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1、SAPPHIRE 研究研究ANGIOGUARD血栓保护装置血栓保护装置Cordis PRECISE支架支架CONSENSUS一致同意一致同意RANDOMIZED, PROSPECTIVE随机,前瞻随机,前瞻性性310 (12 month)Stenting支架组支架组=159 / CEA=151STENTREGISTRY支架注册支架注册407SURGICAL REFUSAL外科拒绝外科拒绝SURGICALREGISTRY外科注册外科注册7INTERVENTIONALREFUSAL介入拒绝介入拒绝 EventsStent (159 pst)CEA (151 pts)p ValueStent (15
2、9 pts)CEA (151 pts)p ValueDeath0.6%2.0%0.366.9%12.6%0.12Stroke3.1%3.3% 0.995.7%7.3%0.66Major ipsilateral0.0%1.3%0.240.0%3.3%0.03Major Non-Ipsilateral0.6%0.7% 0.990.6%0.7% 0.99Minor Ipsilateral2.5%0.7%0.373.8%2.0%0.5Minor Non -Ipsilateral0.6%0.7 0.991.9%2.0% 0.99MI (Q or NQ)1.9%6.6%0.052.5%7.9%0.04Q-
3、Wave MI0.0%1.3%0.240.0%1.3%0.24Non-Q Wave MI1.9%5.3%0.132.5%6.6%0.1Death / Stroke3.8%4.6%0.78Death / Stroke / MI4.4%9.9%0.0811.9%19.9%0.06MAE withoutnon-neuro Death 30 days5.7%12.6% 30 days5.0%7.3%0.48Randomized Patients 12-Month EventsRandomized Patients 30-Day EventsSAPPHIRE (high-risk patients) 3
4、0 days and 12 months results SAPPHIRE (high-risk patients) 30 days and 12 month results“Stented patients are now 12 months out from treatment, and their MAE rate continue to be as good as, and in many ways better than, those for the surgically treated group.”接受治疗接受治疗12个月后,支架组病人不良事件的发生率相当于,甚至在很多方面,优于
5、手术治疗组。个月后,支架组病人不良事件的发生率相当于,甚至在很多方面,优于手术治疗组。Overall MAE rate总体主要不良事件发生率总体主要不良事件发生率11.9% vs. 19.9% : difference 显著差异显著差异, p = 0.06Death rate 死亡率死亡率6.9% vs. 12.6%: double number of patients died in the CEA arm 外科组死亡人数比支架组多一倍外科组死亡人数比支架组多一倍Stroke rate中风发生率中风发生率 5.7% vs. 7.3%: 30% more patients experience
6、d a stroke in the CEA arm 外科组至少发生一次中风的病人数比支架组多外科组至少发生一次中风的病人数比支架组多30%Major Ipsilateral Stroke rate主要同侧大中风发生率主要同侧大中风发生率 0.0% vs. 3.3% was significant higher in CEA 外科组显著高于支架组,外科组显著高于支架组,p = 0.03MI (Q or non Q) rate 心梗发生率心梗发生率2.5% vs. 7.9%: patients got 3 times more MI in the CEA arm 外科组发生心梗的病人数比支架组多三
7、倍以上外科组发生心梗的病人数比支架组多三倍以上Outcome of cranial nerve injury (30 days) 30天内颅神经损伤的发天内颅神经损伤的发生率生率 0.0% vs. 5.3%: was significant for CEA arm外科组显著高于支架组,外科组显著高于支架组,p 0.01CAS(n-1262)CEA(n=1240)年龄6969女性3634无症状性4747高血压8686糖尿病3030血脂异常8285目前吸烟2626心血管病4043平均收缩压mmHg14214170%狭窄的例数8587症状性狭窄发病天数2025 HR=1.11 95%CI 0.81-
8、1.51 P=0.51 HR=1.18 95%CI 0.82-1.68 P=0.38 卒中 HR=1.79 95% CI 1.14-2.82 P=0.01 心梗 HR=1.35 95% CI 0.54-3.36 P=0.52 HR=0.07 95% CI 0.02-0.18 P0.0001 HR=0.94 95% CI 0.50-1.76 P=0.85结论 50100 U/kg)球扩式支架球扩式支架Palmaz Stent (Cordis)自膨式支架自膨式支架Carotid Wallstent (Boston Scientific)PRECISE (Cordis)Protg (ev3) (Ab
9、bott)雕刻支架雕刻支架 编织支架编织支架优点优点支撑力更大支撑力更大, ,不易塌陷不易塌陷柔韧性更强,表面光滑,易于球囊通过柔韧性更强,表面光滑,易于球囊通过网孔密集,限制斑块脱落网孔密集,限制斑块脱落可重新定位、再次释放可重新定位、再次释放不足不足短缩、不易精确定位短缩、不易精确定位拉伸颈动脉、上端扭曲、成角拉伸颈动脉、上端扭曲、成角凹凸不平处贴壁欠佳凹凸不平处贴壁欠佳优点优点顺应性好,适应不同形状而不造成血管顺应性好,适应不同形状而不造成血管强直强直贴壁性好,不易造成死腔贴壁性好,不易造成死腔基本无缩短,定位和选择长度较精确基本无缩短,定位和选择长度较精确不足不足后扩时有连接点断裂的风
10、险后扩时有连接点断裂的风险External Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryTerumo guidewire0.035”100cmHeadhunter5F Tempo200cmINTRODUCE GUIDEWIRE AND INTRODUCER SHEATHExternal Carotid ArteryInternal Carotid ArteryCommon Carotid A
11、rteryTerumo guidewire0.035”100cmHeadhunter5F Tempo200cmINTRODUCE GUIDEWIRE AND INTRODUCER SHEATHExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArterySELECTIVE CATHETHETERISATION OF ECATerumo guidewire0.035”100cmHeadhunter5F Tempo200cmExternal Carotid ArteryInternal Carotid ArteryCommon
12、 Carotid ArteryHeadhunter5F Tempo200cmEXCHANGEGUIDEWIRETerumo guidewire0.035”100cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryHeadhunter5F Tempo200cmEXCHANGEGUIDEWIREExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryHeadhunter5F Tempo200cmEXCHANGEGUIDEWIREAmpl
13、atz Emerald0.035”260cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryAmplatz Emerald0.035”260cmEXCHANGEINTRODUCER SHEATHExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryAmplatz Emerald0.035”260cmBrite Tip Sheath7F80cmEXCHANGEINTRODUCER SHEATHExternal Carotid Art
14、eryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cmREMOVE GUIDEWIRECarotid Artery Disease :Carotid Angioplasty - ProcedureHintsExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cmINTRODUCE PROTECTION DEVICEExternal Carotid ArteryInternal Carotid
15、 ArteryCommon Carotid ArteryAngioguard0.014”300cmBrite Tip Sheath7F80cmINTRODUCE PROTECTION DEVICEAngioguard Device :Delivery Sheath Covering FilterExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cmCROSS LESION WITH PROTECTION DEVICEAngioguard0.014”300cmExterna
16、l Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cmCROSS LESION WITH PROTECTION DEVICEAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryDEPLOYMENT PROTECTION DEVICEBrite Tip Sheath7F80cmAngioguard0.014”300cmAngioguard Device :Filte
17、r DeployedCarotid Artery Disease :Carotid Angioplasty - ProcedureHintsExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArterySTENT DEPLOYMENT Smart Carotid stent7-8mm30-40mmBrite Tip Sheath7F80cmAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite
18、 Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmSTENT DEPLOYMENTAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmANGIOGRAPHICCONTROLAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon
19、Carotid ArteryBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmANGIOGRAPHICCONTROLAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid Artery Savvy balloon5-6mm30-40mmBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmPOSTDILATATIONAngioguard0.014”300cmExternal C
20、arotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmPOSTDILATATIONAngioguard0.014”300cm Savvy balloon5-6mm30-40mmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmANGIOGR
21、APHICCONTROLAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmANGIOGRAPHICCONTROLAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryRETRIEVAL PROTECTION DEVICEBrite Tip Sheath7F80cm Smart Carotid stent7-8mm30-40mmAngioguard0.014”300cmExternal Carotid ArteryInternal Carotid ArteryCommon Carotid ArteryBrite Tip Sheath7F80
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