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: Cardiovascular Interventions

Volumn 11, Issue 10, 2018, Pages 945-953

  Micari, Antonio ^a,i   Brodmann, Marianne ^b,i   Keirse, Koen ^c,i   Peeters, Patrick ^d,i   Tepe, Gunnar ^e,i   Frost, Martin ^f   Wang, Hong ^g   Zeller, Thomas ^h,i   Torsello, Giovanni ⁱ   Scheinert, Dierk ⁱ   Bosiers, Marc ⁱ   Maene, Lieven ⁱ   Do, Dai Do ⁱ   Hendriks, Jeroen ⁱ   Merkely, Bela ⁱ   Lardenoije, Jan Willem ⁱ   Ruzsa, Zoltan ⁱ   Vogel, Britta ⁱ   Veroux, Pierfrancesco ⁱ   Albuquerque e Castro, Joao ⁱ   Periard, Daniel ⁱ   Ludyga, Tomasz ⁱ   Midy, Dominique ⁱ   Choi, Donghoon ⁱ   Lansink, Wouter ⁱ   Ketelsen, Dominik ⁱ   Dubenec, Steven ⁱ   Banyai, Martin ⁱ   Chakfe, Nabil ⁱ   Roithinger, Franz Xaver ⁱ   Trani, Carlo ⁱ   Mansour, Hossam ⁱ   Rha, Seung Woon ⁱ   Vermassen, Frank ⁱ   Belenky, Alexander ⁱ   Spak, Lubomir ⁱ   Chalmers, Nicholas ⁱ   Benko, Andrew ⁱ   Kum, Steven ⁱ   Won, Je Hwan ⁱ   Vozar, Matej ⁱ   Tan, Kong Teng ⁱ   Labib, Mamdouh ⁱ   de Borst, Gert Jan ⁱ   Do, Young Soo ⁱ   Teijink, Joep ⁱ   Gomez, Juan Fernando ⁱ   Falkowski, Aleksander ⁱ   Ferreira, Luis ⁱ   Matela, Jozef ⁱ   Lee, Seung Whan ⁱ   Verhoeven, Bart ⁱ   Mannheim, Dalit ⁱ   Nessi, Franco ⁱ   Vulev, Ivan ⁱ   de Vries, Jean Paul ⁱ   Maly, Radovan ⁱ   Kavteladze, Zaza ⁱ   Turner, Douglas ⁱ   Mendiz, Oscar ⁱ   Kolvenbach, Ralf ⁱ   Karnabatidis, Dimitrios ⁱ   Cuellar, Cesar ⁱ   Venermo, Maarit ⁱ   Velicka, Linas ⁱ   Lundberg, Goran ⁱ   more..

^a MARIA CECILIA HOSPITAL   (Italy)

^b MEDICAL UNIVERSITY OF GRAZ   (Austria)

^c Regionaal Ziekenhuis Heilig Hart Tienen   (Belgium)

^d IMELDA HOSPITAL   (Belgium)

^e Department of Internal Medicine III   (Germany)

^f MEDTRONIC BAKKEN RESEARCH CENTER   (Netherlands)

^g MEDTRONIC INC   (United States)

^h UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

ⁱ NONE

Author keywords

angioplasty; drug coated balloon; femoropopliteal artery; peripheral artery disease; target lesion revascularization

Indexed keywords

PACLITAXEL; BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT;

AGED; ALL CAUSE MORTALITY; ARTICLE; CONTROLLED STUDY; DEVICE SAFETY; FEMALE; HUMAN; IN-STENT RESTENOSIS; INTERMITTENT CLAUDICATION; ISCHEMIC REST PAIN; LIMB AMPUTATION; MAJOR CLINICAL STUDY; MALE; MORTALITY RATE; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TARGET LESION REVASCULARIZATION; THERAPY EFFECT; ADVERSE EVENT; CLINICAL TRIAL; DEVICES; DIAGNOSTIC IMAGING; FEMORAL ARTERY; ISCHEMIA; MIDDLE AGED; MULTICENTER STUDY; PATHOPHYSIOLOGY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; POPLITEAL ARTERY; PROSPECTIVE STUDY; RECURRENT DISEASE; STENOSIS, OCCLUSION AND OBSTRUCTION; TIME FACTOR; TREATMENT OUTCOME; VASCULAR ACCESS DEVICE; VASCULAR PATENCY;

AGED; ANGIOPLASTY, BALLOON; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; CONSTRICTION, PATHOLOGIC; FEMALE; FEMORAL ARTERY; HUMANS; INTERMITTENT CLAUDICATION; ISCHEMIA; MALE; MIDDLE AGED; PACLITAXEL; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; PROSPECTIVE STUDIES; RECURRENCE; TIME FACTORS; TREATMENT OUTCOME; VASCULAR ACCESS DEVICES; VASCULAR PATENCY;

EID: 85047210845     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2018.02.019     Document Type: Article

References (25)

1. Speck, U., Cremers, B., Kelsch, B., et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel?. Circ Cardiovasc Interv 5 (2012), 392–400.
2. Peterson, S., Hasenbank, M., Silvestro, C., Raina, S., IN.PACT™ Admiral™ drug-coated balloon: durable, consistent and safe treatment for femoropopliteal peripheral artery disease. Adv Drug Deliv Rev 112 (2017), 69–77.
3. ® drug-coated balloon: a novel drug delivery technology for the treatment of vascular disease. Adv Drug Deliv Rev 112 (2017), 78–87.
4. Bausback, Y., Willfort-Ehringer, A., Sievert, H., et al. Six-month results from the initial randomized study of the Ranger paclitaxel-coated balloon in the femoropopliteal segment. J Endovasc Ther 24 (2017), 459–467.
5. Micari, A., Cioppa, A., Vadala, G., et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. J Am Coll Cardiol Intv 5 (2012), 331–338.
6. Micari, A., Cioppa, A., Vadala, G., et al. 2-Year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry. J Am Coll Cardiol Intv 6 (2013), 282–289.
7. Scheinert, D., Duda, S., Zeller, T., et al. 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. J Am Coll Cardiol Intv 7 (2014), 10–19.
8. Schroeder, H., Meyer, D.R., 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 86 (2015), 278–286.
9. Stabile, E., Magliulo, F., Zhelev, D., et al. Interim analysis at 6 months from the LEG-Flow Drug Eluting Balloon for the Treatment of Femoropopliteal Occlusions (LEG-DEB) registry. Int J Cardiol 223 (2016), 654–655.
10. Krishnan, P., Faries, P., Niazi, K., et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: 12-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation 19 (2017), 1102–1113.
11. Laird, J.R., Schneider, P.A., 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 66 (2015), 2329–2338.
12. Rosenfield, K., Jaff, M.R., White, C.J., et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 373 (2015), 145–153.
13. Scheinert, D., Schulte, K.L., 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 22 (2015), 14–21.
14. Schroeder, H., Werner, M., Meyer, D.R., et al. 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 135 (2017), 2227–2236.
15. 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 131 (2015), 495–502.
16. 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. J Am Coll Cardiol Intv 8 (2015), 102–108.
17. Jang, S.J., Hsieh, C.A., Huang, H.L., et al. Feasibility and clinical outcomes of peripheral drug-coated balloon in high-risk patients with femoropopliteal disease. PLoS One, 10, 2015, e0143658.
18. Micari, A., Nerla, R., Vadala, G., et al. 2-Year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-Long study. J Am Coll Cardiol Intv 10 (2017), 728–734.
19. Micari, A., Vadala, G., Castriota, F., et al. 1-Year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-Long study. J Am Coll Cardiol Intv 9 (2016), 950–956.
20. Thieme, M., Von Bilderling, P., Paetzel, C., et al. The 24-month results of the Lutonix Global SFA Registry: worldwide experience with Lutonix drug-coated balloon. J Am Coll Cardiol Intv 10 (2017), 1682–1690.
21. Werk, M., Langner, S., Reinkensmeier, B., et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 118 (2008), 1358–1365.
22. Jaff MR. Drug-coated balloon treatment for patients with intermittent claudication: insights from the IN.PACT Global full clinical cohort. Paper presented at: VIVA 16, the 14th Annual Vascular InterVentional Advances Meeting; September 18–22, 2016; Las Vegas, Nevada.
23. Chan, Y.C., Cheng, S.W., Cheung, G.C., Predictors of restenosis in the use of helical interwoven nitinol stents to treat femoropopliteal occlusive disease. J Vasc Surg 62 (2015), 1201–1209.
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 78 (2011), 611–617.
25. Krankenberg, H., Tubler, T., Sixt, S., et al. German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization. J Endovasc Ther 21 (2014), 463–471.