Skip to main content
Editorial

Outstanding effectiveness of paclitaxel-based technologies for the treatment of femoropopliteal artery occlusive disease on the potential expense of increased late all-cause mortality? No reason to panic

Published Online:https://doi.org/10.1024/0301-1526/a000778
Free first page

Literature

  • Feldman DN, Armstrong EJ & Aronow HD, et al. SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions. Catheter Cardiovasc Interv. 2018 Apr 24. doi: 10.1002/ccd.27635. First citation in articleCrossrefGoogle Scholar

  • Bailey SR, Beckman JA & Dao TD et al. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention. J Am Coll Cardiol 2018 Dec 4. Epub ahead of print. First citation in articleGoogle Scholar

  • Tepe G, Laird J & Schneider P, et al.; IN.PACT SFA Trial Investigators. 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 (5):495–502. First citation in articleCrossref MedlineGoogle Scholar

  • Rosenfield K, Jaff MR & White CJ, et al.; LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease N Engl J Med. 2015;373:145–153. First citation in articleCrossref MedlineGoogle Scholar

  • Schroeder H, Werner M & Meyer DR, et al.; ILLUMENATE EU RCT Investigators. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon) Circulation. 2017;135(23):2227–2236. First citation in articleMedlineGoogle Scholar

  • Krishnan P, Faries P & Niazi K, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102–1113. First citation in articleCrossref MedlineGoogle Scholar

  • Micari A, Brodmann M & Keirse K, et al.; IN.PACT Global Study Investigators. Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain: 2-year results from the IN.PACT Global Study JACC Cardiovasc Interv. 2018;11(10):945–953. First citation in articleCrossref MedlineGoogle Scholar

  • Ansel GM, Brodmann M & Keirse K, et al; IN.PACT Global Study Investigators. Drug-coated balloon treatment of femoropopliteal lesions typically excluded from clinical trials: 12- month findings from the IN.PACT Global Study J Endovasc Ther. 2018;25(6):673–682. First citation in articleCrossref MedlineGoogle Scholar

  • Iida O, Soga Y & Urasawa K, et al.; MDT-2113 SFA Japan Investigators. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan randomized trial J Endovasc Ther. 2018 Feb;25(1):109–117. First citation in articleMedlineGoogle Scholar

  • Bausback Y, Willfort-Ehringer A & Sievert H, et al.; RANGER SFA Investigators. Six-month results from the initial randomized study of the Ranger paclitaxel-coated balloon in the femoropopliteal segment J Endovasc Ther. 2017;24(4):459–467. First citation in articleCrossref MedlineGoogle Scholar

  • Thieme M, Von Bilderling P & Paetzel C, et al.; 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(16): 1682–1690. First citation in articleCrossref MedlineGoogle Scholar

  • Katsanos K, Spiliopoulos S & Kitrou P, et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7:e011245. DOI: 10.1161/JAHA.118.011245. First citation in articleCrossref MedlineGoogle Scholar

  • Katsanos K. Paclitaxel-coated balloons in the femoropopliteal artery: it is all about the pharmacokinetic profile and vessel tissue bioavailability. JACC Cardiovasc Interv. 2016;9(16):1743–1745. First citation in articleCrossref MedlineGoogle Scholar

  • Giacoppo D, Cassese S & Harada Y, et al. Drug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and meta-analysis of randomized clinical trials. JACC Cardiovasc Interv. 2016;9(16):1731–1742. First citation in articleCrossref MedlineGoogle Scholar

  • Gongora CA, Shibuya M & Wessler JD, et al. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv. 2015;8(8):1115–1123. First citation in articleCrossref MedlineGoogle Scholar

  • 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. First citation in articleCrossref MedlineGoogle Scholar

  • Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, … Zeller T. five-year follow-up data of the thunder trial: angioplasty of femoro-popliteal arteries with drug coated balloons JACC Cardiovasc Interv. 2015;8:102–108. First citation in articleCrossref MedlineGoogle Scholar

  • Laird JR, Schneider PA & Tepe G et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol 2015; 66:2329–2338. First citation in articleCrossref MedlineGoogle Scholar

  • Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, … Krishnan P; IN.PACT SFA Trial Investigators. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS. 117.005891. First citation in articleCrossref MedlineGoogle Scholar

  • Schneider PA. Drug-coated Balloons Show Superior Four-Year Outcomes versus Angioplasty: Results from the IN.PACT SFA Randomized Trial (Abstract). Vascular InterVentional Advances. Las Vegas, Nevada, 2017. First citation in articleGoogle Scholar

  • Laird JR. 5-Year Results From the IN.PACT SFA Randomized Trial (Abstract). Vascular InterVentional Advances. Las Vegas, NV, 2018. First citation in articleGoogle Scholar

  • Schuyler Jones W, Duke Heart Center, Durham, NC, USA. Use and Outcomes With Drug-Coated Balloons in Patients With Lower Extremity Peripheral Artery Disease. Presentation given at TransCatheterTherapeutics (TCT) 2018 San Diego, Saturday 22. September 2018. https://www.tctmd.com/slide/use-and-outcomes-drug-coated-balloons-patients-lower-extremity-peripheral-artery-disease First citation in articleGoogle Scholar

  • U. S. Food, Drug Administration. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/default.htm First citation in articleGoogle Scholar