Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency twelve-month results of the DEFINITIVE AR study

Circulation: Cardiovascular Interventions

Volumn 10, Issue 8, 2017, Pages

  Zeller, Thomas ^a   Langhoff, Ralf ^b   Rocha Singh, Krishna J ^c   Jaff, Michael R ^d   Blessing, Erwin ^e   Amann Vesti, Beatrice ^f   Krzanowski, Marek ^g   Peeters, Patrick ^h   Scheinert, Dierk ⁱ   Torsello, Giovanni ^j   Sixt, Sebastian ^k   Tepe, Gunnar ^l  

^a UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^b MARTIN LUTHER KRANKENHAUS   (Germany)

^c ST JOHN'S HOSPITAL   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e Klinikum Karlsbad Langensteinbach   (Germany)

^f UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^g Zaklad Leczniczy Angio Medicus   (Poland)

^h IMELDA HOSPITAL   (Belgium)

ⁱ UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^j UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^k BERN UNIVERSITY HOSPITAL   (Switzerland)

^l Klinikum Rosenheim   (Germany)

more..

Author keywords

Atherectomy; Directional atherectomy; Drug eluting balloon; Paclitaxel; Peripheral artery disease; Plaque modification

Indexed keywords

COTAVANCE (DRUG); PACLITAXEL; BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT;

ADULT; AGED; ANGIOGRAPHY; ARTERY; ARTERY CALCIFICATION; ARTERY DILATATION; ARTERY DISSECTION; ARTICLE; CONTROLLED STUDY; DIRECTIONAL ATHERECTOMY; DRUG-ELUTING BALLOON CATHETER; ECHOGRAPHY; FEMALE; FEMOROPOPLITEAL ARTERY; HUMAN; INTERMETHOD COMPARISON; LEG AMPUTATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; SILVERHAWK; STENT; TARGET LESION REVASCULARIZATION; TREATMENT OUTCOME; TURBOHAWK; ALL CAUSE MORTALITY; ARTERIOVENOUS FISTULA; ARTERY PERFORATION; BALLOON; BARE METAL STENTING; CHRONIC KIDNEY FAILURE; CLAUDICATION; COHORT ANALYSIS; DIABETES MELLITUS; DISEASE SEVERITY; EMBOLIC PROTECTION DEVICE; FALSE ANEURYSM; FOLLOW UP; OUTCOME ASSESSMENT; PACLITAXEL COATED BALLOON; PAIN; REST PAIN; ATHERECTOMY; BLOOD VESSEL CALCIFICATION; CLINICAL TRIAL; DEVICES; DIAGNOSTIC IMAGING; EQUIPMENT DESIGN; EUROPE; INTERMITTENT CLAUDICATION; MIDDLE AGED; MORTALITY; PATHOPHYSIOLOGY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PROSPECTIVE STUDY; RECURRENT DISEASE; RISK FACTOR; TIME FACTOR; VASCULAR ACCESS DEVICE; VASCULAR PATENCY;

AGED; ANGIOPLASTY, BALLOON; ATHERECTOMY; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; EQUIPMENT DESIGN; EUROPE; FEMALE; HUMANS; INTERMITTENT CLAUDICATION; MALE; MIDDLE AGED; PACLITAXEL; PERIPHERAL ARTERIAL DISEASE; PILOT PROJECTS; PROSPECTIVE STUDIES; RECURRENCE; RISK FACTORS; STENTS; TIME FACTORS; TREATMENT OUTCOME; VASCULAR ACCESS DEVICES; VASCULAR CALCIFICATION; VASCULAR PATENCY;

EID: 85030997904     PISSN: 19417640     EISSN: 19417632     Source Type: Journal    
DOI: 10.1161/CIRCINTERVENTIONS.116.004848     Document Type: Article

References (24)

1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013; 382:1329-1340. doi:10.1016/S0140-6736(13)61249-0.
2. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2017; 135:e686-e725. doi:10.1161/CIR.0000000000000470.
3. Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, Reekers J, Norgren L. 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): the TASC steering committee(.). Ann Vasc Dis. 2015; 8:343-357. doi:10.3400/avd.tasc.15-01000.
4. The SH, Gussenhoven EJ, Zhong Y, Li W, van Egmond F, Pieterman H, van Urk H, Gerritsen GP, Borst C, Wilson RA. Effect of balloon angioplasty on femoral artery evaluated with intravascular ultrasound imaging. Circulation. 1992; 86:483-493.
5. Ikeno F, Braden GA, Kaneda H, Hongo Y, Hinohara T, Yeung AC, Simpson JB, Kandzari DE. Mechanism of luminal gain with plaque excision in atherosclerotic coronary and peripheral arteries: assessment by histology and intravascular ultrasound. J Interv Cardiol. 2007; 20:107-113. doi:10.1111/j.1540-8183.2007.00244.x.
6. Scheinert D, Scheinert S, Sax J, Piorkowski C, Bräunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005; 45:312-315. doi:10.1016/j.jacc.2004.11.026.
7. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008; 358:689-699. doi:10.1056/NEJMoa0706356.
8. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008; 118:1358-1365. doi:10.1161/CIRCULATIONAHA.107.735985.
9. Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; 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. doi:10.1161/CIRCULATIONAHA.114.011004.
10. 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; 7:10-19. doi:10.1016/j.jcin.2013.05.022.
11. Micari A, Vadalà G, Castriota F, Liso A, Grattoni C, Russo P, Marchese A, Pantaleo P, Roscitano G, Cesana BM, Cremonesi A. 1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-Long study. JACC Cardiovasc Interv. 2016; 9:950-956. doi:10.1016/j.jcin.2016.02.014.
12. Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, d'Adamo A, Salvatori FM. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014; 37:898-907. doi:10.1007/s00270-014-0904-3.
13. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010; 3:267-276. doi:10.1161/CIRCINTERVENTIONS.109.903468.
14. Fanelli F, Cannavale A, Boatta E, Corona M, Lucatelli P, Wlderk A, Cirelli C, Salvatori FM. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial. J Endovasc Ther. 2012; 19:571-580. doi:10.1583/JEVT-12-3926MR.1.
15. McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014; 7:923-933. doi:10.1016/j.jcin.2014.05.006.
16. Sixt S, Carpio Cancino OG, Treszl A, Beschorner U, Macharzina R, Rastan A, Krankenberg H, Neumann FJ, Zeller T. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries. J Vasc Surg. 2013; 58:682-686. doi:10.1016/j.jvs.2013.02.019.
17. Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, Ambrosini V, Sorropago G, Tesorio T, Agresta A, Biamino G, Rubino P. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med. 2012; 13:219-223. doi:10.1016/j.carrev.2012.04.007.
18. Stavroulakis K, Bisdas T, Torsello G, Stachmann A, Schwindt A. Combined directional atherectomy andd-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease. J Endovasc Ther. 2015; 22:847-852. doi:10.1177/1526602815608194.
19. Stavroulakis K, Schwindt A, Torsello G, Stachmann A, Hericks C, Bosiers MJ, Beropoulis E, Stahlhoff S, Bisdas T. Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions. J Endovasc Ther. 2017; 24:181-188. doi:10.1177/1526602816683933.
20. Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, Ambrosini V, Sorropago G, Tesorio T, Agresta A, Biamino G, Rubino P. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med. 2012; 13:219-223. doi:10.1016/j.carrev.2012.04.007.
21. ++ trial. Catheter Cardiovasc Interv. 2014; 84:236-244. doi:10.1002/ccd.25384.
22. Panaich SS, Arora S, Patel N, Patel NJ, Patel SV, Savani C, Singh V, Jhamnani S, Sonani R, Lahewala S, Thakkar B, Patel A, Dave A, Shah H, Bhatt P, Jaiswal R, Ghatak A, Gupta V, Deshmukh A, Kondur A, Schreiber T, Grines C, Badheka AO. In-hospital outcomes of atherectomy during endovascular lower extremity revascularization. Am J Cardiol. 2016; 117:676-684. doi:10.1016/j.amjcard.2015.11.025.
23. Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. Economic analysis of endovascular interventions for femoropopliteal arterial disease: a systematic review and budget impact model for the United States and Germany. Catheter Cardiovasc Interv. 2014; 84:546-554. doi:10.1002/ccd.25536.
24. Katsanos K, Geisler BP, Garner AM, Zayed H, Cleveland T, Pietzsch JB. Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK. BMJ Open. 2016; 6:e011245. doi:10.1136/bmjopen-2016-011245.