The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.
Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.
Am Heart J. 2020 Aug;226:140-146. doi: 10.1016/j.ahj.2020.04.029. Epub 2020 May 15.
The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.
STREAM 研究表明，在早期出现 ST 段抬高型心肌梗死（STEMI）的患者中，药物介入策略与直接经皮冠状动脉介入治疗（pPCI）一样有效。本研究是对以下发现的回应：替奈普酶剂量减半可降低≥75 岁患者的颅内出血（ICH）发生率。此外，对 ASSENT 试验中全剂量替奈普酶或阿替普酶的后续分析表明，出血事件发生率在 60 岁左右开始急剧增加。
STREAM-2 将比较新型药物介入策略与 STEMI 患者在症状发作后 3 小时内就诊且年龄≥60 岁患者的常规 pPCI 的疗效和安全性。在药物介入组中，患者将在尽快转运至 PCI 中心前接受半剂量替奈普酶治疗。在 pPCI 组中，将根据当地实践确定的最佳标准治疗方案对患者进行治疗。主要疗效标准为在基线时 ST 段抬高最大导联中 PCI 前后达到≥50%ST 段回落的患者比例，以及 30 天时死亡、充血性心力衰竭、休克或再梗死、挽救性 PCI 和急性心肌梗死的发生率，以及两者的复合发生率。主要安全性标准是总卒中、ICH 和主要非颅内出血。大约 600 名患者将被随机分组（400 名接受药物介入治疗，200 名接受 pPCI）。计划在入组 300 名患者后进行中期分析，以考虑调整试验纳入更大的样本量，旨在进行正式的验证性试验。
该研究将提供新的见解，旨在为不能及时接受 pPCI 的越来越多的老年 STEMI 患者建立一种有效且更安全的药物介入治疗方法。
