Vascular Specialist International

The Korean Society for Vascular Surgery (대한혈관외과학회)
권호 표지
DOI QR코드

DOI QR Code

Prognostic Factors in Patients Treated with DrugCoated Balloon Angioplasty for Symptomatic Peripheral Artery Disease

  • Sigala, Fragiska (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Galyfos, George (First Department of Propaedeutic Surgery, Ethnikon and Kapodistriakon University of Athens, Hippocration Hospital) ;
  • Stavridis, Kyriakos (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Tigkiropoulos, Konstantinos (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Lazaridis, Ioannis (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Karamanos, Dimitrios (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Mpontinis, Vangelis (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Melas, Nikolaos (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Zournatzi, Ioulia (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital) ;
  • Filis, Konstantinos (First Department of Propaedeutic Surgery, Ethnikon and Kapodistriakon University of Athens, Hippocration Hospital) ;
  • Saratzis, Nikolaos (First Department of Surgery, Aristotle University of Thessaloniki, Papageorgiou General Hospital)
  • Received : 2018.08.21
  • Accepted : 2018.09.23
  • Published : 2018.12.31
⟨ Previous Next ⟩

Abstract

Purpose: Aim of this study is to report real-life experience on the treatment of peripheral artery disease (PAD) with a specific drug-coated balloon (DCB), and to evaluate potential prognostic factors for outcomes. Materials and Methods: This is a retrospective study reporting outcomes in patients with PAD who were treated with the Lutonix DCB during a four-year period. Major outcomes included: all-cause mortality, amputation, clinical improvement, wound healing and target lesion revascularization (TLR). Mean follow-up was $24.2{\pm}2.3$ months. Results: Overall, 149 patients (mean age: $68.6{\pm}8.3$ years; 113 males) were treated, either for intermittent claudication (IC) (n=86) or critical limb ischemia (CLI) (n=63). More than half the target lesions (n=206 in total) were located in the superficial femoral artery and 18.0% were below-the-knee lesions. CLI patients presented more frequently with infrapopliteal (P=0.002) or multilevel disease (P=0.0004). Overall, all-cause mortality during follow-up was 10.7%, amputation-free survival was 81.2% and TLR-free survival was 96.6%. CLI patients showed higher all-cause mortality (P=0.007) and total amputation (P=0.0001) rates as well as lower clinical improvement (P=0.0002), compared to IC patients. Coronary artery disease (CAD), gangrene and infrapopliteal disease were found to be predictors for death whereas CLI and gangrene were found to be predictors for amputation, during follow-up. Conclusion: PAD treatment with Lutonix DCBs seems to be an efficient and safe endovascular strategy yielding promising results. However, CAD, gangrene, CLI and infrapopliteal lesions were found to be independent predictors for adverse outcomes. Larger series are needed to identify additional prognostic factors.

Keywords

References

  1. Lumsden AB, Davies MG, Peden EK. Medical and endovascular management of critical limb ischemia. J Endovasc Ther 2009;16(2 Suppl 2):II:31-62.
  2. Aihara H, Soga Y, Mii S, Okazaki J, Yamaoka T, Kamoi D, et al.; RECANALISE Registry Investigators. Comparison of long-term outcome after endovascular therapy versus bypass surgery in claudication patients with Trans-Atlantic Inter-Society Consensus-II C and D femoropopliteal disease. Circ J 2014;78:457-464. https://doi.org/10.1253/circj.CJ-13-1147
  3. Soderstrom MI, Arvela EM, Korhonen M, Halmesmaki KH, Alback AN, Biancari F, et al. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg 2010;252:765-773. https://doi.org/10.1097/SLA.0b013e3181fc3c73
  4. Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975-981. https://doi.org/10.1016/j.jvs.2008.01.005
  5. Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, et al. Randomized comparison of everolimuseluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg 2012;55:390-398. https://doi.org/10.1016/j.jvs.2011.07.099
  6. Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2012;60:2290-2295. https://doi.org/10.1016/j.jacc.2012.08.989
  7. Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 2012;5:831-840. https://doi.org/10.1161/CIRCINTERVENTIONS.112.971630
  8. Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxelcoated 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;7:10-19. https://doi.org/10.1016/j.jcin.2013.05.022
  9. Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol 2011;58:1105-1109. https://doi.org/10.1016/j.jacc.2011.05.034
  10. Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 2013;128:615-621. https://doi.org/10.1161/CIRCULATIONAHA.113.001811
  11. Antoniou GA, Chalmers N, Georgiadis GS, Lazarides MK, Antoniou SA, Serracino-Inglott F, et al. A meta-analysis of endovascular versus surgical reconstruction of femoropopliteal arterial disease. J Vasc Surg 2013;57:242-253. https://doi.org/10.1016/j.jvs.2012.07.038
  12. Steiner S, Schmidt A, Bausback Y, Braunlich S, Ulr ich M, Banning-Eichenseer U, et al. Single-center experience with lutonix drug-coated balloons in infrapopliteal arteries. J Endovasc Ther 2016;23:417-423. https://doi.org/10.1177/1526602816645080
  13. Rosenf ield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, et al; LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 2015;373:145-153. https://doi.org/10.1056/NEJMoa1406235
  14. Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, et al. Drug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and metaanalysis of randomized clinical trials. JACC Cardiovasc Interv 2016;9:1731-1742. https://doi.org/10.1016/j.jcin.2016.06.008
  15. Katsanos K, Spiliopoulos S, Karunanithy N, Krokidis M, Sabharwal T, Taylor P. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014;59:1123-1133.e8. https://doi.org/10.1016/j.jvs.2014.01.041
  16. Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-month results of the lutonix global SFA registry: worldwide experience with lutonix drug-coated balloon. JACC Cardiovasc Interv 2017;10:1682-1690. https://doi.org/10.1016/j.jcin.2017.04.041
  17. Jang SJ, Hsieh CA, Huang HL, Juang JM, Chou HH, Tsao CY, et al. Feasibility and clinical outcomes of peripheral drug-coated balloon in high-risk patients with femoropopliteal disease. PLoS One 2015;10:e0143658. https://doi.org/10.1371/journal.pone.0143658
  18. Schmidt A, Piorkowski M, Gorner H, Steiner S, Bausback Y, Scheinert S, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC Cardiovasc Interv 2016;9:715-724.
  19. Garg K, Kaszubski PA, Moridzadeh R, Rockman CB, Adelman MA, Maldonado TS, et al. Endovascular-first approach is not associated with worse amputation-free survival in appropriately selected patients with critical limb ischemia. J Vasc Surg 2014;59:392-399. https://doi.org/10.1016/j.jvs.2013.09.001
  20. Vierthaler L, Callas PW, Goodney PP, Schanzer A, Patel VI, Cronenwett J, et al.; Vascular Study Group of New England. Determinants of survival and major amputation after peripheral endovascular intervention for critical limb ischemia. J Vasc Surg 2015;62:655-664. https://doi.org/10.1016/j.jvs.2015.04.391
  21. Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, et al. 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;8:1614-1622. https://doi.org/10.1016/j.jcin.2015.07.011
  22. Wu R, Tang S, Wang M, Li Z, Yao C, Wang S. Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: a meta-analysis of randomized trials. Int J Surg 2016;35:88-94. https://doi.org/10.1016/j.ijsu.2016.09.014
  23. Cassese S, Ndrepepa G, Liistro F, Fanelli F, Kufner S, Ott I, et al. Drugcoated balloons for revascularization of infrapopliteal arteries: a metaanalysis of randomized trials. JACC Cardiovasc Interv 2016;9:1072-1080. https://doi.org/10.1016/j.jcin.2016.02.011
  24. Westin GG, Armstrong EJ, Bang H, Yeo KK, Anderson D, Dawson DL, et al. Association between statin medications and mortality, major adverse cardiovascular event, and amputationfree survival in patients with critical limb ischemia. J Am Coll Cardiol 2014;63:682-690. https://doi.org/10.1016/j.jacc.2013.09.073
  25. Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg 2010;51:230-241. https://doi.org/10.1016/j.jvs.2009.08.073
  26. Jalkanen J, Maksimow M, Hollmen M, Jalkanen S, Hakovirta H, et al. Compared to intermittant claudication critical limb ischemia is associated with elevated levels of cytokines. PLoS One 2016;11:e0162353. https://doi.org/10.1371/journal.pone.0162353
  27. Todoran TM, Connors G, Engelson BA, Sobieszczyk PS, Eisenhauer AC, Kinlay S. Femoral artery percutaneous revascularization for patients with critical limb ischemia: outcomes compared to patients with claudication over 2.5 years. Vasc Med 2012;17:138-144. https://doi.org/10.1177/1358863X12440141
  28. Trocciola SM, Chaer R, Dayal R, Lin SC, Kumar N, Rhee J, et al. Comparison of results in endovascular interventions for infrainguinal lesions: claudication versus critical limb ischemia. Am Surg 2005;71:474-479; discussion 480.

Cited by

  1. Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis vol.27, pp.4, 2018, https://doi.org/10.1177/1526602820931559