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

Journal of Endovascular Therapy

Volumn 25, Issue 1, 2018, Pages 109-117

  Iida, Osamu ^a   Soga, Yoshimitsu ^b   Urasawa, Kazushi ^c   Saito, Shigeru ^d   Jaff, Michael R ^e   Wang, Hong ^f   Ookubo, Hiroko ^g   Yokoi, Hiroyoshi ^h  

^a KANSAI ROSAI HOSPITAL   (Japan)

^b KOKURA MEMORIAL HOSPITAL   (Japan)

^c Tokeidai Memorial Hospital   (Japan)

^d SHONAN KAMAKURA GENERAL HOSPITAL   (Japan)

^e HARVARD MEDICAL SCHOOL   (United States)

^f MEDTRONIC INC   (United States)

^g Medtronic   (Japan)

^h FUKUOKA SANNO HOSPITAL   (Japan)

Author keywords

angioplasty; claudication; drug coated balloon; femoropopliteal segment; paclitaxel; peripheral artery disease; popliteal artery; randomized controlled trial; superficial femoral artery

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; PACLITAXEL; BIOCOMPATIBLE COATED MATERIAL;

ADULT; ARTICLE; ATHEROSCLEROSIS; BLOOD CLOTTING TIME; CLAUDICATION; CONTROLLED STUDY; DIABETES MELLITUS; ECHOGRAPHY; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; PEAK SYSTOLIC VELOCITY; PHASE 3 CLINICAL TRIAL; POPLITEAL ARTERY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SIX MINUTE WALK TEST; TARGET LESION REVASCULARIZATION; THROMBOSIS; ADVERSE EVENT; AGED; ATHEROSCLEROTIC PLAQUE; CLINICAL TRIAL; COMPARATIVE STUDY; DEVICES; DIAGNOSTIC IMAGING; EQUIPMENT DESIGN; FEMALE; FEMORAL ARTERY; JAPAN; MULTICENTER STUDY; PATHOPHYSIOLOGY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; RECURRENT DISEASE; RISK FACTOR; TIME FACTOR; VASCULAR ACCESS DEVICE; VASCULAR PATENCY; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANGIOPLASTY, BALLOON; COATED MATERIALS, BIOCOMPATIBLE; EQUIPMENT DESIGN; FEMALE; FEMORAL ARTERY; HUMANS; JAPAN; MALE; PERIPHERAL ARTERIAL DISEASE; PLAQUE, ATHEROSCLEROTIC; POPLITEAL ARTERY; PROGRESSION-FREE SURVIVAL; PROSPECTIVE STUDIES; RECURRENCE; RISK FACTORS; SINGLE-BLIND METHOD; TIME FACTORS; VASCULAR ACCESS DEVICES; VASCULAR PATENCY;

EID: 85040734515     PISSN: 15266028     EISSN: 15451550     Source Type: Journal    
DOI: 10.1177/1526602817745565     Document Type: Article

References (28)

1. Schillinger M, Sabeti S, Loewe C. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888.
2. Dick P, Wallner H, Sabeti S. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090–1095.
3. Laird JR, Katzen BT, Scheinert D. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1–9.
4. Dake MD, Ansel GM, Jaff MR. 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.
5. Yokoi H, Ohki T, Kichikawa K. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results. JACC Cardiovasc Interv. 2016;9:271–277.
6. Soga Y, Iida O, Hirano K. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52:608–615.
7. Rocha-Singh KJ, Bosiers M, Schultz G, for the DURABILITY II Investigators. A single stent strategy in patients with lifestyle limiting claudication: 3-year results from the DURABILITY II trial. Catheter Cardiovasc Interv. 2015;86:164–170.
8. Scheinert D, Scheinert S, Sax J. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–315.
9. Schlager O, Dick P, Sabeti S. Long-segment SFA stenting–the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–684.
10. Laird JR, Yeo KK., The treatment of femoropopliteal in-stent restenosis: back to the future. J Am Coll Cardiol. 2012;59:24–25.
11. Tepe G, Laird J, Schneider P,; 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;131:495–502.
12. Scheinert D, Duda S, Zeller T. 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;7:10–19.
13. Rosenfield K, Jaff MR, White CJ,; LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:145–153.
14. Scheinert D, Schulte KL, Zeller T. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015;22:14–21.
15. Krishnan P, Faries P, Niazi K. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136: 1102–1113.
16. Schroeder H, Werner M, Meyer DR,; 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;135:2227–2236.
17. TASC Steering Committee, Jaff MR, White CJ. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015;22:663–677.
18. Tepe G, Zeller T, Albrecht T. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–699.
19. Werk M, Langner S, Reinkensmeier B. Inhibition of restenosis in femoropopliteal arteries: Paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358–1365.
20. Werk M, Albrecht T, Meyer DR. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5:831–840.
21. Laird JR, Schneider PA, Tepe G,; IN.PACT SFA Investigators. 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.
22. Hobbs SD, Wilmink AB, Bradbury AW., Ethnicity and peripheral arterial disease. Eur J Vasc Endovasc Surg. 2003;25:505–512.
23. Bennett PC, Silverman S, Gill PS. Ethnicity and peripheral artery disease. QJM. 2009;102:3–16.
24. Ohki T, Yokoi H, Kichikawa K. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014;21:644–653.
25. Schlager O, Francesconi M, Haumer M. Duplex sonography versus angiography for assessment of femoropopliteal arterial disease in a “real-world” setting. J Endovasc Ther. 2007;14:452–459.
26. Chetter IC, Spark JI, Dolan P. Quality of life analysis in patients with lower limb ischaemia: suggestions for European standardisation. Eur J Vasc Endovasc Surg. 1997;13:597–604.
27. McDermott MM, Ades PA, Dyer A. Corridor-based functional performance measures correlate better with physical activity during daily life than treadmill measures in persons with peripheral arterial disease. J Vasc Surg. 2008;48:1231–1237.
28. Regensteiner JG, Panzer RJ, Hiatt WR., Evaluation of walking impairment by questionnaire in patients with peripheral arterial disease. J Vasc Med Biol. 1990;2:142–152.