Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
EuroIntervention. 2018 Oct 20;14(8):857-867. doi: 10.4244/EIJ-D-18-00341.
Although three recent trials have shown a significant stroke risk reduction after tPFOc, the individual statistical power is limited and the impact on pooled evidence needs to be explored. We aimed to pool data from available randomised clinical trials (RCT) to assess whether tPFOc is more effective and safe than antithrombotic therapy alone (ATA).
Major electronic databases and tangential sources were searched. Six trials (3,560 patients) were identified. At a median follow-up of 3.6 (2.0-5.2) years (13,930 person-years), the risk of stroke was significantly lower after tPFOc compared with ATA (HR 0.28, 95% CI: 0.12-0.64, p=0.003). Significant heterogeneity was detected (I2=66.1%), although single trials did not significantly influence the results. Reconstructed time-to-event data revealed that tPFOc benefits accrue after approximately one year and persist over time without significant variations (96.4% versus 88.0%; HR 0.25, 95% CI: 0.09-0.66, p=0.005; NNT=11). Although results showed a greater benefit in patients <45 years old, male, and with substantial shunt, interaction between subgroups was not significant. Trial sequential analysis showed that accumulated evidence appeared to be sufficient. However, tPFOc did not confer protection against transient ischaemic attack (TIA; HR 0.69, 95% CI: 0.31-1.54, p=0.365) and a significant excess in the risk of atrial fibrillation was observed (OR 4.99, 95% CI: 1.99-10.10, p<0.001), though generally early and transient. Major bleeding and migraine were comparable between treatments.
Compared with ATA, tPFOc significantly reduces the risk of stroke at long-term follow-up but no benefit is observed in terms of TIA. Atrial fibrillation is higher after tPFOc, though generally early and transient. The risks of major bleeding and migraine are comparable between the groups.
尽管最近三项试验表明经皮卵圆孔未闭封堵术（tPFOc）可显著降低卒中风险，但个体的统计效能有限，需要探讨对汇总证据的影响。我们旨在汇总来自现有随机临床试验（RCT）的数据，以评估 tPFOc 是否比单独抗血栓治疗（ATA）更有效和安全。
主要电子数据库和相关来源进行了检索。确定了 6 项试验（3560 例患者）。中位随访 3.6 年（2.0-5.2 年）（13930 人年），与 ATA 相比，tPFOc 后卒中风险显著降低（HR 0.28，95%CI：0.12-0.64，p=0.003）。尽管各单中心试验未显著影响结果，但检测到显著的异质性（I2=66.1%）。重建的生存数据表明，tPFOc 的益处大约在 1 年后出现，并随着时间的推移持续存在，且无明显变化（96.4%对 88.0%；HR 0.25，95%CI：0.09-0.66，p=0.005；NNH=11）。尽管结果表明年龄<45 岁、男性和存在大量分流的患者获益更大，但亚组之间无显著的交互作用。试验序贯分析表明，累积证据似乎充足。然而，tPFOc 并不能预防短暂性脑缺血发作（TIA；HR 0.69，95%CI：0.31-1.54，p=0.365），且观察到心房颤动的风险显著增加（OR 4.99，95%CI：1.99-10.10，p<0.001），尽管通常为早期和短暂性的。tPFOc 组与 ATA 组的主要出血和偏头痛发生率相当。
与 ATA 相比，tPFOc 可显著降低长期随访时的卒中风险，但在 TIA 方面无获益。tPFOc 后心房颤动的发生率较高，但通常为早期和短暂性的。两组之间的主要出血和偏头痛风险相当。
