Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients: A detailed cost analysis and meta-analysis of randomized controlled trials

Christopher A. Pickett, Todd C. Villines, Jon R Resar, Edward A. Hulten

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalInternational Journal of Cardiology
DOIs
StateAccepted/In press - Jan 1 2018

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Patent Foramen Ovale
Cost-Benefit Analysis
Meta-Analysis
Randomized Controlled Trials
Stroke
Confidence Intervals
Costs and Cost Analysis
Therapeutics
Quality-Adjusted Life Years
Transient Ischemic Attack
Observational Studies

Keywords

  • Cost analysis
  • Cryptogenic stroke
  • Meta-analysis
  • Patent foramen ovale
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{23b2430a3879480b8833727dfcc531c0,
title = "Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients: A detailed cost analysis and meta-analysis of randomized controlled trials",
abstract = "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.",
keywords = "Cost analysis, Cryptogenic stroke, Meta-analysis, Patent foramen ovale, Stroke",
author = "Pickett, {Christopher A.} and Villines, {Todd C.} and Resar, {Jon R} and Hulten, {Edward A.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.ijcard.2018.07.099",
language = "English (US)",
journal = "International Journal of Cardiology",
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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.

PY - 2018/1/1

Y1 - 2018/1/1

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

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KW - Meta-analysis

KW - Patent foramen ovale

KW - Stroke

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