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Drug-Coated Balloon and Antithrombotic Therapy

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Abstract

In patients with lower extremity arterial disease (LEAD), antiplatelet therapy is used to prevent major adverse cardiac events (MACE) and major adverse limb events (MALE). Different strategies have been tested, involving the use of a single antiplatelet (SAPT) or a dual antiplatelet (DAPT) therapy, but their beneficial effect is still unclear, and specific indications are lacking.

SAPT seems to be effective in symptomatic patients only, with clopidogrel being more effective.

The effect of DAPT in LEAD patients is still unclear. Few studies have evaluated the effect of antiplatelet therapy after percutaneous treatment of LEAD patients, and the benefit of DAPT in these patients is still unclear and only confined to specific subpopulation of patients.

The increasing use of drug-coated balloon (DCB) in LEAD patients is usually followed by DAPT in the first weeks after treatment, and this approach seems to be effective.

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References

  1. Schmit K, Dolor RJ, Jones WS, Vemulapalli S, Hasselblad V, Subherwal S, Heidenfelder B, Patel MR. Comparative effectiveness review of antiplatelet agents in peripheral artery disease. J Am Heart Assoc. 2014;3:e001330.

    Article  Google Scholar 

  2. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996;348:1329–39.

    Article  Google Scholar 

  3. Belch JJ, Dormandy J, Biasi GM, Cairols M, Diehm C, Eikelboom B, Golledge J, Jawien A, Lepantalo M, Norgren L, Hiatt WR, Becquemin JP, Bergqvist D, Clement D, Baumgartner I, Minar E, Stonebridge P, Vermassen F, Matyas L, Leizorovicz A. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010;52:825–33.

    Article  Google Scholar 

  4. Cacoub PP, Bhatt DL, Steg PG, Topol EJ, Creager MA. Patients with peripheral arterial disease in the CHARISMA trial. Eur Heart J. 2009;30:192–201.

    Article  CAS  Google Scholar 

  5. Fowkes FG, Price JF, Stewart MC, Butcher I, Leng GC, Pell AC, Sandercock PA, Fox KA, Lowe GD, Murray GD. Aspirin for prevention of cardiovascular events in a general population screened for a low ankle brachial index: a randomized controlled trial. JAMA. 2010;303:841–8.

    Article  CAS  Google Scholar 

  6. Belch J, MacCuish A, Campbell I, Cobbe S, Taylor R, Prescott R, Lee R, Bancroft J, MacEwan S, Shepherd J, Macfarlane P, Morris A, Jung R, Kelly C, Connacher A, Peden N, Jamieson A, Matthews D, Leese G, McKnight J, O’Brien I, Semple C, Petrie J, Gordon D, Pringle S, MacWalter R. The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease. BMJ. 2008;337:a1840.

    Article  Google Scholar 

  7. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324:71–86.

    Article  Google Scholar 

  8. Berger JS, Krantz MJ, Kittelson JM, Hiatt WR. Aspirin for the prevention of cardiovascular events in patients with peripheral artery disease: a meta-analysis of randomized trials. JAMA. 2009;301:1909–19.

    Article  CAS  Google Scholar 

  9. Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L, Jones WS, Blomster J, Millegard M, Reist C, Patel MR. Ticagrelor versus clopidogrel in symptomatic peripheral artery disease. N Engl J Med. 2017;376:32–40.

    Article  CAS  Google Scholar 

  10. Bonaca MP, Scirica BM, Creager MA, Olin J, Bounameaux H, Dellborg M, Lamp JM, Murphy SA, Braunwald E, Morrow DA. Vorapaxar in patients with peripheral artery disease: results from TRA2 TIMI 50. Circulation. 2013;127:1522–9.

    Article  CAS  Google Scholar 

  11. Bonaca MP, Gutierrez JA, Creager MA, Scirica BM, Olin J, Murphy SA, Braunwald E, Morrow DA. Acute limb ischemia and outcomes with vorapaxar in patients with peripheral artery disease: results from the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis in Myocardial Infarction 50 (TRA TIMI 50). Circulation. 2016;133:997–1005.

    Article  CAS  Google Scholar 

  12. Norgren L, Hiatt W, Dormandy J, Nehler M, Harris K, Fowkes F, on behalf of the TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45:S5e67.

    Article  Google Scholar 

  13. 2005 Writing Committee Members, ACCF/AHA TASK FORCE MEMBERS Circulation. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2011;124:2020–45.

    Google Scholar 

  14. Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, et al. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013;20:699–706.

    Article  Google Scholar 

  15. Thott O, Granath F, Malmstedt J, Wahlgren CM. Dual antiplatelet therapy improves outcome in diabetic patients undergoing endovascular femoropopliteal stenting for critical limb ischaemia. Eur J Vasc Endovasc Surg. 2017;53:403–10.

    Article  CAS  Google Scholar 

  16. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Miekusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.

    Article  CAS  Google Scholar 

  17. Krankenberg H, Schlüter M, Steinkamp H, Bürgelin K, Scheinert D, Schulte K, 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.

    Article  CAS  Google Scholar 

  18. Aboyans V, Ricco JB, Bartelink M-LEL, Bjorck M, Brodmann M. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur Heart J. 2017;00:1–60.

    Google Scholar 

  19. Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131:495–502.

    Article  CAS  Google Scholar 

  20. Tepe G, Schnorr B, Albrecht T, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015;8:102–811.

    Article  Google Scholar 

  21. Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7(1):10–9.

    Article  Google Scholar 

  22. Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Müller-Hülsbeck S, Nehler MR, Benenati JF, Scheinert D, LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.

    Article  CAS  Google Scholar 

  23. Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cardiovasc Interv. 2015;86(2):278–86.

    Article  Google Scholar 

  24. Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015;22(1):14–21.

    Article  Google Scholar 

  25. Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Hiendlmayer R, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Randomized comparison of paclitaxel-eluting balloon and stenting versus plain balloon plus stenting versus directional atherectomy for femoral artery disease (ISAR-STATH). Circulation. 2017;135(23):2218–26.

    Article  CAS  Google Scholar 

  26. Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102–13.

    Article  CAS  Google Scholar 

  27. Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. 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(13):1386–92.

    Article  Google Scholar 

  28. Krankenberg H, Tübler T, Ingwersen M, Schlüter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. 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(23):2230–6.

    Article  CAS  Google Scholar 

  29. Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (paclitaxel-eluting balloon versus conventional balloon angioplasty for in-stent restenosis of superficial femoral artery): a randomized trial. J Am Heart Assoc. 2017;6(7):e006321.

    Article  Google Scholar 

  30. Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014;21(1):1–8.

    Article  Google Scholar 

  31. Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ, IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64(15):1568–76.

    Article  Google Scholar 

  32. Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, Scheinert D, Schulte KL, Rastan A, Brodmann M. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8(12):1614–22.

    Article  Google Scholar 

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Alfani, A., Gerardi, D., Esposito, G., Stabile, E. (2019). Drug-Coated Balloon and Antithrombotic Therapy. In: Cortese, B. (eds) Drug-Coated Balloons . Springer, Cham. https://doi.org/10.1007/978-3-319-92600-1_20

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  • DOI: https://doi.org/10.1007/978-3-319-92600-1_20

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