Halabi Majdi, Gruberg Luis, Pitchersky Sirush, Kouperberg Efim, Nikolsky Eugenia, Hoffman Aharon, Beyar Rafael
Division of Invasive Cardiology, Rambam Medical Center and Technion-Israel Institute of Technology, Haifa, Israel.
Catheter Cardiovasc Interv. 2006 Apr;67(4):513-8. doi: 10.1002/ccd.20640.
Recent studies have shown that carotid artery angioplasty and stenting may offer a viable alternative for symptomatic and asymptomatic patients with carotid artery stenosis, especially in high-risk patients. We report the results of a prospective single-center registry designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting with and without distal protection devices in high-risk patients. A total of 116 consecutive patients underwent 126 procedures and 127 stents were deployed successfully in 130 lesions. The majority of patients (63%) had restenosis after a prior carotid endarterectomy; 31% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 9% were considered ineligible for surgery due to hostile neck anatomy. Periprocedural and follow-up evaluation included a thorough independent clinical and neurological assessment. Distal embolic protection devices were used in 44% of all cases. Procedural success was achieved in 122 procedures (97%). The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, and myocardial infarction) was 2.6%. Event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 5.2% vs. 2.4% death/stroke at 30 days and 8.3% and 6.6% stroke/death rates at 1 year, respectively. When distal protection devices were used, death/stroke rates were 0% as compared to 4.5% when distal protection was not used (P = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection.
近期研究表明,对于有症状和无症状的颈动脉狭窄患者,尤其是高危患者,颈动脉血管成形术和支架置入术可能是一种可行的替代治疗方法。我们报告了一项前瞻性单中心注册研究的结果,该研究旨在评估在高危患者中使用和不使用远端保护装置进行颈动脉血管成形术和支架置入术的可行性和安全性。共有116例连续患者接受了126次手术,在130个病变中成功植入了127枚支架。大多数患者(63%)曾接受过颈动脉内膜切除术且出现了再狭窄;31%的患者被血管外科医生和介入心脏病专家认为不适合进行颈动脉内膜切除术,9%的患者因颈部解剖结构复杂而被认为不适合手术。围手术期和随访评估包括全面的独立临床和神经学评估。所有病例中44%使用了远端栓塞保护装置。122次手术(97%)取得了手术成功。住院期间主要不良脑血管事件(死亡、中风和心肌梗死)的总发生率为2.6%。曾接受过颈动脉内膜切除术的患者的事件发生率与初发病变患者相当,30天时死亡/中风发生率分别为5.2%和2.4%,1年时中风/死亡率分别为8.3%和6.6%。使用远端保护装置时,死亡/中风发生率为0%,而未使用远端保护时为4.5%(P =无显著性差异)。然而,无论是否使用远端保护,在原发和继发病变中均观察到了轻微栓塞现象。这些结果支持在有严重原发性或继发性颈动脉狭窄的高危患者中使用颈动脉血管成形术和支架置入术。在这两种病变类型中,可接受的结果证明其作为一种有效的血运重建方法是合理的。虽然在这两种病变类型中,少数患者会发生临床栓塞事件,但远端保护并不能完全预防这些事件。