-
摘要: 慢性完全闭塞病变(CTO)被称作是冠状动脉经皮介入治疗的最后一座堡垒,基于CTO病变病理成分相关研究而开发的血管内药物辅助介入治疗可软化CTO病变成分,易化导丝通过,目前Ⅱ期临床试验已经完成,有望为CTO病变再通提供新途径。本文就胶原酶辅助介入治疗研究进展进行综述。
-
关键词:
- 冠心病 /
- 经皮冠状动脉介入治疗 /
- 慢性完全闭塞病变 /
- 基质金属蛋白酶
Abstract: Chronic total occlusion(CTO) remains one of the major challenging obstacles in coronary intervention. Collagenase-assisted interventional therapy based on the study of pathological components of CTO lesions can soften the components of CTO lesions and make the wire across the lesions easier. Phase Ⅱ clinical trials have been completed, which is expected to provide a new way for the recanalization of CTO lesions. This article will review the progress in collagenase-assisted interventional therapy. -
表 1 胶原酶相关临床研究
Table 1. Characteristics of clinical study on collagenase
项目 入选人群 有效性终点 安全性终点 围术期 术后 Ⅰ期临床研究 既往导丝通过失败的CTO患者(20例) 导丝通过率:80%(16例) 心肌梗死:3例患者因侧支缺血发生非ST段抬高型心肌梗死。 术后3个月的CTA显示,在成功开通的CTO患者中,支架通畅且没有迟发并发症。 Ⅱ期临床研究 既往导丝通过失败的CTO患者(75例) PCI手术成功率:组间无显著差异。软导丝通过率:对照组小于两胶原酶组(P=0.03) 围术期心肌坏死:对照组出现2例,900 μg剂量组2例,1200 μg剂量组4例。全部与侧支闭塞或穿孔相关。 术后30 d内对照组出现1例心肌梗死,而胶原酶组未出现相关并发症。 -
[1] Ybarra LF, Rinfret S, Brilakis ES, et al. Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations[J]. Circulation, 2021, 143(5): 479-500. doi: 10.1161/CIRCULATIONAHA.120.046754
[2] Schumacher SP, Stuijfzand WJ, de Winter RW, et al. Ischemic Burden Reduction and Long-Term Clinical Outcomes After Chronic Total Occlusion Percutaneous Coronary Intervention[J]. JACC Cardiovasc Interv, 2021, 14(13): 1407-1418. doi: 10.1016/j.jcin.2021.04.044
[3] Samy M, El Awady WS, Al-Daydamony MM, et al. Echocardiographic assessment of left ventricular function recovery post percutaneous coronary intervention of chronic total occlusions in patients with low and mid-range left ventricular ejection fractions[J]. Echocardiography, 2020, 37(2): 239-246. doi: 10.1111/echo.14582
[4] Zhang J, Dong P, Dong X, et al. Long-term changes in ischemic burden after chronic total occlusion percutaneous coronary intervention: a retrospective observational study[J]. Am J Transl Res, 2021, 13(7): 7632-7640.
[5] Gong ML, Mao Y, Liu JH. Long-Term Outcomes of Percutaneous Coronary Intervention for in-Stent Chronic Total Occlusion[J]. Chin Med J(Engl), 2020, 134(3): 302-308.
[6] Bell MR, Berger PB, Bresnahan JF, et al. Initial and long-term outcome of 354 patients after coronary balloon angioplasty of total coronary artery occlusions[J]. Circulation, 1992, 85(3): 1003-1011. doi: 10.1161/01.CIR.85.3.1003
[7] Brilakis ES, Burke MN. Chronic Total Occlusion Percutaneous Coronary Intervention[J]. Circ Cardiovasc Interv, 2018, 11(10): e007362. doi: 10.1161/CIRCINTERVENTIONS.118.007362
[8] Tanaka H, Tsuchikane E, Muramatsu T, et al. A Novel Algorithm for Treating Chronic Total Coronary Artery Occlusion[J]. J Am Coll Cardiol, 2019, 74(19): 2392-2404. doi: 10.1016/j.jacc.2019.08.1049
[9] Wu EB, Tsuchikane E, Ge L, et al. Retrograde Versus Antegrade Approach for Coronary Chronic Total Occlusion in an Algorithm-Driven Contemporary Asia-Pacific Multicentre Registry: Comparison of Outcomes[J]. Heart Lung Circ, 2020, 29(6): 894-903. doi: 10.1016/j.hlc.2019.05.188
[10] Lamelas P, Padilla L, Abud M, et al. In-stent chronic total occlusion angioplasty in the LATAM-CTO registry[J]. Catheter Cardiovasc Interv, 2021, 97(1): E34-E39.
[11] 贾若飞, 朱华刚, 李响, 等. 慢性完全闭塞病变中"顽固的近端纤维帽"的治疗策略[J]. 中国介入心脏病学杂志, 2017, 25(1): 42-44. doi: 10.3969/j.issn.1004-8812.2017.01.010
[12] Jaffe R, Leung G, Munce NR, et al. Natural history of experimental arterial chronic total occlusions[J]. J Am Coll Cardiol, 2009, 53(13): 1148-1158. doi: 10.1016/j.jacc.2008.09.064
[13] Seifter S, Harper E. Collagenases[M]//Goldstein L, Perlmann G, Lorand L. Methodsin Enzymology. XIX. New York: Academic Press, 1970: 613-635.
[14] Zhang D, Earp BE, Benavent KA, et al. Collagenase Treatment of Dupuytren's Disease with Minimum 5-Year Follow-Up: Recurrence, Reintervention, and Satisfaction[J]. Plast Reconstr Surg, 2020, 146(5): 1071-1079. doi: 10.1097/PRS.0000000000007243
[15] Goldstein I, Lipshultz LI, McLane M, et al. Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease[J]. J Urol, 2020, 203(6): 1191-1197. doi: 10.1097/JU.0000000000000743
[16] Beecher SM, Wilkinson JE, Cuggy C, et al. Patient's perspective of treatment in Dupuytren's Disease: collagenase versus limited fasciectomy[J]. J Hand Surg Eur Vol, 2022: 17531934221095681.
[17] Yuksel SS, Shah ND, Sasson DC, et al. A 12-Year Review of Clinical Practice Patterns in Dupuytren Contracture Based on Continuous Certification by the American Board of Plastic Surgery[J]. Plast Reconstr Surg, 2022, 150(1): 127e-135e. doi: 10.1097/PRS.0000000000009181
[18] Srivatsa SS, Edwards WD, Boos CM, et al. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition[J]. J Am Coll Cardiol, 1997, 29(5): 955-963. doi: 10.1016/S0735-1097(97)00035-1
[19] Strauss BH, Goldman L, Qiang B, et al. Collagenase plaque digestion for facilitating guide wire crossing in chronic total occlusions[J]. Circulation, 2003, 108(10): 1259-1262. doi: 10.1161/01.CIR.0000086320.24172.A1
[20] Segev A, Nili N, Qiang B, et al. Human-grade purified collagenase for the treatment of experimental arterial chronic total occlusion[J]. Cardiovasc Revasc Med, 2005, 6(2): 65-69. doi: 10.1016/j.carrev.2005.05.007
[21] 强北平, Bradley Strauss. 胶原酶软化CTO中纤维瘢块的实验研究进展[J]. 实用心脑肺血管病杂志, 2012, 20(8): 1267-1269. doi: 10.3969/j.issn.1008-5971.2012.08.006
[22] Thind AS, Strauss BH, Karshafian R, et al. The use of ultrasound-stimulated contrast agents as an adjuvant for collagenase therapy in chronic total occlusions[J]. EuroIntervention, 2014, 10(4): 484-493. doi: 10.4244/EIJV10I4A82
[23] Goertz DE, Thind AS, Karshafian R, et al. In vivo feasibility study of ultrasound potentiated collagenase therapy of chronic total occlusions[J]. Ultrasonics, 2014, 54(1): 20-24. doi: 10.1016/j.ultras.2013.07.014
[24] Strauss BH, Osherov AB, Radhakrishnan S, et al. Collagenase Total Occlusion-1(CTO-1) trial: a phase I, dose-escalation, safety study[J]. Circulation, 2012, 125(3): 522-528. doi: 10.1161/CIRCULATIONAHA.111.063198
[25] Graham JJ, Bagai A, Wijeysundera H, et al. Collagenase to facilitate guidewire crossing in chronic total occlusion PCI-The Total Occlusion Study in Coronary Arteries-5(TOSCA-5) trial[J]. Catheter Cardiovasc Interv, 2022, 99(4): 1065-1073. doi: 10.1002/ccd.30101
[26] Fefer P, Carlino M, Strauss BH. Intraplaque therapies for facilitating percutaneous recanalization of chronic total occlusions[J]. Can J Cardiol, 2010, 26 Suppl A: 32A-36A.
[27] de la Fuente M, Lombardero L, Gómez-González A, et al. Enzyme Therapy: Current Challenges and Future Perspectives[J]. Int J Mol Sci, 2021, 22(17): 9181. doi: 10.3390/ijms22179181
[28] Harding SA, Wu EB, Lo S, et al. A New Algorithm for Crossing Chronic Total Occlusions From the Asia Pacific Chronic Total Occlusion Club[J]. JACC Cardiovasc Interv, 2017, 10(21): 2135-2143. doi: 10.1016/j.jcin.2017.06.071
[29] 葛均波, 葛雷, 霍勇, 等. 中国冠状动脉慢性完全闭塞病变介入治疗推荐路径更新[J]. 中国介入心脏病学杂志, 2021, 29(6): 302-305. doi: 10.3969/j.issn.1004-8812.2021.06.002
[30] 中国冠状动脉慢性闭塞病变介入治疗俱乐部. 中国冠状动脉慢性完全闭塞病变介入治疗推荐路径[J]. 中国介入心脏病学杂志, 2018, 26(3): 121-128. doi: 10.3969/j.issn.1004-8812.2018.03.001
[31] 赵林, 汝磊生, 柳景华. 正向夹层再入真腔技术在慢性完全闭塞病变介入治疗中的应用体会[J]. 临床心血管病杂志, 2021, 37(10): 879-881. https://www.cnki.com.cn/Article/CJFDTOTAL-LCXB202110001.htm
[32] 于子翔, 董佳佳, 赵龙, 等. 冠状动脉慢性完全闭塞病变侧支循环的预测因素和预后意义[J]. 临床心血管病杂志, 2021, 37(8): 705-709. https://www.cnki.com.cn/Article/CJFDTOTAL-LCXB202108005.htm
[33] Aljabbary T, Katyukha A, Elbaz-Greener G, et al. Overview of Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Techniques: A Narrative Systematic Review[J]. CJC Open, 2021, 3(10): 1273-1281. doi: 10.1016/j.cjco.2021.05.018
[34] Mohandes M, Moreno C, Fuertes M, et al. Angiographic Characteristics and Outcomes of Percutaneous Coronary Intervention of Reattempted Chronic Total Occlusion: Potential Contributing Factors to Procedural Success[J]. J Clin Med, 2021, 10(23): 5661. doi: 10.3390/jcm10235661