Kołtowski Lukasz, Filipiak Krzysztof J, Kochman Janusz, Pietrasik Arkadiusz, Rdzanek Adam, Huczek Zenon, Scibisz Anna, Mazurek Tomasz, Opolski Grzegorz
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny.
Kardiol Pol. 2014;72(7):604-11. doi: 10.5603/KP.a2014.0071. Epub 2014 Mar 27.
Percutaneous treatment of patients with ST segment elevation myocardial infarction (STEMI) has become the standard and default mode of management as recommended by the European Society of Cardiology guidelines for managing acute myocardial infarction in patients presenting with STEMI. The choice of vascular access is made by the operator and has a potential impact on the safety and efficacy of the procedure and outcomes.
To understand the influence of a radial approach on bleeding complications and angiographic success, we performed a prospective, controlled randomised trial.
Patients were allocated to radial (TR) or femoral (TF) vascular access. The primary endpoints were major bleeding by the REPLACE-2 scale and minor bleeding by the EASY scale (TR arm) or the FEMORAL scale (TF arm). Other outcomes included procedural data, in-hospital and long-term survival.
There were 103 patients analysed in total, 52 in the TR arm and 51 in the TF arm. The demographic and clinical baseline characteristics were well matched between the two study groups. The frequency of the primary endpoint was the same in both arms (TR: 25.0% vs. TF: 33.3%, p = 0.238). In per protocol analysis, there was a significant benefit of the TR approach among independent operators (17.4% vs. 36.8%, p = 0.038). Major bleeding by the REPLACE-2 scale occurred in 4.2% of patients (TR: 5.8% vs. TF: 3.9%, p = 0.509). There were no differences in terms of the rate of major cardiac adverse events, which happened in 10.7% of the study population (TR: 9.6% vs. TF: 11.8%, p = 0.48). In the TF arm, there was a trend towards a higher risk of local bleedings (TR: 22.4% vs. TF: 37.7%, p = 0.081) and a significantly higher frequency of local haematoma (class III, EASY/FEMORAL) (TR: 0% vs. TF: 9.8%, p = 0.027).
There were no significant differences between the TR and TF approaches in terms of clinical efficacy and patient safety. However, patients treated by independent operators might benefit from TR access. The overall complication risk of percutaneous coronary intervention treatment of STEMI patients remains low.
经皮治疗ST段抬高型心肌梗死（STEMI）患者已成为欧洲心脏病学会管理STEMI患者急性心肌梗死指南推荐的标准和默认管理模式。血管通路的选择由操作者决定，对手术的安全性、有效性及预后有潜在影响。
为了解桡动脉入路对出血并发症和血管造影成功的影响，我们进行了一项前瞻性对照随机试验。
将患者分配至桡动脉（TR）或股动脉（TF）血管通路组。主要终点为采用REPLACE - 2量表评估的大出血及采用EASY量表（TR组）或FEMORAL量表（TF组）评估的小出血。其他结局包括手术数据、院内及长期生存率。
共分析103例患者，TR组52例，TF组51例。两组研究对象的人口统计学和临床基线特征匹配良好。两组主要终点的发生率相同（TR组：25.0% vs. TF组：33.3%，p = 0.238）。在符合方案分析中，独立操作者采用TR入路有显著优势（17.4% vs. 36.8%，p = 0.038）。采用REPLACE - 2量表评估的大出血发生率为4.2%（TR组：5.8% vs. TF组：3.9%，p = 0.509）。主要心脏不良事件发生率无差异，在研究人群中为10.7%（TR组：9.6% vs. TF组：11.8%，p = 0.48）。在TF组，局部出血风险有升高趋势（TR组：22.4% vs. TF组：37.7%，p = 0.081），局部血肿（III级，EASY/FEMORAL）发生率显著更高（TR组：0% vs. TF组：9.8%，p = 0.027）。
TR和TF入路在临床疗效和患者安全性方面无显著差异。然而，独立操作者治疗的患者可能从TR入路中获益。STEMI患者经皮冠状动脉介入治疗的总体并发症风险仍然较低。
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