CARESS: 颈动脉支架术与颈动脉内膜切除术效果相当

要点：

      两组之间的30天中风和全因死亡率之间没有重大差别。

      根据前瞻性非随机试验CARESS的最新结果，在行颈动脉支架置入与颈动脉内膜切除两组之间，无论30天还是4年时的全因死亡率都没有差别。然而，颈动脉支架置入术与颈动脉内膜切除术在4年期间相比较，确实有高出两倍的再狭窄发生。

      在主要重点30天的全因死亡方面，颈动脉内膜切除组发生率是0.4%（n=254），在颈动脉支架置入组是0%（n=143；P=0.45）。4年时，全因死亡率在颈动脉内膜切除组是21.2%，颈动脉支架置入组是18.7% (P=0.83)。4年存活率在内膜切除组是79%，支架组是81%（P=0.83）。

      30天时，内膜切除组的中风发生率是3.6%，颈动脉支架置入组是2.1%（P=0.41）。4年时，中风在内膜切除组的发生率是9.6%，支架组是8.6%（P=0.44）。4年时的未发生中风率没有显著差别（颈动脉内膜切除组和颈动脉支架置入组分别为90.4% 和91.4%，P=0.44)。

      颈动脉内膜切除组心肌梗塞在30天的发生率是0.8%，颈动脉支架置入组是0%(P=0.29)。在31天到4年的这段时间内，MI的发生率在颈动脉内膜切除组是2.2%，支架组是1.6%（P=0.63）。

      4年时未发生中风或死亡的，在内膜切除组是73.5%，支架组是78.3%（P=0.36）。再狭窄率在内膜切除组是5.9%，支架组是14.7%（P=0.01，如图所示）。

        Christopher K. Zarins医生是CARESS指导委员会的成员之一，他说，在患者性别、有症状vs.无症状状态以及高vs.低风险分层方面两组也没有明显差别。

        “在全因死亡和中风的主要结果评估方面，对于标危型颈动脉狭窄患者来说，行血栓保护下的颈动脉支架置入与颈动脉内膜切除在30天和随后4年的随访当中结果是相当的。”Zarins医生说。

       CARESS收入了397例颈动脉狭窄的有症状患者（0.50%）和无症状患者（0.75%）。在2001年至2002年期间，患者在14个临床研究点接受治疗。两组之间的患者特征是相似的。

该研究由国际血管腔内手术学会与美国FDA、医疗保障及补助服务中心、美国国立卫生研究院共同进行。

声明：
      Zarins医生报告没有相关利益冲突。

（医心评论：孟祥飞 译  朱婧 校）

CARESS: Carotid Stenting Equivalent to Carotid Endarterectomy

Key Points:
No significant differences in 30-day stroke and all-cause mortality between approaches.

By TCT Daily Staff

There was no difference between carotid artery stenting and carotid endarterectomy in rates of 30-day or four-year all-cause mortality, according to updated results from the prospective, non-randomized CARESS trial. However, carotid artery stenting did have a twofold higher restenosis rate compared with carotid endarterectomy over a four-year period.

The primary endpoint of all-cause mortality at 30 days occurred in 0.4% of those in the carotid endarterectomy group (n=254) compared with 0% in the carotid artery stenting group (n=143; P=.45). At four years, all-cause mortality occurred in 21.2% of those in the endarterectomy group compared with 18.7% in the carotid stenting group (P=.83). Four-year survival in the endarterectomy group was 79% and was 81% in the stenting group (P=.83).

At 30 days, stroke occurred in 3.6% of those in the carotid endarterectomy group compared with 2.1% in the carotid artery stenting group (P=.41). At four years, stroke occurred in 9.6% of those in the endarterectomy group compared with 8.6% in the stenting group (P=.44). There was no significant difference in freedom from stroke at four years (carotid endarterectomy 90.4% vs. carotid artery stenting 91.4%; P=.44).

MI at 30 days occurred in 0.8% of those in the carotid endarterectomy group compared with 0% in the carotid artery stenting group (P=.29). At 31 days through four years, MI occurred in 2.2% of those in the endarterectomy group compared with 1.6% of those in the stenting group (P=.63).

Combined freedom from stroke or death at four years was 73.5% for carotid endarterectomy and 78.3% for carotid artery stenting (P=.36). Restenosis was 5.9% in the carotid endarterectomy group compared with 14.7% in the carotid artery stenting group (P=.01; see Figure).

There were no significant differences according to sex, symptomatic vs. asymptomatic status, and high- vs. low-risk stratification, according to Christopher K. Zarins, MD, a member of the CARESS steering committee.

"In standard-risk patients with carotid stenosis, carotid artery stenting with embolic protection is equivalent to carotid endarterectomy at 30 days and during four-year follow-up, with respect to the primary outcome measures of all-cause mortality and stroke," said Zarins.

CARESS included 397 patients with symptomatic (.50%) and asymptomatic (.75%) carotid stenosis. Patients were treated at 14 clinical sites from 2001 through 2002. Patient characteristics were similar for the two groups.

The study was sponsored by the International Society for Endovascular Surgery in collaboration with the FDA, Centers for Medicare and Medicaid Services, and the National Institutes of Health.

Disclosures:

Dr. Zarins reports no relevant conflicts of interest.