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1 Korean J Vasc Endovasc Surg 2011;27(2):80-84 DOI: /kjves 슬와하부만성완전폐쇄성병변에대한약물방출스텐트삽입 1 예 서울대학교의과대학분당서울대학병원외과 1, 영상의학과 2, 서울대학교의과대학외과학교실 3, 영상의학교실 4 유영선 1 ㆍ박형섭 1 ㆍ이태승 1,3 ㆍ강성권 2,4 Drug-eluting Stent Implantation for a Below-the-knee Chronic Total Occlusion Lesion: A Case Report Young Sun Yoo, M.D. 1, Hyung Sub Park, M.D. 1, Taeseung Lee, M.D. 1,3 and Sung Kwon Kang, M.D. 2,4 Departments of Surgery 1, Radiology 2, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam; Departments of Surgery 3, Radiology 4, Seoul National University College of Medicine, Seoul, Korea For many years, surgical bypass has been considered mainstream therapy of below-the-knee peripheral arterial occlusive disease. The introduction of endovascular techniques and devices has made percutaneous transluminal angioplasty (PTA) and stenting feasible and safe in these patients. However, PTA has a significant risk of restenosis by elastic recoil and stenting is associated with restenosis by neointinal hyperplasia and vessel wall remodeling. With the advent of coronary artery drug eluting stent (DES), these limitations of PTA and stenting have been circumvented. Herein, we report a successful case of DES implantation for below-the-knee chronic total occlusion lesion. A 65-year-old male patient presented with severe claudication on his left leg. Computed tomography angiography showed long segment total occlusion involving the left distal superficial femoral, popliteal and proximal anterior tibial arteries. We tried to treat the lesion using endovascular surgery. During balloon angioplasty, flow limiting dissection developed in the proximal anterior tibial artery and we deployed a DES (Cypher, Cordis, Johnson & Johnson, USA) in that lesion. To our knowledge, this is the first report of DES for the treatment of below-the-knee chronic total occlusion lesion in Korea. Key Words: Below-the-knee, Chronic total occlusion lesion, Drug eluting stent 중심단어 : 슬와하부, 만성완전폐쇄성병변, 약물방출스텐트 서 최근혈관내수술의급격한발전과함께혈관외과영역중말초동맥폐쇄질환의치료에있어중요한패러다임의변화가일어나고있다. 여러가지치료방법중비침습적인방법들이개발되고우선적으로선택되고있지만슬와하부의동맥폐쇄질환에대하서는아직도원위 접수일 : 2011년 3월 29일, 수정일 : 2011년 5월 21일, 승인일 : 2011년 5월 23일책임저자 : 이태승, 경기도성남시분당구구미로 166 우 , 분당서울대병원외과 Tel: , Fax: tslee@snubh.org 론 부경골동맥혹은족부동맥우회술이주요한위치를차지하고있다 (1,2). Trans-Atlantic Inter-Society Consensus II (TASC II) 에서도아직까지슬와하부의경피적혈관성형술이나스텐트삽입술이아직까지충분한근거를가지고있지않으며환자의전신상태가좋지않거나기대수명이길지않고, 적절한이식편이없을경우에한해일차적인치료방법으로고려해볼수있다고규정하고있다 (3). 1964년 Dotter와 Judkins (4) 가처음으로슬와하부의동맥병변에대해 coxial Teflon catheter을이용한경피적혈관성형술을시도하고 1974년 Gruntzig와 Hopff (5) 가 coxial balloon catheter를이용한경피적풍선혈관성형술에대해기술한이후다양한 guidewire와 balloon의꾸준 80

Young Sun Yoo, et al: Drug-eluting Stent in Below-the-knee CTO Lesion 81 한개발로슬와하부의동맥병변에대한경피적혈관성형술이계속보고되었다 (6,7). 그러나풍선만을사용한경우혈관의탄력반동에의한재협착으로성적이좋지않아이를보완하기위해혈관내스텐트삽입이시도되었다.

국내에서는아직슬와하부의말초동맥폐쇄질환에대한 DES의사용이보고되지않은상태로본저자들은만성완전폐쇄성병변 (chronic total occlusion [CTO] lesion) 에대해 DES를성공적으로시술하였기에문헌고찰과함께이를보고하는바이다. 증례 69세남자환자가내원수개월전부터시작된우측하지의파행을주소로내원하였다.

2 Young Sun Yoo, et al: Drug-eluting Stent in Below-the-knee CTO Lesion 81 한개발로슬와하부의동맥병변에대한경피적혈관성형술이계속보고되었다 (6,7). 그러나풍선만을사용한경우혈관의탄력반동에의한재협착으로성적이좋지않아이를보완하기위해혈관내스텐트삽입이시도되었다. 하지만이러한스텐트들은혈관의탄력반동에의한재협착은줄여주지만내막증식에의한재협착을극복하지는못해최근관상동맥경화에사용되던내막증식억제제를처리한 drug eluting stent (DES) 의사용이임상에소개되고있다. 국내에서는아직슬와하부의말초동맥폐쇄질환에대한 DES의사용이보고되지않은상태로본저자들은만성완전폐쇄성병변 (chronic total occlusion [CTO] lesion) 에대해 DES를성공적으로시술하였기에문헌고찰과함께이를보고하는바이다. 증례 69세남자환자가내원수개월전부터시작된우측하지의파행을주소로내원하였다. 환자는내원 20년전부터고혈압과당뇨로약물치료를하고있었고 13년전뇌졸증이있었다. 환자는내원 3년전우총대퇴동맥폐쇄로 8 mm ring type PTFE 인조혈관을이용한외장골동맥총대퇴동맥간우회술을시행하였다. 내원시시행한전산화단층촬영을이용한혈관조영술 (computed tomography [CT] angiography) 상우표재대퇴동맥원위부에서슬와동맥을거쳐전경골동맥근위부까지의폐쇄소견이관찰되었다 (Fig. 1). 환자는전신상태가좋지않아전신마취, 우회로수술이힘들것으로판단했으며국소마취로혈관내수술을 시행하기로결정하고초음파유도하에우외장골동맥총대퇴동맥간우회술시행부위의인조혈관을천자하여 6 Fr sheath를삽입하였다. 환자의대동맥분지부의각도가 crossover하기어려운예각이어서동측 antegrade 접근을하기로하였다. 이후시행한혈관조영술에서 CT에서와같은우표재대퇴동맥원위부에서전경골동맥근위부까지의 CTO와함께발달된측부혈관이관찰되었고전경골동맥원위부에서 run-off 혈관이관찰되었다. 우선 guidewire가우전경골동맥까지통과하는것을확인한후표재대퇴동맥원위부와슬와동백부위의만성완전폐쇄병변에대하여 5 mm, 8 mm 풍선을이용하여풍선혈관성형술을시행하고혈류가개선되었으나표재대퇴동맥원위부의잔존협착부위에대하여 mm 스텐트 (Heracules, S&G Biotech, Seongnam, Korea) 를삽입하였다. 이후슬와동맥원위부와전경골동맥근위부에잔존협착이관찰되어 5 mm 풍선을이용하여수차례풍선혈관성형술시행후혈관조영술상이전에보이던측부혈류가보이지않을정도로혈류가개선되었으나몇차례더풍선성혈술을시행후예기치않은혈류제한박리 (flow-limiting dissection) 소견보여 (Fig. 2A) 숙고끝에 3 28 mm DES (Cypher, Cordis, Johnson & Johnson, Warren, NJ, USA) 를삽입하고다시풍선성형술을시행하였다 (Fig. 2B). 스텐트삽입후협착부위는호전되었으며최종혈관조영상에서표재대퇴동맥원위부, 슬와동맥, 전경골동맥, 족배동맥의혈류가호전됨을확인하였다. 지혈기구는사용하지않고도수압박으로지혈을확인한후시술을종료하였다. 환자는 aspirin, clopidogrel, warfarin 투약하면서퇴원하였으며후시술 16개월째시행한 CT angiography에서스텐트삽입부위가협착소견없이혈류를 Fig. 1. Computed tomography arteriogram at admission shows occlusion of Rt. superficial femoral artery, popliteal artery and tibioperoneal trunk with anterior tibial artery run-off.

82 Korean J Vasc Endovasc Surg Vol. 27, No. 2, 2011 Fig. 2. After several times of balloon angioplasty, there was a flow-limiting dissection (arrow) on proximal anterior tibial artery (A).

In CT arteriogram 16 months after implantation of stents, drug eluting stent in proximal anterior tibial artery keeps good patency. 잘유지하고있음을확인하였다 (Fig. 3). 환자는현재시술후 22개월째특별한문제없이외래에서경과관찰중이다.

Dorros 등 (10) 이처음으로관상동맥에서사용되던 Palmaz-Schatz stent를슬와하부동맥박리의치료에성공적으로시술함을보고한이후혈관성혈술에의한탄력반동과이에의한재협착등의제약을극복하기위한대안으로슬와하부동맥병변의스텐트사용이본격화되었다.

3 82 Korean J Vasc Endovasc Surg Vol. 27, No. 2, 2011 Fig. 2. After several times of balloon angioplasty, there was a flow-limiting dissection (arrow) on proximal anterior tibial artery (A). After implantation of drug eluting stent on proximal anterior tibial artery, good antegrade flow could be obtained (B). Fig. 3. In CT arteriogram 16 months after implantation of stents, drug eluting stent in proximal anterior tibial artery keeps good patency. 잘유지하고있음을확인하였다 (Fig. 3). 환자는현재시술후 22개월째특별한문제없이외래에서경과관찰중이다. 고 풍선혈관성형술은슬와하부말초동맥폐쇄질환이원인인만성, 중증사지허혈환자의치료방법으로점점그폭을넓혀왔으며사지구제의측면에서나쁘지않은결 찰 과를보고하였지만장기개존율과재협착률에서실망스런결과를가져왔다 (8,9). Dorros 등 (10) 이처음으로관상동맥에서사용되던 Palmaz-Schatz stent를슬와하부동맥박리의치료에성공적으로시술함을보고한이후혈관성혈술에의한탄력반동과이에의한재협착등의제약을극복하기위한대안으로슬와하부동맥병변의스텐트사용이본격화되었다. Feiring 등 (11) 은처음으로 82명의환자 92예의슬와하부의동맥병변에대한연구에서 94% 의기술적성공률과 96% 에서 1년동안통증의개선, 상처의치유, 보행정도의개선이있었음을보고하여스텐트의사용이슬와하부동맥질환의치료에한대안이될수있을것으로보았다. 이들은슬와하부동맥과관상동맥은비슷한단면적을갖는중형동맥 (medium-sized artery) 이기때문에관상동맥에서의스텐트시술과마찬가지로슬와하부동맥에서도 3.5 mm ( 범위, mm) 정도비슷한구경의스텐트를사용할수있다고주장하였다. 또한시술후혈관내강의단면적을증가시킬수있고초기의탄력반동, 리모델링, 내막판 (intimal flap) 이나내막박리 (intimal dissection) 의형성을막을수있어서슬와하부동맥질환에서도관상동맥스텐트를적용할수있다고주장하였다. 이후지속적인연구를통해슬와하부동맥에대한스텐트사용은풍선혈관성형술로성공하지못한경우나우회수술을시행할수없는고위험군환자에있어안전하고유용한것으로알려졌다 (12,13). 하지만초기에사용되던 bare metal stent (BMS) 는스텐트내의내막증식과이로인한조기협착이문제로제기되었으며이로인한증상의재발과반복적인재시술이 BMS의단점으로지적되었다. 지난 20여년동안이러

4 Young Sun Yoo, et al: Drug-eluting Stent in Below-the-knee CTO Lesion 83 한스텐트재협착을줄이고자하는여러가지노력들이있어왔으나대부분성공적이지못한결과를보였다. 하지만최근항염증, 항증식작용을가진 DES가내막증식과혈관내민무늬근육세포증식을억제하여관상동맥의재협착을줄인다는보고가발표된후 (14) 많은연구자들이슬와하부동맥병변의 BMS 삽입후내막증식과이로인한재협착에대한대안으로 DES를고려하기시작했다. Bosiers 등 (15) 에의해처음으로슬와하부말초동맥폐쇄에대한 DES의 6개월단기성적이보고되었는데 Rutherford 분류4 이상의중증하지허혈환자 18명에게시행된 20 예의시술에서모든경우 6개월후스텐트내의재협착은보이지않았고평균 0.25 mm이던혈관의내경은평균 2.39 mm까지유지하였으며평균내강소실은 0.38 mm였다. 또한 6개월생존율과사지구제율은 94.4%, 94% 를보여슬와하부의동맥병변에대한 DES의사용이재협착과사지구제의측면에서효과적이라고보고하였다. Siablis 등 (16) 도 DES와 BMS간의 6개월단기성적비교에서사지구제율, 사망률의큰차이는없었지만일차개존율, 재협착률, 표적병변에대한재시술률에서통계적으로유의하게 DES의성적이좋아슬와하부동맥병변에대하여 DES의사용이스텐트내막증식을억제할것으로보았다. 이들그룹은다시 1년과 3년간후의추적조사결과에서마찬가지로사망률과사지구제율에서는통계적으로유의한차이가없었지만 DES 그룹이일차개존율, 재협착률, 표적병변에대한재시술률에서성적이좋음을보고하여 DES가슬와하부동맥병변에효과적인치료방법이될것임을주장하였다 (17). Scheinert 등 (18) 의 DES와 BMS 각각 30명슬와하부동맥병변에의한중증하지허혈환자군을대상으로한연구에서도 DES 그룹의 6개월재협착률, 표적병변의재시술률, 주요사지절단율이유의하게낮음을보고하였으며같은기관 72명의 DES 그룹을대상으로한 24개월추적관찰에서도 1차, 2차개존율이각각 89.2%, 95.9% 로높게보고되었다. 또한최근 Biondi-Zoccai 등 (19) 이슬와하부동맥병변의 DES와 BMS 사용에대한 18개의논문을비교한메타분석에서도 DES가 BMS에비해조영술상의결과나임상적결과로볼때우월한것으로결론짓고있다. 아직까지많은연구에서스텐트삽입이풍선혈관성형술이실패할경우시행하는대안적인방법 ( bail-out ) 의스텐트였던반면최근 Feiring 등 (20) 은다시 106명 118 예의비교적많은환자군을대상으로한연구에서일차적인 DES 시술의결과를발표하였는데 94% 의 3년사지구제율과 93% 의상처치유, 휴식통호전등의좋은결과를보고하였다. 하지만아직까지 DES와우회수술, 혹은 DES와풍선혈관성형술간에무작위연구결과는나오고있지않고있으며 TASC II에서도명확한결론은내리고있지않다. 또한대부분의보고들이슬와하부의스텐트삽입에대한긍적적인측면을주로부각시켜보고하고있긴하지만좋지않은하나의 run-off 혈관을가지고있는경우무문별한시술과시술중의기계적인손상으로인해오히려혈관에손상을주어상처치유를불가능하게하고휴식통이나파행을더욱악화시킬수있음을주지하여야한다. 엄밀히말하면본증례는처음부터스텐트삽입을목표로했던것은아니고일종의 bail-out 스텐트로스텐트를이용한스텐트보조혈관성형술 (stent-assisted angioplasty) 이라고할수있다. 몇몇연구에서이러한경우를전술한바와같이스텐트보조혈관성혈술이란용어로표현하기도하였다 (11,13). 또한탄력반동, 30% 이상의잔존협착, 내막판형성된경우와함께혈관성형술후박리소견이보이는경우도 DES 삽입후추적결과를보는연구의 inclusion criteria로포함하는예가있어 (16,17) 본증례도혈관박리에대한시술이긴했지만슬와하부병변에대한 DES의적용과그결과들에대해전반적으로살펴보았다. 우리나라에서는아직까지슬와하부의동맥질환의치료에서있어슬와하부의동맥질환에대한스텐트삽입이보편화되지는않았고더구나 DES의사용에대한보고는아직없는실정이다. 하지만머지않아슬와하부의동맥폐쇄질환에있어서도풍선혈관성형술과함께스텐트삽입술이많이시도될것으로생각되며보다많은임상적연구결과를바탕으로스텐트삽입에대한타당성을평가하여야하겠다. 국내에서는아직보고되지않은슬와하부의동맥병변에대해 DES를성공적으로시술하였기에이를보고하는바이다. REFERENCES 1)Chew DK, Conte MS, Donaldson MC, Whittemore AD, Mannick JA, Belkin M. Autogenous composite vein bypass graft for infrainguinal arterial reconstruction. J Vasc Surg 2001;33: ) Halloran BG, Lilly MP, Cohn EJ, Benjamin ME, Flinn WR. Tibial bypass using complex autologous conduit: patency and limb salvage. Ann Vasc Surg 2001;15: ) Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg 2007;33 Suppl 1:S1-S75. 4) Dotter CT, Judkins MP. Transluminal treatment of arteriosclerotic obstruction. Description of a new technic and a

5 84 Korean J Vasc Endovasc Surg Vol. 27, No. 2, 2011 preliminary report of its application. Circulation 1964;30: ) Grüntzig A, Hopff H. Percutaneous recanalization after chronic arterial occlusion with a new dilator-catheter (modification of the Dotter technique) (author's transl). Dtsch Med Wochenschr 1974;99: ) Schwarten DE, Cutcliff WB. Arterial occlusive disease below the knee: treatment with percutaneous transluminal angioplasty performed with low-profile catheters and steerable guide wires. Radiology 1988;169: ) Bakal CW, Cynamon J, Sprayregen S. Infrapopliteal percutaneous transluminal angioplasty: what we know. Radiology 1996;200: ) Söder HK, Manninen HI, Jaakkola P, Matsi PJ, Räsänen HT, Kaukanen E, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 2000;11: ) Nasr MK, McCarthy RJ, Hardman J, Chalmers A, Horrocks M. The increasing role of percutaneous transluminal angioplasty in the primary management of critical limb ischaemia. Eur J Vasc Endovasc Surg 2002;23: ) Dorros G, Hall P, Prince C. Successful limb salvage after recanalization of an occluded infrapopliteal artery utilizing a balloon expandable (Palmaz-Schatz) stent. Cathet Cardiovasc Diagn 1993;28: ) Feiring AJ, Wesolowski AA, Lade S. Primary stent-supported angioplasty for treatment of below-knee critical limb ischemia and severe claudication: early and one-year outcomes. J Am Coll Cardiol 2004;44: ) Tepe G, Zeller T, Heller S, Wiskirchen J, Fischmann A, Coerper S, et al. Self-expanding nitinol stents for treatment of infragenicular arteries following unsuccessful balloon angioplasty. Eur Radiol 2007;17: ) Donas KP, Schwindt A, Schönefeld T, Tessarek J, Torsello G. Below-knee bare nitinol stent placement in high-risk patients with critical limb ischaemia and unlimited supragenicular inflow as treatment of choice. Eur J Vasc Endovasc Surg 2009;37: ) Schofer J, Schlüter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362: ) Bosiers M, Deloose K, Verbist J, Peeters P. Percutaneous transluminal angioplasty for treatment of below-the-knee critical limb ischemia: early outcomes following the use of sirolimus-eluting stents. J Cardiovasc Surg (Torino) 2006;47: ) Siablis D, Kraniotis P, Karnabatidis D, Kagadis GC, Katsanos K, Tsolakis J. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study. J Endovasc Ther 2005;12: ) Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, et al. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol 2009;20: ) Scheinert D, Ulrich M, Scheinert S, Sax J, Bräunlich S, Biamino G. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions. Euro- Intervention 2006;2: ) Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, et al. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther 2009;16: ) Feiring AJ, Krahn M, Nelson L, Wesolowski A, Eastwood D, Szabo A. Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: the PaRADISE (PReventing Amputations using Drug eluting StEnts) trial. J Am Coll Cardiol 2010;55:

HANYANG MEDICAL REVIEWS Vol. 31 No. 1, 무릎밑동맥의혈관내치료 : Critical Limb Ischemia 를중심으로 Endovascular Management for Infrapopliteal Stenocclusive Les

HANYANG MEDICAL REVIEWS Vol. 31 No. 1, 2011 17 무릎밑동맥의혈관내치료 : Critical Limb Ischemia 를중심으로 Endovascular Management for Infrapopliteal Stenocclusive Lesions Manifestating Critical Limb Ischemia 박상우건국대학교병원영상의학과