使用 Guglielmi 可脱性弹簧圈对 150 例基底动脉尖部动脉瘤进行血管内栓塞：美国食品药品监督管理局多中心临床试验结果

Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial.

作者信息

Eskridge J M, Song J K

机构信息

Department of Neurological Surgery, University of Washington, Seattle 98195, USA.

出版信息

J Neurosurg. 1998 Jul;89(1):81-6. doi: 10.3171/jns.1998.89.1.0081.

DOI:10.3171/jns.1998.89.1.0081

PMID:9647176

Abstract

OBJECT

To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device.

METHODS

The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0-43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0-40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms).

CONCLUSIONS

Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

摘要

目的

为评估使用 Guglielmi 可脱卸弹簧圈（GDC）进行动脉瘤栓塞的安全性和有效性，作者回顾了美国多中心 GDC 临床试验早期阶段一组 150 例基底动脉尖部动脉瘤患者的治疗结果，这些患者中 83 例为破裂动脉瘤，67 例为未破裂动脉瘤，该试验最终使该装置获得了美国食品药品监督管理局的批准。

方法

该组患者最常见的表现是头痛（53%）。所有患者在经过神经外科评估被排除为动脉瘤夹闭手术候选者后进入试验。75%的患者实现了超过 90%的弹簧圈填充。对于那些有随访信息的患者，61 例破裂动脉瘤患者的血管造影和临床评估平均随访时间为 13.7 个月（范围 0 - 43 个月），49 例未破裂动脉瘤患者的平均随访时间为 9.8 个月（范围 0 - 40 个月）。保守死亡率方面，破裂动脉瘤组高达 23%，未破裂动脉瘤组高达 12%；治疗后的破裂动脉瘤再出血率高达 3.3%，未破裂动脉瘤出血率高达 4.1%。破裂或未破裂动脉瘤患者因中风导致的永久性神经功能缺损发生率分别高达 5%和 9%。8%的患者发生血管痉挛，其中 2 例死亡。围手术期死亡率为 2.7%（4 例破裂动脉瘤患者）。