Abstract
OBJECTIVE: Transcatheter arterialization of the deep veins (TADV) has been demonstrated to be safe and effective among no-option chronic limb-threatening ischemia (CLTI) patients, who lack suitable treatment alternatives. This study reports clinical and economic outcomes based on pooled data from PROMISE I and II trials of TADV for no-option compared with propensity-matched standard of care (SoC) patients from the concurrent CLariTI natural history registry.
METHODS: PROMISE I and II were single-arm, multicenter, prospective studies evaluating the safety and efficacy of TADV in no-option CLTI patients, assessed by an independent committee. Both the PROMISE and CLariTI cohorts included patients with Rutherford disease class 5 or 6. Propensity score matching (PSM) was performed on 118 TADV patients and 132 SoC patients based on age, sex, diabetes status, and Rutherford classification. Patients on dialysis at baseline were excluded from analysis. One-year clinical outcomes including limb salvage, overall survival, and amputation-free survival (AFS), were analyzed using Cox regression and Kaplan-Meier methods. The cost effectiveness of TADV vs SoC was evaluated using a decision analytic Markov model, projecting outcomes over a lifetime horizon. One-year clinical event rates previously discussed were relied upon in conjunction with contemporary US cost data, including the incorporation of the new technology add-on payment granted for TADV. The resulting incremental cost-effectiveness ratio, reported in dollars per quality-adjusted life-year (QALY) gained, was evaluated against established willingness-to-pay thresholds. Extensive scenario and sensitivity analyses were performed.
RESULTS: After matching, 228 patients (114 matched pairs) were analyzed. At 1 year, compared with matched SoC, patients treated with TADV demonstrated superior limb salvage rates (74.6% vs 57.8%; P = .003), survival rates (86.4% vs 71.1%; P = .013), and AFS rates (64.9% vs 39.1%; P < .001). Over lifetime and under the base case assumptions, TADV (vs SoC) provided an additional 1.15 QALYs (2.32 vs 1.17), with increased costs of $24,738 ($101,235 vs $76,497), and a projected survival gain of 2.33 life-years. The base case incremental cost-effectiveness ratio was $21,600 per QALY gained. TADV demonstrated to be highly cost effective across the range of sensitivity analyses explored, including scenarios considering application of the new technology add-on payment.
CONCLUSIONS: TADV with the LimFlow System resulted in significantly improved limb salvage, survival, and AFS rates at 1 year compared with the SoC. Based on projections using a previously validated health economic model, these improvements were shown to translate to meaningful lifetime benefits that help to justify the upfront cost of TADV, rendering it a cost-effective intervention for no-option CLTI patients.