药物涂层球囊治疗下肢动脉硬化闭塞症的应用进展
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摘要
经皮腔内血管成形术(PTA)或支架置入术已被公认是治疗下肢动脉硬化闭塞症(LEASO)的重要方法,但术后再狭窄的发生限制了其疗效。药物涂层球囊(DCB)含有抗增殖药物,可以抑制新生血管内膜增生,降低再狭窄发生,从而克服了经皮腔内血管成形术的局限性。近年来的临床试验显示,DCB在治疗股腘动脉的初次病变及支架内再狭窄方面,可明显提高一期通畅率(PP),降低晚期管腔损失(LLL),但DCB在膝下动脉(BTK)中的治疗作用仍不明确。本文对DCB在治疗LEASO病变中的应用进展进行综述。
Percutaneous transluminal angioplasty(PTA) or stent implantation has been recognized as an important method in the treatment of lower extremity arteriosclerosis obliterans(LEASO), but restenosis is an important limiting factor. Drug coated balloon(DCB) contains antiproliferative drugs, which can inhibit neointimal hyperplasia and reduce restenosis, thus overcoming the limitation of percutaneous transluminal angioplasty. The main clinical trials published over the last 5 years showed that DCB significantly improved the primary patency(PP) and reduced late lumen loss(LLL) in the treatment of the primary and stent restenosis of the femoral popliteal artery. The role of DCB in the treatment of arteries below the knee(BTK)is still unclear. This article reviewed the application of DCB in the treatment of LEASO lesions.
Percutaneous transluminal angioplasty(PTA) or stent implantation has been recognized as an important method in the treatment of lower extremity arteriosclerosis obliterans(LEASO), but restenosis is an important limiting factor. Drug coated balloon(DCB) contains antiproliferative drugs, which can inhibit neointimal hyperplasia and reduce restenosis, thus overcoming the limitation of percutaneous transluminal angioplasty. The main clinical trials published over the last 5 years showed that DCB significantly improved the primary patency(PP) and reduced late lumen loss(LLL) in the treatment of the primary and stent restenosis of the femoral popliteal artery. The role of DCB in the treatment of arteries below the knee(BTK)is still unclear. This article reviewed the application of DCB in the treatment of LEASO lesions.
引文
[1] 蒋米尔,张培华.临床血管外科学[M].北京:科学出版社,2014:230-234.
[2] Dotter CT,Judkins MP.Transluminal treatment of arteriosclerotic obstruction:Description of a new technic and a preliminary report of its application[J].Radiology,1989,30(1):904-920.
[3] Payne MM,Dotter CT.The father of intervention [J].Tex Heart Inst J,2001,28(1):28-38.
[4] Rocha-Singh KJ,Jaff MR,Crabtree TR,et al.Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease[J].Catheter Cardiovasc Interv,2007,69(6):910-919.
[5] Hwang CW,Wu D,Edelman ER.Physiological transport forces govern drug distribution for stent-based delivery[J].Circulation,2001,104(5):600-605.
[6] Virmani R,Guagliumi G,Farb A,et al.Localized hypersensitivity and late coronary thrombosis secondary to a Sirolimus-eluting stent.Should we be cautious?[J].Circulation,2004,109(6):701-705.
[7] Speck U,Stolzenburg N,Peters D,et a1.How does a drug-coated balloon work?Overview of coating technologies and their im pact[J].J Cardiovasc Surg,2016,57(1):3-11.
[8] Ng VG,Mena C,Pietras C,et al.Local delivery of paclitaxel in the treatment of peripheral arterial disease [J].Eur J Clin Invest,2015,45(1):333-345.
[9] 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(7):689-699.
[10] Mauri L,Orav EJ,Candia SC,et al.Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials[J].Circulation,2005,112(18):2833-2839.
[11] Tepe G,Schnorr B,Albrecht T,et al.Angioplasty of femoralpopliteal arteries with drug-coated balloons:5-year follow-up of the THUNDER trial[J].JACC Cardiovasc Interv,2015,8(1):102-108.
[12] Scheinert D,Schulte KL,Zeller T,et al.Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient:twelve-month results from theBIOLUX P-I randomized trial[J].J Endovasc Ther,2015,22(1):14-21.
[13] 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-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty[J].JACC Cardiovasc Interv,2014,7(1):10-19.
[14] Schroeder H,Meyer DR,Lux B,et al.Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery:outcomes from the ILLUMENATE first-in-human study[J].Catheter Cardiovasc Interv,2015,86(2):278-286.
[15] Nicholas C,Eugene N,Ramesh V.Paclitaxel-coated balloon reduces target lesion revascularization compared with standard balloon angioplasty [J].J Vasc Surg,2017,65(2):558-570.
[16] 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(5):495-502.
[17] Laird JR,Schneider PA,Tepe G,et al.Durability of Treatment Effect Using a Drug Coated Balloon for Femoropopliteal Lesions :24-Month Results of IN.PACT SFA[J].J Am Coll Cardiol,2015,66(21):2329-2338.
[18] Schneider PA,Laird JR,Tepe G,et al.Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries:Long-Term Results of the IN.PACT SFA Randomized Trial [J].Circ Cardiovasc Interv,2018,11(1):e005891.
[19] Micari A,Vadala G,Castriota F,et al.1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease:evidence from the SFA-long study [J].JACC Cardiovasc Interv,2016,9(9):950-956.
[20] Micari A,Nerla R,Vadala G,et al.2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease :Evidence From the SFA-Long Study[J].JACC Cardiovasc Interv,2017,10(7):728-734.
[21] Krishnan P,Faries Peter,Niazi K,et al.Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease:Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies [J].Circulation,2017,136(12):1102-1113.
[22] Schroeder H,Werner M,Meyer,et al.Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease:One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon) [J].Circulation,2017,135(23):2227-2236.
[23] Schroe H,Holden AH,Goueffic Y,et al.Stellarex drug-coated balloon for treatment of femoropoplitealarterial disease—The ILLUMENATE Global Study:12-Month results from a prospective,multicenter,single-arm study [J].Catheter Cardiovasc Interv,2018,91(3):497-504.
[24] Scheinert D,Schmidt A,Zeller T,et al.German Center Subanalysis of the Levant 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease[J].J Endovasc Ther,2016,23(3):409-416.
[25] Rosenfield K,Jaff MR,White CJ,et al.Trial of a paclitaxel-coated balloon for femoropopliteal artery disease[J].N Engl J Med,2015,373(2) :145-153.
[26] Bosiers M,Deloose K,Callaert J,et al.Results of the Protégé Exverflex 200-mm-long nitinol stent in TASC C and D femoropopliteal lesions[J].J Vasc Surg,2011,54(4):1042-1050.
[27] Tosaka A,Soga Y,Iida O,et al.Classification and clinical impact of restenosis after femoropopliteal stenting[J].J am Coll Cardiol,2012,59(1):16-23.
[28] Kinstner CM,Hammer J,Willfort-Ehringer A,et al.Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery:1-Year Results of the PACUBA Trial[J].JACC Cardiovasc Interv,2016,9(13):1386-1392.
[29] Virga V,Stabile E,Biamino G,et al.Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis:2-year follow-up[J] .JACC Cardiovasc Interv,2014,7(4):411-415.
[30] Krankenberg H,Tubler T,Ingwersen M,et al.Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis:the randomized femoral artery in-stent restenosis (FAIR) trial[J].Circulation 2015,132(23):2230-22366.
[31] Liistro F,Angioli P,Porto I,et al.Paclitaxel-eluting balloon vs.standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries:the DEBATE-ISR study[J].J Endovasc Ther,2014,21(1):1-8.
[32] Grotti S,Liistro F,Angioli P,et al.Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with In-stent restenosis of the superficial femoral and proximal popliteal arteries:three-year results of the DEBATE-ISR study [J].J Endovasc Ther,2016,23(1):52-57.
[33] Cassese S,Ndrepepa G,Kufner S,et al.Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries.A meta-analysis[J].Euro Intervention,2017,13(4):483-489.
[34] Brodmann M,Keirse K,Scheinert D,et al.Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease:The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort[J].JACC Cardiovasc Interv,2017,10(20):2113-2123.
[35] 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(18):1941-1949.
[36] Clair D,Shah S,Weber J.Current state of diagnosis and management of critical limb ischemia[J].Curr Cardiol Rep,2012,14(2):160-170.
[37] Faglia E,Clerici G,Clerissi J,et al.Long-term prognosis of diabetic patients with critical limb ischemia:a population-based cohort study[J].Diabetes Care,2009,32(5):822-827.
[38] Schmidt A,Piorkowski Ml,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(11):1105-1109.
[39] Zeller T,Baumgartner I,Scheinert D,et al.Drug-eluting balloon versus standard balloon angioplasty forinfrapopliteal arterial revascularization in critical limb ischemia:12-month results from the IN.PACT DEEP randomized trial[J].J Am Coll Cardiol,2014,64(15):1568-1576.
[40] Zeller T,Beschorner U,Pilger E,et al.Paclitaxel-coated balloon in infrapopliteal arteries:12-month results from the BIOLUX P-II Randomized Trial (BIOTRONIK’S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs.The uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)[J].JACC Cardiovasc Interv,2015,8(12):1614-1622.
[41] Wu R,Tang S,Wang M,et al.Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease:A meta analysis of randomized trials[J].Int J Surg,2016,35:88-94.
[42] Cassese S,Ndrepepa G,Liistro F,et al.Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries:A Meta-Analysis of Randomized Trials[J].JACC Cardiovasc Interv,2016,9(10):1072-1080.
[43] Steiner S,Schmidt A,Bausback Y,et al.Single-center experience with lutonix drug-coated balloons in infrapopliteal arteries[J].J Endovasc Ther,2016,23(3):417-423.
[44] Thieme M,Lichtenberg M,Brodmann M,et al.Lutonix? 014 DCB global below the knee registry study.Interim 6 month outcomes[J].J Cardiovasc Surg (Torino),2018,59(2):232-236.
[45] Oz II,Serifoglu I,Bilici M,et al.Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients[J].Vasc Endovascular Surg,2016,50(8):534-540.
[2] Dotter CT,Judkins MP.Transluminal treatment of arteriosclerotic obstruction:Description of a new technic and a preliminary report of its application[J].Radiology,1989,30(1):904-920.
[3] Payne MM,Dotter CT.The father of intervention [J].Tex Heart Inst J,2001,28(1):28-38.
[4] Rocha-Singh KJ,Jaff MR,Crabtree TR,et al.Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease[J].Catheter Cardiovasc Interv,2007,69(6):910-919.
[5] Hwang CW,Wu D,Edelman ER.Physiological transport forces govern drug distribution for stent-based delivery[J].Circulation,2001,104(5):600-605.
[6] Virmani R,Guagliumi G,Farb A,et al.Localized hypersensitivity and late coronary thrombosis secondary to a Sirolimus-eluting stent.Should we be cautious?[J].Circulation,2004,109(6):701-705.
[7] Speck U,Stolzenburg N,Peters D,et a1.How does a drug-coated balloon work?Overview of coating technologies and their im pact[J].J Cardiovasc Surg,2016,57(1):3-11.
[8] Ng VG,Mena C,Pietras C,et al.Local delivery of paclitaxel in the treatment of peripheral arterial disease [J].Eur J Clin Invest,2015,45(1):333-345.
[9] 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(7):689-699.
[10] Mauri L,Orav EJ,Candia SC,et al.Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials[J].Circulation,2005,112(18):2833-2839.
[11] Tepe G,Schnorr B,Albrecht T,et al.Angioplasty of femoralpopliteal arteries with drug-coated balloons:5-year follow-up of the THUNDER trial[J].JACC Cardiovasc Interv,2015,8(1):102-108.
[12] Scheinert D,Schulte KL,Zeller T,et al.Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient:twelve-month results from theBIOLUX P-I randomized trial[J].J Endovasc Ther,2015,22(1):14-21.
[13] 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-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty[J].JACC Cardiovasc Interv,2014,7(1):10-19.
[14] Schroeder H,Meyer DR,Lux B,et al.Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery:outcomes from the ILLUMENATE first-in-human study[J].Catheter Cardiovasc Interv,2015,86(2):278-286.
[15] Nicholas C,Eugene N,Ramesh V.Paclitaxel-coated balloon reduces target lesion revascularization compared with standard balloon angioplasty [J].J Vasc Surg,2017,65(2):558-570.
[16] 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(5):495-502.
[17] Laird JR,Schneider PA,Tepe G,et al.Durability of Treatment Effect Using a Drug Coated Balloon for Femoropopliteal Lesions :24-Month Results of IN.PACT SFA[J].J Am Coll Cardiol,2015,66(21):2329-2338.
[18] Schneider PA,Laird JR,Tepe G,et al.Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries:Long-Term Results of the IN.PACT SFA Randomized Trial [J].Circ Cardiovasc Interv,2018,11(1):e005891.
[19] Micari A,Vadala G,Castriota F,et al.1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease:evidence from the SFA-long study [J].JACC Cardiovasc Interv,2016,9(9):950-956.
[20] Micari A,Nerla R,Vadala G,et al.2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease :Evidence From the SFA-Long Study[J].JACC Cardiovasc Interv,2017,10(7):728-734.
[21] Krishnan P,Faries Peter,Niazi K,et al.Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease:Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies [J].Circulation,2017,136(12):1102-1113.
[22] Schroeder H,Werner M,Meyer,et al.Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease:One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon) [J].Circulation,2017,135(23):2227-2236.
[23] Schroe H,Holden AH,Goueffic Y,et al.Stellarex drug-coated balloon for treatment of femoropoplitealarterial disease—The ILLUMENATE Global Study:12-Month results from a prospective,multicenter,single-arm study [J].Catheter Cardiovasc Interv,2018,91(3):497-504.
[24] Scheinert D,Schmidt A,Zeller T,et al.German Center Subanalysis of the Levant 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease[J].J Endovasc Ther,2016,23(3):409-416.
[25] Rosenfield K,Jaff MR,White CJ,et al.Trial of a paclitaxel-coated balloon for femoropopliteal artery disease[J].N Engl J Med,2015,373(2) :145-153.
[26] Bosiers M,Deloose K,Callaert J,et al.Results of the Protégé Exverflex 200-mm-long nitinol stent in TASC C and D femoropopliteal lesions[J].J Vasc Surg,2011,54(4):1042-1050.
[27] Tosaka A,Soga Y,Iida O,et al.Classification and clinical impact of restenosis after femoropopliteal stenting[J].J am Coll Cardiol,2012,59(1):16-23.
[28] Kinstner CM,Hammer J,Willfort-Ehringer A,et al.Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery:1-Year Results of the PACUBA Trial[J].JACC Cardiovasc Interv,2016,9(13):1386-1392.
[29] Virga V,Stabile E,Biamino G,et al.Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis:2-year follow-up[J] .JACC Cardiovasc Interv,2014,7(4):411-415.
[30] Krankenberg H,Tubler T,Ingwersen M,et al.Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis:the randomized femoral artery in-stent restenosis (FAIR) trial[J].Circulation 2015,132(23):2230-22366.
[31] Liistro F,Angioli P,Porto I,et al.Paclitaxel-eluting balloon vs.standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries:the DEBATE-ISR study[J].J Endovasc Ther,2014,21(1):1-8.
[32] Grotti S,Liistro F,Angioli P,et al.Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with In-stent restenosis of the superficial femoral and proximal popliteal arteries:three-year results of the DEBATE-ISR study [J].J Endovasc Ther,2016,23(1):52-57.
[33] Cassese S,Ndrepepa G,Kufner S,et al.Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries.A meta-analysis[J].Euro Intervention,2017,13(4):483-489.
[34] Brodmann M,Keirse K,Scheinert D,et al.Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease:The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort[J].JACC Cardiovasc Interv,2017,10(20):2113-2123.
[35] 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(18):1941-1949.
[36] Clair D,Shah S,Weber J.Current state of diagnosis and management of critical limb ischemia[J].Curr Cardiol Rep,2012,14(2):160-170.
[37] Faglia E,Clerici G,Clerissi J,et al.Long-term prognosis of diabetic patients with critical limb ischemia:a population-based cohort study[J].Diabetes Care,2009,32(5):822-827.
[38] Schmidt A,Piorkowski Ml,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(11):1105-1109.
[39] Zeller T,Baumgartner I,Scheinert D,et al.Drug-eluting balloon versus standard balloon angioplasty forinfrapopliteal arterial revascularization in critical limb ischemia:12-month results from the IN.PACT DEEP randomized trial[J].J Am Coll Cardiol,2014,64(15):1568-1576.
[40] Zeller T,Beschorner U,Pilger E,et al.Paclitaxel-coated balloon in infrapopliteal arteries:12-month results from the BIOLUX P-II Randomized Trial (BIOTRONIK’S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs.The uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)[J].JACC Cardiovasc Interv,2015,8(12):1614-1622.
[41] Wu R,Tang S,Wang M,et al.Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease:A meta analysis of randomized trials[J].Int J Surg,2016,35:88-94.
[42] Cassese S,Ndrepepa G,Liistro F,et al.Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries:A Meta-Analysis of Randomized Trials[J].JACC Cardiovasc Interv,2016,9(10):1072-1080.
[43] Steiner S,Schmidt A,Bausback Y,et al.Single-center experience with lutonix drug-coated balloons in infrapopliteal arteries[J].J Endovasc Ther,2016,23(3):417-423.
[44] Thieme M,Lichtenberg M,Brodmann M,et al.Lutonix? 014 DCB global below the knee registry study.Interim 6 month outcomes[J].J Cardiovasc Surg (Torino),2018,59(2):232-236.
[45] Oz II,Serifoglu I,Bilici M,et al.Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients[J].Vasc Endovascular Surg,2016,50(8):534-540.