研究证实手术高危患者中颈动脉支架的安全性

Carotid Stenting Safe for Patients at High Risk for Surgery  

（北京武警总医院 韩玮 翻译） 

SAPPHIRE 全球颈动脉注册研究结果显示MACE 发生率4.4％，优于SAPPHIRE随机试验的4.8％和CASES-PMS 的5%。田纳西Wellmont Hoiston Valley医院导管室主任Chris Metzger教授发布了该多中心、前瞻性、获批后注册研究最初2001例患者结果。

研究中应用的器械包括Cordis的Precise 镍钛支架和Angioguard XP/RX 血栓保护导丝，该注册包括216个中心，26%的患者年龄超过80岁，27.7％有症状。研究终点包括术后30天死亡、心肌梗死或卒中的MACE，分别是1.1％、0.7％和3.2％，和SAPPHIRE和CASES-PMS随机试验比较该注册研究的30天MACE 有所降低。

无症状患者(n=1,446)的30天MACE显著低于有症状的患者(n=555) (33% vs. 7%; P=.0005)，另外死亡率也更低(0.8% vs 0.6%; P=.0286)，MI发生率无显著差异(0.6% vs0.9%; P=NS)，卒中发生率更低(2.4% vs 5.4%; P=.001)，卒中或死亡联合发生率更低(2.9% vs6.7%; P=.0003)。

正如所料MACE 在80岁以上组更高(6.2% vs3.7%; P=0.024)，“尽管可完成颈动脉支架术的医生数量的增加，该注册中的MACE发生率仍在可接受的范围内。该注册研究支持颈动脉支架术是除颈动脉外科手术之外的可选策略，尤其在手术高危的患者中可代替外科手术。”

Carotid Stenting Safe for Patients at High Risk for Surgery  

Key Points:

• SAPPHIRE World Wide registry supports carotid artery stenting as alternative to endarterectomy.

By TCT Daily Staff

In the SAPPHIRE World Wide carotid artery stenting registry, the rate of major adverse events was 4.4%, which compared favorably with a 4.8% rate in the SAPPHIRE randomized trial, and a rate of 5% in the CASES-PMS trial.

D. Chris Metzger, MD, director of cardiac and peripheral cath labs, medical director of clinical research at Wellmont Hoiston Valley Medical Center in Kingsport, Tenn., presented results of the first 2,001 patients enrolled in the multicenter, prospective, post-approval registry.

The researchers evaluated outcomes after carotid artery stenting with the Cordis Precise Nitinol Stent and Angioguard XP/RX Emboli Capture Guidewire System. The registry included data from 216 centers; 26% of the patients were older than 80 years and 27.7% were symptomatic.

Study endpoints included major adverse events such as death, MI, or stroke up to 30 days after the procedure. Death occurred in 1.1% of patients, MI in 0.7%, and stroke in 3.2%, according to Metzger. Compared with the SAPPHIRE randomized trial and CASES-PMS trial, patients in the registry had decreased major adverse events at 30 days (see Figure).

"Contralateral strokes were minimal compared to what has been previously reported, demonstrating an improvement in technique," Metzger said. Stroke or death occurred in 2.5% of those with anatomic risk and 4.5% of those with physiological risk (P=.0443).

Major adverse event rates at 30 days were significantly lower in asymptomatic patients (n=1,446) compared with symptomatic patients (n=555) (33% vs. 7%; P=.0005), according to Metzger. In addition, death occurred in 0.8% of asymptomatic patients vs. 2% of symptomatic (P=.0286); MI, 0.6% of asymptomatic patients vs. 0.9% symptomatic (P=ns); stroke, 2.4% of asymptomatic patients vs. 5.4% symptomatic (P=.0010); stroke or death, 2.9% of asymptomatic patients vs. 6.7% symptomatic (P=.0003).

As expected, major adverse events occurred in more patients aged 80 years and older (6.2%) compared with those younger than age 80 (3.7%; P=.0240).

"While the number of physicians performing carotid artery stenting continues to increase, major adverse event rates seen in this registry are well within an acceptable range, as was first seen in the SAPPHIRE randomized trial," Metzger said.

"The SAPPHIRE World Wide registry supports the use of carotid artery stenting as an alternative to carotid endarterectomy, especially in patients who are at high risk for surgery due to anatomical risk factors."