半剂量重组葡激酶易化经皮冠状动脉介入治疗急性ST段抬高型心肌梗死的有效性及安全性Efficacy and safety of a facilitated percutaneous coronary intervention with half-dose recombinant staphylokinase in ST-segment elevation myocardial infarction
吴天予,张文豪,陈彭生,李宸,吴添,吕展,王彤,刘琨,陶志文,龚晓璇,袁亮,李勇,陈波,陈新,陈增光,杨乃全,桑园园,王晓彦,礼拜红,朱莉,王国余,赵昕,卢川,蒋峻,郝睿娜,李春坚
摘要(Abstract):
目的 探讨预计120 min内可行经皮冠状动脉介入治疗(PCI)的急性ST段抬高型心肌梗死(STEMI)患者接受半剂量重组葡激酶(r-SAK)易化PCI的有效性及安全性。方法 纳入2021年10月29日至2022年8月14日在8家中心就诊的200例STEMI患者,按1﹕1随机分入r-SAK组或生理盐水对照组。所有患者溶栓前均口服负荷剂量的阿司匹林、替格瑞洛及静脉推注普通肝素。比较两组PCI术后60~90 min罪犯血管相关导联ST段回落率(STR)、术后第5天病理性Q波比例及转归、起病12 h内超敏肌钙蛋白T(hs-cTnT)到达峰值比例。安全性评价为住院期间以出血学术研究联合会(BARC)分级标准判定的BARC≥3型大出血。结果 与对照组相比,r-SAK组显著提高了PCI术后60~90 min STR≥70%的比例(58.3%比40.3%,P=0.009);r-SAK组病理性Q波比例显著降低(59.1%比74.1%,P=0.040);Q波进展比例更低(14.8%比43.2%,P<0.001);Q波消失比例更高(12.5%比3.7%,P=0.027);起病12 h内hs-cTnT到达峰值比例r-SAK组显著高于对照组[31/40(77.5%)比17/33(51.5%),P=0.027]。住院期间BARC≥3型大出血发生率组间比较,差异无统计学意义(P>0.05)。结论 在STEMI起病12 h内,预计120 min内可接受PCI的患者,接受半剂量r-SAK易化PCI可显著提高术后STR≥70%比例、减少病理性Q波形成、缩短hs-cTnT到达峰值时间,且不增加患者出血风险,是值得进一步研究的再灌注治疗策略。
关键词(KeyWords): 急性ST段抬高型心肌梗死;经皮冠状动脉介入治疗;溶栓;重组葡激酶
基金项目(Foundation): 国家重点研发计划项目(2022YFC2402404);; 江苏省人民医院临床能力提升工程项目(JSPH-MA-2022-3);; 国家自然科学基金项目(82170351)
作者(Author): 吴天予,张文豪,陈彭生,李宸,吴添,吕展,王彤,刘琨,陶志文,龚晓璇,袁亮,李勇,陈波,陈新,陈增光,杨乃全,桑园园,王晓彦,礼拜红,朱莉,王国余,赵昕,卢川,蒋峻,郝睿娜,李春坚
参考文献(References):
- [1]刘明波,何新叶,杨晓红,等.《中国心血管健康与疾病报告2023》概要(心血管疾病流行及介入诊疗状况)[J].中国介入心脏病学杂志,2024,32(10):541-550. DOI:10.3969/j.issn.1004-8812.2024.10.001.
- [2] Rao SV,O’Donoghue ML,Ruel M,et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the management of patients with acute coronary syndromes:a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines[J]. Circulation,2025,151(13):e771-e862. DOI:10.1161/cir.0000000000001309.
- [3]国家心血管病医疗质量控制中心.《2021年中国心血管病医疗质量报告》概要[J].中国循环杂志,2021,36(11):1041-1064. DOI:10.3969/j.issn.1000-3614.2021.11.001.
- [4] Masoudi FA,Ponirakis A,de Lemos JA,et al. Trends in U.S. cardiovascular care:2016 report from 4 ACC National Cardiovascular Data Registries[J]. J Am Coll Cardiol,2017,69(11):1427-1450. DOI:10.1016/j.jacc.2016.12.005.
- [5] Biswas S,Duffy SJ,Lefkovits J,et al. Australian trends in procedural characteristics and outcomes in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction[J]. Am J Cardiol,2018,121(3):279-288.DOI:10.1016/j.amjcard.2017.10.025.
- [6] Fazel R,Joseph TI,Sankardas MA,et al. Comparison of reperfusion Strategies for ST-segment-elevation myocardial infarction:a multivariate network meta-analysis[J]. J Am Heart Assoc,2020,9(12):e015186. DOI:10.1161/JAHA.119.015186.
- [7] Assessment of the Safety and E ffi cacy of a New Treatment Strategy with Percutaneous Coronary Intervention(ASSENT-4 PCI)investigators. Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction(ASSENT-4 PCI):randomised trial[J]. Lancet,2006,367(9510):569-578. DOI:10.1016/s0140-6736(06)68147-6.
- [8] Ellis SG,Tendera M,de Belder MA,et al. Facilitated PCI in patients with ST-elevation myocardial infarction[J]. N Engl J Med,2008,358(21):2205-2217. DOI:10.1056/NEJMoa0706816.
- [9] Vanderschueren S,Barrios L,Kerdsinchai P,et al. A randomized trial of recombinant staphylokinase versus alteplase for coronary artery patency in acute myocardial infarction. The STAR Trial Group[J]. Circulation,1995,92(8):2044-2049. DOI:10.1161/01.cir.92.8.2044.
- [10] Collen D. Staphylokinase:a potent,uniquely fi brin-selective thrombolytic agent[J]. Nat Med,1998,4(3):279-284.DOI:10.1038/nm0398-279.
- [11] Toombs CF. New directions in thrombolytic therapy[J]. Curr Opin Pharmacol,2001,1(2):164-168. DOI:10.1016/s1471-4892(01)00030-3.
- [12]江苏省医学会心血管病学分会,江苏省医师协会心血管内科医师分会,江苏省医师协会心脏重症专业委员会,等.急性ST段抬高型心肌梗死溶栓治疗专家共识[J].中国介入心脏病学杂志,2024,32(7):364-382. DOI:10.3969/j.issn.1004-8812.2024.07.002.
- [13] Li CJ,Huang J,Yang ZJ,et al. Thrombolytic e ffi cacy of native recombinant staphylokinase on femoral artery thrombus of rabbits[J]. Acta Pharmacol Sin,2007,28(1):58-65. DOI:10.1111/j.1745-7254.2007.00455.x.
- [14] Geravandi M,Nourabi M,Navabifar S,et al. A comparison of the ef fects of ticagrelor and clopidogrel in patients with acute ST-segment elevation myocardial infarction:a systematic review and meta-analysis of randomized clinical trials[J]. BMC Pharmacol Toxicol,2024,25(1):93. DOI:10.1186/s40360-024-00817-8.
- [15] Thygesen K,Alpert JS,Jaff e AS,et al. Fourth universal defi nition of myocardial infarction(2018)[J]. Circulation,2018,138(20):e618-e651. DOI:10.1161/cir.0000000000000617.
- [16] Pu J,Ding S,Ge H,et al. E ffi cacy and safety of a pharmacoinvasive strategy with half-dose alteplase versus primary angioplasty in ST-segment-elevation myocardial infarction:EARLY-MYO trial(early routine catheterization after alteplase fibrinolysis versus primary PCI in acute ST-segment-elevation myocardial infarction)[J]. Circulation,2017,136(16):1462-1473. DOI:10.1161/CIRCULATIONAHA.117.030582.
- [17] Delewi R,Ijff G,van de Hoef TP,et al. Pathological Q waves in myocardial infarction in patients treated by primary PCI[J].JACC Cardiovasc Imaging,2013,6(3):324-331. DOI:10.1016/j.jcmg.2012.08.018.
- [18] Mehran R,Rao SV,Bhatt DL,et al. Standardized bleeding definitions for cardiovascular clinical trials:a consensus report from the Bleeding Academic Research Consortium[J].Circulation,2011,123(23):2736-2747. DOI:10.1161/CIRCULATIONAHA.110.009449.
- [19]苏州工业园区东方华夏心血管健康研究院,国家放射与治疗临床医学研究中心胸痛中心专家委员会.《胸痛中心质控报告(2023)》概要[J].中国介入心脏病学杂志,2024,32(11):618-625. DOI:10.3969/j.issn.1004-8812.2024.11.002.
- [20] Terkelsen CJ,S?rensen JT,Maeng M,et al. System delay and mortality among patients with STEMI treated with primary percutaneous coronary intervention[J]. JAMA,2010,304(7):763-771. DOI:10.1001/jama.2010.1139.
- [21]急性ST段抬高型心肌梗死诊断和治疗指南(2019)[J].中华心血管病杂志,2019,47(10):766-783. DOI:10.3760/cma.j.issn.0253?3758.2019.10.003.
- [22] Ibanez B,James S,Agewall S,et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation:the task force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology(ESC)[J]. Eur Heart J,2018,39(2):119-177. DOI:10.1093/eurheartj/ehx393.
- [23] Murray V,Norrving B,Sandercock PA,et al. The molecular basis of thrombolysis and its clinical application in stroke[J]. J Intern Med,2010,267(2):191-208. DOI:10.1111/j.1365-2796.2009.02205.x.
- [24]急性心肌梗死再灌注治疗研究协作组.重组葡激酶与重组组织型纤溶酶原激活剂治疗急性心肌梗死的随机多中心临床试验[J].中华心血管病杂志,2007,35(8):691-696. DOI:10.3760/j.issn:0253-3758.2007.08.002.
- [25] Rapold HJ. Promotion of thrombin activity by thrombolytic therapy without simultaneous anticoagulation[J]. Lancet,1990,335(8687):481-482. DOI:10.1016/0140-6736(90)90720-p.
- [26] Zalewski J,Bogaerts K,Desmet W,et al. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention:an angiographic substudy of the ASSENT-4 PCI(Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention)trial[J]. J Am Coll Cardiol,2011,57(19):1867-1873. DOI:10.1016/j.jacc.2010.10.061.
- [27]中华医学会心血管病学分会,中华心血管病杂志编辑委员会. ST段抬高型心肌梗死患者急诊PCI微循环保护策略中国专家共识[J].中华心血管病杂志,2022,50(3):221-230.DOI:10.3760/cma.j.cn112148-20211112-00987.
- [28] McDonald MA,Fu Y,Zeymer U,et al. Adverse outcomes in fi brinolytic-based facilitated percutaneous coronary intervention:insights from the ASSENT-4 PCI electrocardiographic substudy[J]. Eur Heart J,2008,29(7):871-879. DOI:10.1093/eurheartj/ehn078.
- [29] Spitaleri G,Brugaletta S,Scalone G,et al. Role of ST-segment resolution in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention(from the 5-year outcomes of the EXAMINATION[evaluation of the xience-V stent in acute myocardial infarction] trial)[J]. Am J Cardiol,2018,121(9):1039-1045. DOI:10.1016/j.amjcard.2018.01.015.
- [30] Rovai D,Di Bella G,Rossi G,et al. Q-wave prediction of myocardial infarct location,size and transmural extent at magnetic resonance imaging[J]. Coron Artery Dis,2007,18(5):381-389. DOI:10.1097/MCA.0b013e32820588c2.
- [31] Moon JC,De Arenaza DP,Elkington AG,et al. The pathologic basis of Q-wave and non-Q-wave myocardial infarction:a cardiovascular magnetic resonance study[J]. J Am Coll Cardiol,2004,44(3):554-560. DOI:10.1016/j.jacc.2004.03.076.
- [32] Chen P,Eikelboom JW,Tan C,et al. Single bolus r-S A K before primary PCI for ST-segment-elevation myocardial infarction[J]. Circ Cardiovasc Interv,2024,17(2):e013455. DOI:10.1161/CIRCINTERVENTIONS.123.013455.