Post-angioplasty and In-stent Restenosis

Chapter

Abstract

Restenosis is the Achilles’ heel of endovascular therapy for peripheral artery disease. Long-term care of patients following arterial interventions must include aggressive modification of cardiovascular risk factors and surveillance of all arterial beds. Intervention-specific surveillance should include clinical, physiologic, and anatomic evaluation using physical examination, vascular testing, and arterial ultrasound. Detection of restenosis is not a stand-alone indication for re-intervention because there is no single pharmacologic or invasive therapy that treats restenosis in an effective and durable manner. The decision to re-intervene must be patient-specific. There is wide gap between the clinical management strategies for restenosis and evidence-based medicine.

References

  1. 1.
    Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American college of cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69:e71–e126.CrossRefPubMedGoogle Scholar
  2. 2.
    Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267–76.CrossRefPubMedGoogle Scholar
  3. 3.
    Iida O, Takahara M, Soga Y, et al. 1-year results of the ZEPHYR Registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. JACC Cardiovasc Interv. 2015;8:1105–12.CrossRefPubMedGoogle Scholar
  4. 4.
    Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996–2005. J Vasc Surg. 2009;49:910–7.CrossRefPubMedGoogle Scholar
  5. 5.
    Baker JD, Dix DE. Variability of Doppler ankle pressures with arterial occlusive disease: an evaluation of ankle index and brachial-ankle pressure gradient. Surgery. 1981;89:134–7.PubMedGoogle Scholar
  6. 6.
    Mills JL, Harris EJ, Taylor LM Jr, Beckett WC, Porter JM. The importance of routine surveillance of distal bypass grafts with duplex scanning: a study of 379 reversed vein grafts. J Vasc Surg. 1990;12:379–86. discussion 87–9.CrossRefPubMedGoogle Scholar
  7. 7.
    Lundell A, Lindblad B, Bergqvist D, Hansen F. Femoropopliteal-crural graft patency is improved by an intensive surveillance program: a prospective randomized study. J Vasc Surg. 1995;21:26–33. discussion 4.CrossRefPubMedGoogle Scholar
  8. 8.
    Davies AH, Hawdon AJ, Sydes MR, Thompson SG. Is duplex surveillance of value after leg vein bypass grafting? Principal results of the vein graft surveillance randomised trial (VGST). Circulation. 2005;112:1985–91.CrossRefPubMedGoogle Scholar
  9. 9.
    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;45(Suppl S):S5–67.CrossRefPubMedGoogle Scholar
  10. 10.
    Back MR, Novotney M, Roth SM, et al. Utility of duplex surveillance following iliac artery angioplasty and primary stenting. J Endovasc Ther. 2001;8:629–37.PubMedGoogle Scholar
  11. 11.
    Baril DT, Rhee RY, Kim J, Makaroun MS, Chaer RA, Marone LK. Duplex criteria for determination of in-stent stenosis after angioplasty and stenting of the superficial femoral artery. J Vasc Surg. 2009;49:133–8. discussion 9.CrossRefPubMedGoogle Scholar
  12. 12.
    Baril DT, Marone LK. Duplex evaluation following femoropopliteal angioplasty and stenting: criteria and utility of surveillance. Vasc Endovasc Surg. 2012;46:353–7.CrossRefGoogle Scholar
  13. 13.
    Connors G, Todoran TM, Engelson BA, Sobieszczyk PS, Eisenhauer AC, Kinlay S. Percutaneous revascularization of long femoral artery lesions for claudication: patency over 2.5 years and impact of systematic surveillance. Catheter Cardiovasc Interv. 2011;77:1055–62.CrossRefPubMedGoogle Scholar
  14. 14.
    Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation. 2011;123:87–97.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Pinto DS, Stone GW, Ellis SG, et al. Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial. J Am Coll Cardiol. 2006;48:32–6.CrossRefPubMedGoogle Scholar
  16. 16.
    Ranke C, Creutzig A, Alexander K. Duplex scanning of the peripheral arteries: correlation of the peak velocity ratio with angiographic diameter reduction. Ultrasound Med Biol. 1992;18:433–40.CrossRefPubMedGoogle Scholar
  17. 17.
    Schlager O, Francesconi M, Haumer M, et al. Duplex sonography versus angiography for assessment of femoropopliteal arterial disease in a “real-world” setting. J Endovasc Ther. 2007;14:452–9.CrossRefPubMedGoogle Scholar
  18. 18.
    Troutman DA, Madden NJ, Dougherty MJ, Calligaro KD. Duplex ultrasound diagnosis of failing stent grafts placed for occlusive disease. J Vasc Surg. 2014;60:1580–4.CrossRefPubMedGoogle Scholar
  19. 19.
    Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.CrossRefPubMedGoogle Scholar
  20. 20.
    Krankenberg H, Schluter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285–92.CrossRefPubMedGoogle Scholar
  21. 21.
    Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.CrossRefPubMedGoogle Scholar
  22. 22.
    Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015;65:931–41.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Shammas NW, Kapalis MJ, Dippel EJ, et al. Clinical and angiographic predictors of restenosis following renal artery stenting. J Invasive Cardiol. 2004;16:10–3.PubMedGoogle Scholar
  24. 24.
    Iida O, Uematsu M, Soga Y, et al. Timing of the restenosis following nitinol stenting in the superficial femoral artery and the factors associated with early and late restenoses. Catheter Cardiovasc Interv. 2011;78:611–7.CrossRefPubMedGoogle Scholar
  25. 25.
    Dube H, Clifford AG, Barry CM, Schwarten DE, Schwartz LB. Comparison of the vascular responses to balloon-expandable stenting in the coronary and peripheral circulations: long-term results in an animal model using the TriMaxx stent. J Vasc Surg. 2007;45:821–7.CrossRefPubMedGoogle Scholar
  26. 26.
    Schillinger M, Exner M, Mlekusch W, et al. Vascular inflammation and percutaneous transluminal angioplasty of the femoropopliteal artery: association with restenosis. Radiology. 2002;225:21–6.CrossRefPubMedGoogle Scholar
  27. 27.
    Schillinger M, Exner M, Mlekusch W, et al. Endovascular revascularization below the knee: 6-month results and predictive value of C-reactive protein level. Radiology. 2003;227:419–25.CrossRefPubMedGoogle Scholar
  28. 28.
    Laxdal E, Eide GE, Wirsching J, et al. Homocysteine levels, haemostatic risk factors and patency rates after endovascular treatment of the above-knee femoro-popliteal artery. Eur J Vasc Endovasc Surg. 2004;28:410–7.CrossRefPubMedGoogle Scholar
  29. 29.
    Iida O, Takahara M, Soga Y, et al. Shared and differential factors influencing restenosis following endovascular therapy between TASC (Trans-Atlantic Inter-Society Consensus) II class A to C and D lesions in the femoropopliteal artery. JACC Cardiovasc Interv. 2014;7:792–8.CrossRefPubMedGoogle Scholar
  30. 30.
    Tosaka A, Soga Y, Iida O, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16–23.CrossRefPubMedGoogle Scholar
  31. 31.
    Soga Y, Iida O, Hirano K, et al. Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery. J Vasc Surg. 2011;54:1058–66.CrossRefPubMedGoogle Scholar
  32. 32.
    Iida O, Nanto S, Uematsu M, Morozumi T, Kitakaze M, Nagata S. Cilostazol reduces restenosis after endovascular therapy in patients with femoropopliteal lesions. J Vasc Surg. 2008;48:144–9.CrossRefPubMedGoogle Scholar
  33. 33.
    Soga Y, Yokoi H, Kawasaki T, et al. Efficacy of cilostazol after endovascular therapy for femoropopliteal artery disease in patients with intermittent claudication. J Am Coll Cardiol. 2009;53:48–53.CrossRefPubMedGoogle Scholar
  34. 34.
    Iida O, Yokoi H, Soga Y, et al. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study. Circulation. 2013;127:2307–15.CrossRefPubMedGoogle Scholar
  35. 35.
    Iftikhar O, Oliveros K, Tafur AJ, Casanegra AI. Prevention of femoropopliteal in-stent restenosis with cilostazol: a meta-analysis. Angiology. 2016;67:549–55.CrossRefPubMedGoogle Scholar
  36. 36.
    Zen K, Takahara M, Iida O, et al. Drug-eluting stenting for femoropopliteal lesions, followed by cilostazol treatment, reduces stent restenosis in patients with symptomatic peripheral artery disease. J Vasc Surg. 2017;65:720–5.CrossRefPubMedGoogle Scholar
  37. 37.
    Kufner S, Hausleiter J, Ndrepepa G, et al. Long-term risk of adverse outcomes and new malignancies in patients treated with oral sirolimus for prevention of restenosis. JACC Cardiovasc Interv. 2009;2:1142–8.CrossRefPubMedGoogle Scholar
  38. 38.
    Hausleiter J, Kastrati A, Mehilli J, et al. Randomized, double-blind, placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) trial. Circulation. 2004;110:790–5.CrossRefPubMedGoogle Scholar
  39. 39.
    Rodriguez AE, Granada JF, Rodriguez-Alemparte M, et al. Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study. J Am Coll Cardiol. 2006;47:1522–9.CrossRefPubMedGoogle Scholar
  40. 40.
    Waksman R, Ajani AE, Pichard AD, et al. Oral rapamycin to inhibit restenosis after stenting of de novo coronary lesions: the Oral Rapamune to Inhibit Restenosis (ORBIT) study. J Am Coll Cardiol. 2004;44:1386–92.PubMedGoogle Scholar
  41. 41.
    Yokoi H, Daida H, Kuwabara Y, et al. Effectiveness of an antioxidant in preventing restenosis after percutaneous transluminal coronary angioplasty: the probucol angioplasty restenosis trial. J Am Coll Cardiol. 1997;30:855–62.CrossRefPubMedGoogle Scholar
  42. 42.
    Tardif JC, Cote G, Lesperance J, et al. Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group. N Engl J Med. 1997;337:365–72.CrossRefPubMedGoogle Scholar
  43. 43.
    Gallino A, Do DD, Alerci M, et al. Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal angioplasty: the PAB randomized multicenter trial. J Endovasc Ther. 2004;11:595–604.CrossRefPubMedGoogle Scholar
  44. 44.
    El Sayed H, Kerensky R, Stecher M, Mohanty P, Davies M. A randomized phase II study of Xilonix, a targeted therapy against interleukin 1alpha, for the prevention of superficial femoral artery restenosis after percutaneous revascularization. J Vasc Surg. 2016;63:133–41 e1.CrossRefPubMedGoogle Scholar
  45. 45.
    Shin SH, Baril DT, Chaer RA, Makaroun MS, Marone LK. Cryoplasty offers no advantage over standard balloon angioplasty for the treatment of in-stent stenosis. Vascular. 2013;21:349–54.CrossRefPubMedGoogle Scholar
  46. 46.
    Dick P, Sabeti S, Mlekusch W, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248:297–302.CrossRefPubMedGoogle Scholar
  47. 47.
    Virga V, Stabile E, Biamino G, et al. Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up. JACC Cardiovasc Interv. 2014;7:411–5.CrossRefPubMedGoogle Scholar
  48. 48.
    Grotti S, Liistro F, Angioli P, et al. Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: three-year results of the DEBATE-ISR study. J Endovasc Ther. 2016;23:52–7.CrossRefPubMedGoogle Scholar
  49. 49.
    Bague N, Julia P, Sauguet A, et al. Femoropopliteal in-stent restenosis repair: midterm outcomes after paclitaxel eluting balloon use (PLAISIR trial). Eur J Vasc Endovasc Surg. 2017;53:106–13.CrossRefPubMedGoogle Scholar
  50. 50.
    Kinstner CM, Lammer J, Willfort-Ehringer A, et al. Paclitaxel-eluting balloon versus standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery: 1-year results of the PACUBA trial. JACC Cardiovasc Interv. 2016;9:1386–92.CrossRefPubMedGoogle Scholar
  51. 51.
    Krankenberg H, Tubler T, Ingwersen M, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized femoral artery in-stent restenosis (FAIR) trial. Circulation. 2015;132:2230–6.CrossRefPubMedGoogle Scholar
  52. 52.
    Stahlhoff S, Donas KP, Torsello G, Osada N, Herten M. Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: midterm results. J Endovasc Ther. 2015;22:314–8.CrossRefPubMedGoogle Scholar
  53. 53.
    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;82:1176–84.CrossRefPubMedGoogle Scholar
  54. 54.
    Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. JetStream rotational and aspiration atherectomy in treating in-stent restenosis of the femoropopliteal arteries: results of the JETSTREAM-ISR feasibility study. J Endovasc Ther. 2016;23:339–46.CrossRefPubMedGoogle Scholar
  55. 55.
    Zeller T, Rastan A, Sixt S, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol. 2006;48:1573–8.CrossRefPubMedGoogle Scholar
  56. 56.
    Trentmann J, Charalambous N, Djawanscher M, Schafer J, Jahnke T. Safety and efficacy of directional atherectomy for the treatment of in-stent restenosis of the femoropopliteal artery. J Cardiovasc Surg. 2010;51:551–60.Google Scholar
  57. 57.
    Shammas NW, Shammas GA, Jerin M. Differences in patient selection and outcomes between SilverHawk atherectomy and laser ablation in the treatment of femoropopliteal in-stent restenosis: a retrospective analysis from a single center. J Endovasc Ther. 2013;20:844–52.CrossRefPubMedGoogle Scholar
  58. 58.
    Shammas NW, Shammas GA, Hafez A, Kelly R, Reynolds E, Shammas AN. Safety and one-year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center. Cardiovasc Revasc Med. 2012;13:341–4.CrossRefPubMedGoogle Scholar
  59. 59.
    Yeo KK, Malik U, Laird JR. Outcomes following treatment of femoropopliteal in-stent restenosis: a single center experience. Catheter Cardiovasc Interv. 2011;78:604–8.CrossRefPubMedGoogle Scholar
  60. 60.
    Dippel EJ, Makam P, Kovach R, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015;8:92–101.CrossRefPubMedGoogle Scholar
  61. 61.
    Schmidt A, Zeller T, Sievert H, et al. Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve-month results from the PATENT study. J Endovasc Ther. 2014;21:52–60.CrossRefPubMedGoogle Scholar
  62. 62.
    van den Berg JC, Pedrotti M, Canevascini R, Chimchila Chevili S, Giovannacci L, Rosso R. In-stent restenosis: mid-term results of debulking using excimer laser and drug-eluting balloons: sustained benefit? J Invasive Cardiol. 2014;26:333–7.PubMedGoogle Scholar
  63. 63.
    Bosiers M, Deloose K, Callaert J, et al. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015;22:1–10.CrossRefPubMedGoogle Scholar
  64. 64.
    Zeller T, Dake MD, Tepe G, et al. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013;6:274–81.CrossRefPubMedGoogle Scholar
  65. 65.
    Schopohl B, Leirmann D, Pohlit LJ, et al. 192IR endovascular brachytherapy for avoidance of intimal hyperplasia after percutaneous transluminal angioplasty and stent implantation in peripheral vessels: 6 years of experience. Int J Radiat Oncol Biol Phys. 1996;36:835–40.CrossRefPubMedGoogle Scholar
  66. 66.
    Wolfram RM, Budinsky AC, Pokrajac B, Potter R, Minar E. Endovascular brachytherapy: restenosis in de novo versus recurrent lesions of femoropopliteal artery–the Vienna experience. Radiology. 2005;236:338–42.CrossRefPubMedGoogle Scholar
  67. 67.
    Pokrajac B, Kirisits C, Schmid R, et al. Beta endovascular brachytherapy using CO2-filled centering catheter for treatment of recurrent superficial femoropopliteal artery disease. Cardiovasc Revasc Med. 2009;10:162–5.CrossRefPubMedGoogle Scholar
  68. 68.
    Werner M, Scheinert D, Henn M, et al. Endovascular brachytherapy using liquid Beta-emitting rhenium-188 for the treatment of long-segment femoropopliteal in-stent stenosis. J Endovasc Ther. 2012;19:467–75.CrossRefPubMedGoogle Scholar
  69. 69.
    Levy MTT, Kinlay S, Eisenhauer A, Sobieszczyk P. Endovascular brachytherapy as an adjunctive treatment for long segment lower extremity in-stent restenosis. Catheter Cardiovasc Interv. 2010;75:S93.Google Scholar
  70. 70.
    Ho KJ, Devlin PM, Madenci AL, et al. High dose-rate brachytherapy for the treatment of lower extremity in-stent restenosis. J Vasc Surg. 2017;65:734–43.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Harvard Medical School, Cardiovascular Division, Vascular Medicine SectionBrigham and Women’s HospitalBostonUSA

Personalised recommendations