DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial

Trials

Bram Fioole¹  Jean-Paul PM de Vries⁴  Ruud A Aarts²  Jan Albert Vos³  Joost A Bekken¹ 

[1] Department of Vascular Surgery, Maasstad Ziekenhuis, Maasstadweg 21, Rotterdam, 3079 DZ, The Netherlands;Department of Interventional Radiology, Maasstad Ziekenhuis, Maasstadweg 21, Rotterdam, 3079 DZ, The Netherlands;Department of Interventional Radiology, St. Antonius Ziekenuis, Koekoekslaan 1, Nieuwegein, 3435 CM, The Netherlands;Department of Vascular Surgery, St. Antonius Ziekenuis, Koekoekslaan 1, Nieuwegein, 3435 CM, The Netherlands

关键词: Covered stent;    Stenting;    Endovascular;    Critical Limb Ischemia;    Intermittent Claudication;    Common Iliac Artery;    Atherosclerotic disease;    Peripheral arterial occlusive disease;   

Others  :  1095188
DOI  :  10.1186/1745-6215-13-215

 received in 2012-05-03, accepted in 2012-10-04,  发布年份 2012

【 摘 要 】

Background

Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents.

Methods/Design

This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included.

The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment.

The primary endpoint is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure-related parameters.

Trial registration

Dutch Trial Register, NTR3381.

【 授权许可】

   
2012 Bekken et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG: Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007, Suppl 45 S:S5-67.
• [2]Balzer JO, Thalhammer A, Khan V, Zangos S, Vogl TJ, Lehnert T: Angioplasty of the pelvic and femoral arteries in PAOD: results and review of the literature. Eur J Radiol 2010, 75:48-56.
• [3]Leng GC, Lee AJ, Fowkes FG, Whiteman M, Dunbar J, Housley E, Ruckley CV: Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol 1996, 25:1172-1181.
• [4]Aquino R, Johnnides C, Makaroun M, Whittle JC, Muluk VS, Kelley ME, Muluk SC: Natural history of claudication: long-term serial follow-up study of 1,244 claudicants. J Vasc Surg 2001, 34:962-970.
• [5]Jelnes R, Gaardsting O, Hougaard Jensen K, Baekgaard N, Tonnesen KH, Schroeder T: Fate in intermittent claudication: outcome and risk factors. Br Med J (Clin Res Ed) 1986, 293:1137-1140.
• [6]Zeller T: Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med 2007, 12:223-234.
• [7]Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D: Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol 1999, 19:538-545.
• [8]Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ: High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis 2004, 172:95-105.
• [9]Kannel WB, Skinner JJ Jr, Schwartz MJ, Shurtleff D: Intermittent claudication. Incidence in the Framingham Study. Circulation 1970, 41:875-883.
• [10]Dotter CT, Judkins MP: Transluminal treatment of arteriosclerotic obstruction. Description of a new technique and a preliminary report of its application. Circulation 1964, 30:654-670.
• [11]Gruntzig 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, 99:2502-2510. 2511
• [12]Palmaz JC, Sibbitt RR, Reuter SR, Tio FO, Rice WJ: Expandable intraluminal graft: a preliminary study. Work in progress. Radiology 1985, 156:73-77.
• [13]de Vries SO, Hunink MG: Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997, 26:558-569.
• [14]Naylor AR, Ah-See AK, Engeset J: Aortoiliac endarterectomy: an 11-year review. Br J Surg 1990, 77:190-193.
• [15]Reed AB, Conte MS, Donaldson MC, Mannick JA, Whittemore AD, Belkin M: The impact of patient age and aortic size on the results of aortobifemoral bypass grafting. J Vasc Surg 2003, 37:1219-1225.
• [16]Urayama H, Ohtake H, Yokoi K, Fujimori H, Kawaguchi M, Ishikawa T, Watanabe Y: Long-term results of endarterectomy, anatomic bypass and extraanatomic bypass for aortoiliac occlusive disease. Surg Today 1998, 28:151-155.
• [17]Brothers TE, Greenfield LJ: Long-term results of aortoiliac reconstruction. J Vasc Interv Radiol 1990, 1:49-55.
• [18]Funovics MA, Lackner B, Cejna M, Peloschek P, Sailer J, Philipp MO, Maca T, Ahmadi A, Minar E, Lammer J: Predictors of long-term results after treatment of iliac artery obliteration by transluminal angioplasty and stent deployment. Cardiovasc Intervent Radiol 2002, 25:397-402.
• [19]Gandini R, Fabiano S, Chiocchi M, Chiappa R, Simonetti G: Percutaneous treatment in iliac artery occlusion: long-term results. Cardiovasc Intervent Radiol 2008, 31:1069-1076.
• [20]Henry M, Amor M, Ethevenot G, Henry I, Mentre B, Tzvetanov K: Percutaneous endoluminal treatment of iliac occlusions: long-term follow-up in 105 patients. J Endovasc Surg 1998, 5:228-235.
• [21]Galaria II, Davies MG: Percutaneous transluminal revascularization for iliac occlusive disease: long-term outcomes in TransAtlantic Inter-Society Consensus A and B lesions. Ann Vasc Surg 2005, 19:352-360.
• [22]Hans SS, DeSantis D, Siddiqui R, Khoury M: Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease. Surgery 2008, 144:583-589. discussion 589–590
• [23]Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O'Hara PJ, Lyden SP, Clair DG: The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008, 48:1451-1457. 1457 e1451-1453
• [24]Bosch JL, Hunink MG: Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology 1997, 204:87-96.
• [25]Tetteroo E, van der Graaf Y, Bosch JL, van Engelen AD, Hunink MG, Eikelboom BC, Mali WP: Randomised comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac-artery occlusive disease. Dutch Iliac Stent Trial Study Group. Lancet 1998, 351:1153-1159.
• [26]Klein WM, van der Graaf Y, Seegers J, Spithoven JH, Buskens E, van Baal JG, Buth J, Moll FL, Overtoom TT, van Sambeek MR, Mali WP: Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement. Radiology 2006, 238:734-744.
• [27]Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR: Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg 1997, 25:829-838. discussion 838–829
• [28]Koizumi A, Kumakura H, Kanai H, Araki Y, Kasama S, Sumino H, Ichikawa S, Kurabayashi M: Ten-year patency and factors causing restenosis after endovascular treatment of iliac artery lesions. Circ J 2009, 73:860-866.
• [29]Sixt S, Alawied AK, Rastan A, Schwarzwalder U, Kleim M, Noory E, Schwarz T, Frank U, Muller C, Hauk M, et al.: Acute and long-term outcome of endovascular therapy for aortoiliac occlusive lesions stratified according to the TASC classification: a single-center experience. J Endovasc Ther 2008, 15:408-416.
• [30]Leville CD, Kashyap VS, Clair DG, Bena JF, Lyden SP, Greenberg RK, O'Hara PJ, Sarac TP, Ouriel K: Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 2006, 43:32-39.
• [31]Ozkan U, Oguzkurt L, Tercan F: Technique, complication, and long-term outcome for endovascular treatment of iliac artery occlusion. Cardiovasc Intervent Radiol 2010, 33:18-24.
• [32]De Roeck A, Hendriks JM, Delrue F, Lauwers P, Van Schil P, De Maeseneer M, Francois O, Parizel P, d'Archambeau O: Long-term results of primary stenting for long and complex iliac artery occlusions. Acta Chir Belg 2006, 106:187-192.
• [33]Ichihashi S, Higashiura W, Itoh H, Sakaguchi S, Nishimine K, Kichikawa K: Long-term outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)-II. J Vasc Surg 2011, 53:992-999.
• [34]AbuRahma AF, Hayes JD, Flaherty SK, Peery W: Primary iliac stenting versus transluminal angioplasty with selective stenting. J Vasc Surg 2007, 46:965-970.
• [35]Murphy TP, Webb MS, Lambiase RE, Haas RA, Dorfman GS, Carney WI Jr, Morin CJ: Percutaneous revascularization of complex iliac artery stenoses and occlusions with use of Wallstents: three-year experience. J Vasc Interv Radiol 1996, 7:21-27.
• [36]Burke CR, Henke PK, Hernandez R, Rectenwald JE, Krishnamurthy V, Englesbe MJ, Kubus JJ, Escobar GA, Upchurch GR Jr, Eliason JL: A contemporary comparison of aortofemoral bypass and aortoiliac stenting in the treatment of aortoiliac occlusive disease. Ann Vasc Surg 2010, 24:4-13.
• [37]Piazza M, Ricotta JJ, Bower TC 2nd, Kalra M, Duncan AA, Cha S, Gloviczki P: Iliac artery stenting combined with open femoral endarterectomy is as effective as open surgical reconstruction for severe iliac and common femoral occlusive disease. J Vasc Surg 2011, 54(2):402-411.
• [38]Mousa AY, Beauford RB, Flores L, Faries PL, Patel P, Fogler R: Endovascular treatment of iliac occlusive disease: review and update. Vascular 2007, 15:5-11.
• [39]Lam C, Gandhi RT, Vatakencherry G, Katzen BT: Iliac artery revascularization:overview of current interventional therapies. Interv Cardiol 2010, 2:851-859.
• [40]Balzer JO, Gastinger V, Ritter R, Herzog C, Mack MG, Schmitz-Rixen T, Vogl TJ: Percutaneous interventional reconstruction of the iliac arteries: primary and long-term success rate in selected TASC C and D lesions. Eur Radiol 2006, 16:124-131.
• [41]Kudo T, Rigberg DA, Reil TD, Chandra FA, Ahn SS: The influence of the ipsilateral superficial femoral artery on iliac angioplasty. Ann Vasc Surg 2006, 20:502-511.
• [42]Dyet JF, Watts WG, Ettles DF, Nicholson AA: Mechanical properties of metallic stents: how do these properties influence the choice of stent for specific lesions? Cardiovasc Intervent Radiol 2000, 23:47-54.
• [43]Duda SH, Wiskirchen J, Tepe G, Bitzer M, Kaulich TW, Stoeckel D, Claussen CD: Physical properties of endovascular stents: an experimental comparison. J Vasc Interv Radiol 2000, 11:645-654.
• [44]Henry M, Klonaris C, Amor M, Henry I, Tzvetanov K: State of the art: which stent for which lesion in peripheral interventions? Tex Heart Inst J 2000, 27:119-126.
• [45]Jamshidi P, Mahmoody K, Erne P: Covered stents: a review. Int J Cardiol 2008, 130:310-318.
• [46]Elsner M, Auch-Schwelk W, Britten M, Walter DH, Schachinger V, Zeiher AM: Coronary stent grafts covered by a polytetrafluoroethylene membrane. Am J Cardiol 1999, 84:335-338. A338
• [47]Palmaz JC: Review of polymeric graft materials for endovascular applications. J Vasc Interv Radiol 1998, 9:7-13.
• [48]Ahmadi R, Schillinger M, Maca T, Minar E: Femoropopliteal arteries: immediate and long-term results with a Dacron-covered stent-graft. Radiology 2002, 223:345-350.
• [49]Schurmann K, Vorwerk D, Uppenkamp R, Klosterhalfen B, Bucker A, Gunther RW: Iliac arteries: plain and heparin-coated Dacron-covered stent-grafts compared with noncovered metal stents - an experimental study. Radiology 1997, 203:55-63.
• [50]Rzucidlo EM, Powell RJ, Zwolak RM, Fillinger MF, Walsh DB, Schermerhorn ML, Cronenwett JL: Early results of stent-grafting to treat diffuse aortoiliac occlusive disease. J Vasc Surg 2003, 37:1175-1180.
• [51]Ford SJ, Rehman A, Bradbury AW: External iliac endofibrosis in endurance athletes: a novel case in an endurance runner and a review of the literature. Eur J Vasc Endovascular surgery 2003, 26:629-634.
• [52]Timaran CH, Stevens SL, Freeman MB, Goldman MH: External iliac and common iliac artery angioplasty and stenting in men and women. J Vasc Surg 2001, 34:440-446.
• [53]Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ: Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. J Vasc Surg 2008, 48:362-367.
• [54]Sabri SS, Choudhri A, Orgera G, Arslan B, Turba UC, Harthun NL, Hagspiel KD, Matsumoto AH, Angle JF: Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol 2010, 21:995-1003.
• [55]Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, Diehm C, Biamino G, Vermassen F, Scheinert D, et al.: A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J 2007, 28:798-805.
• [56]Diehm N, Pattynama PM, Jaff MR, Cremonesi A, Becker GJ, Hopkins LN, Mahler F, Talen A, Cardella JF, Ramee S, et al.: Clinical endpoints in peripheral endovascular revascularization trials: a case for standardized definitions. Eur J Vasc Endovasc Surg 2008, 36:409-419.
• [57]Verspaget M, Nicolai SP, Kruidenier LM, Welten RJ, Prins MH, Teijink JA: Validation of the Dutch version of the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg 2009, 37:56-61.
• [58]Hays RD, Sherbourne CD, Mazel RM: The RAND 36-Item Health Survey 1.0. Health Econ 1993, 1993(2):217-227.
• [59]SF-36 Website. http://www.sf-36.org/faq/generalinfo.aspx webcite.
• [60]Zee KI, Sanderman R: Het meten van de algemene gezondheidstoestand met de RAND-36 Een handleiding. Groningen: Noordelijk centrum voor gezondheidsvraagstukken/Rijksuniversiteit Groningen; 1993.
• [61]Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA: Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology 2000, 217:95-104.
• [62]Wiesinger B, Beregi JP, Oliva VL, Dietrich T, Tepe G, Bosiers M, Huttl K, Muller-Hulsbeck S, Bray A, Tielemans H, Duda SH: PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study. J Endovasc Ther 2005, 12:240-246.
• [63]Bosiers M, Iyer V, Deloose K, Verbist J, Peeters P: Flemish experience using the Advanta V12 stent-graft for the treatment of iliac artery occlusive disease. J Cardiovasc Surg (Torino) 2007, 48:7-12.