Author + information
- Sammy Elmariah,
- Anthony Furlan,
- Mark Reisman,
- David Burke,
- Moshe Vardi,
- Shuqiong Ling,
- Xiaohua Chen,
- Laura Mauri,
- CLOSURE I Investigators
Transcatheter closure of patent foramen ovale (PFO) is controversial for the secondary prevention of cryptogenic ischemic neurologic events in patients with PFO. The CLOSURE I trial found that PFO closure was not superior to medical therapy in patients with stroke or transient ischemic attacks (TIA); however, several of the recurrent neurologic events were felt to be unrelated to PFO. We seek to identify predictors of recurrent ischemic neurologic events in patients with PFO within the CLOSURE I trial.
The CLOSURE I trial is a multicenter, randomized, open–label trial of transcatheter PFO closure compared to medical therapy alone 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 logistic regression models within the modified intention–to–treat analysis set.
A total of 851 patients were included in this analysis, 400 of which underwent PFO closure. During follow–up, the cumulative incidence of recurrent events was 6.4% with 25 (3.3%) patients suffering a recurrent stroke and 29 (3.9) a TIA. Patients who had an event had higher body mass index (30.4 ± 6.2 vs 28.4 ± 5.8; P=0.027) and more frequently had hypertension (47 vs 30%; P=0.011). Of patients with an index TIA, 9.3% had a recurrence compared to 4.8% of those with an index stroke (P=0.017). Atrial fibrillation was diagnosed in 26 patients after study enrollment, 24 of which received a closure device. Atrial fibrillation was associated with increased risk of ischemic events (HR = 6.53, 95% CI, 2.61 – 16.4; P<0.0001), but anatomic PFO characteristics and shunt severity were not.
Body mass index, hypertension history, type of index event, and detection of atrial fibrillation after enrollment, and not PFO characteristics, predicted recurrent neurologic events. These findings suggest an alternative etiology to paradoxical embolism frequently caused events within the CLOSURE I trial.
West, Room 2022
Sunday, March 10, 2013, 8:00 a.m.–8:10 a.m.
Session Title: Structural Heart Disease (Non–TAVR)
Abstract Category: 51. TCT@ACC–i2: Non–valvular Structural Heart Disease
Presentation Number: 2906–1
- 2013 American College of Cardiology Foundation