Romoli Michele, Giannandrea David, Eusebi Paolo, Cupini Letizia M, Ricci Stefano, Calabresi Paolo
Neurology Unit, Rimini "Infermi" Hospital - AUSL Romagna, Rimini, Italy.
Neurology Clinic, University of Perugia - S. Maria della Misericordia Hospital, Perugia, Italy.
Neurol Sci. 2020 Oct;41(10):2819-2824. doi: 10.1007/s10072-020-04388-4. Epub 2020 Apr 18.
Since closure has restrictive eligibility criteria, the vast majority of patients with cryptogenic stroke and patent foramen ovale (PFO) receive medical treatment. However, the optimal antithrombotic strategy is still unclear. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to define risk/benefit profile of anticoagulation compared with antiplatelet treatment in PFO-related stroke.
Systematic review protocol was registered in PROSPERO (CRD42019117559). Following PRISMA guidelines, we searched MEDLINE, EMBASE, and Cochrane CENTRAL database (2000-2019) for RCTs randomly allocating patients with cryptogenic stroke and PFO to medical treatment. Risk of bias was assessed with Cochrane RoB tool. Main outcomes were stroke recurrence and major bleeding. RoPE score-dependent analysis was implemented to define a possible role for patient selection.
Five RCTs met inclusion criteria (3 high-, 1 fair-, 1 poor-quality RCTs). Overall, meta-analysis included 1565 patients (mean age 55.5 years), 753 (48.1%) receiving anticoagulation. Compared with antiplatelet treatment, anticoagulation conveyed no net benefit in prevention of recurrent stroke (OR = 0.66, 95% CI 0.41-1.07, p = 0.46), and associated with a non-significant higher risk of major bleeding (OR = 1.64, 95% CI 0.79-3.43, p = 0.57). In patients with high RoPE score, anticoagulation significantly reduced the risk of recurrent stroke (OR = 0.22, 95% CI 0.06-0.8, p = 0.88).
Our meta-analysis shows that anticoagulation confers no net benefit in recurrent stroke prevention over antiplatelets in patients with PFO-related stroke. RoPE score might help in selecting patients benefiting from anticoagulation, but further trials are needed to delineate risk/benefit profile of anticoagulation.
由于封堵术的入选标准具有局限性，绝大多数患有不明原因卒中且伴有卵圆孔未闭（PFO）的患者接受药物治疗。然而，最佳的抗栓策略仍不明确。我们对随机对照试验（RCT）进行了系统评价和荟萃分析，以确定在PFO相关性卒中中，抗凝治疗与抗血小板治疗相比的风险/获益情况。
系统评价方案已在国际前瞻性系统评价注册库（PROSPERO，注册号CRD42019117559）登记。按照PRISMA指南，我们检索了MEDLINE、EMBASE和Cochrane CENTRAL数据库（2000 - 2019年），以查找将不明原因卒中和PFO患者随机分配至药物治疗组的RCT。采用Cochrane偏倚风险工具评估偏倚风险。主要结局为卒中复发和大出血。实施基于风险预测概率（RoPE）评分的分析，以确定患者选择的可能作用。
5项RCT符合纳入标准（3项高质量、1项中等质量、1项低质量RCT）。总体而言，荟萃分析纳入了1565例患者（平均年龄55.5岁），其中753例（48.1%）接受抗凝治疗。与抗血小板治疗相比，抗凝治疗在预防卒中复发方面未带来净获益（OR = 0.66，95%CI 0.41 - 1.07，p = 0.46），且大出血风险虽有升高但不显著（OR = 1.64，95%CI 0.79 - 3.43，p = 0.57）。在RoPE评分高的患者中，抗凝治疗显著降低了卒中复发风险（OR = 0.22，95%CI 0.06 - 0.8，p = 0.88）。
我们的荟萃分析表明，在PFO相关性卒中患者中，抗凝治疗在预防卒中复发方面相较于抗血小板治疗未带来净获益。RoPE评分可能有助于选择能从抗凝治疗中获益的患者，但需要进一步试验来明确抗凝治疗的风险/获益情况。
