6/29/23, 1:12 AM RESPECT Pathway Feedback Search Clinical Topics Home Studies RESPECT RESPECT Disease Disease Disease Acute ischemic stroke Patent foramen ovale Transient Trial question What is the role of closure of patent foramen ovale in patients who had a cryptogenic stroke? Study design Multi-center Open label RCT Population Characteristics of study participants 45.0% female N = 980 55.0% male 980 patients (444 female, 536 male) Inclusion criteria: patients who have had a cryptogenic stroke, and a patent foramen ovale identified by means of transesophageal echocardiography Key exclusion criteria: large-vessel disease, any cardioembolic source, a lacunar infarct that was probably due to intrinsic small-vessel disease, or an arterial hypercoagulable state Interventions N=499 patent foramen ovale closure (insertion of Amplatzer PFO Occluder) N=481 medical therapy (receipt of 1 antiplatelet medications or warfarin) Primary outcome Recurrent stroke https://web.pathway.md/studies/rec0R5rmojEBhKWn4 1/2 6/29/23, 1:12 AM RESPECT Pathway 3.3 % 3.3 2.5 % 1.8 1.6 % 0.8 % No significant difference 0.0 % Patent foramen ovale closure Medical therapy No significant difference in recurrent stroke (1.8% vs. 3.3%; HR 0.49, 95% CI 0.22 to 1.11) Secondary outcomes Significant decrease in recurrence of stroke, as treated cohort (1.1% vs. 3.3%; HR 0.27, 95% CI 0.1 to 0.75) Safety outcomes No significant difference in serious adverse events and AF. Conclusion In patients who have had a cryptogenic stroke, and a patent foramen ovale identified by means of transesophageal echocardiography, patent foramen ovale closure was not superior to medical therapy with respect to recurrent stroke. Reference Carroll JD, Saver JL, Thaler DE et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. Open reference URL https://web.pathway.md/studies/rec0R5rmojEBhKWn4 2/2