定向斑块旋切联合药物涂层球囊治疗股腘动脉病变进展
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摘要
股腘动脉硬化闭塞症是影响人类健康的常见疾病。目前腔内治疗已成为主流术式,但术后再狭窄率仍很高。定向斑块旋切术(DA)通过斑块切除改善血管顺应性,但降低再狭窄率效果不明显。药物涂层球囊(DCB)出现为解决这一问题带来曙光,其通过承载的药物进入血管壁防止内皮细胞和平滑肌细胞增殖,从而发挥远期抗内膜增生作用。多项研究表明DCB可降低晚期管腔丢失(LLL)和再狭窄率,减少再次手术率。DA与DCB联合应用可提高药物摄取,取得较好疗效。然而目前的研究证据还不充分,仍需更多大样本多中心随机对照研究加以验证。
Femoropopliteal arteriosclerosis obliteration has been a common disease affecting human health. Currently, endovascular treatment has become the mainstream of operation, but the postoprative restenosis rate is still very high. Directional atherectomy(DA) can improve blood vessel compliance by removing plaque, but it has no obvious effect in reducing the restenosis rate. The emergence of drug-coated balloon(DCB) has brought the dawn to solve this problem. Through the entry of its loaded drug into the vascular wall to prevent the proliferation of endothelial cells and smooth muscle cells, DCB exerts its long-term anti-intimal hyperplasia effect. A number of studies have shown that DCB can reduce the late lumen loss and the restenosis rate, thus decrease the re-operation rate. Combination use of DA and DCB can improve the uptake of drugs, then, better results can be expected. However, the present research results are not sufficient to support the above theoretical speculation, and large sample and more multicenter randomized controlled studies need to be done before it can be validated.
Femoropopliteal arteriosclerosis obliteration has been a common disease affecting human health. Currently, endovascular treatment has become the mainstream of operation, but the postoprative restenosis rate is still very high. Directional atherectomy(DA) can improve blood vessel compliance by removing plaque, but it has no obvious effect in reducing the restenosis rate. The emergence of drug-coated balloon(DCB) has brought the dawn to solve this problem. Through the entry of its loaded drug into the vascular wall to prevent the proliferation of endothelial cells and smooth muscle cells, DCB exerts its long-term anti-intimal hyperplasia effect. A number of studies have shown that DCB can reduce the late lumen loss and the restenosis rate, thus decrease the re-operation rate. Combination use of DA and DCB can improve the uptake of drugs, then, better results can be expected. However, the present research results are not sufficient to support the above theoretical speculation, and large sample and more multicenter randomized controlled studies need to be done before it can be validated.
引文
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[15]项以力,张温凯,杨镛.药物涂层球囊和无涂层球囊治疗股腘动脉缺血性疾病疗效及安全性meta分析[J].介入放射学杂志, 2017, 26:500-507.
[16] Axel DI, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery[J]. Circulation, 1997, 96:636-645.
[17] Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries:restenosis rate and clinical outcome[J]. J Am Coll Cardiol, 2011, 58:1105-1109.
[18] Tellez A, Dattilo R, Mustapha JA, et al. Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention:early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis[J]. EuroIntervention, 2014, 10:1002-1008.
[19] Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg[J]. N Engl J Med, 2008, 358:689-699.
[20] Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty:evidence from the randomized PACIFIER trial[J]. Circ Cardiovasc Interv, 2012, 5:831-840.
[21] Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease:12-month results from the IN.PACT SFA randomized trial[J].Circulation, 2015, 131:495-502.
[22] Scheinert D, Duda S, Zeller T, et al. The LEVANT I(Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis)trial for femoropopliteal revascularization:first-inhuman randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty[J]. JACC Cardiovasc Interv, 2014,7:10-19.
[23] Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxelcoated balloon for femoropopliteal artery disease[J]. N Engl J Med, 2015, 373:145-153.
[24] Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons:6-month results from the DEBELLUM randomized trial[J]. J Endovasc Ther, 2012, 19:571-580.
[25] Liistro F, Grotti S, Porto I, et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery:the DEBATE-SFA randomized trial(drug eluting balloon in peripheral intervention for the superficial femoral artery)[J]. JACC Cardiovasc Interv, 2013, 6:1295-1302.
[26] Bausback Y, Willfort-Ehringer A, Sievert H, et al. Six-month results from the initial randomized study of the ranger paclitaxelcoated balloon in the femoropopliteal segment[J]. J Endovasc Ther, 2017, 24:459-467.
[27] Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter:randomized, multicenter, controlled clinical study in femoropopliteal arteries:evidence from the acoArt I trial[J].JACC Cardiovasc Interv, 2016, 9:1941-1949.
[28] Tepe G, Zeller T, Schnorr B, et al. High-grade, non-flowlimiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty:an additional analysis from the THUNDER study[J]. J Endovasc Ther, 2013, 20:792-800.
[29] Tepe G, Beschorner U, Ruether C, et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease:predictors of outcome with a special emphasis on calcium[J]. J Endovasc Ther, 2015, 22:727-733.
[30] Beschorner U, Zeller T. Combination of mechanical atherectomy and drug-eluting balloons for femoropopliteal in-stent restenosis[J]. J Cardiovasc Surg(Torino), 2014, 55:347-349.
[31] Cioppa A, Stabile E, Popusoi G, et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon:one-year single centre clinical results[J]. Cardiovasc Revasc Med, 1900, 13:219-223.
[32] Sixt S, Carpio Cancino OG, Treszl A, et al. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries[J]. J Vasc Surg, 2013, 58:682-686.
[33] Zeller T, Langhoff R, Rocha-Singh KJ, et al. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency:twelve-month results of the DEFINITIVE AR study[J]. Circ Cardiovasc Interv, 2017, 10,pii:e004848.
[34] Stavroulakis K, Schwindt A, Torsello G, et al. Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions[J]. J Endovasc Ther, 2017, 24:181-188.
[2] Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010:a systematic review and analysis[J].Lancet, 2013, 382:1329-1340.
[3] Kasapis C, Gurm HS. Current approach to the diagnosis and treatment of femoral-popliteal arterial disease. A systematic review[J]. Curr Cardiol Rev, 2009, 5:296-311.
[4] Garcia L, Jaff MR, Metzger C, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries:twelve-month results of the SUPERB trial[J]. Circ Cardiovasc Interv, 2015, 8,pii:e000937.
[5] Leon LR, Dieter RS, Gadd CL, et al. Preliminary results of the initial United States experience with the supera woven nitinol stent in the popliteal artery[J]. J Vasc Surg, 2013, 57:1014-1022.
[6] Conrad MF, Kang J, Cambria RP, et al. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease[J]. J Vasc Surg, 2009, 50:799-805.
[7] Vardi M, Novack V, Pencina MJ, et al. Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease:a meta-analysis and critical examination of current methodologies[J]. Catheter Cardiovasc Interv, 2014, 83:975-983.
[8]刘勇,刘怡辰.药物涂层球囊新技术的临床应用进展及述评[J].生物医学工程与临床, 2012, 16:301-303.
[9] Chaabane C, Otsuka F, Virmani R, et al. Biological responses in stented arteries[J]. Cardiovasc Res, 2013, 99:353-363.
[10] Yongquan G, Lianrui G, Lixing Q, et al. Plaque excision in the management of lower-limb ischemia of atherosclerosis and instent restenosis with the SilverHawk atherectomy catheter[J]. Int Angiol, 2013, 32:362-367.
[11] Quevedo HC, Arain SA, Ali G, et al. A critical view of the peripheral atherectomy data in the treatment of infrainguinal arterial disease[J]. J Invasive Cardiol, 2014, 26:22-29.
[12] Diamantopoulos A, Katsanos K. Atherectomy of the femoropopliteal artery:a systematic review and meta-analysis of randomized controlled trials[J]. J Cardiovasc Surg(Torino), 2014, 55:655-665.
[13] Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease:the multicenter pathway PVD trial[J]. J Endovasc Ther, 2009, 16:653-662.
[14] Shammas NW. Commentary:the adluminal origin of restenosis in peripheral artery interventions and its implications for the development of future treatment strategies:searching deep into the arterial wall[J]. J Endovasc Ther, 2015, 22:716-718.
[15]项以力,张温凯,杨镛.药物涂层球囊和无涂层球囊治疗股腘动脉缺血性疾病疗效及安全性meta分析[J].介入放射学杂志, 2017, 26:500-507.
[16] Axel DI, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery[J]. Circulation, 1997, 96:636-645.
[17] Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries:restenosis rate and clinical outcome[J]. J Am Coll Cardiol, 2011, 58:1105-1109.
[18] Tellez A, Dattilo R, Mustapha JA, et al. Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention:early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis[J]. EuroIntervention, 2014, 10:1002-1008.
[19] Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg[J]. N Engl J Med, 2008, 358:689-699.
[20] Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty:evidence from the randomized PACIFIER trial[J]. Circ Cardiovasc Interv, 2012, 5:831-840.
[21] Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease:12-month results from the IN.PACT SFA randomized trial[J].Circulation, 2015, 131:495-502.
[22] Scheinert D, Duda S, Zeller T, et al. The LEVANT I(Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis)trial for femoropopliteal revascularization:first-inhuman randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty[J]. JACC Cardiovasc Interv, 2014,7:10-19.
[23] Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxelcoated balloon for femoropopliteal artery disease[J]. N Engl J Med, 2015, 373:145-153.
[24] Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons:6-month results from the DEBELLUM randomized trial[J]. J Endovasc Ther, 2012, 19:571-580.
[25] Liistro F, Grotti S, Porto I, et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery:the DEBATE-SFA randomized trial(drug eluting balloon in peripheral intervention for the superficial femoral artery)[J]. JACC Cardiovasc Interv, 2013, 6:1295-1302.
[26] Bausback Y, Willfort-Ehringer A, Sievert H, et al. Six-month results from the initial randomized study of the ranger paclitaxelcoated balloon in the femoropopliteal segment[J]. J Endovasc Ther, 2017, 24:459-467.
[27] Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter:randomized, multicenter, controlled clinical study in femoropopliteal arteries:evidence from the acoArt I trial[J].JACC Cardiovasc Interv, 2016, 9:1941-1949.
[28] Tepe G, Zeller T, Schnorr B, et al. High-grade, non-flowlimiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty:an additional analysis from the THUNDER study[J]. J Endovasc Ther, 2013, 20:792-800.
[29] Tepe G, Beschorner U, Ruether C, et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease:predictors of outcome with a special emphasis on calcium[J]. J Endovasc Ther, 2015, 22:727-733.
[30] Beschorner U, Zeller T. Combination of mechanical atherectomy and drug-eluting balloons for femoropopliteal in-stent restenosis[J]. J Cardiovasc Surg(Torino), 2014, 55:347-349.
[31] Cioppa A, Stabile E, Popusoi G, et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon:one-year single centre clinical results[J]. Cardiovasc Revasc Med, 1900, 13:219-223.
[32] Sixt S, Carpio Cancino OG, Treszl A, et al. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries[J]. J Vasc Surg, 2013, 58:682-686.
[33] Zeller T, Langhoff R, Rocha-Singh KJ, et al. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency:twelve-month results of the DEFINITIVE AR study[J]. Circ Cardiovasc Interv, 2017, 10,pii:e004848.
[34] Stavroulakis K, Schwindt A, Torsello G, et al. Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions[J]. J Endovasc Ther, 2017, 24:181-188.