Abstract | OBJECTIVES: BACKGROUND: METHODS: The CLOSURE I trial is a multicenter, randomized trial of transcatheter PFO closure compared with medical therapy in patients who presented with cryptogenic stroke or TIA and had a PFO. We identified clinical predictors of recurrent ischemic stroke or TIA during 2 years of follow-up using Cox proportional hazards regression within the pooled intention-to-treat cohort. RESULTS: In 909 patients, the incidence of recurrent events was 5.7% with 25 patients suffering a recurrent stroke and 30 a TIA. Patients who had a recurrent event had higher body mass index (30.2 ± 6.2 vs. 28.3 ± 5.8%; p = 0.03) and more frequently had diabetes (19.2% vs. 7.1%; p = 0.0016), hypertension (46.2% vs. 30.1%; p = 0.015), and ischemic heart disease (3.8% vs. 0.9%; p = 0.05). Diabetes (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.69 to 6.84; p = 0.0007), index TIA (HR vs. stroke: 2.13; 95% CI: 1.20 to 3.80; p = 0.01), and the detection of atrial fibrillation after study enrollment (HR: 4.85; 95% CI: 2.05 to 11.47; p = 0.0003) independently predicted recurrent ischemic neurologic events. Recurrent neurologic events were more frequent in subjects with RoPE (Risk of Paradoxical Embolism) score ≤5 than those with >5 (14.5% vs. 4.2%; p < 0.0001). CONCLUSIONS: These findings suggest an alternative etiology to paradoxical embolism was frequently responsible for recurrent events within the CLOSURE I trial. (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) [CLOSURE I]; NCT00201461).
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Authors | Sammy Elmariah, Anthony J Furlan, Mark Reisman, David Burke, Moshe Vardi, Neil J Wimmer, Shuqiong Ling, Xiaohua Chen, David M Kent, Joseph Massaro, Laura Mauri, CLOSURE I Investigators |
Journal | JACC. Cardiovascular interventions
(JACC Cardiovasc Interv)
Vol. 7
Issue 8
Pg. 913-20
(Aug 2014)
ISSN: 1876-7605 [Electronic] United States |
PMID | 25147037
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Topics |
- Adult
- Cardiac Catheterization
(adverse effects, instrumentation)
- Chi-Square Distribution
- Comorbidity
- Embolism, Paradoxical
(diagnosis, etiology, prevention & control)
- Female
- Foramen Ovale, Patent
(complications, diagnosis, therapy)
- Humans
- Intention to Treat Analysis
- Ischemic Attack, Transient
(diagnosis, etiology, prevention & control)
- Male
- Middle Aged
- Multivariate Analysis
- Proportional Hazards Models
- Prospective Studies
- Prosthesis Design
- Recurrence
- Risk Factors
- Secondary Prevention
(instrumentation, methods)
- Septal Occluder Device
- Stroke
(diagnosis, etiology, prevention & control)
- Time Factors
- Treatment Outcome
- United States
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