一项比较三种市售闭合装置（Angioseal、Vasoseal和Duett）安全性和有效性的前瞻性随机试验。

A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett).

作者信息

Michalis Lampros K, Rees Michael R, Patsouras Demetrios, Katsouras Christos S, Goudevenos John, Pappas Spyridon, Sourla Eleni, Kolettis Theophilos, Sioros Lampros, Zotou Paraskevi, Gartzou-Matsouka Panoraia, Sideris Dimitris A

机构信息

Cardiac Department, University Hospital of Ioannina, Ioannina, Greece.

出版信息

Cardiovasc Intervent Radiol. 2002 Sep-Oct;25(5):423-9. doi: 10.1007/s00270-002-1942-9. Epub 2002 Jul 23.

DOI:10.1007/s00270-002-1942-9

PMID:12132030

Abstract

PURPOSE

We compared the safety and efficacy of three closure devices (Angioseal, Vasoseal and Duett) used to close arterial puncture sites in patients who underwent coronary percutaneous procedures.

METHODS

A prospective randomized, single-center trial was carried out of consecutive patients who underwent coronary angiography [705 patients: Angioseal (243),Vasoseal (228) and Duett (234)] or angioplasty [146 patients:Angioseal (47), Vasoseal (52) and Duett (47)].

RESULTS

In the angiography patients the device deployment rates were similar, with the Angioseal been significantly slower in achieving hemostasis (p = 0.0001) but resulting in earlier ambulation (p = 0.0001). In the coronary angioplasty patients the deployment rates were similar to those for angiography: time to hemostasis was longer for the Angioseal (p = 0.003), while ambulation times were not different, although prolonged compared with angiography (p = 0.0001). The three devices had similar major complication rates. The Vasoseal had a higher major complication rate after angioplasty than after angiography (p = 0.004). The incidence rate of peripheral embolization was lower when the Angioseal was utilized. Severe complications were mainly seen in patients who received abciximab.

CONCLUSIONS

The three closure devices had high rates of successful deployment and were relatively safe. The Angioseal resulted in earlier ambulation after angiography. Utilization of closure devices after abciximab administration possibly increased the complications.

摘要

目的

我们比较了三种用于封堵接受冠状动脉介入手术患者动脉穿刺部位的闭合装置（Angioseal、Vasoseal和Duett）的安全性和有效性。

方法

对连续接受冠状动脉造影的患者[705例：Angioseal（243例）、Vasoseal（228例）和Duett（234例）]或血管成形术的患者[146例：Angioseal（47例）、Vasoseal（52例）和Duett（47例）]进行了一项前瞻性随机单中心试验。

结果

在冠状动脉造影患者中，装置植入率相似，Angioseal实现止血的速度明显较慢（p = 0.0001），但可使患者更早下床活动（p = 0.0001）。在冠状动脉血管成形术患者中，植入率与冠状动脉造影患者相似：Angioseal达到止血的时间更长（p = 0.003），而下床活动时间没有差异，尽管与冠状动脉造影相比有所延长（p = 0.0001）。三种装置的主要并发症发生率相似。Vasoseal在血管成形术后的主要并发症发生率高于冠状动脉造影后（p = 0.004）。使用Angioseal时外周栓塞的发生率较低。严重并发症主要见于接受阿昔单抗治疗的患者。