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J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

Collaborators (266)

Farah B, Petit F, Dubois C, van Oosterwijck G, Feldman R, McIntyre D, Dens J, Swijsen C, Bouchard A, Wade W, Carrié D, Cahuzac J, Moellmann H, Kisselbach C, Oldroyd K, Kelly J, Hall J, Burkert M, Stoler R, Kang L, Hagiwara N, Naganuma M, Rabinowitz A, Meier S, Kabour A, Hickam M, Pompili V, Mazanec L, Stuckey T, Ricks D, Curzen N, Nicholas Z, Mishkel G, Jones J, Swinford R, Erglis A, Grave A, Saito S, Kobayashi I, Levy G, Leperchois C, Schiele F, Sergent G, Downes T, Kaczkowski S, Kereiakes D, McGary E, Mann T, Mulkey S, Buchbinder M, Nielsen H, Asano R, Tajima T, Foster M, Sheriod-Scott J, Dudek D, Kolny E, Lui H, Gibbons P, Vermeersch P, Aerts N, Whitbourn R, Gough J, Wilson J, Mooney M, MacDonald H, Taussig A, Barnes D, Dorogy M, Knott C, Niemelä M, Niemelae E, Teirstein P, Fanning D, Moebius-Winkler S, Doehnert C, Bauer H, Palazzo D, Ring M, Fulton S, Kubica J, Cannon L, LaLonde J, Grady T, Kaliebe J, Lee T, Marsh J, Koolen J, van Leur L, Radcliffe J, Banning A, Moreby B, Kimmelstiel C, Castaneda V, Richardt G, Schuermann-Kuchenbrandt D, Kellett M, Berg C, Burchenal J, Batchelor W, Knap P, Bertolet B, Tutor T, Soltau M, Desai A, Braam L, Airaksinen J, Vasankari T, Igarashi K, Oshima Y, Breall J, Foltz J, Muramatsu T, Kanbe Y, Yajima J, Matsuda K, Gammon R, Robison M, Hovasse T, Baudry M, Perin E, DeFreitas G, Low R, Carlson J, Jaffe W, Lindesay MA, Summerscales I, Huber P, Ciccarello J, De Belder M, Smith G, Yokoi H, Inoue K, Kozina J, Hogan C, Reczuch K, Meredith I, Baldi M, Plunkett J, McGarry T, Hanes S, Kelbaek H, Kloevgaard L, Suttorp M, Maarten C, Taeymans Y, Verdegem P, Laule M, Kuhn C, Turco M, Pond D, Ghali M, Barnes H, Martin S, Godfrey C, Caulfield T, Muir E, Nakamura M, Mori Y, Kutcher M, Young T, Neunteufl T, Vertesich M, Mego D, Thomas M, Witkowski A, Sim KH, Dudu DD, Thuesen L, Joergensen L, Vos J, de Craen-de Moor M, Moses J, Kim J, O'Shaughnessy C, Walton A, Sandhu G, Herrmann R, Fujii K, Uehara M, Zajarias A, Myers M, Harding S, Middleditch D, Loli A, Mangum H, Gips S, Markiewicz N, Dobies D, Watt S, Burstein S, Mayoralgo C, Thomas M, Wilson K, Gilchrist I, Frey P, Barth C 3rd, Rutherford C, Mahoney P, Bullivant M, Walters D, Clement L, Wolford D, Temizer D, Kathman D, Nygaard T, Harris W, White J, Janzer S, Pensyl C, de Swart J, van der Meij Y, Wong A, Law DY, Dave R, McMullen S, Mahmud E, Judd C, Schweiger M, Fleurent J, Wiemer M, Pape C, Niederman A, Vujanic S, Zambahari R, Safarinaz SI, Xenopoulos N, McDonald N, Masud AR, Giambra T, Frankel R, Kini A, Fusilero M, McKenzie C, Higano S, Castner C, Yakubov S, Terry T, Rankin J, Venn-Edmonds C, Deibele A, Leone C, Isshiki T, Misawa K, Wang J, Raqueno J, Niemelä K, Nappila H, Rottbauer W, Selter C, Darremont O, Reuter L, Teles R, Simao P, Scott D, Caveney D, Manoharan G, Smith B, Wohns D, Holens J, Shlofmitz R, Haag E, Tolleson T, Rasor C, Dixon S, Richardson D.

Author information

  • 1Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, 111 East 59th Street, New York, NY 10022, USA. gs2184@columbia.edu

Abstract

OBJECTIVES:

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).

BACKGROUND:

Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.

METHODS:

A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.

RESULTS:

The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).

CONCLUSIONS:

In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.

Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PMID:
21470815
[PubMed - indexed for MEDLINE]
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