吴轶喆,殷嘉晟,葛雷,钱菊英,沈雳,葛均波

• 1:复旦大学附属中山医院心内科上海市心血管病研究所
• 2:XINSORB RCT研究组

摘要(Abstract)：

目的评价XINSORB生物可吸收支架(XINSORB BRS)治疗原发性冠状动脉狭窄病变4年临床疗效和安全性。方法 XINSORB RCT研究是前瞻性、随机、对照、多中心设计的临床研究。将符合临床纳入标准的患者按1︰1比例随机分配至XINSORB BRS组和TIVOLI SES组。临床终点包括靶病变失败(TLF)、患者相关不良事件(Po CE)、主要不良心脏事件(MACE)和确定的/很有可能的支架内血栓形成事件。结果本研究共入选了395例患者,分为XINSORB BRS组200例、TIVOLI SES组195例。超过92%患者接受了4年临床随访。4年临床结果显示,XINSORB BRS组和TIVOLI SES组分别有54.0%和51.8%患者仍在接受双联抗血小板治疗(P=0.574)。两组患者无论是TLF(5.0%比6.2%)、Po CE(10.3%比8.7%)、MACE(5.0%比6.2%)、全因死亡(2.5%比0.0)、靶血管心肌梗死(1.0%比0.0)还是缺血驱动的靶血管血运重建(4.5%比6.2%)发生率比较,差异均无统计学意义(均P>0.05)。XINSORB BRS组共有2例确定的支架内血栓形成事件发生,TIVOLI SES组无支架内血栓形成事件发生。XINSORB BRS组在介入治疗后2～4年,无新增支架内血栓形成事件发生。结论 XINSORB RCT研究4年随访结果显示,XINSORB BRS治疗简单/中度复杂的冠状动脉原位病变,具有和传统药物洗脱支架相当的有效性和安全性,TLF和支架内血栓形成发生率均较低。

关键词(KeyWords)： 生物可吸收支架;靶病变失败;主要不良心脏事件

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发项目（2016YFC1102300）;; 国家自然科学基金（81521001、81670319）

作者(Author): 吴轶喆,殷嘉晟,葛雷,钱菊英,沈雳,葛均波

参考文献(References)：

• [1] Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimuseluting metallic stent for the treatment of coronary artery stenosis(ABSORBⅡ）：a 3 year, randomised, controlled,single-blind, multicentre clinical trial. Lancet, 2016, 388(10059):2479-2491.
• [2] Kereiakes DJ, Ellis SG, Metzger C, et al. 3-Year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds:the ABSORBⅢtrial. J Am Coll Cardiol, 2017, 70(23):2852-2862.
• [3] Stone GW, Kimura T, Gao R, et al. Time-varying outcomes withthe absorb bioresorbable vascular scaffold during 5-year follow-up:a systematic Meta-analysis and individual patient data pooled study. JAMA Cardiol, 2019, 4(12):1261-1269.
• [4] Xu B, Yang Y, Han Y, et al. Comparison of everolimus-eluting bioresorbable vascular scaffolds and metallic stents:three-year clinical outcomes from the ABSORB China randomised trial.EuroIntervention, 2018, 14(5):e554-e561.
• [5] Wu Y, Shen L, Ge L, et al. Six-month outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in treating single de novo lesions in human coronary artery. Catheter Cardiovasc Interv, 2016, 87 Suppl 1:630-637.
• [6] Wu Y, Shen L, Yin J, et al. Twelve-month angiographic and clinical outcomes of the XINSORB bioresorbable sirolimuseluting scaffold and a metallic stent in patients with coronary artery disease. Int J Cardiol, 2019, 293:61-66.
• [7] Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials:a case for standardized definitions.Circulation, 2007, 115(17):2344-2351.
• [8] Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent:the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv, 2007, 69(1):128-131.
• [9] Stone GW, Ellis SG, Gori T, et al. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds:30-day and 1-year results from the ABSORBⅣrandomised trial. Lancet, 2018, 392(10157):1530-1540.
• [10] Dudek D, Onuma Y, Ormiston JA, et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease:the ABSORB trial. EuroIntervention, 2012, 7(9):1060-1061.
• [11] Serruys PW, Ormiston J, van Geuns RJ, et al. A polylactide bioresorbable scaffold eluting everolimus for treatment of coronary stenosis:5-year follow-up. J Am Coll Cardiol, 2016, 67(7):766-776.
• [12] Gori T, Wiebe J, Capodanno D, et al. Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions:insights from the GHOST-EU registry. EuroIntervention,2016, 12(5):e550-e556.
• [13] Testa L, De Carlo M, Petrolini A, et al. One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry(IT-DISAPPEARS). EuroIntervention, 2017, 13(4):424-431.
• [14] Grimfj?rd P, James S, Persson J, et al. Outcome of percutaneous coronary intervention with the Absorb bioresorbable scaffold:data from the Swedish Coronary Angiography and Angioplasty Registry(SCAAR). EuroIntervention, 2017, 13(11):1303-1310.
• [15] Tijssen RYG, Kraak RP, Hofma SH, et al. Complete twoyear follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI. EuroIntervention, 2018, 14(4):e426-e433.
• [16]中华医学会心血管病学分会.冠状动脉生物可吸收支架临床应用中国专家共识.中华心血管病杂志，2020, 48(5):350-358.
• [17]中华医学会心血管病学分会介入心脏病学组，中国医师协会心血管内科医师分会血栓防治专业委员会，中华心血管病杂志编辑委员会.中国经皮冠状动脉介入治疗指南（2016）.中华心血管病杂志，2016,44(5):382-400.
• [18] Felix CM, Vlachojannis GJ, IJsselmuiden AJJ, et al. Potentially increased incidence of scaffold thrombosis in patients treated with absorb BVS who terminated DAPT before 18 months. EuroIntervention,2017, 13(2):e177-e184.
• [19] Chevalier B, Cequier A, Dudek D, et al. Four-year followup of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis(ABSORBⅡtrial).EuroIntervention, 2018, 13(13):1561-1564.
• [20] Mauri L, Kereiakes DJ, Yeh RW, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med, 2014, 371(23):2155-2166.
• [21] Ge J. Bioresorbable vascular scaffold for the treatment of coronary in-stent restenosis:New dawn or frost on snow? Catheter Cardiovasc Interv, 2018, 92(4):678-679.
• [22] Sotomi Y, Suwannasom P, Tenekecioglu E, et al. Imaging assessment of bioresorbable vascular scaffolds. Cardiovasc Interv Ther, 2018, 33(1):11-22.