直接经皮冠状动脉介入治疗急性 ST 段抬高型心肌梗死患者血栓切除术的安全性和有效性：随机对照试验的荟萃分析。

BACKGROUND

Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI.

METHODS

Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models.

RESULTS

There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07).

CONCLUSIONS

Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

背景

比较急性 ST 段抬高型心肌梗死（STEMI）患者使用血栓切除术装置与传统经皮冠状动脉介入治疗（PCI）的临床试验得出了相互矛盾的结果。我们的研究目的是系统评估目前比较急性 STEMI 患者接受血栓切除术联合 PCI 与单纯传统 PCI 的可用数据。

方法

本荟萃分析纳入了 17 项血栓切除术与 PCI 的随机试验（n = 3909 例患者）。我们使用随机效应和固定效应模型计算死亡率、卒中和术后心肌灌注分级（MBG）、心肌梗死溶栓治疗（TIMI）血流、以及术后 ST 段缓解（STR）的汇总优势比。

结果

与接受传统 PCI 的患者相比，随机接受血栓切除术的患者 30 天死亡率无差异（44/1914 例 vs. 50/1907 例，OR 0.84，95%CI 0.54-1.29，P = 0.42）。血栓切除术与 TIMI 3 级血流（1616/1826 例 vs. 1533/1806 例，OR 1.41，P = 0.007）、MBG 3 级（730/1526 例 vs. 486/1513 例，OR 2.42，P < 0.001）、STR（923/1500 例 vs. 715/1494 例，OR 2.30，P < 0.001）显著相关，并且卒中风险更高（14/1403 例 vs. 3/1413 例，OR 2.88，95%CI 1.06-7.85，P = 0.04）。不同设备类型之间的结果存在显著差异，手动抽吸血栓切除术（MAT）的死亡率呈下降趋势（21/949 例 vs. 36/953 例，OR 0.59，95%CI 0.35-1.01，P = 0.05），而机械装置则呈上升趋势（20/416 例 vs. 10/418 例，OR 2.07，95%CI 0.95-4.48，P = 0.07）。