22. European Stroke Conference 10:30-12:30 Oral Session Auditorium Large clinical trials B Chairs: D. Easton, USA and G.-L. Lenzi, Italy 1 Large clinical trials (RCTs) B 10:30 - 10:40 Percutaneous Closure of Patent Foramen Ovale versus Medical Treatment in Patients With Cryptogenic Embolism - PC-Trial H.P. Mattle1, B. Meier2, B Kalesan3, S. Windecker4, P Jüni5 PC Trial Investigators Department of Neurology, Inselspital Bern, Bern, SWITZERLAND1,Department of Cardi-ology, Inselspital Bern, Bern, SWITZERLAND2, Institute of Social and Preventive Medicine, University of Bern,, Bern, SWITZERLAND3, Department of Cardiology, Inselspital Bern, Bern, SWITZERLAND4, Clinical Trials Unit, University of Bern,, Bern, SWITZERLAND5 Background The options for secondary prevention in patients with patent foramen ovale (PFO) and crypto-genic stroke or embolism are continuous anticoagulation, antiplatelet medication or closure of the PFO. We determined whether percutaneous PFO closure is superior to medical therapy. Methods We undertook a multicenter, assessor-blind, superiority trial in 29 centers in Europe, Canada, Brazil and Australia. Patients with a PFO and ischemic stroke, transient ischemic attack (TIA) or peripheral thromboembolism were randomly assigned to PFO closure with the Amplatzer PFO Occluder or medical therapy. The primary endpoint was a composite of death, nonfatal stroke, TIA, or peripheral embolism. Analysis was by intention-to-treat. Results A total of 204 patients were randomized to PFO closure and 210 to medical therapy. The mean durations of follow-up were 4.1 years in the closure and 4.0 years in the medical group, with 845.1 and 835.0 patient-years of follow-up, respectively. The primary endpoint occurred in 7 patients of the closure versus 11 patients in the medical group (HR 0.63, 95%-CI 0.24 to 1.62, p=0.34). Nonfatal stroke occurred in 1 (0.5%) versus 5 (2.4%) patients (HR 0.20, 95% CI 0.02 to 1.72, p=0.14), and TIAs in 5 (2.5%) versus 7 (3.3%) patients (HR 0.71, 95%-CI 0.23 to 2.24, p=0.56). Conclusions PFO closure with the Amplatzer PFO Occluder for secondary prevention of cryptogenic em-bolism did not show a statistically significant reduction in embolic events or death. (Research Grant by St. Jude Medical; ClinicalTrials.gov number, NCT00166257) 2 Large clinical trials (RCTs) B 10:40 - 10:50 Effect of Having an Amplatzer Patent Foramen Occlusion Device in Place in the RE-SPECT Trial D.E. Thaler1, J.L. Saver2, R.W. Smalling3, J.D. Carroll4, S. Berry5, L.A. MacDonald6, D.S. Marks7, D.L. Tirschwell8, D.S. Book9, L.B. Goldstein10 For the RESPECT Trialists Tufts University/ Tufts Medical Center, Boston, USA1,University of California, Los Ange-les, Los Angeles, USA2, University of Texas/Memorial Hermann Heart and Vascular Institute, Houston, USA3, University of Colorado Denver/University of Colorado Hospital, Aurora, USA4, Berry Consultants, Austin, USA5, South Denver Cardiology/ Swedish Medical Center, Littleton, USA6, Medical College of Wisconsin/ Froedtert Hospital, Milwaukee, USA7, Univer-sity of Washington, Seattle, USA8, Medical College of Wisconsin/ Froedtert Hospital, Milwau-kee, USA9,Duke University Medical Center, Durham, USA10 Background: In pre-specified secondary analyses, device superiority was demonstrated in the RESPECT trial i.e. fewer recurrent strokes compared with medical therapy. To characterize the device effect further a post-hoc, “device in place” analysis, was done. Methods: RESPECT was a prospective, multicenter, randomized trial designed to test whether PFO closure (AMPLATZER™ PFO Occluder) is superior to medical treatment for preventing recurrent ischemic strokes or death in young cryptogenic stroke (CS) patients. In this analysis, all patient days with a device in place were analyzed in the device group and all days without a device were analyzed in the medical group. Results: We enrolled 980 patients (mean age 46y). Follow-up was 2,559 patient years; median 2.1y (interquartile range 1.0 -4.1). Baseline characteristics were well-balanced across treatment arms. All 25 primary end point events (16 medical, 9 device) were recurrent ischemic strokes. In time to event analyses, device therapy was associated with a trend for benefit in the intention to treat population (hazard ratio, HR 0.49; CI 0.22-1.11; P=0.08), and significant benefit in the per protocol (HR 0.37; CI 0.14-0.96; P=0.03), and as-treated (HR 0.27; CI 0.10-0.75; P=0.007) populations. Of the 9 device arm ischemic strokes, 3 occurred without a device in place, i.e. 1) after randomization but before device placement; 2) assigned to device arm but declined; and 3) received surgical PFO closure. For this analysis, these 3 events were assigned to the “no device in place” group. Having a device in place was associated with a significant benefit, HR 0.30; CI 0.12-0.75, p=0.006. Conclusion: In patients with CS and PFO, the AMPLATZER PFO Occluder showed benefit over medical management which was magnified in the patient population defined by presence or absence of a device in place. These data provide evidence of a genuine biologic effect of de-vice closure in reducing recurrent stroke due to paradoxical embolization. 106 © 2013 S. Karger AG, Basel Scientific Programme
Karger_ESC London_2013
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