Patent foramen ovale closure vs. medical therapy for recurrent stroke prevention: Evolution of treatment effect during follow-up.
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BORIS DOI
Publisher DOI
PubMed ID
29338916
Description
BACKGROUND
Little is known regarding changes in treatment effect over time associated with patent foramen ovale (PFO) closure among patients with embolic stroke of unknown origin.
METHODS
We reconstructed Kaplan-Meier curves for stroke from individual randomized trials comparing PFO closure vs. medical therapy among patients with embolic stroke. Random effects Cox-regression analyses were performed in order to estimate hazard ratios (HRs) with 95% confidence intervals (95%CIs).
RESULTS
A total of 2531 patients enrolled across 4 randomized trials were included. PFO closure was associated with a significant reduction in the risk of stroke at longest available follow-up (HR 0.18, 95%CI 0.06 to 0.59, P=0.005). However, recurrent stroke was already significantly reduced among patients randomized to PFO closure at 1-year (HR 0.40, 95%CI 0.20 to 0.80, P=0.010), with the treatment effect remaining consistent (P-for-interaction=0.356) between 1- and 5-year (HR 0.14, 95%CI 0.05 to 0.55, P=0.005) and beyond 5-year (HR 0.20, 95%CI 0.03 to 1.19, P=0.077).
CONCLUSIONS
Among patients with embolic stroke of unknown origin, PFO closure reduces the risk of stroke compared with medical therapy, with a significant reduction in recurrences starting already within 1-year after percutaneous PFO closure.
Little is known regarding changes in treatment effect over time associated with patent foramen ovale (PFO) closure among patients with embolic stroke of unknown origin.
METHODS
We reconstructed Kaplan-Meier curves for stroke from individual randomized trials comparing PFO closure vs. medical therapy among patients with embolic stroke. Random effects Cox-regression analyses were performed in order to estimate hazard ratios (HRs) with 95% confidence intervals (95%CIs).
RESULTS
A total of 2531 patients enrolled across 4 randomized trials were included. PFO closure was associated with a significant reduction in the risk of stroke at longest available follow-up (HR 0.18, 95%CI 0.06 to 0.59, P=0.005). However, recurrent stroke was already significantly reduced among patients randomized to PFO closure at 1-year (HR 0.40, 95%CI 0.20 to 0.80, P=0.010), with the treatment effect remaining consistent (P-for-interaction=0.356) between 1- and 5-year (HR 0.14, 95%CI 0.05 to 0.55, P=0.005) and beyond 5-year (HR 0.20, 95%CI 0.03 to 1.19, P=0.077).
CONCLUSIONS
Among patients with embolic stroke of unknown origin, PFO closure reduces the risk of stroke compared with medical therapy, with a significant reduction in recurrences starting already within 1-year after percutaneous PFO closure.
Date of Publication
2018-03-15
Publication Type
Article
Subject(s)
600 - Technology::610 - Medicine & health
Keyword(s)
Embolic stroke Meta-analysis Patent foramen ovale
Language(s)
en
Contributor(s)
Additional Credits
Universitätsklinik für Kardiologie
Emeriti, Medizinische Fakultät
Series
International journal of cardiology
Publisher
Elsevier
ISSN
0167-5273
Access(Rights)
restricted