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1、SAPPHIRE 研究研究ANGIOGUARD血栓保護(hù)裝置血栓保護(hù)裝置Cordis PRECISE支架支架CONSENSUS一致同意一致同意RANDOMIZED, PROSPECTIVE隨機,前瞻隨機,前瞻性性310 (12 month)Stenting支架組支架組=159 / CEA=151STENTREGISTRY支架注冊支架注冊407SURGICAL REFUSAL外科拒絕外科拒絕SURGICALREGISTRY外科注冊外科注冊7INTERVENTIONALREFUSAL介入拒絕介入拒絕 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.”接受治療接受治療12個月后,支架組病人不良事件的發(fā)生率相當(dāng)于,甚至在很多方面,優(yōu)于
5、手術(shù)治療組。個月后,支架組病人不良事件的發(fā)生率相當(dāng)于,甚至在很多方面,優(yōu)于手術(shù)治療組。Overall MAE rate總體主要不良事件發(fā)生率總體主要不良事件發(fā)生率11.9% vs. 19.9% : difference 顯著差異顯著差異, p = 0.06Death rate 死亡率死亡率6.9% vs. 12.6%: double number of patients died in the CEA arm 外科組死亡人數(shù)比支架組多一倍外科組死亡人數(shù)比支架組多一倍Stroke rate中風(fēng)發(fā)生率中風(fēng)發(fā)生率 5.7% vs. 7.3%: 30% more patients experience
6、d a stroke in the CEA arm 外科組至少發(fā)生一次中風(fēng)的病人數(shù)比支架組多外科組至少發(fā)生一次中風(fēng)的病人數(shù)比支架組多30%Major Ipsilateral Stroke rate主要同側(cè)大中風(fēng)發(fā)生率主要同側(cè)大中風(fēng)發(fā)生率 0.0% vs. 3.3% was significant higher in CEA 外科組顯著高于支架組,外科組顯著高于支架組,p = 0.03MI (Q or non Q) rate 心梗發(fā)生率心梗發(fā)生率2.5% vs. 7.9%: patients got 3 times more MI in the CEA arm 外科組發(fā)生心梗的病人數(shù)比支架組多三
7、倍以上外科組發(fā)生心梗的病人數(shù)比支架組多三倍以上Outcome of cranial nerve injury (30 days) 30天內(nèi)顱神經(jīng)損傷的發(fā)天內(nèi)顱神經(jīng)損傷的發(fā)生率生率 0.0% vs. 5.3%: was significant for CEA arm外科組顯著高于支架組,外科組顯著高于支架組,p 0.01CAS(n-1262)CEA(n=1240)年齡6969女性3634無癥狀性4747高血壓8686糖尿病3030血脂異常8285目前吸煙2626心血管病4043平均收縮壓mmHg14214170%狹窄的例數(shù)8587癥狀性狹窄發(fā)病天數(shù)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結(jié)論 50100 U/kg)球擴式支架球擴式支架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 編織支架編織支架優(yōu)點優(yōu)點支撐力更大支撐力更大, ,不易塌陷不易塌陷柔韌性更強,表面光滑,易于球囊通過柔韌性更強,表面光滑,易于球囊通過網(wǎng)孔密集,限制斑塊脫落網(wǎng)孔密集,限制斑塊脫落可重新定位、再次釋放可重新定位、再次釋放不足不足短縮、不易精確定位短縮、不易精確定位拉伸頸動脈、上端扭曲、成角拉伸頸動脈、上端扭曲、成角凹凸不平處貼壁欠佳凹凸不平處貼壁欠佳優(yōu)點優(yōu)點順應(yīng)性好,適應(yīng)不同形狀而不造成血管順應(yīng)性好,適應(yīng)不同形狀而不造成血管強直強直貼壁性好,不易造成死腔貼壁性好,不易造成死腔基本無縮短,定位和選擇長度較精確基本無縮短,定位和選擇長度較精確不足不足后擴時有連接點斷裂的風(fēng)
10、險后擴時有連接點斷裂的風(fēng)險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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