Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.
Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.
Am Heart J. 2020 Jun;224:98-104. doi: 10.1016/j.ahj.2020.03.014. Epub 2020 Mar 19.
Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI).
We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications.
A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm.
In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.
随机对照试验(RCT)在经皮冠状动脉介入治疗(PCI)中,桡动脉入路(TRA)与股动脉入路(TFA)对 ST 段抬高型心肌梗死(STEMI)患者的影响结果相互矛盾。
我们对比较 TRA 和 TFA 在 STEMI 患者中的 RCT 进行了试验序贯分析(TSA)。感兴趣的结局包括 30 天死亡率、大出血、主要不良心血管事件(MACE)、心肌梗死(MI)、卒中和入路部位并发症。
共有 17 项研究,涉及 11992 例患者纳入本次 TSA。TRA 组 30 天死亡率较低(风险比 [RR] 0.72,95%置信区间 [CI] 0.58-0.90,P=0.003)、大出血(RR 0.62,95% CI 0.49-0.79,P=0.0001)、MACE(RR 0.74,95% CI 0.58-0.93,P=0.01)和入路部位并发症(RR 0.37,95% CI 0.28-0.48,P<0.00001)。两组之间 MI 和卒中有无差异。应用 TSA 边界,30 天死亡率、大出血、MACE 和入路部位并发症的 z 曲线均穿过常规和 TSA 边界,表明 TRA 组的结局有更好的证据。对于 MI 和卒中,z 曲线未能穿过常规和 TSA 边界,表明这两种结局均无获益或危害的信号。
在当前的 TSA 中,来自 RCT 的可用数据支持在 PCI 中通过桡动脉入路治疗 STEMI 患者,可改善 30 天死亡率、大出血、MACE 和入路部位并发症发生率。