Patent foramen ovale, cardiac valve thickening, and antiphospholipid antibodies as risk factors for subsequent vascular events: the PICSS-APASS study.
Patent foramen ovale, cardiac valve thickening, and antiphospholipid antibodies as risk factors for subsequent vascular events: the PICSS-APASS study.
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DOI：
10.1161/strokeaha.108.539171
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发表时间：
2009-07
期刊：
影响因子：
8.3
通讯作者：
PICSS-APASS Investigators
中科院分区：
文献类型：
--
作者：
Rajamani K;Chaturvedi S;Jin Z;Homma S;Brey RL;Tilley BC;Sacco RL;Thompson JL;Mohr JP;Levine SR;PICSS-APASS Investigators
(1)估计隐源性卒中研究（PICSS）队列中存在卵圆孔未闭（PFO）和抗磷脂抗体（aPL）的卵圆孔未闭亚组的复发性卒中/TIA/死亡风险，（2）估计aPL阳性且左心瓣膜（VaT）增厚患者的复发性卒中/TIA/死亡风险。PFO与隐源性缺血性卒中相关。此外，aPL的存在与缺血性脑血管疾病有关。对华法林阿司匹林复发性卒中试验（WARSS）的2个主要子研究的合并数据进行了评价。如果PICSS受试者入组抗磷脂抗体和卒中研究（APASS），并且在卒中1个月内进行了基线aPL试验（狼疮抗凝剂、抗心磷脂抗体或两者），则纳入PICSS受试者。PICSS中的所有患者均接受了PFO和VaT的经食管超声心动图检查，对aPL状态和治疗组（325 mg/d阿司匹林或调整剂量华法林，目标INR 1.4-2.8）设盲。主要结局事件为2年复发性卒中/TIA/死亡的风险，并使用考克斯比例风险模型进行评估。由于没有治疗效果，华法林和阿司匹林组合并使用以增加把握度。对于联合终点，PFO和aPL阳性组检测HR为2的把握度为47.8%，瓣膜增厚和aPL阳性组为75.3%，假设双侧I型错误为0.05，525例受试者接受了PFO和aPL联合存在的检验，可用于评价。PFO阳性/aPL阳性组的主要结局事件发生率为23.9%（HR 1.39，95% CI 0.75-2.59），而PFO阳性/aPL阴性组为13.9%（HR 0.83，95% CI 0.44-1.56），PFO阴性/aPL阳性组为19.9%（HR 1.16，95% CI 0.68-1.90）。545例受试者接受了aPL和左侧心脏VaT的联合检测，可用于评价。VaT阳性/aPL阳性组的主要事件发生率为22.6%（HR 1.65，95% CI 0.88-3.09），而VaT阳性/aPL阴性组为19.4%（HR 1.50，95% CI 0.82-2.75），VaT阴性/aPL阳性组为20.2%（HR 1.63，95% CI 0.81-3.25）。在该PICCS/APASS患者队列中，aPL与PFO或左侧心脏VaT的联合存在并未显著增加随后脑血管事件的风险。
(1) Estimate risk of recurrent stroke/TIA/death in the subgroup of the Patent foramen ovale in the Cryptogenic Stroke Study (PICSS) cohort with patent foramen ovale (PFO) and antiphospholipid antibodies (aPL) and (2) Estimate risk of recurrent stroke/TIA/death in aPL positive patients who have thickened left-sided heart valves (VaT). PFO is associated with cryptogenic ischemic stroke. Also, the presence of aPL is associated with ischemic cerebrovascular disease. Combined data from 2 major sub studies of the Warfarin Aspirin Recurrent Stroke Trial (WARSS) were evaluated. PICSS subjects were included if they were enrolled in the Antiphospholipid Antibodies and Stroke Study (APASS) and had a baseline aPL test (lupus anticoagulant, anticardiolipin antibodies, or both) within one month of the stroke. All patients in PICSS underwent transesophageal echocardiography for PFO as well as VaT, which was performed blinded to aPL status and treatment arm (325mg/d aspirin or adjusted dose warfarin, target INR 1.4–2.8). The primary outcome event was the 2-year risk of recurrent stroke/TIA/death and was evaluated using Cox proportional hazards model. As there was no treatment effect, warfarin and aspirin groups were combined to increase power. For the combined endpoint, power to detect a HR of 2 was 47.8% for the PFO and aPL positive group, and 75.3% for the valve thickening and aPL positive group, assuming two-sided type I error of 0.05 525 subjects were tested for the combined presence of PFO and aPL and were available for evaluation. The primary outcome event rate was 23.9% (HR 1.39, 95% CI 0.75–2.59) in the PFO positive/aPL positive group, compared to 13.9% (HR 0.83, 95% CI 0.44–1.56) in the PFO positive/aPL negative group and 19.9% (HR 1.16 95% CI 0.68–1.90) in the PFO negative/aPL positive group. 545 subjects tested for combined presence of aPL and left sided cardiac VaT were available for evaluation. The primary event rate was 22.6% (HR1.65, 95% CI 0.88–3.09) in the VaT positive/aPL positive group, compared to 19.4% (HR 1.50, 95% CI 0.82–2.75) in the VaT positive/aPL negative group and 20.2% (HR 1.63, 95% CI 0.81–3.25) in the VaT negative /aPL positive group. The combined presence of aPL with either a PFO or with left sided cardiac VaT did not significantly increase risk of subsequent cerebrovascular events in this PICCS/APASS cohort of patients.