P766 Elegibility for CLOSE and REDUCE trials of real world patients with Transient Ischemic Attack (TIA) or Acute Ischemic Stroke (AIS) and Patent Foramen Ovale (PFO)
Authors: Beringuilho M , Faria D , Freitas A , Bernardo F , Rego A , Machado S , Nogueira Pinto A 
Published: January 2020

Introduction

In the last decade there has been an intense discussion in which therapeutic option is most suitable for patients with TIA or cryptogenic AIS and a PFO. Recently two randomised studies (CLOSE and REDUCE) have been published tackling this question. Both have showed preference in lower recurrence rates in the group assigned for PFO closure. The eligibility criteria of these types of studies frequently are very restricted, becoming difficult to ascertain the best therapeutic option for a large number of patients.

Goal

Analyse a real world cohort of patients with TIA or cryptogenic AIS with PFO and identify the eligibility of these patients for the inclusion in the CLOSE and REDUCE trials.

Methods

We made a retrospective observational analysis of a cohort of patients discussed in a multidisciplinary meeting (Cardiology and Neurology departments) of our Hospital in which is made the decision of PFO closure vs conservative management between November 2017 and November 2018. We included all the patients with probable TIA or AIS and PFO. Demographic, clinical, image and therapeutic data was registered. The inclusion and exclusion criteria used in CLOSE and REDUCE trial were applied.

Results

25 patients were analysed, 56.0% (n = 14) were male. Median age of 47 years. Median RoPE score 7. The commonest cardiovascular risk factors were hypertension (36.0%, n = 9) and smoking (28.0%, n = 7). Eight patients met criteria for cortical cryptogenic AIS, three had lacunar strokes, two had TIA with findings in cerebral imaging and twelve presented with TIA without findings in cerebral imaging. Transesophagic echocardiography was performed in 92.0% (n = 23) of patients, transthoracic echocardiography with bubble study was performed in two cases. At the time of data collection, six patients were waiting completion of the workup. PFO closure was performed in three cases. Closure was proposed in other two. When applying the eligibility criteria of CLOSE and REDUCE the main reasons for exclusion in the REDUCE trial were TIA without cerebral imaging (48.0%, n = 12), incomplete antiphospholipid antibody syndrome screening (36.0%, n = 9) and age greater than 59 years (28.0%, n = 7). The main reasons for exclusion in the CLOSE trial were TIA without cerebral imaging (48.0%, n = 12), age greater than 60 years (28%, n = 7) and failing to meet the designated echocardiography criteria (20.0%, n = 5).

Conclusion

2 real world patients met eligibility criteria for the REDUCE trial and 3 for CLOSE. The main reason for exclusion in both REDUCE and CLOSE was TIA without cerebral imaging (48.0% n = 12). Older patients, and patients with a prothrombotic condition were also excluded. Multidisciplinary meetings are essential to ascertain the most beneficial therapeutic option for these patients. It is our believe that the management of risk factors should be similar in a TIA and a AIS and also that the presence of a prothrombotic condition should favor the closure of PFO.