紫杉醇涂层球囊的应用现状和不足以及新一代药物涂层球囊的研究进展Application status and deficiencies of paclitaxel-coated balloons and research progress of newgeneration drug-coated balloons
李占鲁,黄翯
摘要(Abstract):
药物涂层球囊(DCB)的诞生为我们提供了一种新的冠状动脉介入治疗的工具。随着越来越多研究证据的支持,DCB的适应证也越来越广泛。2016年之前DCB的涂层药物都是紫杉醇,紫杉醇作为涂层药物本身存在一些不足,如易脱落、治疗窗窄、抗增殖效果不佳等。随着研究的不断探索,新技术不断出现,主要针对两方面,一方面是新的涂层技术使涂层药物更稳定,不易脱落,大大方便了临床应用;另一方面是新的技术使新涂层药物的使用成为可能,如西罗莫司涂层球囊的应用已经取得了临床研究结果的支持,但其确切疗效仍需更深入的研究进行探索和证实。
关键词(KeyWords): 药物涂层球囊;紫杉醇;新进展;西罗莫司
基金项目(Foundation): 浙江省卫生健康委员会青年人才项目(2019RC185)
作者(Author): 李占鲁,黄翯
参考文献(References):
- [1] Tada T,Byrne RA,Simunovic I,et al. Risk of stent thrombosis among bare-metal stents,fi rst-generation drug-eluting stents,and second-generation drug-eluting stents:results from a registry of 18 334 patients[J]. JACC Cardiovasc Interv,2013,6(12):1267-1274.
- [2] Palmerini T,Biondi-Zoccai G,Della Riva D,et al. Stent thrombosis with drug-eluting and bare-metal stents:evidence from a comprehensive network meta-analysis[J]. Lancet,2012,379(9824):1393-1402.
- [3] Byrne RA,Joner M,Kastrati A. Stent thrombosis and restenosis:what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014[J]. Eur Heart J,2015,36(47):3320-3331.
- [4] Cassese S,Byrne RA,Schulz S,et al. Prognostic r o l e of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting[J]. Eur Heart J,2015,36(2):94-99.
- [5] Kirtane AJ,Gupta A,Iyengar S,et al. Safety and efficacy of drug-eluting and bare metal stents:comprehensive metaanalysis of randomized trials and observational studies[J].Circulation,2009,119(25):3198-3206.
- [6] Siontis GC,Stefanini GG,Mavridis D,et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis:a network meta-analysis[J]. Lancet,2015,386(9994):655-664.
- [7] Neumann FJ,Sousa-Uva M,Ahlsson A,et al. 2018 ESC/EACTS guidelines on myocardial revascularization[J].EuroIntervention,2019,14(14):1435-1534.
- [8] Jeger RV,Farah A,Ohlow MA,et al. Drug-coated balloons for small coronary artery disease(BASKET-SMALL 2):an open-label randomised non-inferiority trial[J]. Lancet,2018,392(10150):849-856.
- [9] Stella PR,Belkacemi A,Dubois C,et al. A multicenter randomized comparison of drug-eluting balloon plus baremetal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique:sixmonth angiographic and 12-month clinical results of the drugeluting balloon in bifurcations trial[J]. Catheter Cardiovasc Interv,2012,80(7):1138-1146.
- [10] López Mínguez JR,Nogales Asensio JM,Doncel Vecino LJ,et al. A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions(BABILON trial):24-month clinical and angiographic results[J].EuroIntervention,2014,10(1):50-57.
- [11] Schulz A,Hauschild T,Kleber FX. Treatment of coronary de novo bifurcation lesions with DCB only strategy[J]. Clin Res Cardiol,2014,103(6):451-456.
- [12] Worthley S,Hendriks R,Worthley M,et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations:12-month results of the multicenter BIOLUX-I study[J]. Cardiovasc Revasc Med,2015,16(7):413-417.
- [13] Berland J,Lefèvre T,Brenot P,et al. DANUBIO-a new drug-eluting balloon for the treatment of side branches in bifurcation lesions:six-month angiographic follow-up results of the DEBSIDE trial[J]. EuroIntervention,2015,11(8):868-876.
- [14] Kleber FX,Rittger H,Ludwig J,et al. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions:results of the randomized multicenter PEPCAD-BIF trial[J].Clin Res Cardiol,2016,105(7):613-621.
- [15] W?hrle J,Werner GS. Paclitaxel-coated balloon with baremetal stenting in patients with chronic total occlusions in native coronary arteries[J]. Catheter Cardiovasc Interv,2013,81(5):793-799.
- [16] K?ln PJ,Scheller B,Liew HB,et al. Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting-a feasibility and safety study[J].Int J Cardiol,2016,225:262-267.
- [17] Waksman R,Serra A,Loh JP,et al. Drug-coated balloons for de novo coronary lesions:results from the Valentines II trial[J]. EuroIntervention,2013,9(5):613-619.
- [18] Vos NS,Dirksen MT,Vink MA,et al. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam(PAPPA):one-year clinical outcome of a pilot study[J]. EuroIntervention,2014,10(5):584-590.
- [19] Nijhoff F,Agostoni P,Belkacemi A,et al. Primary percutaneous coronary intervention by drug-eluting balloon angioplasty:the nonrandomized fourth arm of the DEB-AMI(drug-eluting balloon in ST-segment elevation myocardial infarction)trial[J]. Catheter Cardiovasc Interv,2015,86Suppl 1:S34-S44.
- [20] Fang CY,Fang HY,Chen CJ,et al. Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction:a retrospective study[J]. Peer J,2018,6:e4646.
- [21]李占鲁,王敏,栾毅,等. SeQuent Please药物涂层球囊扩张术治疗冠状动脉粥样硬化性心脏病患者临床预后的回顾性分析[J].中国介入心脏病学杂志,2019,27(7):380-385.
- [22] Cortese B,D'Ascenzo F,Fetiveau R,et al. Treatment of coronary artery disease with a new-generation drug-coated balloon:final results of the Italian Elutax SV rEgistry-DCBRISE[J]. J Cardiovasc Med(Hagerstown),2018,19(5):247-252.
- [23] Jeger RV,Eccleshall S,Wan Ahmad WA,et al. Drugcoated balloons for coronary artery disease:third report of the international DCB consensus group[J]. JACC Cardiovasc Interv,2020,13(12):1391-1402.
- [24] Rowinsky EK, Donehower RC. Paclitaxel(taxol)[J]. N Engl J Med,1995,332(15):1004-1014.
- [25] Scheller B,Speck U,Abramjuk C,et al. Paclitaxel balloon coating,a novel method for prevention and therapy of restenosis[J]. Circulation,2004,110(7):810-814.
- [26] Speck U,Cremers B,Kelsch B,et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel[J]? Circ Cardiovasc Interv,2012,5(3):392-400.
- [27] Granada JF,Milewski K,Zhao H,et al. Vascular response to zotarolimus-coated balloons in injured superficial femoral arteries of the familial hypercholesterolemic Swine[J]. Circ Cardiovasc Interv, 2011,4(5):447-455.
- [28] Cremers B,Toner JL,Schwartz LB,et al. Inhibition of neointimal hyperplasia with a novel zotarolimus-coated balloon catheter[J]. Clin Res Cardiol,2012,101(6):469-476.
- [29] Kolachalama VB,Pacetti SD,Franses JW,et al. Mechanisms of tissue uptake and retention in zotarolimus-coated balloon therapy[J]. Circulation,2013,127(20):2047-2055.
- [30] Granada JF,Tellez A,Baumbach WR,et al. In vivo delivery and long-term tissue retention of nano-encapsulated sirolimus using a novel porous balloon angioplasty system[J].EuroIntervention,2016,12(6):740-747.
- [31] Lemos PA,Farooq V,Takimura CK,et al. Emerging technologies:polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plusballoon or a stand-alone balloon catheter[J]. EuroIntervention,2013,9(1):148-156.
- [32] Wessely R,Blaich B,Belaiba RS,et al.Comparative characterization of cellular and molecular anti-restenotic profi les of paclitaxel and sirolimus. Implications for local drug delivery[J].Thromb Haemost,2007,97(6):1003-1012.
- [33] Wessely R,Kastrati A,Mehilli J,et al. Randomized tr ial of rapamycin-and paclitaxel-eluting stents with identical biodegradable polymeric coating and design[J]. Eur Heart J,2007,28(22):2720-2725.
- [34] Dangas GD,Serruys PW,Kereiakes DJ,et al. Metaanalysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease:fi nal 3-year results of the SPIRIT clinical trials program(clinical evaluation of the xience V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions)[J].JACC Cardiovasc Interv,2013,6(9):914-922.
- [35] Alfonso F,Pérez-Vizcayno MJ,Cárdenas A,et al.A prospective randomized trial of drugeluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting stents:the RIBS IV randomized clinical trial[J].J Am Coll Cardiol,2015,66(1):23-33.
- [36] Zhu J,Liu L,Zhu Z,et al. A randomized comparison of a novel iopromide-based paclitaxel-coated balloon Shenqi versus SeQuent Please for the treatment of in-stent restenosis[J].Coron Artery Dis,2021,32(6):526-533.
- [37] Chen Y,Gao L,Qin Q,et al. Comparison of 2 dif ferent drugcoated balloons in in-stent restenosis:the RESTORE ISR China randomized trial[J]. JACC Cardiovasc Interv,2018,11(23):2368-2377.
- [38] Clever YP,Peters D,Calisse J,et al. Novel sirolimus-coated balloon catheter:in vivo evaluation in a porcine coronary model[J]. Circ Cardiovasc Interv,2016,9(4):e003543.
- [39] Ali RM,Abdul Kader MASK,Wan Ahmad WA,e t a l. Treatment of coronary drug-eluting stent restenosis by a sirolimus-or paclitaxel-coated balloon[J]. JACC Cardiovasc Interv,2019,12(6):558-566.
- [40] Verheye S,Vrolix M,Kumsars I,et al. The SABRE trial(sirolimus angioplasty balloon for coronary in-stent restenosis):angiographic results and 1-year clinical outcomes[J]. JACC Cardiovasc Interv,2017,10(20):2029-2037.
- [41] El-Mokdad R,di Palma G,Cortese B. Long-term follow-up after sirolimus-coated balloon use for coronary artery disease.Final results of the Nanolutèstudy[J]. Catheter Cardiovasc Interv,2020,96(5):E496-E500.
- [42] Cortese B,Testa L,Di Palma G,et al. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease:EASTBOURNE registry[J]. J Cardiovasc Med(Hagerstown),2021,22(2):94-100.
- [43] Basavarajaiah S,Athukorala S,Kalogeras K,et al. Midterm clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population[J].Catheter Cardiovasc Interv,2021,98(1):57-65.