Covered stents for symptomatic iliac artery in-stent restenosis treatment: Midterm Results

Konstantinos Palialexis, Stavros Spiliopoulos, Apostolos Dalakidis, Elias Primetis, Dimitrios Mourikis, Achilles Chatziioannou


Purpose: To evaluate the safety and efficacy of balloon-expandable covered stent (CS) for treatment of symptomatic iliac artery in-stent restenosis (ISR).

Material and methods: This was a retrospective, single-arm, single-centre study, which included 25 consecutive patients referred for percutaneous endovascular treatment of angiographically proven symptomatic iliac artery ISR using balloon expandable CS. All patients presented with recurrent Rutherford 1 to 3 chronic limb ischaemia that deteriorated over an average period of 45 months after bare stenting. Study’s primary safety outcome measures were peri-procedural (30-days) device-related major complications rate and 12 months patient survival rate, while primary efficacy outcome measure was 12-months clinically-driven target lesion reintervention rate. Secondary endpoints included 12-months binary restenosis rates and 30-day procedure related complication rates.

Results: Initial technical success was 100%. No device-related major complications occurred. No patient was lost to follow up. According to Kaplan-Meier analysis target lesion revascularisation-free survival rates were 92% at 6- and 12-months follow up, respectively. Restenosis rates were 8% and 12% at 6- and 12-months follow up, respectively. Survival was 100% (25/25 patients). No major complications were noted (0%). Minor complication rate was 4% (1/25 case of medium size haematoma).

Conclusions: The use of a balloon-expandable covered stent seems to achieve promising results in the management of symptomatic iliac artery in-stent restenosis.

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Aggarwal V, Waldo SW, Armstrong EJ. Endovascular revascularization for aortoiliac atherosclerotic disease.Vasc Health Risk Manag 2016; 12: 117-127.

Sapoval MR, Chatellier G, Long AL, et al. Self-expandable stents for the treatment of iliac artery obstructive lesions: Long-term success and prognostic factors. AJR Am J Roentgenol 1996; 166(5): 1173-1179.

Kumakura H, Kanai H, Araki Y, et al. 15-Year Patency and Life Expectancy After Primary Stenting Guided by Intravascular Ultrasound for Iliac Artery Lesions in Peripheral Arterial Disease. JACC Cardiovasc Interv 2015; 8(14): 1893-1901.

Di Mario C, Marsico F, Adamian M, et al. New recipes for in-stent restenosis: Cut, grade, roast, or sandwich the neointima? Heart 2000; 84: 471-475.

Ettles DF, MacDonald AW, Burgess AA, et al. Directional atherectomy in iliac stent failure: Clinical technique and histopathologic correlation. Cardiovasc Intervent Radiol 1998; 21: 475-480.

Adamian M, Colombo A, Briguori C, et al. Cutting balloon angioplasty for the treatment of in-stent restenosis: A matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol 2001; 38: 672-679.

Zeller T, Rastan A, Sixt S, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J AM Coll Cardiol 2006; 48: 1553-1558.

Trentmann J, Charalambous N, Djawanshcer M, et al. Safety and efficacy of directional atherectomy for the treatment of in-stent restenosis of the femoropopliteal artery. J Cardiovasc Surg 2010; 51: 551-560.

Sharma SK, et al. Rotational atherectomy for in-stent restenosis: Acute and long-term results of the first 100 cases. J Am Coll Cardiol 1998; 32: 1358-1365.

Chen WH, Nq W, Lee PY, et al. Recanalization of chronic and long occlusive in-stent restenosis using optical coherence reflectometry-guided radiofrequency ablation guidewire. Catheter Cardiovasc Interv 2003; 59: 223-229.

Bottner RK and Hardigan KR. High-speed rotational ablation for in-stent restenosis. Cathet Cardiovasc Diagn 1997; 40: 144-149.

Tsetis D, Belli A, Morgan R, et al. Preliminary experience with cutting balloon angioplasty for iliac artery in-stent restenosis. J Endovasc Ther 2008; 15: 193-202.

Setacci C, de Donato G, Setacci F, et al. In-stent restenosis after carotid angioplasty and stenting: A challenge for the vascular surgeon. Eur J Vasc Endovasc Surg 2005; 29: 601-607.

Tamperella MR, Yadav JS, Bajzer CT, et al. Cutting balloon angioplasty to treat carotid instent restenosis. J Invasive Cardiol 2004; 16: 133-135.

Bendok BR, Roubin GS, Katzen BT, et al. Cutting balloon to treat carotid in-stent stenosis: Technical note. J Invasive Cardiol 2003; 15: 227-232.

Albiero R, Silber S, Di Mario C, et al. Cutting balloon vs. conventional balloon angioplasty for the treatment of in-stent restenosis: Results of the restenosis cutting balloon evaluation trial (RESCUT). J Am Coll Cardiol 2004; 43: 943-949.

Muramatsu T, Tsukahara R, Ho M, et al. Efficacy of cutting balloon angioplasty for in-stent restenosis: An intravascular ultrasound evaluation. J Invasive Cardiol 2001; 13: 439-444.

Ahmed JM, Mintz GS, Castagna M, et al. Intravascular ultrasound assessment of the mechanism of lumen enlargement during cutting balloon angioplasty treatment of in-stent restenosis. Am J Cardiol 2001; 88: 1032-1034.

Criado E, Marston WA, Ligush J, et al. Endovascular repair of peripheral aneurysms, pseudoaneurysms, and arteriovenous fistulas. Ann Vasc Surg 1997; 11: 256-263.

Cormier F, Ayoubi AA, Laridon D, et al. Endovascular treatment of iliac aneurysms with covered stents. Ann Vasc Surg 2000; 14: 561-566.

Beregi JP, Prat A, Willoteaux S, et al. Covered stents in the treatment of peripheral arterial aneurysms: Procedural results and midterm follow-up. Cardiovasc Intervent Radiol 1999; 22: 13-19.

Rundback JH, Rizvi A, Rozenblit GN, et al. Percutaneous stent-graft management of renal artery aneurysms. J Vasc Interv Radiol 2000; 11: 1189-1193.

Bartorelli AL, Trabattoni D, Agrifoglio M, et al. Endovascular repair of iatrogenic subclavian artery perforations using the Hemobahn stentgraft. J Endovasc Ther 2001; 8: 417–421.

Bruce M, Kuan YM. Endoluminal stent-graft repair of a renal artery aneurysm. J Endovasc Ther 2002; 9: 359-362.

Brunkwall J, Lindblad B, Ivancev K, et al. Iatrogenic AV fistula treated by a graft-covered self-expandable stent. Eur J Vasc Endovasc Surg 1996; 12: 243-245.

Bauermeister G. Endovascular stent-grafting in the treatment of superficial femoral artery occlusive disease. J Endovasc Ther 2001; 8: 315-320.

Rubin BG and Sicard GA. The Hemobahn endoprosthesis: a self-expanding polytetrafluoroethylene- covered endoprosthesis for the treatment of peripheral arterial occlusive disease after balloon angioplasty. J Vasc Surg 2001; 33: S124-128.

Lammer J, Dake MD, Bleyn J, et al. Peripheral arterial obstruction: Prospective study of treatment with a transluminally placed self-expanding stent-graft. Radiology 2000; 217: 95-104.

Gaxotte V, Laurens B, Haulon S, et al. Multicenter trial of the Jostent balloon-expandable stent-graft in renal and iliac artery lesions. J Endovasc Ther 2003; 10: 361-365.

Wiesinger B, Beregi JP, Oliva VL, et al. 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.

Craqq AH and Dake MD. Treatment of peripheral vascular disease with stent-grafts. Radiology 1997; 205: 307-314.

Katsanos K, Spiliopoulos S, Karunanithy N, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014; 59(4): 1123-1133.

Omary RA, Bettmann MA, John F et al. Quality Improvement Guidelines for the Reporting and Archiving of Interventional Radiology Procedures. J Vasc Interv Radiol 2003; 14: S293-S295.

Busquet J. The current role of vascular stents. Int Angiol 1993; 12: 206–213.

Yoon CJ, Chung JW, Park JH, et al. A newly designed nitinol stent: Early clinical experience in the treatment of iliac artery stenoses and occlusions. Korean J Radiol 2001; 2:145-150.

Hausegger KA, Lammer J, Klein GE, et al. Percutaneous recanalization of pelvic artery occlusions-fibrinolysis, PTA, stents [in German]. Rofo 1991; 155: 550-555.

Cikrit DF, Gustafson PA, Dasling MC, et al. Long-term follow-up of the Palmaz stent for iliac occlusive disease. J Vasc Surg 1995; 118: 608-613.

Becquemin JP, Allaire E, Qvarfordt P, et al. Surgical transluminal iliac angioplasty with selective stenting: Long-term results assessed by means of duplex scanning. J Vasc Surg 1999; 23: 422-249.

Schurmann K, Mahnken A, Meyer J, et al. Long-term results 10 years after iliac artery stent placement. Radiology 2002; 224: 731-738.

Mwipatayi BP, Thomas S, Wong J, et al. A comparison of covered vs. bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg 2011; 54(6): 1561-1570.

Mwipatayi BP, Sharma S, Daneshmand A, et al. COBEST co-investigators. Durability of the balloon-expandable covered vs. bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease. J Vasc Surg 2016; 64(1): 83-94.

Javed U, Balwanz CR, Armstrong EJ, et al. Mid-term outcomes following endovascular re-intervention for iliac artery in-stent restenosis. Catheter Cardiovasc Interv 2013; 82(7): 1176-1184.

Katsanos K, Al-Lamki SA, Parthipun A, et al. Peripheral Stent Thrombosis Leading to Acute Limb Ischemia and Major Amputation: Incidence and Risk Factors in the Aortoiliac and Femoropopliteal Arteries. Cardiovasc Intervent Radiol 2017; 40(3): 351-359.

Dolmatch BL, Tio FO, Li XD, et al. Patency and tissue response related to two types of polytetrafluoroethylene-covered stents in the dog. J Vasc Interv Radiol 1996; 7: 641-649.

Virmani R, Kolodgie DL, Dake MD, et al. Histopathologic evaluation of an expanded polytetrafluoroethylene-nitinol stent endoprosthesis in canine iliofemoral arteries. J Vasc Interv Radiol 1999; 10: 445-456.

Marin J, Veith F, Cynamon J, et al. Human transluminally placed endovascular stented grafts: Preliminary histopathologic analysis of healing grafts in aortoiliac and femoral artery occlusive disease. J Vasc Surg 1995; 21: 595-604.

Marin J, Veith F, Cynamon J, et al. Effect of polytetrafluoroethylene covering of Palmaz stents on the development of intimal hyperplasia in human iliac arteries. J Vasc Interv Radiol 1996; 7: 651-656.

Kessel DO, Wijesinghe LD, Robertson I, et al. Endovascular stent-grafts for superficial femoral artery disease: Results of 1-year follow-up. J Vasc Interv Radiol 1999; 10: 289-296.

Lammer J, Dake MD, Bleyn J, et al. Peripheral arterial obstruction: Prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology 2000; 217: 95-104.

Deutschmann HA, Schedlbauer P, Berczi V, et al. Placement of Hemobahn stent-grafts in femoropopliteal arteries: Early experience and midterm results in 18 patients. J Vasc Interv Radiol 2001; 12: 943-950.

Ahmadi R, Schillinger M, Maca T, et al. Femoropopliteal arteries: Immediate and long-term results with a Dacron-covered stent-graft. Radiology 2002; 223: 345-350.

Krajcer Z, Sioco G, Reynolds T. Comparison of Wallgraft and Wallstent for treatment of complex iliac artery stenosis and occlusion. Tex Heart Inst J 1997; 24: 193-199.



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