Format

Send to

Choose Destination
N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

Collaborators (470)

Stone GW, Ellis SG, Kereiakes DJ, Autry G, Bandley A, Barnes J, Barry B, Berryman J, Bosworth-Farrell S, Boyd J, Cabe D, Cogollo O, Creech J, Davis B, Farrell C, Gashwiler V, Glass L, Gleason H, Glenn D, Guthrie BJ, Hart S, Haudek D, Heavner T, Key J, Khanum K, Kraft C, Lewis C, Lewis C, Mar N, Maxwell J, McGee C, Mitchell C, Moorhead M, Muncey MJ, Nix K, Ornelas L, Pickering B, Polito AM, Reaves S, Reyes A, Romcevich K, Sestrich T, Shouse J, Sloan P, Tafanelli S, Todd E, Van Houten N, Wagner M, Warren D, West T, White B, Wilson S, Yamamoto R, Yarbrough N, Dressler J, Su X, Marx S, Dogan O, Rosendorff C, Teirstein P, Lawrence J, Aragon J, Littlefield M, Del Vicario M, Jongsma E, Wyman R, Burkhardt J, Gordon J, Kohlmyer C, Shaikh S, Alford S, Tannenbaum M, French D, Lieppe W, Bailey-Ellis C, Bein M, Matar F, Lee C, Ziada K, Rodgers C, Fleischhauer FJ, Lehmann J, Taussig A, Mink K, Hillis S, Westerhausen D, Weil R, Mauri L, O'Neill K, Breall J, Foltz J, Carrozza J, Harmon K, Jacobs A, Fine D, Batchelor W, Knap P, Stein B, Cambier P, Boyd J, Swan K, Leesar M, Croom V, Moss D, Gershony G, Warburton C, Ellini K, Salazar S, Naidu S, Patel D, Bach M, Murphy L, Bortnick A, Srinivas V, Bastien G, Garratt K, Chu P, Braun D, Jauhar R, Hyland M, Gigliotti O, Janak L, Anthony S, Goldmeier M, Mechem C, Singh J, Marzluf K, Wiesehan H, Rade J, Agrillo A, Wang J, Raqueno J, Silverman P, Braun D, Samady H, Holloway B, Nandish S, Kavanagh A, Solankhi N, Copeland S, Villa A, Shah N, Wettermann E, Feldman R, Grubbs R, Williams J Jr, Richards P, Wilson B, Krueger S, Sanz M, Hoffman K, Boehm H, Burstein S, Mayoralgo C, Chang M, Hogan C, Pohwani A, Fisher J, Brill D, Richmond N, Aronow H, Wippler K, Kini A, Meelu O, Mejia V, Schreiber T, Alexander S, Stuver T, Noll P, Oak R, Abbas A, Richardson D, Paulowski J, Rambaud B, Temizer D, Krabbe C, Raymond R, Dolney D, Costa M, Kinder C, Pompili V, Mazanec L, Spaedy A, Melegrito K, Reddy M, Bradford L, Chrysant G, Fife B, Kaddissi G, Thron B, Applegate R, Young T, Zidar J, Neri-Mynatt G, Pierre-Louis J, Kong D, Hamill J, Gruberg L, Ramgadoo M, Ling F, Yeager C, Korngold E, Grant S, Dave R, Yost R, Skelding K, Kilbride S, Bachinsky W, Everhart J, Heyrich G, Campbell M, Shah A, Garrett J, Bersin RM, Lubatti S, Mulumudi M, Rocco D, Mahoney P, Rudloff C, McPherson J, Crook S, McCormick D, Hammond M, Allaqaband S, Lobacz D, Oxborough S, Negus B, Andrews P, Nielsen C, Carson L, Wilson S, Cavendish J, Fortuna R, Weaver S, Hall P, Sheriod-Scott J, Greenbaum A, Fox M, Sharaf B, DeSimone L, Yeung A, Perlas M, Donohue B, Malecky A, Travis M, Piegari G, Petersheim K, Purow J, Crowe K, Cohen M, Lang B, Garas S, Joseph L, Chang G, Divito P, Farah T, Carothers W, Ricciardi M, Jordan K, Pershad A, Russo E, Perin E, De Freitas G, Qureshi W, Ryan T, Burgess J, Nukta E, Bittel B, Makkar R, Domingo M, Broderick T, Sikora T, White D, Cleman M, Thomas L, Metzger D, Wilson S, Martinez-Arraras J, Mincher L, Toma C, Dennis L, Roberts D, Seiler B, Raybuck B, Yazdani S, Banks S, Ver Lee P, Balmas C, Dabbous S, Meharg L, Yamasaki H, Davis T, Jacobson T, Watson R, Nolte S, Jain A, Chang J, Yakubov S, Terry T, Quesada R, Cruz I, Litt M, Bell K, Kabour A, Hickam M, Lambert C Jr, Posey M, Shirley J, Tami L, Lee J, Gneiting A, Wong S, Marine M, Tadros G, Antolick A, Helmy T, Mardis R, Stys T, Reilly K, Mcellany S, Gaither N, Stanford J, Ball T, Wilson V, Bouchard A, Wade W, Cebe J, Mitchell L, Calhoun E, Patel A, Bain M, Martyak T, Rana Z, Buwe P, Shammas N, Weakley D, Dib N, Mutoff B, Sernyak A, Verma V, Ervin A, Laskowski N, Renaldo G, Norwood D, Hutchison G, Jorgensen J, Chandwaney R, Durham J, Cohen B, Lobur E, Bertolet B, Harlow L, Cannon L, LaLonde J, Caputo R, Rolfe M, Lorenz DP, Malak T, Studeny M, Marcum M, Hearne S, Daniels E, Kayner K, Agarwal A, Michel K, Kandzari D, Dixon M, Liu S, Bikkina M, Turnbull K, Jung S, Firsich N, Low R, Payne C, Walters G, Madell S, Edwards M, Jones M, Chapman J, Clayton K, Boettcher J, Petrella R, Henry P, Marshall J, Patrick D, Saltiel F, Fischell T, Schneider C, Newman W, Kessler H, DeGregorio J, Kelra N, Farhat N, Fritsch J, Tamboli H, Foster T, Ramanathan P, Barnhizer T, Ambrosia A, Schaffner T, Bhalla N, Burnett L, D'Haem C, Mitchell S, Merritt RF, Braekel P, Bass T, Green E, Petty J, Albirini A, Campbell T, Gordon P, Gordon C, Trotter J, Dickinson R, Carney R, Conaway A, Guidera S, Withers N, Israel C, Dicamillo P, Gory D, Hammerschmith R, McLaurin B, Bair S, Waksman R, Pokharel S, Burke M, Stone C, Kaplan A, Hart J, Feit F, Casaula D, Beglin P, Zimmermann T, Dauerman H, Straight F, Wiley M, Bush J, Nicholson W, Delio-Cox B, Mego D, Griffin B, Choi J, St John V, Moses J, Mattone A, Rizik D, Saczynski J, McGarry T, Hightower B, Hermiller J, Gall J, Netz D, Holcomb R, Brown D, McCracken J, Doing A, Robeson D, Whisenant B, Chisum B, Whitbourn R, Peeler C, Stewart P, Palethorpe L, Perez J, Foster M, Polk B, Haghighat A, Deenan L.

Author information

1
From Cleveland Clinic, Cleveland (S.G.E.), the Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati (D.J.K.), and Mercy St. Vincent's Medical Center, Toledo (A. Kini) - all in Ohio; Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.); St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.); Scottsdale Healthcare, Scottsdale, AZ (D.G.R.); Scripps Clinic, La Jolla (P.S.T.), and Abbott Vascular, Santa Clara (R.M., Z.Z., C.S.) - both in California; Baptist Medical Center, Jacksonville, FL (M.R.L.); Mount Sinai Medical Center (A. Kabour), Columbia University Medical Center (S.O.M., G.W.S.), and the Cardiovascular Research Foundation (G.W.S.) - all in New York; and the Beth Israel Deaconess Medical Center, Boston (J.J.P.).

Abstract

BACKGROUND:

In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.

METHODS:

In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.

RESULTS:

Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).

CONCLUSIONS:

In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).

PMID:
26457558
DOI:
10.1056/NEJMoa1509038
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center