弹力绷带法与气囊加压止血器对经桡动脉冠状动脉介入术后止血效果比较的单中心、前瞻性、随机对照研究

闵英; 刘艳杰; 赵妍; 赵威; 孙宁; 彭岩松; 邵丹; 刘晶; 金凤宇; 王燕娣; 许燕红

doi:10.12125/j.chj.201908025

弹力绷带法与气囊加压止血器对经桡动脉冠状动脉介入术后止血效果比较的单中心、前瞻性、随机对照研究

Hemostatic effect between bandage compression and balloon compression hemostat in patients undergoing transradial coronary intervention: a single-center, prospective, randomized controlled study

摘要

摘要:
目的比较常规弹力绷带加压止血法与气囊加压止血器在经桡动脉行经皮冠状动脉介入（PCI）治疗术后穿刺血管止血效果。
方法将2018年1月1日至2018年3月22日于北部战区总医院经右侧桡动脉行PCI的300例患者，随机分为弹力绷带加压止血组和气囊加压止血器组（比例为1：1）。主要终点定义为术区出血、腕部及前臂皮肤瘀斑、上肢麻木、上肢疼痛、上肢肿胀、手部发绀、张力性水疱、发生迷走神经反射、桡动脉闭塞、动静脉瘘等桡动脉血管并发症组成的复合终点。次要终点定义为两组止血方法的所需费用。
结果两组之间性别、年龄、吸烟史、高血压病史等既往史及入院诊断等均无统计学差异。住院期间，两组间桡动脉血管并发症发生率的差异为1.3%（95%CI，−4.8%～7.5%），其中弹力绷带加压止血组事件发生率为8.7%（13/150），气囊加压止血器组为7.3%（11/150），弹力绷带加压止血组非劣效于气囊加压止血器组（非劣效性检验P＜0.01）。两组间术区出血、腕部及前臂皮肤瘀斑、上肢麻木、上肢疼痛、上肢肿胀、手部发绀、张力性水疱、迷走神经反射、桡动脉闭塞、动静脉瘘等桡动脉血管并发症发生情况均无统计学差异。气囊加压止血器组4例（2.7%）患者出现出血、血肿后转化为弹力绷带加压包扎法，采用上肢悬挂治疗比例有增高趋势，但两组差异无显著性统计学意义（1.3% vs. 0.7%，P = 1.00）。气囊加压止血器组费用明显高于弹力绷带加压止血组（254 ± 0）元vs.（25 ± 12）元，P < 0.01。
结论弹力绷带加压止血法具有效价比高的优点。弹力绷带加压止血法预防在院期间桡动脉血管并发症发生的效果不劣于桡动脉气囊加压止血器。

Abstract:
AIM To compare the hemostatic effect between compression and balloon compression hemostat in patients undergoing transradial coronary intervention.
METHODS A total of 300 consecutive patients from January 1, 2018 to March 22, 2018 were randomized to 2 groups, 150 patients in bandage compression group and 150 patients in balloon compression hemostat group. The primary study endpoint was in-hospital vascular related complication, including operative area bleeding, skin ecchymosis of wrist and forearm, upper limb numbness, upper limb pain, upper extremity edema, cyanosis of hand, tension blister, vagus reflex, radial artery occlusion and arteriovenous fistula. The secondary study endpoint was the cost of two groups of hemostasis methods.
RESULTS There were no significant differences in sex, age, smoking history, hypertension history and admission diagnosis between the two groups (P > 0.05). The incidence of vascular related complication as the primary endpoint was similar between the bandage compression group versus the balloon compression hemostat group (8.67% vs. 7.33%, Non-inferiority test P < 0.01). There were no significant differences in operative area bleeding, skin ecchymosis of wrist and forearm, upper limb numbness, upper limb pain, upper extremity edema, cyanosis of hand, tension blister, vagus reflex, radial artery occlusion and arteriovenous fistula between the two groups (all P > 0.05). In the balloon compression hemostat group, 4 patients (2.7%) occurred hemorrhage and hematoma, which were converted to bandage compression. The proportion of upper limb suspension treatment increased in the group of balloon compression hemostat, but there was no significant difference between the two groups (1.3% vs. 0.7%, P = 1.00). The cost of balloon pressure hemostat group was significantly higher than the bandage compression group (254 ± 0) yuan vs. (25 ± 12) yuan, P < 0.01.
CONCLUSION The advantage of bandage compression is high potency-price ratio. The effect of bandage compression in preventing vascular related complication is not worsen than balloon compression hemostat.

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