李占鲁,王敏,栾毅,赵炎波,傅国胜,黄翯

• 1:浙江大学医学院附属邵逸夫医院心内科

摘要(Abstract)：

目的评估SeQuent Please药物涂层球囊(DCB)扩张术在临床使用的安全性和有效性。方法回顾性分析2015年5月7日至2017年6月28日在浙江大学医学院附属邵逸夫医院因冠状动脉粥样硬化性心脏病行DCB扩张术治疗的246例患者。观察患者预后情况,以发生主要不良心血管事件[MACE,包括心原性死亡、非致死性急性心肌梗死(AMI)及靶病变再次血运重建(TLR)]和TLR为观察终点。结果 246例患者中,共包含270处病变,其中支架内再狭窄(ISR)患者117例(47.6%,病变130处),冠状动脉原发小血管病变患者91例(37.0%,病变101处),原发大血管病变患者15例(6.1%,病变16处),慢性完全闭塞病变患者21例(8.5%,病变21处)以及冠状动脉旁路移植术后桥血管病变患者2例(0.8%,病变2处),所有患者共使用312枚DCB。平均随访(18.8±7.7)个月,主要MACE共发生11例(4.5%),其中1例(0.4%)患者确认为心原性死亡,1例(0.4%)患者为非致死性AMI行TLR,9例(4.1%)患者为再狭窄后行TLR。ISR患者TLR发生率(5.1%比2.2%,P=0.276)和MACE发生率(5.1%比3.3%,P=0.520)均较冠状动脉原发小血管病变患者高,但差异无统计学意义。而15例冠状动脉原发大血管病变患者无MACE(包括TLR)发生。结论在临床上,DCB扩张术被证实是一种有效的冠状动脉血运重建策略,无论对ISR患者还是冠状动脉小血管原发病变患者,其应用安全有效,且对大血管原发病变的使用前景同样值得期待。

关键词(KeyWords)： 冠状动脉粥样硬化性心脏病;药物涂层球囊;主要不良心血管事件

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 李占鲁,王敏,栾毅,赵炎波,傅国胜,黄翯

参考文献(References)：

• [1] Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med,2013, 368(16):1558.
• [2] Unverdorben M, Kleber FX, Heuer H, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol, 2010, 99(3):165-174.
• [3] Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization:the task force on myocardial revascularization of the European Society of Cardiology(ESC)and European Association for Cardio-Thoracic Surgery(EACTS). Developed with the special contribution of the European Association for Percutaneous Cardiovascular Interventions(EAPCI). Eur Heart J, 2019, 40(2):87-165.
• [4]《药物涂层球囊临床应用中国专家共识》专家组.药物涂层球囊临床应用中国专家共识.中国介入心脏病学杂志, 2016, 24(2):61-67.
• [5] Hee L, Terluk A, Thomas L, et a1. Late clinical outcomes for Se Quent please paclitaxel-coated balloons in PCI of instent restenosis and de novo lesions:a single-center, real world registry. Catheter Cardiovasc Interv, 2017, 89(3):375-382.
• [6] Zivelonghi C, Ghione M, Benfari G, et a1. Drug-coated balloon:long-term outcome from a real world three-center experience. J Interv Cardiol, 2017, 30(4):318-324.
• [7] Cortese B, D'Ascenzo F, Fetiveau R, et a1. Treatment of coronary artery disease with a new-generation drug-coated balloon:final results of the Italian Elutax SV rEgistry-DCB-RISE. J Cardiovasc Med(Hagerstown), 2018, 19(5):247-252.
• [8] Jeger RV, Farah A, Ohlow MA, et a1. Drug-coated balloons for small coronary artery disease(BASKET-SMALL 2):an open-label randomised non-inferiority trial. Lancet, 2018, 392(10150):849-856.
• [9] Latib A, Colombo A, Castriota F, et a1. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxeleluting stent in small coronary vessels:the BELLO(balloon elution and late loss optimization)study. J Am Coll Cardiol, 2012, 60(24):2473-2480.
• [10] W?hrle J, Zadura M, M?bius-Winkler S, et a1. SeQuentPlease world wide registry:clinical results of SeQuent please paclitaxelcoated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol, 2012, 60(18):1733-1738.
• [11] Ho HH, Ooi YW, Loh KK, et a1. Clinical efficacy and s afety of SeQuent please paclitaxel-eluting balloon in a real-world singlecenter registry of south-east asian patients. Int J Cardiol Heart Vessel, 2013, 1:37-41.
• [12]于雪,季福绥,许锋,等.紫杉醇涂层球囊治疗直径2.8 mm及以上冠状动脉原发病变的效果.中华心血管病杂志, 2018, 46(1):32-38.
• [13] Yu X,Ji F,Xu F,et a1. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only:results from a Chinese institute.Clin Res Cardiol, 2018, 108(3):234-243.
• [14] Siontis GC, Stefanini GG, Mavridis D, et a1. Percutaneous coronary interventional strategies for treatment of in-stent restenosis:a network meta-analysis. Lancet, 2015, 386(9994):655-664.
• [15] Kufner S, Cassese S, Valeskini M, et a1. Long-term efficacy and safety of paclitaxel-eluting balloon for the treatment of drug-eluting stent restenosis:3-year results of a randomized controlled trial.JACC Cardiovasc Interv, 2015, 8(7):877-884.
• [16] Naganuma T, Latib A, Costopoulos C, et a1. Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations. EuroIntervention,2016, 11(9):989-995.
• [17] Habara S, Kadota K, Kanazawa T, et a1. Paclitaxel-coated balloon catheter compared with drugeluting stent for drug-eluting stent restenosis in routine clinical practice. EuroIntervention, 2016,11(10):1098-1105.
• [18]翟东东,高炬,张萌,等.药物涂层球囊在冠状动脉分支开口病变中的应用.中国介入心脏病学杂志, 2017, 25(7):390-394.
• [19] Schulz A, Hauschild T, Kleber FX. Treatment of coronary de novo bifurcation lesions with DCB only strategy. Clin Res Cardiol, 2014, 103(6):451-456.
• [20] Bruch L, Zadura M, Waliszewski M, et a1. Results from the international drug coated balloon registry for the treatment of bifurcations. Can a bifurcation be treated without stents? J Interv Cardiol, 2016, 29(4):348-356.
• [21] W?hrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv, 2013, 81(5):793-799.
• [22] K?ln PJ, Scheller B, Liew HB, et a1. Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting-a feasibility and safety study. Int J Cardiol, 2016,225:262-267.
• [23] Resch M,Ostheim P,Endemann DH,et a1. Drug coated balloon is less eff ective for treatment of DES in-stent restenosis both in native coronary arteries and saphenous vein grafts:results from a bicenter registry. J Interv Cardiol, 2016, 29(5):461-468.