Home > Interventional Cardiology > Closure I trial: PFO closure versus medical therapy for cryptogenic stroke

Closure I trial: PFO closure versus medical therapy for cryptogenic stroke

The Closure I trial randomised clinical trial of patent foramen ovale closure versus medical therapy for cryptogenic stroke has been published in the New England Journal of Medicine.

909 patients were enrolled. The follow up was 2 years. The primary end-point was a composite of death from any cause within 30 days,  neurologic death 31 days to 2 years, stroke or transient ischemic attack during 2 years. The STARFlex closure system was used for closure of the PFO.

Closure did not reduce the primary end-point  in the study.

The neurological end-points (2 year event rates) are tabulated below:

PFO Closure Medical therapy
Stroke 2.9% 3.1%
TIA 3.1% 4.1%

This is an important trial. There are issues of power to detect differences and other comments. See the short editorial .

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  1. April 12, 2012 at 10:19 am

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