From Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China (J.P., S.D., H.G., B.H.); Department of Cardiology, General Hospital of Shenyang Military Region, China (Y.H.); Department of Cardiology, Beijing Luohe Hospital, Capital Medical University, China (J.G.); Department of Cardiology, Fujian Medical University Affiliated the First Quanzhou Hospital, China (R.L.); Department of Cardiology, Wuhan Asia Heart Hospital, China (X.S.); Department of Cardiology, Bengbu Medical University Affiliated the First Hospital, China (H.Z.); and Department of Cardiology, Union Hospital, Fujian Medical University, Fuzhou, China (L.C.)
From Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China (J.P., S.D., H.G., B.H.); Department of Cardiology, General Hospital of Shenyang Military Region, China (Y.H.); Department of Cardiology, Beijing Luohe Hospital, Capital Medical University, China (J.G.); Department of Cardiology, Fujian Medical University Affiliated the First Quanzhou Hospital, China (R.L.); Department of Cardiology, Wuhan Asia Heart Hospital, China (X.S.); Department of Cardiology, Bengbu Medical University Affiliated the First Hospital, China (H.Z.); and Department of Cardiology, Union Hospital, Fujian Medical University, Fuzhou, China (L.C.).
Circulation. 2017 Oct 17;136(16):1462-1473. doi: 10.1161/CIRCULATIONAHA.117.030582. Epub 2017 Aug 27.
Timely primary percutaneous coronary intervention (PPCI) cannot be offered to all patients with ST-segment-elevation myocardial infarction (STEMI). Pharmaco-invasive (PhI) strategy has been proposed as a valuable alternative for eligible patients with STEMI. We conducted a randomized study to compare the efficacy and safety of a PhI strategy with half-dose fibrinolytic regimen versus PPCI in patients with STEMI.
The EARLY-MYO trial (Early Routine Catheterization After Alteplase Fibrinolysis Versus Primary PCI in Acute ST-Segment-Elevation Myocardial Infarction) was an investigator-initiated, prospective, multicenter, randomized, noninferiority trial comparing a PhI strategy with half-dose alteplase versus PPCI in patients with STEMI 18 to 75 years of age presenting ≤6 hours after symptom onset but with an expected PCI-related delay. The primary end point of the study was complete epicardial and myocardial reperfusion after PCI, defined as thrombolysis in myocardial infarction flow grade 3, thrombolysis in myocardial infarction myocardial perfusion grade 3, and ST-segment resolution ≥70%. We also measured infarct size and left ventricular ejection fraction with cardiac magnetic resonance and recorded 30-day clinical and safety outcomes.
A total of 344 patients from 7 centers were randomized to PhI (n=171) or PPCI (n=173). PhI was noninferior (and even superior) to PPCI for the primary end point (34.2% versus 22.8%, <0.05, =0.022), with no significant differences in the frequency of the individual components of the combined end point: thrombolysis in myocardial infarction flow 3 (91.3% versus 89.2%, =0.580), thrombolysis in myocardial infarction myocardial perfusion grade 3 (65.8% versus 62.9%, =0.730), and ST-segment resolution ≥70% (50.9% versus 45.5%, =0.377). Infarct size (23.3%±11.3% versus 25.8%±13.7%, =0.101) and left ventricular ejection fraction (52.2%±11.0% versus 51.4%±12.0%, =0.562) were similar in both groups. No significant differences occurred in 30-day rates of total death (0.6% versus 1.2%, =1.0), reinfarction (0.6% versus 0.6%, =1.0), heart failure (13.5% versus 16.2%, =0.545), major bleeding events (0.6% versus 0%, =0.497), or intracranial hemorrhage (0% versus 0%), but minor bleeding (26.9% versus 11.0%, <0.001) was observed more often in the PhI group.
For patients with STEMI presenting ≤6 hours after symptom onset and with an expected PCI-related delay, a PhI strategy with half-dose alteplase and timely PCI offers more complete epicardial and myocardial reperfusion when compared with PPCI. Adequately powered trials with this reperfusion strategy to assess clinical and safety outcomes are warranted.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01930682.
对于发生 ST 段抬高型心肌梗死（STEMI）的患者，并非所有患者都能及时接受经皮冠状动脉介入治疗（PPCI）。药物溶栓联合直接经皮冠状动脉介入治疗（PhI）策略已被提出，作为适合接受溶栓治疗的 STEMI 患者的一种替代治疗方法。我们开展了一项随机研究，比较了 PhI 策略联合半剂量纤溶酶原激活剂与 PPCI 在 STEMI 患者中的疗效和安全性。
EARLY-MYO 试验（急性 ST 段抬高型心肌梗死中阿替普酶溶栓后早期常规导管术与直接经皮冠状动脉介入治疗比较）是一项由研究者发起的、前瞻性的、多中心的、随机的、非劣效性试验，比较了 PhI 策略联合半剂量阿替普酶与 PPCI 在 STEMI 患者中的疗效。这些患者在症状发作后 6 小时内就诊，且预计与 PPCI 相关的延迟时间。该研究的主要终点是 PCI 后完全的心外膜和心肌再灌注，定义为心肌梗死溶栓血流分级 3、心肌梗死溶栓心肌灌注分级 3 和 ST 段回落≥70%。我们还通过心脏磁共振测量了梗死面积和左心室射血分数，并记录了 30 天的临床和安全性结局。
共有来自 7 个中心的 344 名患者被随机分为 PhI 组（n=171）或 PPCI 组（n=173）。PhI 组在主要终点方面不劣于（甚至优于）PPCI 组（34.2%比 22.8%，<0.05，=0.022），且联合终点的各个组成部分的发生率无显著差异：心肌梗死溶栓血流分级 3（91.3%比 89.2%，=0.580）、心肌梗死溶栓心肌灌注分级 3（65.8%比 62.9%，=0.730）和 ST 段回落≥70%（50.9%比 45.5%，=0.377）。两组的梗死面积（23.3%±11.3%比 25.8%±13.7%，=0.101）和左心室射血分数（52.2%±11.0%比 51.4%±12.0%，=0.562）相似。两组 30 天总死亡率（0.6%比 1.2%，=1.0）、再梗死率（0.6%比 0.6%，=1.0）、心力衰竭发生率（13.5%比 16.2%，=0.545）、大出血事件发生率（0.6%比 0%，=0.497）或颅内出血发生率（0%比 0%）无显著差异，但 PhI 组Minor bleeding（26.9%比 11.0%，<0.001）更常见。
对于症状发作后 6 小时内就诊且预计与 PPCI 相关的延迟时间的 STEMI 患者，PhI 策略联合半剂量阿替普酶和及时的 PCI 比 PPCI 能提供更完全的心外膜和心肌再灌注。需要进行充分的临床试验来评估该再灌注策略的临床和安全性结局。
