颈动脉支架置入术
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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 生率 0.0% vs. 5.3%: ~ was significant for CEA arm外科组显著高于支架组，p < 0.01
结论
ISC 2010 -CREST
SURGICAL
医生小组：神经科医生，外科医生，介入科医生 INTERVENTIONAL
REFUSAL外科拒绝
REFUSAL介入拒绝
STENT REGISTRY
支架注册
407
RANDOMIZED, PROSPECTIVE随机，前瞻 性
310 (12 month)
Stenting支架组=159 / CEA=151
0.6% 3.1% 0.0% 0.6% 2.5% 0.6%
2.0% 3.3% 1.3% 0.7% 0.7%
0.7
0.36 > 0.99
0.24 > 0.99
0.37 > 0.99
6.9% 5.7% 0.0% 0.6% 3.8% 1.9%
12.6% 7.3% 3.3% 0.7% 2.0% 2.0%
0.12 0.66 0.03 > 0.99 0.5 > 0.99
SURGICAL REGISTRY
外科注册
7
SAPPHIRE (high-risk patients) 30 days and 12 months results
SAPPHIRE (high-risk patients) 30 days and 12 month results
Events
Randomized Patients 30-Day Events Stent (159 pst) CEA (151 pts) p Value
颈动脉支架置入术
SAPPHIRE 研究
➢CEA高危患者保护装置下支架置入与血管 成形试验 （stenting and angioplasty with protection in patient at high rish for endarterectomy, SAPPHIRE）
➢第一项在有症状或无症状颈动脉狭窄患 者中比较CAS和CEA疗效的多中心随机对 照研究
MI (Q or NQ) Q-Wave MI
Non-Q Wave MI Death / Stroke Death / Stroke /
MI
1.9% 0.0% 1.9% 3.8%
4.4%
6.6% 1.3% 5.3% 4.6%
9.9%
0.05 0.24 0.13 0.78
0.08
2.5% 0.0% 2.5%
CREST设计
➢ 前瞻、多中心、随机对照试验，盲法判定 ➢ 比较对于症状性和无症状性颈动脉狭窄患者是CEA还是
CAS更好 ➢ 每个中心团队包括神经科医生、介入医生、外科医生和
研究协调员
9
患者分组和基本情况
年龄 女性％ 无症状性％ 高血压％ 糖尿病％ 血脂异常％ 目前吸烟％ 心血管病％ 平均收缩压mmHg ≥70%狭窄的例数％ 症状性狭窄发病天数
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，优于手术治疗组。
12 month Results:
CAS vs. CEA
• Overall MAE rate总体主要不良事件发生率11.9% vs. 19.9% :
~ difference 显著差异, p = 0.06
• Death rate 死亡率6.9% vs. 12.6%:
Randomized Patients 12-Month Events Stห้องสมุดไป่ตู้nt (159 pts) CEA (151 pts) p Value
Death Stroke Major ipsilateral Major Non-Ipsilateral Minor Ipsilateral Minor Non -Ipsilateral
11.9%
7.9% 1.3% 6.6%
19.9%
0.04 0.24 0.1
0.06
MAE without
non-neuro Death
5.7%
12.6%
< 0.05
> 30 days
MAE without MI
or non-neuro Death
5.0%
7.3%
0.48
> 30 days
“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.”
~ double number of patients died in the CEA arm 外科组死亡人数比支架组多一倍
• Stroke rate中风发生率 5.7% vs. 7.3%:
~ 30% more patients experienced 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30%
介入器材
ANGIOGUARD血栓保护装置
Cordis PRECISE支架
The SAPPHIRE Trial
入选病例被随机分入使用保护装置的支架介入术组(n=159)和内膜切除术组 (n=151),对于风险过高的病人，由介入科医生、血管外科医生和神经科医生组 成的医生小组共同决定进入注册组
CONSENSUS一致同意
CAS(n-1262) 69 36 47 86 30 82 26 40 142 85 20
CEA(n=1240) 69 34 47 86 30 85 26 43 141 87 25
• Major Ipsilateral Stroke rate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，p = 0.03
• MI (Q or non Q) rate 心梗发生率2.5% vs. 7.9%: ~ patients got > 3 times more MI in the CEA arm
• Outcome of cranial nerve injury (30 days) 30天内颅神经损伤的发 生率 0.0% vs. 5.3%: ~ was significant for CEA arm外科组显著高于支架组，p < 0.01
结论
ISC 2010 -CREST
SURGICAL
医生小组：神经科医生，外科医生，介入科医生 INTERVENTIONAL
REFUSAL外科拒绝
REFUSAL介入拒绝
STENT REGISTRY
支架注册
407
RANDOMIZED, PROSPECTIVE随机，前瞻 性
310 (12 month)
Stenting支架组=159 / CEA=151
0.6% 3.1% 0.0% 0.6% 2.5% 0.6%
2.0% 3.3% 1.3% 0.7% 0.7%
0.7
0.36 > 0.99
0.24 > 0.99
0.37 > 0.99
6.9% 5.7% 0.0% 0.6% 3.8% 1.9%
12.6% 7.3% 3.3% 0.7% 2.0% 2.0%
0.12 0.66 0.03 > 0.99 0.5 > 0.99
SURGICAL REGISTRY
外科注册
7
SAPPHIRE (high-risk patients) 30 days and 12 months results
SAPPHIRE (high-risk patients) 30 days and 12 month results
Events
Randomized Patients 30-Day Events Stent (159 pst) CEA (151 pts) p Value
颈动脉支架置入术
SAPPHIRE 研究
➢CEA高危患者保护装置下支架置入与血管 成形试验 （stenting and angioplasty with protection in patient at high rish for endarterectomy, SAPPHIRE）
➢第一项在有症状或无症状颈动脉狭窄患 者中比较CAS和CEA疗效的多中心随机对 照研究
MI (Q or NQ) Q-Wave MI
Non-Q Wave MI Death / Stroke Death / Stroke /
MI
1.9% 0.0% 1.9% 3.8%
4.4%
6.6% 1.3% 5.3% 4.6%
9.9%
0.05 0.24 0.13 0.78
0.08
2.5% 0.0% 2.5%
CREST设计
➢ 前瞻、多中心、随机对照试验，盲法判定 ➢ 比较对于症状性和无症状性颈动脉狭窄患者是CEA还是
CAS更好 ➢ 每个中心团队包括神经科医生、介入医生、外科医生和
研究协调员
9
患者分组和基本情况
年龄 女性％ 无症状性％ 高血压％ 糖尿病％ 血脂异常％ 目前吸烟％ 心血管病％ 平均收缩压mmHg ≥70%狭窄的例数％ 症状性狭窄发病天数
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，优于手术治疗组。
12 month Results:
CAS vs. CEA
• Overall MAE rate总体主要不良事件发生率11.9% vs. 19.9% :
~ difference 显著差异, p = 0.06
• Death rate 死亡率6.9% vs. 12.6%:
Randomized Patients 12-Month Events Stห้องสมุดไป่ตู้nt (159 pts) CEA (151 pts) p Value
Death Stroke Major ipsilateral Major Non-Ipsilateral Minor Ipsilateral Minor Non -Ipsilateral
11.9%
7.9% 1.3% 6.6%
19.9%
0.04 0.24 0.1
0.06
MAE without
non-neuro Death
5.7%
12.6%
< 0.05
> 30 days
MAE without MI
or non-neuro Death
5.0%
7.3%
0.48
> 30 days
“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.”
~ double number of patients died in the CEA arm 外科组死亡人数比支架组多一倍
• Stroke rate中风发生率 5.7% vs. 7.3%:
~ 30% more patients experienced 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30%
介入器材
ANGIOGUARD血栓保护装置
Cordis PRECISE支架
The SAPPHIRE Trial
入选病例被随机分入使用保护装置的支架介入术组(n=159)和内膜切除术组 (n=151),对于风险过高的病人，由介入科医生、血管外科医生和神经科医生组 成的医生小组共同决定进入注册组
CONSENSUS一致同意
CAS(n-1262) 69 36 47 86 30 82 26 40 142 85 20
CEA(n=1240) 69 34 47 86 30 85 26 43 141 87 25
• Major Ipsilateral Stroke rate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，p = 0.03
• MI (Q or non Q) rate 心梗发生率2.5% vs. 7.9%: ~ patients got > 3 times more MI in the CEA arm