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卒中后卵圆孔未闭封堵术或药物治疗的远期结局
Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke


Jeffrey L. Saver ... 心脑血管疾病 • 2017.09.14
相关阅读
• 卵圆孔未闭封堵术治疗隐源性卒中:数据有限,争论持续 • 隐源性卒中后卵圆孔未闭(PFO)封堵术的复兴? • 特定隐源性卒中患者行卵圆孔未闭(PFO)封堵术的益处 • FDA批准PFO封堵器用于预防复发性卒中 • 隐源性卒中

摘要


背景

卵圆孔未闭封堵术能否降低已有隐源性卒中患者的缺血性卒中复发风险,目前仍然未知。

 

方法

在对终点进行盲法裁定的一项多中心、随机、开放标签试验中,有卵圆孔未闭(patent foramen ovale,PFO)且发生隐源性缺血性卒中的18~60岁患者被随机分组接受PFO封堵术(PFO封堵术组)或仅接受药物治疗(阿司匹林、华法林、氯吡格雷,或阿司匹林联合缓释双嘧达莫;药物治疗组)。主要疗效终点为随机分组后复发非致死性缺血性卒中、致死性缺血性卒中或早期死亡构成的复合终点。此前已有文献报告了原试验期的主要结局分析结果。本文中对延长随访期进行的数据分析属于探索性。

 

结果

我们在69个中心共纳入患者980例(平均年龄45.9岁)。患者的中位随访期为5.9年。两组治疗暴露时间不等(PFO封堵术组3,141患者年vs.药物治疗组2,669患者年),原因为药物治疗组的脱组率较高。意向性治疗人群中,PFO封堵术组和药物治疗组分别有18例和28例患者发生复发的缺血性卒中,对应发生率分别为0.58起事件/100患者年和1.07起事件/100患者年(PFO封堵术组vs.药物治疗组的风险比,0.55;95%置信区间[CI],0.31~0.999;时序检验P=0.046)。PFO封堵术组和药物治疗组中,分别有10例和23例患者发生未确定原因的复发缺血性卒中(风险比,0.38;95% CI,0.18~0.79;P=0.007)。PFO封堵术组中静脉血栓栓塞(事件包括肺栓塞与深静脉血栓形成)比药物治疗组常见。

 

结论

在已经有过隐源性卒中的成人患者中,在延长随访期间,PFO封堵术和单纯药物治疗相比,与较低的复发缺血性卒中发生率相关(由圣犹达医疗[St. Jude Medical]资助;RESPECT在ClinicalTrials.gov注册号为NCT00465270)。





作者信息

Jeffrey L. Saver, M.D., John D. Carroll, M.D., David E. Thaler, M.D., Ph.D., Richard W. Smalling, M.D., Ph.D., Lee A. MacDonald, M.D., David S. Marks, M.D., and David L. Tirschwell, M.D., for the RESPECT Investigators*
From the University of California, Los Angeles (UCLA), Ronald Reagan UCLA Medical Center, Los Angeles (J.L.S.); University of Colorado, Denver, and University of Colorado Hospital, Aurora (J.D.C.), and South Denver Cardiology, Swedish Medical Center, Littleton (L.A.M.) — all in Colorado; Tufts University, Tufts Medical Center, Boston (D.E.T.); University of Texas, Memorial Hermann Heart and Vascular Institute, Houston (R.W.S.); Medical College of Wisconsin, Milwaukee (D.S.M.); and University of Washington, Seattle (D.L.T.). Address reprint requests to Dr. Saver at UCLA, Neurology Department, 710 Westwood Plaza, Los Angeles, CA 90095, or at jsaver@mednet.ucla.edu. *A complete list of investigators in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial is provided in theSupplementary Appendix, available at NEJM.org.

 

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