Fernandez Ritin S, Lee Astin
1Centre for Evidence Based Initiatives in Health Care: a Joanna Briggs Institute Centre of Excellence 2School of Nursing, University of Wollongong, Wollongong, Australia 3Centre for Research in Nursing and Health, St George Hospital, Sydney, Australia 4Wollongong Hospital, Wollongong, Australia 5School of Medicine, University of Wollongong, Wollongong, Australia.
JBI Database System Rev Implement Rep. 2017 Mar;15(3):738-764. doi: 10.11124/JBISRIR-2016-002964.
Transradial access to percutaneous coronary procedures is becoming the preferred access route, and it is being increasingly used for emergent and elective procedures. However, radial artery occlusion (RAO) continues to remain an adverse occurrence following sheath removal or in the first 24 hours following sheath removal due to the smaller diameter of the artery.
The overall objective of this study was to synthesize the best available research evidence related to the effects of methods used to achieve hemostasis on RAO rates after percutaneous coronary procedures.
The current review considered trials that included adult patients (18 years and over) who have had a coronary angiography or coronary re-vascularization intervention via the radial artery.
TYPES OF INTERVENTION(S): The interventions of interest were the use of various hemostatic methods compared to traditional interventions to prevent RAO.
All randomized and quasi-randomized controlled trials evaluating the effect of various hemostatic methods on RAO rates after percutaneous coronary procedures were included in the review.
The primary outcome of interest was the incidence of RAO at the time of discharge and persistent occlusion at the time of follow-up.
The search aimed to find published and unpublished trials through electronic databases, reference lists and key reports. An extensive search was undertaken for the following databases - CINAHL, Embase, PubMed and the Cochrane Central Register of Controlled Trials (CENTRAL). Databases were searched up to May 2016. The search for unpublished trials included Dissertation Abstracts International, World Cat, Clinicaltrials.gov, ProQuest Dissertation and Theses and MedNar.
Methodological quality was assessed independently by two reviewers using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) checklist. Disagreements that arose between the reviewers were resolved through discussion.
Quantitative data were extracted from papers included in the review by one reviewer using the standardized data extraction tool from JBI-MAStARI. The data extracted were checked by a second reviewer. Disagreements that arose between the reviewers were resolved through discussion. All results were subject to double data entry in Review Manager.
Statistical pooling of the data was not possible due to the heterogeneity of the trials; therefore, the findings are presented in narrative form. However, figures have been used to illustrate the results.
A total of seven trials were included in the review. One trial demonstrated a significant reduction in RAO rates in patients who had a mean arterial pressure (MAP)-guided TR band to a standard TR band (odds ratio [OR] 0.08; 95% confidence interval [CI] 0.02, 0.37). A statistically significant reduction in the incidence of RAO was observed among patients who received a biopolymer dressing (Chitosen) compared to those who received the TR band (OR 2.20; 95% CI 1.20, 4.02). No statistically significant difference in the incidence of RAO was reported between those who received the TR band and those who received either the elastic bandage (P = 0.08) or T band (P = 0.76). Similarly, no statistically significant difference in rates of RAO among patients was reported among those who had pro-coagulant dressings compared to those who had short or long manual compression. One trial that compared the TR band to a MAP-guided TR band demonstrated no statistically significant difference in the time taken to obtain hemostasis between the two groups (P = 0.61). A statistically significant reduction in the time taken to obtain hemostasis was observed among patients who received the hemostatic biopolymer dressing compared to the TR band. No statistically significant difference in the incidence of hematoma was identified among patients who received pneumatic compression or traditional compression to achieve hemostasis.
There is limited evidence to support the use of any single hemostatic method to prevent RAO rates after percutaneous coronary procedures. Although used extensively, there is evidence of no effect of the pneumatic compression method using the TR band on the incidence of RAO at discharge or follow-up, the time taken to obtain hemostasis and the incidence of hematoma. The MAP-guided compression method and the Biopolymer dressing (Chitosen) were superior to the TR band compression method, and patent hemostasis was superior to hemoband in the prevention of RAO. However, these results are based on single trials and should be interpreted with caution. The evidence obtained from the review does not provide a concrete base for the development of practice guidelines. Until more robust evidence is available, practices will continue to be dictated by local preferences and available resources.
经桡动脉途径进行经皮冠状动脉介入治疗正成为首选的介入途径,并且越来越多地用于急诊和择期手术。然而,由于动脉直径较小,桡动脉闭塞(RAO)在拔除鞘管后或拔除鞘管后的头24小时内仍然是一种不良事件。
本研究的总体目标是综合现有最佳研究证据,探讨用于实现止血的方法对经皮冠状动脉手术后桡动脉闭塞率的影响。
纳入标准
本综述纳入了包括通过桡动脉进行冠状动脉造影或冠状动脉血运重建干预的成年患者(18岁及以上)的试验。
感兴趣的干预措施是使用各种止血方法与传统干预措施相比,以预防桡动脉闭塞。
所有评估各种止血方法对经皮冠状动脉手术后桡动脉闭塞率影响的随机和半随机对照试验均纳入本综述。
感兴趣的主要结局是出院时桡动脉闭塞的发生率以及随访时的持续闭塞情况。
检索旨在通过电子数据库、参考文献列表和关键报告找到已发表和未发表的试验。对以下数据库进行了广泛检索——CINAHL、Embase、PubMed和Cochrane对照试验中央注册库(CENTRAL)。数据库检索截至2016年5月。对未发表试验的检索包括《国际学位论文摘要》、World Cat、Clinicaltrials.gov、ProQuest学位论文和论文数据库以及MedNar。
两名评审员使用乔安娜·布里格斯研究所统计评估与综述工具(JBI-MAStARI)清单独立评估方法学质量。评审员之间出现的分歧通过讨论解决。
一名评审员使用JBI-MAStARI的标准化数据提取工具从纳入综述的论文中提取定量数据。提取的数据由另一名评审员检查。评审员之间出现的分歧通过讨论解决。所有结果都在Review Manager中进行了双数据录入。
由于试验的异质性,无法对数据进行统计合并;因此,研究结果以叙述形式呈现。然而,已使用图表来说明结果。
本综述共纳入七项试验。一项试验表明,与标准TR带相比,平均动脉压(MAP)引导下的TR带患者的桡动脉闭塞率显著降低(优势比[OR]0.08;95%置信区间[CI]0.02,0.37)。与接受TR带的患者相比,接受生物聚合物敷料(壳聚糖)的患者中观察到桡动脉闭塞发生率有统计学显著降低(OR 2.20;95%CI 1.20,4.02)。接受TR带的患者与接受弹性绷带(P = 0.08)或T带(P = 0.76)的患者之间,桡动脉闭塞发生率未报告有统计学显著差异。同样,与短时间或长时间手动压迫的患者相比,接受促凝血敷料的患者中桡动脉闭塞率也未报告有统计学显著差异。一项将TR带与MAP引导下的TR带进行比较的试验表明,两组之间实现止血所需的时间没有统计学显著差异(P = 0.61)。与TR带相比,接受止血生物聚合物敷料的患者中观察到实现止血所需的时间有统计学显著减少。在接受气动压迫或传统压迫以实现止血的患者中,血肿发生率未发现有统计学显著差异。
支持使用任何单一止血方法预防经皮冠状动脉手术后桡动脉闭塞率的证据有限。尽管广泛使用,但有证据表明使用TR带的气动压迫方法对出院时或随访时的桡动脉闭塞发生率、实现止血所需的时间以及血肿发生率没有影响。MAP引导下的压迫方法和生物聚合物敷料(壳聚糖)优于TR带压迫方法,在预防桡动脉闭塞方面,专利止血优于止血带。然而,这些结果基于单项试验,应谨慎解释。本综述获得的证据并未为制定实践指南提供具体依据。在获得更有力的证据之前,实践将继续由当地的偏好和可用资源决定。