Goel Sunny, Patel Shanti, Zakin Elina, Pasam Ravi Teja, Gotesman Joseph, Malik Bilal Ahmad, Ayzenberg Sergey, Frankel Robert, Shani Jacob
Department of Cardiology, Maimonides Medical Center, Brooklyn, NY, 11219, USA.
Department of Cardiology, Maimonides Medical Center, Brooklyn, NY, 11219, USA.
Indian Heart J. 2019 Nov-Dec;71(6):446-453. doi: 10.1016/j.ihj.2019.10.002. Epub 2019 Oct 22.
The objective of this study was to compare safety and efficacy of patent foramen ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke (CS).
The role of PFO closure in preventing recurrent stroke in patients with prior CS has been controversial.
We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials that compared device closure with medical management and reported on subsequent stroke and adverse events. Event rates were compared using a forest plot of relative risk using a random-effects model assuming interstudy heterogeneity.
A total of 6 studies (n = 3747) were included in the final analysis. Mean follow-up ranged from 2 to 5.9 years. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (risk ratio [RR] = 0.41, 95% CI = 0.20-0.83, I = 51%, P = 0.01). There was, however, a significant increase in atrial fibrillation with device therapy (RR = 5.29, 95% CI = 2.32-12.06, I = 38%, P < 0.0001). No effect was observed on major bleeding (P = 0.50) or mortality (P = 0.42) with device therapy. Subgroup analyses showed that device closure significantly reduced the incidence of the composite primary end point among patients who had large shunt sizes (RR = 0.35, 95% CI = 0.18-0.68, I = 27%, P = 0.002). The presence/absence of atrial septal aneurysm (P = 0.52) had no effect on the outcome.
PFO closure is associated with a significant reduction in the risk of stroke compared to medical management. However, it causes an increased risk of atrial fibrillation.
本研究的目的是比较卵圆孔未闭（PFO）封堵术与药物治疗对隐源性卒中（CS）患者的安全性和有效性。
PFO封堵术在预防既往CS患者复发性卒中中的作用一直存在争议。
我们检索了PubMed、EMBASE、Cochrane对照试验中央注册库以及clinicaltrials.gov上维护的临床试验注册库，以查找比较器械封堵与药物治疗并报告后续卒中和不良事件的随机对照试验。使用随机效应模型的森林图比较事件发生率，该模型假设研究间存在异质性。
最终分析纳入了6项研究（n = 3747）。平均随访时间为2至5.9年。汇总分析显示，与药物治疗相比，器械封堵与卒中显著减少相关（风险比[RR] = 0.41，95%置信区间[CI] = 0.20 - 0.83，I² = 51%，P = 0.01）。然而，器械治疗导致房颤风险显著增加（RR = 5.29，95% CI = 2.32 - 12.06，I² = 38%，P < 0.0001）。器械治疗对大出血（P = 0.50）或死亡率（P = 0.42）无影响。亚组分析表明，器械封堵显著降低了大分流患者复合主要终点的发生率（RR = 0.35，95% CI = 0.18 - 0.68，I² = 27%，P = 0.002）。房间隔瘤的存在与否（P = 0.52）对结果无影响。
与药物治疗相比，PFO封堵术与卒中风险显著降低相关。然而，它会导致房颤风险增加。
