Narins Craig R, Zareba Wojciech, Rocco Vicki, McNitt Scott
Division of Cardiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA.
J Invasive Cardiol. 2008 Nov;20(11):579-84.
The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.
尽管支持局部止血贴临床效用的证据不足，但局部止血贴的使用仍迅速增加。我们进行了一项随机对照试验，以评估局部止血贴作为经皮介入后加速血管止血手段的疗效。150例通过6F股动脉鞘进行冠状动脉或外周介入的患者被随机分为两组，分别采用以下方法拔除鞘管：（1）手动压迫并辅助使用含有多糖类促凝材料的止血贴（SafeSeal止血贴，Possis Medical公司）；或（2）仅采用传统手动压迫。当活化凝血时间（ACT）降至≤250秒时拔除鞘管。止血成功后2小时让患者下床活动。止血贴组的止血时间（拔除鞘管后直至出血停止所需的压迫持续时间）显著缩短（11.8±3.6分钟 vs. 13.8±5.8分钟；p = 0.02）。随机接受止血贴治疗的患者比仅接受手动压迫的患者更有可能在15分钟内实现止血（优势比 = 2.5；95%置信区间1.2, 5.1；p = 0.014）。止血贴组患者的中位下床活动时间（从介入手术结束到下床活动的总时长）显著缩短（2.8小时 vs. 3.8小时；p = 0.03）。出血并发症并不常见，且两组之间无差异。总之，该试验支持以下观点：基于多糖的SafeSeal止血贴可增强血管内介入后穿刺部位的止血效果。
