药物涂层球囊治疗下肢动脉硬化闭塞症的疗效与随访分析
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摘要
目的比较药物涂层球囊与普通球囊治疗下肢动脉硬化闭塞症的临床效果。方法回顾性分析2015年9月—2017年12月蚌埠医学院第一附属医院收治的下肢动脉硬化闭塞症患者的临床资料,并分析其病因、临床症状、体征、治疗方式、临床疗效及安全性。共纳入297例患者(315条患肢,334处病变),其中接受药物涂层球囊治疗的54例患者(57条患肢,62处病变)作为药物涂层球囊组(DCB组),接受普通球囊治疗的243例患者(258条患肢,272处病变)作为普通球囊组(SAB组),两组均随访6~33个月。结果药物涂层球囊组的再狭窄发生率、晚期管腔丢失及靶病变血运重建率低于普通球囊组,差异有统计学意义(P<0.05);药物涂层球囊组的卢瑟福分级的改善及踝肱指数的改善优于普通球囊组,差异有统计学意义(P<0.05);两组的手术并发症、血栓形成率及截肢率比较,差异无统计学意义(P>0.05)。结论药物涂层球囊相较于普通球囊在下肢动脉硬化的治疗中具有更优的临床疗效,且不会增加患者的安全性风险。
Objective Comparison of the clinical effects of drug-coated balloons and standard angioplasty balloon in the treatment of lower extremity arteriosclerosis obliterans. Methods Retrospectively analyzed the clinical data of patients with arteriosclerosis obliterans of lower extremities admitted to the first affiliated hospital of Bengbu Medical College from September 2015 to December 2017. Its etiology,clinical symptoms,signs,treatment methods,clinical efficacy and safety were analyzed.A total of 297 patients( 315 limbs,334 lesions) were enrolled,54 patients( 57 limbs,62 lesions) received drug-coated balloon therapy were in drugcoated balloon group( DCB),and 243 patients( 258 limbs,272 lesions) received standard angioplasty balloon were in standard angioplasty balloon group( SAB),followed up for 6 to 33 months. Results The incidence of restenosis,late lumen loss and target lesion revascularization rate in the drug-coated balloon group were lower than those in the standard angioplasty balloon group,the difference was statistically significant( P < 0. 05). The improvement of Rutherford class and the improvement of Ankle Brachial Pressure Index in the drug-coated balloon group were better than those in the standard angioplasty balloon group,and the difference was statistically significant( P < 0. 05). There were no significant differences in surgical complications,thrombosis rate,and amputation rate between the two groups.Conclusions Drug-coated balloons have superior clinical efficacy in the treatment of lower extremity arteriosclerosis compared to ordinary balloons,and do not increase the safety risk of patients.
Objective Comparison of the clinical effects of drug-coated balloons and standard angioplasty balloon in the treatment of lower extremity arteriosclerosis obliterans. Methods Retrospectively analyzed the clinical data of patients with arteriosclerosis obliterans of lower extremities admitted to the first affiliated hospital of Bengbu Medical College from September 2015 to December 2017. Its etiology,clinical symptoms,signs,treatment methods,clinical efficacy and safety were analyzed.A total of 297 patients( 315 limbs,334 lesions) were enrolled,54 patients( 57 limbs,62 lesions) received drug-coated balloon therapy were in drugcoated balloon group( DCB),and 243 patients( 258 limbs,272 lesions) received standard angioplasty balloon were in standard angioplasty balloon group( SAB),followed up for 6 to 33 months. Results The incidence of restenosis,late lumen loss and target lesion revascularization rate in the drug-coated balloon group were lower than those in the standard angioplasty balloon group,the difference was statistically significant( P < 0. 05). The improvement of Rutherford class and the improvement of Ankle Brachial Pressure Index in the drug-coated balloon group were better than those in the standard angioplasty balloon group,and the difference was statistically significant( P < 0. 05). There were no significant differences in surgical complications,thrombosis rate,and amputation rate between the two groups.Conclusions Drug-coated balloons have superior clinical efficacy in the treatment of lower extremity arteriosclerosis compared to ordinary balloons,and do not increase the safety risk of patients.
引文
[1]鲁景元,顾建平,徐文健,等.药物涂层球囊与普通球囊治疗股腘动脉硬化闭塞的疗效比较:前瞻性随机对照试验[J].南方医科大学学报,2017,(3):296-300.
[2]王深明,姚陈,何榕洲.药物涂层球囊在下肢动脉硬化闭塞症腔内治疗中的应用[J].中国血管外科杂志(电子版),2018,10(1):1-3.
[3] Fow kes 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(9901):1329-1340.
[4]陈旭姣,畅智慧,刘兆玉.药物涂层球囊治疗股腘动脉硬化闭塞症的临床疗效及安全性[J].中国介入影像与治疗学,2018,15(3):139-143.
[5] Scheinert D,Schmidt A,Zeller T,et al.German center subanalysis of the LEVANT 2 global randomized study of the lutonix drugcoated balloon in the treatment of femoropopliteal occlusive disease[J].J Endovasc Ther,2016,23:409-416.
[6] Zeller T,Beschorner U,Pilger E,et al.Paclitaxel-Coated Balloon in Infrapopliteal Arteries:12-Month Results From the BIOLUX PII 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,2015,8:1614-1622.
[7]中华医学会外科学分会血管外科学组.下肢动脉硬化闭塞症诊治指南[J].中华医学杂志,2015,95(24):1883-1896.
[8] Gerhard-Herman MD,Gornik HL,Barrett C,et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease:A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines[J]. J Am Coll Cardiol,2017,69(11):e71-e126.
[9] Aboyans V,Ricco JB,Bartelink MEL,et al.2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases,in collaboration with the European Society for Vascular Surgery(ESVS):Document covering atherosclerotic disease of extracranial carotid and vertebral,mesenteric,renal,upper and lower extremity arteries Endorsed by:the European Stroke Organization(ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology(ESC)and of the European Society for Vascular Surgery(ESVS)[J]. Eur Heart J,2018,39:763-816.
[10] Rocha-Singh KJ,Bosiers M,Schultz G,et al.A single stent strategy in patients with lifestyle limiting claudication:3-year results from the Durability II trial[J]. Catheter Cardiovasc Interv,2015,86(1):164-170.
[11] Laird JR.The treatment of femoropopliteal in-stent restenosis:back to the future[J].J Am Coll Cardiol,2012,59(1):24-25.
[12] 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.
[13] Cremers B,Schmitmeier S,Clever YP,et al. Inhibition of neointimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel-coated scoring balloon catheter[J]. Catheter Cardiovasc Interv,2014,84(7):1089-1098.
[14] Steinfeld DS,Liu AP,Hsu SH,et al. Comparative assessment of transient exposure of paclitaxel or zotarolimus on in vitro vascular cell death,proliferation,migration,and proinflammatory biomarker expression[J].J Cardiovasc Pharmacol,2012,60(2):179-186.
[15] Albrecht T,Speck U,Baier C,et al.Reduction of stenosis due to intimal hyperplasia after stent supported angioplasty of peripheral arteries by local administration of paclitaxel in swine[J]. Invest Radiol,2007,42(8):579-585.
[16] Unverdorben M,Vallbracht C,Cremers B,et al.Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis[J]. Circulation,2009,119(23):2986-2994.
[17] Abe llas-Sequeiros RA,Benezet J,Agarrado Luna A et al.Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels:initial experience with the Essential paclitaxel-coated balloon[J].Coron Artery Dis,2018,29(6):477-481.
[18] Debing E,Aerden D,Vanhulle A,et al. Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients:the Belgian diabetic INPACT Trial[J].J Cardiovasc Surg,2017,58(4):528-534.
[19] Tepe G,G9gebakan,Redlich U,et al.Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter[J].Cardiovasc Intervent Radiol,2017,40(10):1535-1544.
[20] Kolodgie FD,Pacheco E,Yahagi K,et al.Comparison of particulate embolization after femoral artery treatment with INPACT admiral versus Lutonix 035 paclitaxel-coated balloons in healthy swine[J].J Vasc Interv Radiol,2016,27(11):1676-1685.
[21] 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(1):10-19.
[22] 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.
[2]王深明,姚陈,何榕洲.药物涂层球囊在下肢动脉硬化闭塞症腔内治疗中的应用[J].中国血管外科杂志(电子版),2018,10(1):1-3.
[3] Fow kes 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(9901):1329-1340.
[4]陈旭姣,畅智慧,刘兆玉.药物涂层球囊治疗股腘动脉硬化闭塞症的临床疗效及安全性[J].中国介入影像与治疗学,2018,15(3):139-143.
[5] Scheinert D,Schmidt A,Zeller T,et al.German center subanalysis of the LEVANT 2 global randomized study of the lutonix drugcoated balloon in the treatment of femoropopliteal occlusive disease[J].J Endovasc Ther,2016,23:409-416.
[6] Zeller T,Beschorner U,Pilger E,et al.Paclitaxel-Coated Balloon in Infrapopliteal Arteries:12-Month Results From the BIOLUX PII 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,2015,8:1614-1622.
[7]中华医学会外科学分会血管外科学组.下肢动脉硬化闭塞症诊治指南[J].中华医学杂志,2015,95(24):1883-1896.
[8] Gerhard-Herman MD,Gornik HL,Barrett C,et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease:A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines[J]. J Am Coll Cardiol,2017,69(11):e71-e126.
[9] Aboyans V,Ricco JB,Bartelink MEL,et al.2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases,in collaboration with the European Society for Vascular Surgery(ESVS):Document covering atherosclerotic disease of extracranial carotid and vertebral,mesenteric,renal,upper and lower extremity arteries Endorsed by:the European Stroke Organization(ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology(ESC)and of the European Society for Vascular Surgery(ESVS)[J]. Eur Heart J,2018,39:763-816.
[10] Rocha-Singh KJ,Bosiers M,Schultz G,et al.A single stent strategy in patients with lifestyle limiting claudication:3-year results from the Durability II trial[J]. Catheter Cardiovasc Interv,2015,86(1):164-170.
[11] Laird JR.The treatment of femoropopliteal in-stent restenosis:back to the future[J].J Am Coll Cardiol,2012,59(1):24-25.
[12] 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.
[13] Cremers B,Schmitmeier S,Clever YP,et al. Inhibition of neointimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel-coated scoring balloon catheter[J]. Catheter Cardiovasc Interv,2014,84(7):1089-1098.
[14] Steinfeld DS,Liu AP,Hsu SH,et al. Comparative assessment of transient exposure of paclitaxel or zotarolimus on in vitro vascular cell death,proliferation,migration,and proinflammatory biomarker expression[J].J Cardiovasc Pharmacol,2012,60(2):179-186.
[15] Albrecht T,Speck U,Baier C,et al.Reduction of stenosis due to intimal hyperplasia after stent supported angioplasty of peripheral arteries by local administration of paclitaxel in swine[J]. Invest Radiol,2007,42(8):579-585.
[16] Unverdorben M,Vallbracht C,Cremers B,et al.Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis[J]. Circulation,2009,119(23):2986-2994.
[17] Abe llas-Sequeiros RA,Benezet J,Agarrado Luna A et al.Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels:initial experience with the Essential paclitaxel-coated balloon[J].Coron Artery Dis,2018,29(6):477-481.
[18] Debing E,Aerden D,Vanhulle A,et al. Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients:the Belgian diabetic INPACT Trial[J].J Cardiovasc Surg,2017,58(4):528-534.
[19] Tepe G,G9gebakan,Redlich U,et al.Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter[J].Cardiovasc Intervent Radiol,2017,40(10):1535-1544.
[20] Kolodgie FD,Pacheco E,Yahagi K,et al.Comparison of particulate embolization after femoral artery treatment with INPACT admiral versus Lutonix 035 paclitaxel-coated balloons in healthy swine[J].J Vasc Interv Radiol,2016,27(11):1676-1685.
[21] 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(1):10-19.
[22] 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.