Tavris Dale R, Wang Yongfei, Jacobs Samantha, Gallauresi Beverly, Curtis Jeptha, Messenger John, Resnic Frederic S, Fitzgerald Susan
US Food and Drug Administration (FDA), Silver Spring, MD, USA.
J Invasive Cardiol. 2012 Jul;24(7):328-34.
Previous research found at least one vascular closure device (VCD) to be associated with excess vascular complications, compared to manual compression (MC) controls, following cardiac catheterization. Since that time, several more VCDs have been approved by the Food and Drug Administration (FDA). This research evaluates the safety profiles of current frequently used VCDs and other hemostasis strategies.
Of 1089 sites that submitted data to the CathPCI Registry from 2005 through the second quarter of 2009, a total of 1,819,611 percutaneous coronary intervention (PCI) procedures performed via femoral access site were analyzed. Assessed outcomes included bleeding, femoral artery occlusion, embolization, artery dissection, pseudoaneurysm, and arteriovenous fistula. Seven types of hemostasis strategy were evaluated for rate of "any bleeding or vascular complication" compared to MC controls, using hierarchical multiple logistic regression analysis, controlling for demographic factors, type of hemostasis, several indices of co-morbidity, and other potential confounding variables. Rates for different types of hemostasis strategy were plotted over time, using linear regression analysis.
Four of the VCDs and hemostasis patches demonstrated significantly lower bleeding or vascular complication rates than MC controls: Angio-Seal (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.65-0.70); Perclose (OR, 0.54; CI, 0.51-0.57); StarClose (OR, 0.77; CI, 0.72-0.82); Boomerang Closure Wire (OR, 0.63; CI, 0.53-0.75); and hemostasis patches (OR, 0.70; CI, 0.67-0.74). All types of hemostasis strategy, including MC, exhibited reduced complication rates over time. All trends were statistically significant except one.
This large, nationally representative observational study demonstrated better safety profiles for most of the frequently used VCDs, compared to MC controls.
先前的研究发现，与手动压迫（MC）对照组相比，心脏导管插入术后至少有一种血管闭合装置（VCD）与更多的血管并发症相关。自那时以来，又有几种VCD获得了美国食品药品监督管理局（FDA）的批准。本研究评估了当前常用VCD和其他止血策略的安全性。
对2005年至2009年第二季度向CathPCI注册中心提交数据的1089个站点进行分析，共分析了1819611例经股动脉穿刺部位进行的经皮冠状动脉介入治疗（PCI）手术。评估的结果包括出血、股动脉闭塞、栓塞、动脉夹层、假性动脉瘤和动静脉瘘。与MC对照组相比，使用分层多元逻辑回归分析，控制人口统计学因素、止血类型、几种合并症指标和其他潜在混杂变量，评估了七种止血策略的“任何出血或血管并发症”发生率。使用线性回归分析绘制不同类型止血策略的发生率随时间的变化图。
四种VCD和止血贴片的出血或血管并发症发生率显著低于MC对照组：血管封堵器（Angio-Seal）（比值比[OR]，0.68；95%置信区间[CI]，0.65-0.70）；Perclose（OR，0.54；CI，0.51-0.57）；StarClose（OR，0.77；CI，0.72-0.82）；回旋镖闭合线（Boomerang Closure Wire）（OR，0.63；CI，0.53-0.75）；以及止血贴片（OR，0.70；CI，0.67-0.74）。随着时间的推移，所有类型的止血策略（包括MC）的并发症发生率均有所降低。除一种趋势外，所有趋势均具有统计学意义。
这项具有全国代表性的大型观察性研究表明，与MC对照组相比，大多数常用VCD的安全性更好。
