冠状动脉内瑞替普酶在直接经皮冠状动脉介入治疗期间对大面积前壁心肌梗死梗死面积的影响：RECOVER II试验的原理与设计

Impact of intracoronary reteplase during primary percutaneous coronary intervention on infarct size in large anterior myocardial infarction: rationale and design of the RECOVER II trial.

作者信息

Huang Dong, Ma Yuanji, Wu Hongxian, Zhong Xin, Gao Wei, Zhou Jun, Qian Juying, Ge Junbo

机构信息

Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.

Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Cardiovasc Diagn Ther. 2022 Jun;12(3):352-359. doi: 10.21037/cdt-21-756.

DOI:10.21037/cdt-21-756

PMID:35800360

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9253174/

Abstract

BACKGROUND

Thrombus embolization and microvascular obstruction during percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is commonly detected, which causes inadequate myocardial perfusion and elevated infarct size. An approach with low-dose intracoronary fibrinolytic treatment for reducing distal embolization and improving myocardial reperfusion in high-risk STEMI cases remains controversial.

METHODS

The RECOVER II study represents a multicenter, randomized, double-blind, parallel-group trial assessing low-dose adjunctive intracoronary reteplase during primary PCI in individuals with large anterior myocardial infarction and thrombus determined by angiography. The trial will enroll 306 cases who present within 12 h following STEMI for proximal or mid left anterior descending artery occlusion undergoing primary PCI. Cases will be randomized to receive a bolus intracoronary reteplase at 9 mg or 18 mg . placebo. The drug will be delivered over 2 minutes proximal to culprit lesions with an intracoronary catheter early after wire-crossing and before thrombus aspiration or balloon dilation.

RESULTS

The primary outcome will be infarct size assessed by late gadolinium-enhanced magnetic resonance imaging (MRI) (% of left ventricular mass) on day 7 after enrollment. Secondary outcomes will include the amount of microvascular obstruction and myocardial salvage index examined via MRI on day 7, angiographic measures of reperfusion [Thrombolysis in Myocardial Infarction (TIMI) coronary flow grade, TIMI frames count and myocardial blush grade], incidence of complete ST-segment resolution at 2 hours after reperfusion, area under the curve for troponin T, and rates of major adverse cardiovascular events at 30 days.

CONCLUSIONS

RECOVER II will determine whether the addition of low-dose intracoronary reteplase early after wire-crossing as an adjunct to reperfusion treatment reduces infarct size in individuals with large anterior myocardial infarction.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04571580.

摘要

背景

ST段抬高型心肌梗死（STEMI）患者经皮冠状动脉介入治疗（PCI）期间的血栓栓塞和微血管阻塞较为常见，这会导致心肌灌注不足和梗死面积增大。对于高危STEMI病例，采用低剂量冠状动脉内溶栓治疗以减少远端栓塞并改善心肌再灌注的方法仍存在争议。

方法

RECOVER II研究是一项多中心、随机、双盲、平行组试验，评估在经血管造影确定有大面积前壁心肌梗死和血栓的患者进行直接PCI时，冠状动脉内低剂量辅助使用瑞替普酶的效果。该试验将纳入306例在STEMI后12小时内出现、因左前降支近端或中段闭塞而接受直接PCI的患者。患者将被随机分为接受9毫克或18毫克冠状动脉内推注瑞替普酶、安慰剂。药物将在导丝通过后早期、在血栓抽吸或球囊扩张前，通过冠状动脉内导管在罪犯病变近端2分钟内给药。

结果

主要结局将是入组后第7天通过延迟钆增强磁共振成像（MRI）评估的梗死面积（占左心室质量的百分比）。次要结局将包括第7天通过MRI检查的微血管阻塞量和心肌挽救指数、再灌注的血管造影指标[心肌梗死溶栓（TIMI）冠状动脉血流分级、TIMI帧数计数和心肌 blush分级]、再灌注后2小时完全ST段回落的发生率、肌钙蛋白T曲线下面积以及30天时主要不良心血管事件的发生率。