TY - JOUR
T1 - Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients
T2 - A detailed cost analysis and meta-analysis of randomized controlled trials
AU - Pickett, Christopher A.
AU - Villines, Todd C.
AU - Resar, Jon R.
AU - Hulten, Edward A.
N1 - Publisher Copyright:
© 2018 Elsevier B.V.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/12/15
Y1 - 2018/12/15
N2 - Background: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. Methods and results: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2–3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329–$642,674). After 55.4 years (95%CI 51.1–60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27–0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02–0.57)). Conclusions: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.
AB - Background: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. Methods and results: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2–3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329–$642,674). After 55.4 years (95%CI 51.1–60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27–0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02–0.57)). Conclusions: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.
KW - Cost analysis
KW - Cryptogenic stroke
KW - Meta-analysis
KW - Patent foramen ovale
KW - Stroke
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U2 - 10.1016/j.ijcard.2018.07.099
DO - 10.1016/j.ijcard.2018.07.099
M3 - Article
C2 - 30119914
AN - SCOPUS:85051514094
SN - 0167-5273
VL - 273
SP - 74
EP - 79
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -