Cost-Effectiveness of Percutaneous Closure of a Patent Foramen Ovale (PFO) Versus Antiplatelet Therapy After Stroke: A Trial and Model Based Economic Evaluation of the French Close Randomised Controlled Trial

OBJECTIVES:

The French RCT CLOSE demonstrated that patients having experienced cryptogenic stroke and having a patent foramen ovale (PFO) with echocardiographic features representing risk of stroke benefited from PFO closure compared to antiplatelet therapy. This analysis determines the cost-effectiveness from the perspective of the French healthcare system of percutaneous PFO closure in combination with antiplatelet therapy versus antiplatelet therapy alone using economic data collected during the CLOSE trial.

METHODS:

The cost evaluation determined the average cost per patient in both groups at a five-year horizon based on the trial data. Patient resource consummation data was collected in the trial Case Report Forms. Unit costs were collected during the micro-costing observation, from hospital accounts records and from public databases. The comparison of efficacy between the two groups was defined as the proportion of strokes avoided.

The trial-based results were extrapolated to a ten-year horizon using a Markov cohort model comprising four health states. Total costs and incremental cost-effectiveness ratios (ICERs) were calculated. Probabilistic sensitivity analyses using bootstrapping evaluated the robustness of the cost-effectiveness results.

RESULTS:

The trial efficacy results have been published elsewhere but in brief, no strokes occurred among the 238 patients in the PFO closure group and strokes occurred in 14 of the 235 patients in the control group (HR 0.03; CI95% 0 to 0.26). The ICER was estimated to be €104,069 (CI €59,359 – €213,221) per stroke avoided at five years (trial data) and €40,415 (CI €23,373 – €62,254) at ten years (extrapolated data).

CONCLUSIONS:

For patients with cryptogenic stroke and echocardiographic features representing a risk of stroke, PFO closure is an effective preventative intervention for stroke recurrence. The screening strategy must be carefully applied to select the population most at risk of stroke recurrence, and this would render the intervention cost effective in most settings.