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N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.

Collaborators (189)

Rosenfield K, Drachman D, Kwolek C, Ansel G, Botti C, George B, Silver M, Aronow H, Qureshi M, Bernardo N, Akbari C, Lager R, Burket M, Nahhas A, Chamberlin J, Grunenwald P, Johnson S, Davis T, Daher E, Dudar B, Mojares BJ, Dulas D, Akef A, Lee J, Foster M, Michelson B, Reed S, Towne R, Mehta R, Fry D, Scott E, Matsuura J, Bigelow B, Cooke J, Elsner G, Fouts A, Martinez B, Moen E, Natarajan K, Flanders V, Gammon R, Picone M, Selmon M, Zidar F, Gilbert J, Goldstein J, Goswami N, Rocha-Singh K, Nandish S, Gill JB, Kelly MP, Mishkel G, Matos G, Goodwin M, Ramanathan A, Gray B, Androes M, Carsten C, Cull DL, Hanover T, Langan E, Snyder B, Taylor S, York J, Schreiber T, Choksi N, Kassab E, Himmelstein S, Khuddus M, Caputo C, Lee A, Roy DV, Kovach R, George J, Luft U, Sanghvi K, Krishnan P, Dangas G, Wiley J, Krolick M, Cambier P, Klein J, Hagley M, Brachfeld C, Kumar A, Dattillo R, Lopez L, Lyden S, Bajzer C, Clair D, Mayeda G, Burstein S, Economides C, McKinsey J, Shrikhande G, Mena C, Remetz M, Hasan F, Metzger C, Saha PK, Sakhuja R, Kappa J, Parikh S, Cunningham M, Kashyap V, Pigott J, Comerota A, Russell T, Seiwert A, Whalen R, Razavi M, Ballard J, Dorne H, Harward T, Openshaw K, Tien S, Flanigan DP, Sachar R, Hook M, Schneider J, Saxon R, Gooding J, Ponec D, Laird J, Hunter M, Corl J, Reginelli J, Kong J, Sernyak A, Kernis S, Miller W, Staniloae C, Attubato M, Liou M, Feldman R, Von Mering G, Han RO, Santoian E, Wilkins R, Blair G, Theiling C, Levin T, Golzar J, Scheinert D, Bausback Y, Schmidt A, Werner M, Schröeder H, Duda S, Martorana M, Rüecker F, Zellar T, Beschorner U, Bürgelin KH, Goller S, Macharzina R, Noory E, Rastan A, Schwarzwälder U, Sixt S, Krankenberg H, Tübler T, Sixt S, Ricke J, Pech M, Peeters P, Verbist J, Bosiers M, Callaert J, Deloose K, Lammer J, Puchner S, Schoder M, Pilger E, Brodmann M, Dorr A, Brechtel K, Ketelsen D, Müller-Hülsbeck S, Preiss M, Preuss H, Montz T, Warnecke C, Weiss N, Hoffmann RT, Halbritter K, Werth S, Schmidt C, Mahlmann A.

Author information

1
From Massachusetts General Hospital, Boston (K.R., M.R.J.); Ochsner Medical Center, New Orleans (C.J.W.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.R.-S.); Yale School of Medicine, New Haven, CT (C.M.-H.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); Medical University of Graz, Graz, Austria (M.B., E.P.); University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (T.Z.), Diakonissenanstalt zu Flensburg, Flensburg (S.M.-H.), and Park-Krankenhaus Leipzig and Universitätsklinikum Leipzig, Leipzig (D.S.) - all in Germany; Mount Sinai Medical Center, New York (P.K.); Austin Heart, Austin, TX (R.G.); University of Colorado Medical Center, Denver (M.R.N.); and Baptist Cardiac and Vascular Institute, Miami (J.F.B.).

Abstract

BACKGROUND:

The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.

METHODS:

In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.

RESULTS:

The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention.

CONCLUSIONS:

Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

PMID:
26106946
DOI:
10.1056/NEJMoa1406235
[Indexed for MEDLINE]
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