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后扩张改善接受直接经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者的支架贴壁情况:一项使用光学相干断层扫描的多中心随机对照试验

Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography.

作者信息

Jiang Jun, Tian Nai-Liang, Cui Han-Bin, Li Chang-Ling, Liu Xian-Bao, Dong Liang, Sun Yong, Chen Xiao-Min, Chen Shao-Liang, Xu Bo, Wang Jian-An

机构信息

Department of Cardiology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

Department of Cardiology, Nanjing First Hospital, Nanjing, China.

出版信息

World J Emerg Med. 2020;11(2):87-92. doi: 10.5847/wjem.j.1920-8642.2020.02.004.

Abstract

BACKGROUND

Stent failure is more likely in the lipid rich and thrombus laden culprit lesions underlying ST-segment elevation myocardial infarction (STEMI). This study assessed the effectiveness of post-dilatation in primary percutaneous coronary intervention (pPCI) for acute STEMI.

METHODS

The multi-center POST-STEMI trial enrolled 41 consecutive STEMI patients with symptom onset <12 hours undergoing manual thrombus aspiration and Promus Element stent implantation. Patients were randomly assigned to control group (n=20) or post-dilatation group (n=21) in which a non-compliant balloon was inflated to >16 atm pressure. Strut apposition and coverage were evaluated by optical coherence tomography (OCT) after intracoronary verapamil administration via thrombus aspiration catheter, post pPCI and at 7-month follow-up. The primary endpoint was rate of incomplete strut apposition (ISA) at 7 months after pPCI.

RESULTS

There were similar baseline characteristics except for stent length (21.9 [SD 6.5] mm vs. 26.0 [SD 5.8] mm, respectively, P=0.03). In post-dilatation vs. control group, ISA rate was lower (2.5% vs. 4.5%, P=0.04) immediately after pPCI without affecting final TIMI flow 3 rate (95.2% vs. 95.0%, P>0.05) or corrected TIMI frame counts (22.6±9.4 vs. 22.0±9.7, P>0.05); and at 7-month follow-up (0.7% vs. 1.8%, P<0.0001), the primary study endpoint, with similar strut coverage (98.5% vs. 98.4%, P=0.63) and 1-year rate of major adverse cardiovascular events (MACE).

CONCLUSION

In STEMI patients, post-dilatation after stent implantation and thrombus aspiration improved strut apposition up to 7 months without affecting coronary blood flow or 1-year MACE rate. Larger and longer term studies are warranted to further assess safety (ClinicalTrials.gov identifier: NCT02121223).

摘要

背景

在ST段抬高型心肌梗死(STEMI)相关的富含脂质和血栓的罪犯病变中,支架失败的可能性更高。本研究评估了急性STEMI患者在直接经皮冠状动脉介入治疗(pPCI)中进行后扩张的有效性。

方法

多中心POST - STEMI试验纳入了41例症状发作<12小时、接受手动血栓抽吸和Promus Element支架植入的连续STEMI患者。患者被随机分配至对照组(n = 20)或后扩张组(n = 21),后扩张组使用非顺应性球囊在>16个大气压下进行扩张。通过光学相干断层扫描(OCT)在经血栓抽吸导管冠状动脉内给予维拉帕米后、pPCI后以及7个月随访时评估支架小梁贴壁和覆盖情况。主要终点是pPCI后7个月时不完全支架小梁贴壁(ISA)率。

结果

除支架长度外(分别为21.9 [标准差6.5] mm和26.0 [标准差5.8] mm,P = 0.03),两组基线特征相似。与对照组相比,后扩张组在pPCI后即刻ISA率较低(2.5%对4.5%,P = 0.04),且不影响最终TIMI血流3级率(95.2%对95.0%,P>0.05)或校正TIMI帧数(22.6±9.4对22.0±9.7,P>0.05);在7个月随访时(0.7%对1.8%,P<0.0001),即主要研究终点,支架小梁覆盖情况相似(98.5%对98.4%,P = 0.63),1年主要不良心血管事件(MACE)发生率也相似。

结论

在STEMI患者中,支架植入和血栓抽吸后进行后扩张可改善支架小梁贴壁情况长达7个月,且不影响冠状动脉血流或1年MACE发生率。需要开展更大规模和更长期的研究以进一步评估安全性(ClinicalTrials.gov标识符:NCT02121223)。

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