Ambrose John A, Lardizabal Joel, Mouanoutoua Mouatou, Buhari Cyrus F, Berg Ryan, Joshi Bipin, El-Sherief Karim, Wessel Ralph, Singh Manmeet, Kiel Richard
Division of Cardiology, Department of Internal Medicine, UCSF Fresno Medical Education Program, Fresno, Calif., USA.
Cardiology. 2014;129(1):39-43. doi: 10.1159/000362536. Epub 2014 Jul 9.
The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture.
This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤ 24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated.
The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤ 6 Fr all had a significant or near-significant reduction of complications with Micropuncture.
Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations.
Micropuncture® 21号穿刺针可能会减少因意外穿刺静脉或动脉后壁而导致的血管创伤相关并发症。
这是一项单中心、多用户试验。402例可能或确定要接受经皮冠状动脉介入治疗（PCI）的患者按1:1随机分为18号穿刺针组和21号穿刺针组。拔除鞘管及进行随访的患者和工作人员均处于盲态。主要终点是穿刺部位出血的复合指标。在拔除鞘管后、术后≤24小时以及随访时（1 - 2周）记录事件。终点指标由盲态判定。
总体事件发生率为12.4%，两组之间无显著差异，尽管发现21号穿刺针可使事件减少三分之一以上。对预先设定变量的探索性亚组分析表明：未接受PCI或择期手术的患者、女性患者以及最终鞘管尺寸≤6F的患者，使用Micropuncture穿刺针后并发症均有显著或接近显著的减少。
虽然观察到18号和21号穿刺针的使用之间无显著差异，但在几个亚组中，使用Micropuncture穿刺针可使并发症减少50 - 75%。该研究提前终止。使用21号穿刺针可能会减少穿刺部位并发症，尤其是在出血风险不高时。需要进一步的多中心数据来证实这些产生假设的观察结果。
