Patti Giuseppe, Pelliccia Francesco, Gaudio Carlo, Greco Cesare
Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
Department of Heart and Great Vessels "Attilio Reale," La Sapienza University, Rome, Italy.
Am J Cardiol. 2015 Mar 15;115(6):837-43. doi: 10.1016/j.amjcard.2014.12.051. Epub 2015 Jan 6.
We pooled available data on follow-up events in patients with patent foramen ovale and cryptogenic stroke to evaluate the net clinical benefit of different therapeutic strategies (percutaneous closure vs antiplatelet vs anticoagulant therapy). MEDLINE/PubMed and Cochrane databases and reviewed cited references to identify relevant studies were used; 3,311 patients from 21 clinical studies, both observational and randomized, with follow-up ≥12 months were overall included. Net clinical benefit was evaluated considering the cumulative incidence of both stroke and/or transient ischemic attack and major bleeding events. Anticoagulant therapy was more effective than antiplatelet therapy in preventing recurrent stroke and/or transient ischemic attack (event rates: 7.7% vs 9.8%, respectively, p = 0.03), but at the price of more than sixfold greater risk of major bleeding (7.1% vs 1.3%; odds ratio 6.49, 95% confidence interval 3.25 to 12.99, p <0.00001). Patent foramen ovale closure was associated over the long term with significant net clinical benefit versus both antiplatelet and anticoagulant therapy; such benefit was driven by 50% relative reduction of stroke and/or transient ischemic attack versus antiplatelet therapy and by 82% relative reduction of major bleeding versus anticoagulant therapy. In conclusion, results of this large study-level meta-analysis may influence practice patterns in patients with patent foramen ovale and cryptogenic stroke; an individualized approach tailored on both the risk of recurrent cerebral events and the bleeding risk should be used to identify the best therapeutic option (percutaneous closure vs antiplatelet therapy vs anticoagulant therapy).
我们汇总了卵圆孔未闭和隐源性卒中患者随访事件的可用数据，以评估不同治疗策略（经皮封堵术与抗血小板治疗与抗凝治疗）的净临床获益。使用MEDLINE/PubMed和Cochrane数据库，并查阅引用文献以识别相关研究；总共纳入了来自21项观察性和随机临床研究的3311例患者，随访时间≥12个月。考虑到卒中、短暂性脑缺血发作和大出血事件的累积发生率来评估净临床获益。抗凝治疗在预防复发性卒中或短暂性脑缺血发作方面比抗血小板治疗更有效（事件发生率分别为7.7%和9.8%，p = 0.03），但大出血风险高出6倍多（7.1%对1.3%；优势比6.49，95%置信区间3.25至12.99，p <0.00001）。从长期来看，卵圆孔未闭封堵术与抗血小板治疗和抗凝治疗相比均具有显著的净临床获益；这种获益是由于与抗血小板治疗相比，卒中或短暂性脑缺血发作相对减少了50%，与抗凝治疗相比，大出血相对减少了82%。总之，这项大型研究水平的荟萃分析结果可能会影响卵圆孔未闭和隐源性卒中患者的治疗模式；应采用根据复发性脑部事件风险和出血风险量身定制的个体化方法来确定最佳治疗选择（经皮封堵术与抗血小板治疗与抗凝治疗）。
