Department of Cardiology, Campus Benjamin Franklin, Charité Berlin, Berlin, Germany; Institute for Biomaterial Science, Helmholtz-Institute Geesthacht, Campus Teltow, Teltow, Germany.
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf.
Am Heart J. 2018 Jul;201:95-102. doi: 10.1016/j.ahj.2018.03.025. Epub 2018 Apr 6.
Transcatheter foramen ovale closure (TPC) has emerged as a potential treatment option for patients with cryptogenic strokes and persistent foramen ovale (PFO). However, previous randomized controlled trials could hardly demonstrate any benefit compared to medical treatment (Med-Tx). Recently new data have become available which may change current practice of transcatheter PFO closure.
A systematic review and meta-analysis comparing TPC and Med-Tx based on all available multicentric randomized controlled trials was performed. The primary outcome of interest was the recurrence of stroke in both groups.
Five studies met the inclusion criteria with 1829 patients in the TPC and 1622 in the Med-Tx group. The median follow-up was 4 years. In the intention-to-treat analysis we found a statistically significant relative risk reduction in recurrence of strokes in the TPC group compared to the Med-Tx group (pooled hazard ratio (HR): 0.32; 95% CI: 0.13-0.8; P = .018). Excluding one study due to potential publication bias resulted in a pooled HR of 0.48 (95% CI: 0.25-0.91, P = .024). Patients younger than 45 years of age (pooled HR: 0.35; 95% CI: 0.16-0.75; P = .007) and those with moderate to severe shunt (pooled HR: 0.28; 95% CI: 0.14-0.55; P < .001) were more likely to benefit from closure.
According to our meta-analysis TPC plus antiplatelets was superior in terms of stroke prevention when compared to Med-Tx. Furthermore, patients with moderate to severe shunts and those younger than 45 years of age were found to benefit most from TPC.
卵圆孔未闭（PFO）经导管封堵术（TPC）已成为隐源性卒中伴持续性 PFO 患者的一种潜在治疗选择。然而，与药物治疗（Med-Tx）相比，之前的随机对照试验几乎无法显示任何益处。最近，新的数据已经出现，这可能会改变经导管 PFO 封堵术的当前实践。
对所有可用的多中心随机对照试验进行了系统评价和荟萃分析，比较了 TPC 和 Med-Tx。主要观察终点为两组患者的卒中复发情况。
符合纳入标准的有 5 项研究，TPC 组有 1829 例患者，Med-Tx 组有 1622 例患者。中位随访时间为 4 年。在意向治疗分析中，我们发现 TPC 组与 Med-Tx 组相比，卒中复发的相对风险降低具有统计学意义（合并危险比（HR）：0.32；95%可信区间：0.13-0.8；P =.018）。由于潜在的发表偏倚，排除 1 项研究后，合并 HR 为 0.48（95%可信区间：0.25-0.91，P =.024）。年龄小于 45 岁的患者（合并 HR：0.35；95%可信区间：0.16-0.75；P =.007）和中重度分流的患者（合并 HR：0.28；95%可信区间：0.14-0.55；P <.001）更有可能从封堵中获益。
根据我们的荟萃分析，与 Med-Tx 相比，TPC 加抗血小板治疗在预防卒中方面更具优势。此外，中重度分流和年龄小于 45 岁的患者从 TPC 中获益最大。
