Treatment Strategies for Cryptogenic Stroke Patients with Patent Foramen Ovale: What Do We Choose?

IMPORTANCE: The treatment of cryptogenic stroke patients with patent foramen ovale to prevent recurrence of stroke, especially when patients consider drug prevention alone, has caused serious treatment dilemmas in clinical practice. OBJECTIVE: To study the safety and efficacy of different treatment strategies using a network meta-analysis of randomized controlled trials in this population with cryptogenic stroke and patent foramen ovale. STUDY SELECTION: PUBMED, EMBASE, The Cochrane Library, WangFang, and China National Knowledge Infrastructure were searched to identify RCT comparing different treatment strategies. Eleven randomized studies were included (n = 5706). MAIN OUTCOMES: The primary efficacy outcome was recurrence of ischemic stroke, including fatal and non-fatal ischemic strokes. The primary safety outcome was major hemorrhage, but closure surgery includes systemic thrombotic events, persistent atrial fibrillation, surgical deaths and other major events. RESULTS: In terms of efficacy and safety events, compared with antiplatelet, the OR of vitamin K antagonists for stroke recurrence was 0.81 (95% CI, 0.41–1.6), the OR of surgical closure was 0.38 (95% CI, 0.16–0.63), and the OR of NOAC was 0.79 (95% CI, 0.27–2.3). Compared with antiplatelet, the safety event OR of vitamin K antagonists was 1.7 (95% CI, 0.65–4.8), the OR of surgical closure was 1.7 (95% CI, 0.68–3.8), and the OR of NOAC was 2.2 (95% CI, 0.67–7.6). CONCLUSION: In terms of effectiveness, surgical occlusion has the best performance, while anticoagulation is the second best. Vitamin K antagonists and non-vitamin K antagonists are difficult to distinguish between the best in effectiveness. Antiplatelet drugs are considered the worst option. Regarding the safety results, it is generally believed that there are no obvious beneficial interventions, but antiplatelet drugs are considered to be relatively best, followed by surgical intervention and vitamin K antagonists, and non-vitamin K antagonists are considered to be the least safe.