rapid ventricular pacing, there was no significant difference in overall survival and reintervention incidence compared with conventional aortic stent grafts. For the patients with TBAD, although the Gore CTAG stent-graft with ACS was associated with a lower incidence of reintervention and fewer deployments with rapid ventricular pacing, there was no significant difference in initial device use and overall survival compared with the conventional aortic stent grafts. Of the four outcomes set by the manufacturer, the ATAG considered overall survival and reintervention incidence to be the appropriate outcomes and independently conducted a systematic review. The ATAG reanalysis determined that indirect comparisons were difficult to perform because the SURPASS registry did not report results applicable to the target population and insufficient data were available. However, the data suggested that the addition of ACS to a conventional stent graft may be effective in reducing the number of initial device implantations and the deployment with rapid ventricular pacing, although it is not clear how these outcomes themselves would affect clinical outcomes. Based on these results, the ATAG was unable to determine that the Gore CTAG stent-graft with ACS has additional benefits over the conventional aortic stent graft. The manufacturer conducted a cost-effectiveness analysis using a Markov model consisting of four health states: initial surgery, post-operative follow-up, reintervention, and death. The analysis model assumed that quality of life scores did not vary by health status in either analysis group, resulting in a cost-minimization analysis. For both the assessment and the comparator technology, the manufacturer used reintervention data for TAA from the GREAT registry, which evaluated previous-generation stent grafts. For TBAD, they used reintervention data from the GREAT registry as the assessment technology and the MOTHER registry, which evaluated other manufacturerfs products, as the comparator technology. The ATAG found no additional benefit for either TAA or TBAD and performed a cost-minimization analysis. The ATAG conducted a reanalysis for TAA and TBAD using the reintervention incidence data from the GREAT registry in both the assessment and the comparator technology. The results showed that the Gore CTAG stent-graft with ACS reduced costs by JPY 615,824 and JPY 138,594 for TAA and TBAD, respectively. In conclusion, the results of the ATAG reanalysis suggest that the incremental cost-effectiveness ratio (ICER) for the GORE CTAG stent graft with ACS compared to the conventional aortic stent grafts indicates equivalent effectiveness and cost reduction for patients with TAA and TBAD from the perspective of public healthcare payers in Japan.

Project Status: Completed

URL for project: https://c2h.niph.go.jp/

Year Published: 2025

URL for published report: https://c2h.niph.go.jp/results/C2H2302.html

English language abstract: There is no English language summary available

Publication Type: Not Assigned

Country: Japan

Organisation Name: Center for Outcomes Research and Economic Evaluation for Health

Contact Address: 2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan

Contact Name: Takeru Shiroiwa

Contact Email: t.shiroiwa@gmail.com