Sammy Elmariah1, Anthony J Furlan2, Mark Reisman3, David Burke4, Moshe Vardi4, Neil J Wimmer5, Shuqiong Ling4, Xiaohua Chen4, David M Kent6, Joseph Massaro7, Laura Mauri8. 1. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts. 2. Neurology Department, University Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio. 3. Division of Cardiology, University of Washington Medical Center, Seattle, Washington. 4. Harvard Clinical Research Institute, Boston, Massachusetts. 5. Cardiology Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 6. Department of Neurology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts; Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts. 7. Harvard Clinical Research Institute, Boston, Massachusetts; Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts. 8. Harvard Clinical Research Institute, Boston, Massachusetts; Cardiology Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
Abstract
OBJECTIVES: This study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. BACKGROUND: The CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using the STARFlex device was not superior to medical therapy in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. 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).
RCT Entities:
OBJECTIVES: This study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. BACKGROUND: The CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using the STARFlex device was not superior to medical therapy in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. 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).
Authors: Lei Chen; Wenjun Deng; Igor Palacios; Ignacio Inglessis-Azuaje; David McMullin; Dong Zhou; Eng H Lo; Ferdinando Buonanno; MingMing Ning Journal: J Investig Med Date: 2016-03-17 Impact factor: 2.895
Authors: Wenjun Deng; Shanye Yin; David McMullin; Ignacio Inglessis-Azuaje; Sammy Elmariah; Judy Hung; Eng H Lo; Igor F Palacios; Ferdinando S Buonanno; MingMing Ning Journal: Ann Intern Med Date: 2020-12-01 Impact factor: 25.391
Authors: Kyoung-Min Park; Jin Kyung Hwang; Kwang Jin Chun; Seung-Jung Park; Young Keun On; June Soo Kim; Seung Woo Park; I-Seok Kang; Jinyoung Song; June Huh Journal: Medicine (Baltimore) Date: 2016-08 Impact factor: 1.889