Original Articles Micro-Ⅱ Stent 의초기결과 류종철 장양수 김건영 이승환 김종현 전동운 심원흠 조승연 Abstract 조홍근 Immediate Results of AVE Micro- Stent Jong Cheol Ryu, M.D

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1 Original Articles Micro-Ⅱ Stent 의초기결과 류종철 장양수 김건영 이승환 김종현 전동운 심원흠 조승연 Abstract 조홍근 Immediate Results of AVE Micro- Stent Jong Cheol Ryu, M.D., Yangsoo Jang, M.D., Keun Young Kim, M.D., Seung Hwan Lee, M.D., Jong Huyn Kim, M.D., Dong Woon Jeon, M.D., Won-Heum Shim, M.D., Seung-Yun Cho, M.D. Cardiology Division, Yonsei Cardiovascular Center, College of Medicine, Yonsei University, Seoul, Korea Hongkeun Cho, M.D. Department of Cardiology, College of Medicine, Ewha Womans University, Seoul, Korea BackgroundSeveral kinds of stents have shown their safety and efficacy to treat acute or subacute closure after balloon angioplasty as well as to reduce restenosis rate. However, one of the limitations of stents is difficult to deploy especially in tortuous vessels, lesions at a bend, and distal to previously deployed stents. The Micro stent, which was one of the most recently developed stents, is a rapidexchange balloon expandable stainless steel stent with a zigzag design connected with a continuous single weld in each 3mm segments. It scores over excellent trackability and optimum radio-opacity. Therefore, it is easy to operate and feasible in tortuous, distal lesions and variety of lesion lengths. We report our experiences with Micro- stent implantation in the first 76 patients at Yonsei cardiovascular center to assess its safety and efficacy in patients with complex coronary anatomy and clinical results in the first months. MethodsBetween January 1996 and July 1996, eighty-six Micro- stent were implanted in the coronary arteries of 76 patientsmale 65.8, age 591 years. Forty-five patients had unstable angina, the others had stable angina17 pts, acute myocardial infarction14 ptss. Results 1 Indication of stenting was de novo , suboptimal result , restenosis and 91.4 of lesions were stented in bail out situation. 2 Single stent were implanted in lesions, overlapping stent in 111.6lesions. Among overlapping stents, the second stent with Micro- stent and with another kind of stent were 4. 6, 7., respectively. 3 Procedure related complication including a subacute closure was occurred in 11.2 patient 532

2 who had distal dissection and 45 residual stenosis. In 1214 lesions, peristent dissection has been noticed after stent implantation. 4 Angigraphic successdefined as a residual stenosis of 3 without major dissection was achieved in 82 of 86 attempts95.3. The procedural success ratedefined as a residual stenosis of 3 without occurrence of major clinical events within 4 weeks after procedure was /76 patients. Angiographic success and procedural success rate in calcified lesion were 1 and 1, respectively. Angiographic success and procedural success rate in tortuous lesion were 1 and 1, respectively. Angiographic success and procedural success rate in more than 45angulated lesion were 97 and 1, respectively. 5 The mean minimal luminal diameter of the target lesions was increased from.42.4mm before stent implantation to mmp.1. The percentage of diameter stenosis was reduced from to p.1 after stent implantation. ConclusionCoronary stenting with AVE Micro- stent can be safely performed and is particularly beneficial in tortuous and calcified arteries. There was a high tendency for peristent dissection which need to special consideration to avoid. Follow-up data is needed to assess mid and long term patency. KEY WORDSCoronary artery disease AVE Micro- stent Immediate results. 서 론 방 법 1. 대상 2. Stent 시술및약물요법 533

stent는 3mm segment가 single weld로 돌아가면서 mg po bid)을 시술전 2 3일 전부터 시작하여 stent 연속적으로 연결된 zigzag모양으로 되어 있으며, 이 각 삽입후 2주까지 ticlopidine을 사용하였고, aspirin은 각의 segment는 두께가.8 (.21mm)인 8개의 계속해서 사용하였다.

3 stent는 3mm segment가 single weld로 돌아가면서 mg po bid)을 시술전 2 3일 전부터 시작하여 stent 연속적으로 연결된 zigzag모양으로 되어 있으며, 이 각 삽입후 2주까지 ticlopidine을 사용하였고, aspirin은 각의 segment는 두께가.8 (.21mm)인 8개의 계속해서 사용하였다. 시술중에는 heparin을 1, 단 axial struts로 구성되어 혈류와 평행되게 도안이 되 위를 정주하였고, 병변내에 혈전이 있는 경우나, 내막 어 있다(Fig. 1). 3.5mm 구경의 혈관에 시술시 none- 박리등의 합병증으로 인하여 혈전이 생길 경우가 높을 xpened profile은.65 (1.67mm)이고, 3.5mm 혈 경우에는 시술후에 24시간 동안 heparin을 시간당 1, 관에 시술시 확장된 상태에서의 metallic surface area 단위로 연속 점적하였다. 는 8.4%이며, 확장시 foreshortening되는 율은 약 2% 로 보고되고 있다. 제작사에 따르면 stent시술후 recoil 되는 정도는 balloon expansion후 8.7%였다. MicroⅡ stent는 2.5, 3., 3.5, 4., 4.5mm 크기의 balloon catheter에 mounted되어 있고, 길이는 6, 9, 12, 18, 24, 3, 36, 39mm등이 있다. 저자등은 3. 4.mm 의 크기와 18, 3mm 길이의 stent를 사용하였다. Stent balloon은 compliant이며 nominal 기압은 9기압이고, 12기압에서는 3mm 크기의 stent는 3.25mm크기로, 3.5mm는 3.75mm로 각각 약 8.3%, 7.1%의 크기가 3. 자료의 분석 및 통계 1996년 1월부터 7월까지 시술된 Micro-Ⅱ stent의 자료를 분석하여 혈관의 크기, 병변등의 형태는 AHA/ ACC분류에 의거하여 정리하였고, 시술 전후의 관동맥 조영술 소견은 empty catheter를 기준으로 caliper를 이용하여 협착의 정도를 분석하였다. 통계처리는 연속 변수를 평균±표준편차로 표현하였고, 각 결과간의 비 교는 Student t-test를 이용하여 p값이.5이하인 경우 통계학적으로 의미있다고 하였다. 증가되는 특성을 가지고 있다. 결 과 Micro-Ⅱ stent시술은 AVE사의 표준시술 방법으 로 시술하였고, 주로 8F 유도도자 및 175cm의 유도 1. 대상환자 철선을 이용하였으며, stent삽입후 필요한 경우 다른 풍 총 76명의 환자에서 86개의 Micro-Ⅱ stent가 시 선도자를 이용하여 재확장을 하였다. 술되었다. 대상환자의 남녀비는 남자 5명(65.8%), 여 Stent 시술전후의 약물투여는 급성심근경색을 제외 자 26명(34.2%)이었고, 평균연령은 59±1세였다. 임 한 경우에는 aspirin(1mg po qd), ticlopidine(25 상적진단은 급성심근경색 14예(18.4%), 불안정형 협 Fig. 1. The AVE Micro-Ⅱ stent consists of continuously connected stent segments in various lengths from 6mm to 39mm. Flexibility is enhanced utilizing a unique single weld connection between each 3mm segments. 534

4 Table 1. Clinical characteristics of the patients Sexmalefemale Age Risk factors Diabetes mellitus Hypertension Hypercholesterolemia24mg% Smoking Clinical diagnosis Stable angina Unstable angina Acute MI Angiographic diagnosis One vessel disease Two vessel disease Triple vessel disease Number% Characteristics of the lesions 3. 시술결과 Table 2. Angiographic charactersitics of the lesions Location Number% LAD LCX RCA Graft vessels Lesion typeaha/acc classification A B B C Angulation Tortuosity* Calcification Indications De novo lesion Suboptimal result Bailout lesion 91.4 Restenotic lesion No. Of stents by lesion vessel Single stent Overlapping *Moderate tortuositylesion is distal to two bands75 Severe tortuositylesion is distal to three bends75 or two bends9 Table 3. Stent size Number% Diametermm Lengthmm

Fig. 2. An angulated, calcified lesion of proximal LAD artery treated by implantation of AVE Micro-Ⅱ stent. Table 4. Angiographic result Reference diameter(mm) 시술후 1개월간의 임상적인 성공율은 96.1%였다. 3.13±.

5 Fig. 2. An angulated, calcified lesion of proximal LAD artery treated by implantation of AVE Micro-Ⅱ stent. Table 4. Angiographic result Reference diameter(mm) 시술후 1개월간의 임상적인 성공율은 96.1%였다. 3.13±.42 고 MLD(mm) prestent.42±.4 poststent 2.93±.5* 최근들어 stent 삽입술의 성공율(stent시술후 잔여 Percentage of diameter stenosis prestent poststent 안 86.49± ±1.22* Lesion length(mm) 16.27± 7.11 Peristent dissection 12(14%) proximal to stent 2 distal to stent 8 stent를 포함한 거의 모든 stent에서 95% 이상의 성 공율을 보고하고 있다. 저자등의 경우에도 3% 미만 의 잔여 협착이 남아 있는 경우를 stent 삽입술의 성공 으로 정의했을 경우, 95.3%(82/86병변)의 성공율을 보였다. 또한 시술후 잔여 협착이 3% 미만이고, 1개 2 proximal & distal Mean±S.D. * Pre vs Post-stent p<.1 협착이 5% 이하)은 기구와 기술의 발달로 Micro-Ⅱ 월 이내에 major clinical events가 없는 경우를 procedural success rate로 정의했을 경우, 본원에서의 Micro-Ⅱ stent의 procedural success rate는 96.1% Table 5. Procedure related complications Number(%) (73/76명)였다. Major clinical event는 급성 심근경 1(1.2) 색의 합병증(심근 파열 1예, 심실세동 1예)으로 인한 사 Acute closure 망이 2예 있었고, subacute stent thrombosis가 1예 Stent migration (1.2%) 있었다. Q-myocardial infarction Emergency CABG Subacute closure* 금속성 stent의 가장 큰 제한점은 아급성 혈전 형성 Bleeding requiring transfusion * one case who had distal dissection and 45% residual stenosis 의 성향으로, 약 1개월 정도 걸리는 stent의 neointimal coverage가 완성될 때까지는 이러한 stent thrombosis 가 일어날 수 있는 것으로 알려져 있다4). 강력한 항응 peristent dissection이 12병변(14%)에서 발생하였다 고 요법으로 이러한 문제점을 감소 시킬 수 있다는 보 (Table 4). 시술에 따른 합병증으로는 subacute clo- 고가 있었으나5), 혈관 및 출혈의 합병증의 발생율(1 sure가 1예 있었다(Table 5). 시술의 성공율은 95.3%, 16%)은 높게 보고 되었다2,3,6,7). 최근 Colombo등8) 536

6 537

7 요약 연구배경 : 방법 : 결과 : 538

8 결론 : References 1) Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L:Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Eng J Med 316: 71-6, ) Serruys PW, De Jaegere PP, Kiemeneij F, et al:a comparison of balloon expandable stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 331: , ) Fischman DL, Leon MB, Baim DS, et al:a randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Eng J Med 331:496-51, ) Ueda Y, Nanto S, Komamura K, Kodama K:Neointimal coverage of stents in human coronary arteries observed by angioscopy. J Am Coll Cardiol 23: , ) Barragan P, Sainsous J, Silvestri M, Bouvier JL, Comet B, Simeoni JB, Charmasson C, Bremondy M:Ticlopidine and subcutaneous heparin as an alternative regimen following coronary stenting. Cathet Cardiovasc Diagn 32: , ) Muller DWM, Shamir KJ, Ellis SG, Topol EJ:Peripheral vascular complications after conventional and complex percutaneous coronary intervention procedures. Am J Cardiol 69:63-68, ) Carrozza JP Jr, Kuntz RE, Levine MJ, et al:angiographic and clinical outcome of intracoronary stenting:immediate and long term results from a large single-center experience. J Am Coll Cardiol 2: , ) Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G, Saglione A, Goldberg SL, Tobias JM:Intracoronary stenting without anticoa-gulation accomplished with intravascular ultrasound guidance. Circulation 91: , ) Herrmann HC, Buchbinder M, Clemen MW, Fischman D, Goldberg S, Leon M, Schatz RA, Tierstein P, Walker CM, Hirschfield JW:Emergency use of balloon-expandable coronary artery stenting for failed percutaneous transluminal coronary angioplasty. Circulation 86: , ) Sutton JM, Ellis SG, Roubin GS, et al:major clinical events after coronary stenting:the multicenter registry of acute and elective Gianturco-Roubin stent placement. Circulation 89: , ) Haude M, Erbel R, Issa H, Straub U, Rupprecht HJ, Treese N, Heyer J:Subacute thrombotic complications after intracoronary implantation of Palmaz-Schatz stents. Am Heart J 126:15-22, ) Holmes D, Garratt K, Schwartz R:Timing of stent occlusion/thrombosis after stent placement. J Am Coll Cardiol 23:7A, ) Liu MW, Voohees W, Agrawal S, Dean L, Roubin G: Stratification of the risk of thrombosis after intracoronary stenting for threatened or acute closure complicating coronary balloon angioplasty:a Cook registry study. Am Heart J 13:8-13, ) Tresukosol D, Schalij MJ, Savalle LH, Jukema JW, Buis B, Reiber JHC, Bruschke AVG:Micro stent, quantitative coronary angiography, and procedural results. Cathet Cardiovasc Diagn 38: , ) Ozaki Y, Keane D, Ruygrok P, Feyter PD, Stertzer S, Serruys PW:Acute clinical and angiographic results w- ith the new AVE Micro coronary stent in bailout management. Am J Cardiol 76: , ) Wong P, Leung WH, Wong CM:Migration of the AVE Micro coronary stent. Cathe Cardiovasc Diagn 38: ) Mehta S, Popma J, Margolis J, et al:angiographic complications after new device angioplasty in native coronary arteries:a NACI Angiographic Core Laboratory Report. 539

9 The proceedings of TCT Meeting(Washington DC), February, ) Bailey S, Ricci D, Kiesz S, et al:incidence and clinical impact of dissections after PTCA and stent placement: Results from the Randomized Stent REStenosis Study. The proceedings of TCT Meeting(Washington DC), February, ) Tan K, Sulke N, Taub N, Sowton E:Clinical and lesion morphologic determinants of coronary angiop-lasty success and complications:current experience. J Am Coll Cardiol 25:855-65, ) Hermans WR, Foley DP, Rensing BJ, Rutsch W:Usefulness of quantitative and qualitative angiographic lesion morphology, and clinical characteristics in predicting major adverse cardiac events during and after native coronary balloon angioplasty. Am J Cardiol 72:14-2, ) Hermans WR, Rensing BJ, Foley DP, Deckers JW:Therapeutic dissection after successful coronary balloon angioplasty:no influence on restenosis or on clinical outcome in 693 patients. J Am Coll Cardiol 2:767-78, ) Sharma SK, Israel DH, Kamean JL, Bodian CA:Clinical, angiographic, and procedural determinants of major and minor coronary dissection during angioplasty. Am Heart J 126:39-47, ) Chandra P, Jain BL, Agarwal P, Prakash O, et al:intracoronary stenting with AVE Micro stent-single center experience. The proceedings of TCT meeting, J Invasive Cardiol 8:41, ) Hong MK, Chuang YC, Prunka N, Satler LF:Predictors of early and late cardiac events in patients undergoing saphenous vein graft angioplasty with PTCA and new device modalities. Circulation 88:I-61, ) Tamura T, Kimura T, Nosaka H, Nobuyoshi M:Predictors of restenosis after Palmaz-Schatz stent implantation. Circulation 9:I-324, ) Mintz GS, Dusaillant GR, Wong SC, Pichard AD, et al: Rotational atherectomy followed by adjunct stents:the preferred therapy for calcified lesions in large vessels? Circulation 92:I-329, ) Mazur W, Grinstead WC, Hakim AH, Dabaghi SF, Abukhalil JM, Ali NM, Joseph J, French BA, Raizner AE:Fate of side branches after intracoronary implantation of the Gianturco-Roubin flex-stents for acute or threatened closure after percutaneous transluminal coronary angiography. Am J Cardiol 74: , ) Fischman DL, Savage MP, Leon MB, Schatz RA, Ellis S, Cleman MW, Hirshfeld JW, Teirstein P, Baley S, Walker CM, Goldberg S:Fate of lesion-related side branches after coronary artery stenting. J Am Coll Cardiol 22:16 4-6,

Original Articles Korean Circulation J 1998;28 6 : 항혈소판요법을이용한관동맥내 Stent 삽입술의조기결과 손지원 김영준 손민수 오세진 안태훈 최인석 신익균 Initial Results after Implantation

Original Articles Korean Circulation J 1998;286:939-946 항혈소판요법을이용한관동맥내 Stent 삽입술의조기결과 손지원 김영준 손민수 오세진 안태훈 최인석 신익균 Initial Results after Implantation of Coronary Artery Stents with Antiplatelet Agents Ji-Won