文章快速检索     高级检索
   大连医科大学学报  2021, Vol. 43 Issue (2): 97-100      DOI: 10.11724/jdmu.2021.02.01
0
Contents            PDF            Abstract             Full text             Fig/Tab
腘动脉狭窄闭塞性病变的腔内治疗
纪东华    
大连医科大学附属第一医院 介入治疗科, 辽宁 大连 116011
摘要:由于特殊的解剖位置,腘动脉需要承受着巨大的机械性应力,其狭窄闭塞性病变腔内治疗的策略和疗效一直有异于下肢动脉的其他部位。随着腔内治疗的日益发展,腘动脉病变腔内治疗的众多研究也推陈出新,如药物涂层球囊、定向旋切、新型支架的应用等。因此需要系统地对比各种研究并归纳出最优化的临床处理选择。
关键词腘动脉    定向旋切    药物涂层球囊    支架    
Endovascular treatment for popliteal atherosclerotic lesions: current strategies
JI Donghua    
Department of Interventional Therapy, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China
Abstract: Due to its anatomical location, popliteal artery is under great mechanical stress. Thus, the strategy and curative effect of endovascular treatment for stenosis and occlusive disease of popliteal artery have always been different from other parts of the lower extremity. With the increasing progress of endovascular therapy, many clinical studies for atherosclerotic lesions of popliteal artery have been innovated. Clinical evidences for the currently available modalities in the treatment of atherosclerotic lesions of popliteal artery should be systematic reviewed. A proposed algorithm for the management of patients with popliteal artery lesions might be recommended.
Keywords: popliteal artery    directional atherectomy    drug coated balloon    stent    

由于特殊的解剖位置,腘动脉需要承受着巨大的机械性应力,从而其狭窄闭塞性病变的腔内治疗策略和疗效一直有异于下肢动脉其他部位[1-7]。Poulson等[2]通过对14名志愿者28条下肢模拟站立位(180°)、行走状态(110°)、坐位(90°)和园艺位(60°)四种不同姿势下的股腘动脉薄层CT增强扫描结果进行汇总分析后指出, 腘动脉在所有姿势下受到的轴压明显大于股浅动脉近端和股浅动脉内收肌裂孔段。而腘动脉段受压较大主要是因为膝关节屈伸活动的影响,导致此部位要植入的支架时刻面临着金属疲劳后的断裂及急性血栓闭塞的风险,这也使得血管介入医生对腘动脉病变的腔内治疗一直很谨慎[3-7]

近十余年来,下肢动脉缺血性疾病的腔内治疗日新月异,关于腘动脉腔内治疗的临床研究也不断开展,其中一些研究的结果使得我们对腘动脉狭窄闭塞性病变的腔内治疗渐有信心。

1 普通球囊扩张

Rastan等[8]在2013年发表了第一个关于腘动脉腔内处理的前瞻性多中心随机对照研究ETAP (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions-Balloon Angioplasty Versus Primary Stenting)结果:腘动脉一期植入支架组对比普通球囊扩张结合补救支架组的12个月一期通畅率为67.4%和65.7%,推荐腘动脉狭窄及闭塞性病变的治疗首选普通球囊扩张结合补救支架(即球囊扩张后如果存在>30%的残余狭窄或限制血流的夹层则植入支架)。随后的IPAD(Incidence and Endovascular Treatment of Isolated Atherosclerotic Popliteal Artery Disease,IPAD)研究[9]回顾性分析了多中心的临床数据,平均随访期为(32.6 ± 25.6)个月,结果进一步支持孤立性腘动脉病变可选择普通球囊扩张结合补救性支架作为一线治疗。

Elens等[10]2019年报道的一组腘动脉慢性完全性闭塞(chronic total occlusion, CTO)的单纯普通球囊扩张治疗和普通球囊扩张结合补救支架随访对照研究,结果显示单纯普通球囊扩张组对比普通球囊扩张结合补救支架组的12个月一期通畅率为65.8%和58.7%,此研究结果进一步证实腘动脉的CTO病变的腔内治疗还是首选普通球囊扩张,如果出现>30%的残余狭窄或限制血流的夹层则选择补救性支架植入。

2 药物涂层球囊

近十余年来,药物涂层球囊(drug coated balloon, DCB)成为了下肢动脉缺血性疾病腔内治疗的新宠。DCBs应用于股腘动脉病变腔内治疗的大量随机对照研究(randomized controlled study, RCT)都获得了较好的临床结果[11-15]。虽然获得较好临床结果的研究如PACIFIER[11]、LEVANT Ⅰ[12]、DEBELLUM[13]和IN.PACT SFA[14]等国际性RCT研究为股腘动脉病变的DCB临床应用研究,但是所有纳入的病例均为累及近端腘动脉的股腘动脉狭窄闭塞性病变,而无单纯腘动脉病变的病例纳入。国际上至今为止没有一项是关于腘动脉孤立性病变单纯应用DCB治疗的RCT研究,考虑这应该是临床中尝试单纯应用DCB处理腘动脉病变并未获得较好的临床结果所致。

3 冷冻球囊

孤立性腘动脉病变冷冻球囊处理的单中心前瞻随机性研究COLD(compare cryoplasty versus conventional angioplasty in the popliteal artery, COLD)结果显示:冷冻球囊治疗组对比普通球囊组9个月的一期通畅率为(79.3±7.5)%和(66.7±8.1)%,两者在统计学上无显著差异[16]。冷冻球囊在腘动脉病变治疗中无更多的临床应用报道。

4 定向旋切治疗

Semaan等[17]2010年报道了应用定向旋切(directional atherectomy,DA)装置Silverhawk(Medtronic公司)对腘动脉病变进行减容治疗后结果显示,DA治疗组对比普通球囊扩张治疗组12个月的一期通畅率为75%和73%。此结果显示腘动脉病变的单纯DA治疗并未能较普通球囊扩张获得更好的临床疗效。另外一项关于DA治疗股腘动脉狭窄的前瞻性多中心研究DEFINITIVE LE[18]的结果显示:DA治疗在间歇性跛行的腘动脉病变组12个月的一期通畅率为78.2%,而在重度肢体缺血的腘动脉病变组12个月的一期通畅率仅为67.5%。因此单纯的DA治疗并不能显著提高股腘动脉腔内治疗后12个月的一期通畅率。

5 定向旋切结合药物涂层球囊

DA结合DCB治疗(directional atherectomy with anti-restenotic therapy, DAART)应用于腘动脉病变的研究近些年较受关注。其中Stavroulakis等[19]报道的一项单臂的前瞻性DAART处理腘动脉病变研究结果显示:DAART治疗后12个月和18个月的一期通畅率可达95%和90%,二期通畅率更是高达100%。虽然这组病例仅为21例,但是其结果还是很振奋人心的。随后,Stavroulakis等[20]又报道了一组72例DAART(n=41)对比DCB(n=31)的临床研究结果:DAART组12个月的一期通畅率为82%,DCB组12个月的一期通畅率为65%;两组12个月的二期通畅率均为96%。可以看出单纯DCB治疗腘动脉病变的12个月一期通畅率与以往研究中普通球囊扩张的疗效并无明显差异。考虑这个临床结果应该是上文中提及的国际上至今没有腘动脉病变单纯应用DCB治疗之研究的可能原因(即对于腘动脉病变单纯的DCB处理较普通球囊无显著的临床优势)。

6 新型支架的应用

基于传统的金属裸支架植入腘动脉后均面临着断裂的风险,Tamashiro等[21]通过相关的机械力学研究指出,应用于腘动脉的支架应考虑到腘动脉的特殊受力情况,应具有更好的径向支撑力和抗折性等特点。

新一代的仿生支架Supera(Abbott公司)由于其独特的螺旋编制结构,使得其径向支撑力增强,断裂率极低。近些年国际上一些中心将Supera支架用于腘动脉病变的临床研究陆续报道[22-26],发现Supera支架用于腘动脉植入后12个月的一期通畅率为68.4%~88%,支架断裂率为0。这些临床研究中仅SUPERB研究[23]为多中心前瞻性单臂器械临床应用研究,但是其纳入的病例为合并近端腘动脉的股腘动脉病变而非单纯腘动脉病变;其他的研究[24-26]虽然是Supera支架应用于腘动脉病变的临床研究,但均为单中心的回顾性研究。这些研究中有Supera支架植入后12个月一期通畅率为88%的结果,但是因为整体的临床证据等级均不高,使得我们在临床工作中尚不能首选Supera支架植入作为一线治疗。

TIGRIS支架(Gore公司)是新一代薄壁、柔顺性佳且断裂率低的金属支架。应用TIGRIS支架用于腘动脉的研究结果显示:12个月的一期通畅率为85.5%[27]。可见新一代的TIGRIS支架用于腘动脉可以获得较以往的金属裸支架更好的一期通畅率。但是,TIGRIS支架于腘动脉的应用需要更多临床证据等级高的RCT研究。

7 腘动脉狭窄闭塞性病变临床处理推荐

基于以上众多关于腘动脉狭窄闭塞性病变腔内治疗的临床研究,笔者总结了如下的临床处理选择供参考:(1)导丝为真腔内通过,则首选定向旋切装置结合药物球囊治疗(DAART);如果需要补救性支架,可选择Supera支架或者TIGRIS支架(局部钙化较重的病变推荐Supera支架)。(2)内膜下开通或者无法确定是否为真腔开通,可以选择普通球囊扩张或药物球囊扩张结合补救性支架(Supera或TIGRIS支架),对于局部钙化较重的病变推荐Supera支架。

参考文献
[1]
Nikanorov A, Smouse HB, Osman K, et al. Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions[J]. J Vasc Surg, 2008, 48(2): 435-440. [DOI]
[2]
Poulson W, Kamenskiy A, Seas A, et al. Limb flexion-induced axial compression and bending in human femoropopliteal artery segments[J]. J Vasc Surg, 2018, 67(2): 607-613. [DOI]
[3]
Avisse C, Marcus C, Ouedraogo T, et al. Anatomo-radiological study of the popliteal artery during knee flexion[J]. Surg Radiol Anat, 1995, 17(3): 255-262. [DOI]
[4]
Kröger K, Santosa F, Goyen M. Biomechanical incompatibility of popliteal stent placement[J]. J Endovasc Ther, 2004, 11(6): 686-694. [DOI]
[5]
Babalik E, Gülbaran M, Gürmen T, et al. Fracture of popliteal artery stents[J]. Circ J, 2003, 67(7): 643-645. [DOI]
[6]
Chang IS, Chee HK, Park SW, et al. The primary patency and fracture rates of self-expandable nitinol stents placed in the popliteal arteries, especially in the P2 and P3 segments, in Korean patients[J]. Korean J Radiol, 2011, 12(2): 203-209. [DOI]
[7]
Varcoe RL. Current and evolving strategies for the treatment of atherosclerotic disease of the popliteal artery[J]. J Cardiovasc Surg (Torino), 2015, 56(1): 55-65. [URI]
[8]
Rastan A, Krankenberg H, Baumgartner I, et al. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial[J]. Circulation, 2013, 127(25): 2535-2541. [DOI]
[9]
Spiliopoulos S, Kitrou P, Galanakis N, et al. Incidence and endovascular treatment of isolated atherosclerotic popliteal artery disease: outcomes from the IPAD multicenter study[J]. Cardiovasc Intervent Radiol, 2018, 41(10): 1481-1487. [DOI]
[10]
Elens M, Verhelst R, Mastrobuoni S, et al. Balloon angioplasty versus bailout stenting for isolated chronic total occlusions in the popliteal artery[J]. Vasc Endovascular Surg, 2019, 53(2): 126-131. [DOI]
[11]
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(6): 831-840. [DOI]
[12]
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. [DOI]
[13]
Fanelli F, Cannavale A, Corona M, et al. The "DEBELLUM": lower limb multilevel treatment with drug eluting balloon: randomized trial: 1-year results[J]. J Cardiovasc Surg (Torino), 2014, 55(2): 207-216. [URI]
[14]
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. [DOI]
[15]
Cortese B, Granada JF, Scheller B, et al. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document[J]. Eur Heart J, 2016, 37(14): 1096-1103. [DOI]
[16]
Jahnke T, Mueller-Huelsbeck S, Charalambous N, et al. Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study[J]. J Vasc Interv Radiol, 2010, 21(2): 186-194. [DOI]
[17]
Semaan E, Hamburg N, Nasr W, et al. Endovascular management of the popliteal artery: comparison of atherectomy and angioplasty[J]. Vasc Endovascular Surg, 2010, 44(1): 25-31. [DOI]
[18]
Rastan A, McKinsey JF, Garcia LA, et al. One-year outcomes following directional atherectomy of popliteal artery lesions: subgroup analysis of the prospective, multicenter DEFINITIVE LE trial[J]. J Endovasc Ther, 2018, 25(1): 100-108. [DOI]
[19]
Stavroulakis K, Bisdas T, Torsello G, et al. Combined directional atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease[J]. J Endovasc Ther, 2015, 22(6): 847-852. [DOI]
[20]
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(2): 181-188. [DOI]
[21]
Tamashiro GA, Tamashiro A, Villegas MO, et al. Flexions of the popliteal artery: technical considerations of femoropopliteal stenting[J]. J Invasive Cardiol, 2011, 23(10): 431-433. [URI]
[22]
Goltz JP, Ritter CO, Kellersmann R, et al. Endovascular treatment of popliteal artery segments P1 and P2 in patients with critical limb ischemia: initial experience using a helical nitinol stent with increased radial force[J]. J Endovasc Ther, 2012, 19(3): 450-456. [DOI]
[23]
Scheinert D, Werner M, Scheinert S, et al. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry[J]. JACC Cardiovasc Interv, 2013, 6(1): 65-71. [DOI]
[24]
Werner M, Paetzold A, Banning-Eichenseer U, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry[J]. EuroIntervention, 2014, 10(7): 861-868. [DOI]
[25]
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(5): e000937. [DOI]
[26]
León LR Jr, 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(4): 1014-1022. [DOI]
[27]
Piorkowski M, Freitas B, Steiner S, et al. Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries[J]. J Cardiovasc Surg (Torino), 2015, 56(1): 89-95.

文章信息

纪东华
JI Donghua
腘动脉狭窄闭塞性病变的腔内治疗
Endovascular treatment for popliteal atherosclerotic lesions: current strategies
大连医科大学学报, 2021, 43(2): 97-100.
Journal of Dalian Medical University, 2021, 43(2): 97-100.

工作空间