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N Engl J Med. 2009 May 21;360(21):2176-90. doi: 10.1056/NEJMoa0901316. Epub 2009 Mar 30.

Early versus delayed, provisional eptifibatide in acute coronary syndromes.

Collaborators (1063)

Braunwald E, Giugliano RP, Califf RM, Harrington RA, Newby LK, White JA, Van de Werf F, Armstrong PW, Montalescot G, Veltri E, Hildemann S, Strony JT, Kilian A, Yang B, Gilbert J, Huber K, Aylward P, Labinaz M, Langer A, Tanguay JF, Widimsky P, Grande P, Lindroos M, Steg PG, Bode C, Zeymer U, Keltai M, Prabhakaran D, Lewis BS, Ardissino D, Van 't Hof A, White H, Atar D, Ruzyllo W, da Silva PC, Sulimov V, Dalby A, Betriu A, Mach F, James S, Fox K, Karsch K, Brogan G, Ferguson J, Gibler B, Herrmann H, Hochman J, Hoekstra J, Kleiman N, Ohman EM, O'Neill W, Pollack C Jr, Schweiger M, Newby LK, Harrington RA, Tricoci P, Berdan L, White J, Lee K, Leimberger J, Roe M, Montgomery D, Alexander J, Brennan M, Bushnell C, Chan M, Lopes R, Laskowitz D, Mahaffey K, Mehta R, Melloni C, Mills J, Oliveira G, Patel M, Petersen J, Piccini J, Shah B, Tricoci P, Wang T, Williams K, Wiviott S, Campbell C, Heath A, Weaver D, Alpert J, Cohen E, Faxon D, Fisher L, Verheugt F, Kunadian V, Zorkun C, Williams S, Biller L, Palmer A, Ogando K, Blank B, Newby K, Druken B, Malik A, Williams S, Cohen Y, Perez K, Kumar A, Thomas R, Singh V, Nelson M, Vora K, Vanover M, Metzger DC, Bessinger M, Chang M, Kiech J, Lui H, Holman L, Nygaard T, White J, Sharma M, Gibson T, Krucoff M, Powell M, Surmitis J, Gumm D, Godby D, Caulfield T, Dixon M, Mckendall G, Grogan M, Hodson R, Vassilaros A, Treasure C 2nd, Bales C, Mayer N, Stevens P, D'Urso M, DeRaad R, Khadra S, Peacock G, Nadar V, Darrow K, Chandler AB Jr, Easler P, Puri S, Lopez C, Coram R, Van Hoose B, Chandna H, Holly D, Mody F, Dranovskiy V, Chandrasekaran S, Kemp A, Martin T, Wells A, Miller G, Holt M, Brilakis E, Rangan B, Eaton G, Looney A, Hassinger N, Leone C, Singer A, Kidd J, Rivera E, Sutton M, Drenning D, Cooley T, Tolleson T, Rasor C, Harjai K, Hoey K, Jezior M, Young C, Lu D, Cieszkowski J, Tessmar C, Hindupur M, Eckert F, Bethea C, Fife B, Bissett J, Locke S, Kamalash M, Carlson K, Chandrashekhar Y, Tetrick L, Coram R, Schaffer L, D'Haem C, Zambon T, Forrest T, Barker B, Adjei A, Pulliam K, Gogia H, Kori S, Rivera E, Goad R, Khoury S, Edwards J, Dave R, McMullen S, Bhagwat R, DeLeon M, Arora U, Bolton J, Raisinghani A, Ghannadian B, Zenni M 2nd, Guimaraes K, Cebe J, Harrelson S, Chandna H, Holly D, De Lemos J, Pinkston K, Gory D, Butler D, Arnold A, Kappel D, Palazzo A, Tormey D, Perlman R, Palazzo D, Mayer T, Genova E, Sacchi T, Hammad E, Acheatel R, Biggers J, Fortuin D, Pfrommer J, Kelley M, Fettis C, Minor S, Shipwash T, Tucker K, Harp L, Wheeler K, Nieder S, Broderick G, Mohr R, Niederman A, Kellerman T, Muhlestein B, Briggs B, Birnbaum Y, Allen J, De Gregorio M, Baird C, Garg M, Ferguson M, Bryant F, Unks DM, Blakely J, Wassmer P, Duff R, Miller C, Triplett L, Lohrbauer LA, Bloom K, Gogia H, Kori S, Turk S, Fick S, Schreiter S, Mrozinski D, Omar B, Revere C, Strunk B, Watanabe D, French W, Barillas O, Shirwany A, Douglas L, Dimenna J, Waitkus C, Paulowski J, Amos M, Aji J, Ryan J, Loussararian A, Andreas G, Marsh R, Coombs A, Finney J, Duerr D, Patel D, Bolton J, Bikkina M, Turnbull K, Albirini A, Campbell T, Insel J, Johns M, Masroor M, Meadows C, Margolis J, Suarez H, Liu M, Khan W, Bittman M, Finney J, Saczynski J, Mego D, Thomas M, Jones J, Malone E, Le S, Fettis C, Alexander J, Genova E, Perez J, Addington J, Raveendran G, Engelbrecht R, Singh S, Sesing J, Casino WP, Ernest J, Zughaib M, Telck K, Bissett J, Kidd K, Levy P, Mango LM, McPherson J, Palevo G, Belknap M, Halbe S, Jafar Z, O'Brien P, Khoury S, Werner C, Shah R, Doman A, Bashir R, George C, Buchanan W, Bobek MB, Lieberman C, Williams M, Kontos M, Roach L, Williams G, McGuire J, Zhao D, Myers D, Tolerico P, Delio-Cox B, Levin H, Carle C, Mayor M, Humphreys R, Hotchkiss D, Farley A, Yasin M, Ahmad W, Lakkis N, Bobek J, Lee D, Grape J, Tolleson T, Rasor C, Mulumudi M, Covey M, Leimgruber P, Llewellyn C, Meengs M, Thomas K, Makam S, Smyth C, Chu A, Poremski K, Fintel D, Karpf E, Agarwal J, Manda S, Bhakta D, Abell T, Trageser T, Nahhas A, Winston N, Nahhas A, Winston N, Kesselbrenner M, Sayles K, Bethala V, Perkins T, Hui P, Bernier E, Levine M, Swanson MA, Saltiel F, Fanning G, Khosla S, Pivonka R, LaLonde T, Teller S, Goyal A, Spalding T, Masud AR, Giambra T, Correa L, Suarez H, Buergler J, Garcia M, Lancaster L, Johnston K, Saucedo J, Beard D, Lachterman B, Parks K, Ayres M, Rhule V, Dunne R, Mango LM, Shamoon F, Monel R, Sharma T, Paletta L, Lee B, Lavoie J, Bamdad P, Recker M, Karas S, Howard M, Panayiotou H, Sullivan P, Saha P, Bembridge D, Matheney R, Anthony M, Amidon T, Morris M, Andrea B, Schmida LS, Lurie M, Best K, McNabb L, Wilson D, Thai H, McArthur A, Sandhu L, Leone ML, Foster G, DeFehr S, Sun EL, Bornheimer J, Cohen J, Egbujiobi L, Betz D, Chilakamarri V, Schrader C, Berg W, Lawson K, Latief A, McGrew F, Rye D, Atassi K, Christy L, Karve M, Habetler T, Saltiel F, Fanning G, Nanna M, Diaz-Oliver L, Shapiro T, Sher L, Martin J, Pensyl C, Staniloae C, Hermance E, Cassavar D, Hoagland B, Kabour A, Neidhardt J, Takakuwa K, Grabin J, Humayun N, Appleton D, Shah P, Connors A, Kosinski E, Capasso M, Garratt K, Dalangin I, Suresh D, Pooja B, Chadow H, Hauptman R, Phillips W, Bilodeau T, Meyer T, Knott C, Browne K Jr, Matheny P, Klancke K, Bayer M, Stuckey T, Milks S, Grossman W, Pelchy P, Nelson C, Janet B, Parrott C, Cheryl F, Seaworth J, Primack D, Weaver T, Nyitray W, Antonescu A, Nyitray W, Antonescu A, Carr K, Peek M, Phillips P, Gray N, Patel J, Newell N, Acheatel R, Biggers J, Shammas N, Stoakes P, Dadkhah S, Fisch A, Friedman B, Bernhardt-Wimoski S, Hoff J, Stiles R, Tannenbaum M, Porter R, Tekler L, Stenstrom S, Chamernick C, Fry ET, Burkert M, Farah T, Harter C, Menapace F, Kleman M, Ledley G, Tobias SL, Hudock D, Suresh D, Pooja B, Perlman R, Palazzo D, Saint-Jacques H, Rivera J, Shani J, Gill A, Litt M, Tripp G, Rama P, DePauw J, Niederman A, Kellerman T, Phillips JW 3rd, Griswold M, Bode C, Schwab T, Darius H, Kuckuck A, Schunkert H, Lindemann C, Gottwik M, Zahn R, Werner G, Ferrar M, Zeymer U, Koet O, Strasser RH, Hofmann S, Felix SB, Mieske K, Heitzer T, Baldus S, Nienaber CA, Heider D, Brachmann J, Hoehn A, Klauss V, Baylacher M, Mudra H, Arnold M, Gross M, Gailani M, Willenbrock R, Desaga M, Desaga U, Jung W, Rillig A, Wiemer M, Wellmann B, Haase KK, Weller F, Schieffer B, Ritter B, Katus H, Giannitsis E, Kreuzer J, Nitsche K, Lewalter T, Remerie S, Appel K, Fugmann S, Hossmann V, Horlitz M, Hanefeld C, Khandanpour J, Buerke M, Koenig M, Hauptmann K, Gehrig T, Kasiske HP, Eggenkaemper M, vom Dahl J, Krug-Hoeren B, Lengfelder W, Duerrwald S, Schulze M, Gall K, Neuzner J, Schoebel WA, Simon R, Lins M, Kadel C, Rahn G, Hamann F, Pieper M, Schuster P, Hobbach H, Horacek T, Guenesli A, Lewis B, Yuval R, Uziel-Iunger K, Kracoff O, Roth A, Bogomonali N, Nikolsky E, Ben Zvi M, Rozenman Y, Logvinenko S, Guetta V, Rosenschein U, Harel S, Marmor A, Klutstein M, Rojanski A, Lotan H, Kreisberg B, Zahger D, Grosbard A, Senaratne M, Chanin S, Lutchmedial S, Fitzgerald F, Kornder J, Elliott H, Tanguay J, Caron M, Tymchak W, Harris L, Mukherjee A, Bozek B, Rupka D, Marchand C, Brossoit R, Peck C, Labinaz M, Shore N, Gosselin G, David M, Bata I, Hulan M, Wells C, Childs C, Habot J, McPherson C, Hilton D, Keith-Burgwin J, Pearce M, Janzen I, Van Kieu C, Carignan D, Kouz S, Roy M, Muzyka T, Prosser A, Turek M, Finnigan J, Doucet M, LaRiviere S, Vizel S, Markov G, Rose B, Rideout A, Aymong E, Grieve E, MacFadyen J, Naughton S, Clarke A, Marshall J, De Larochelliere R, Fournier R, Ervin F, Thiessen S, Huynh T, Boudreault C, Laramee P, Therrien D, Kokis A, Gagne G, Hatheway R, Wheatley M, Huber K, Jordanova N, Frank H, Thudt K, Marosi L, Brunner T, Pichler M, Kopp K, Slany J, Steger C, Stockenhuber F, Zenker G, Kaspar K, Brussee H, Zweiker R, Stark G, Meister E, Rainer W, Bernt H, Leisch F, Kammler J, Kypta A, Lenzhofer R, Wimmer F, Weihs W, Geyer G, Steg PG, Feldman L, Montalescot G, Collet J, Beygui F, Coisne D, Berger N, Ferrari E, Lanfranchi P, Khalife K, Ben Ahmed F, Beaufils P, Henry P, Bassand J, Schiele F, Allouch P, sur Seine N, Baron O, Gully C, Zupan M, Bronner F, Halaby AA, Alsagheer S, Dambrine P, Delarche N, Lasserre R, Bonnet P, Cheradame I, Barreau D, Dupont M, Boueri ZM, Bretelle C, Cabrol P, Poulard JE, Livarek D, Schwob J, Traisnel G, El Jarroudi M, Berland J, Kerkeni M, Puel J, Elbaz M, Haridas KK, Kumar S, Rao MB, Hiremath MS, Sinha N, Srivastav A, Kaul U, Gupta R, Mohanan PP, Preetha M, Parikh K, Shah H, Panwar RB, Chauhan BS, Chandra P, Saxena R, Kler TS, Basumatry S, Gil R, Gziut A, Ruzyllo W, Deptuch T, Kubik L, Tkaczewski K, Dubiel J, Mielecki W, Przewlocki T, Zalewski J, Ponikowski P, Powierza S, Musial W, Kuklinska A, Kleinrok A, Dudek J, Goch J, Kawinski J, Trusz-Gluza J, Wita K, Van 't Hof A, Koolen JJ, ten Berg JM, Stella PR, Dunselman PH, Van Boven A, Branny M, Sknouril L, Maly M, Alan D, Bocek P, Tauchman A, Stipal R, Pleva L, Groch L, Hormacek I, Kala P, Poloczek M, Coufal Z, Naplava R, Richter M, Ostransky J, Dvorak J, Jirmar R, Novobilsky K, Linhart A, Belohlavek J, Janek B, Burova N, Belekhov G, Gordeev I, Luchinkina E, Svistov A, Ryzhman N, Markov V, Repin A, Klein G, Kupriyanov A, Vishnevsky A, Kosicin D, Petrov A, Gusarova O, Rudnev D, Bykova N, Ardashev A, Shavarov A, Duda A, Kalugina O, Barbarash O, Berns S, Arutyunov G, Rozanov A, Kosmacheva E, Kruberg L, Boldueva S, Arkharov I, Kostenko V, Sapozhnikova I, Fomin I, Badin Y, Pershukov I, Moreva E, Shcherbak A, Voronina U, Baum S, Andryushina N, Chernyavsky A, Vereshchagin M, Ardissino D, Rolli A, Binetti G, De Ferrari G, Panigada S, Mos L, Vriz O, Moretti L, Zur G, Giagu P, Orlandi M, Tamburino C, Marenzi G, Marana I, Berni A, Marra S, Usmiani T, Percoco GF, Dalby A, Lock E, Mabin T, Roos J, Corbett C, Bodenstein J, Ebrahim I, Bobak C, Blomerus P, Badenhorst J, Mpe M, Darby S, Theron Hdu T, de Beer M, Tayob F, Belekhov G, Moccetti T, Rossi MG, Pieper M, Michel D, Keller P, Sigaud P, James S, Boden U, Lugnegard J, Ahlmark H, Erlinge D, Duckert A, Henareh L, Berglund M, Bang CH, Therneld H, Samad B, Larsdotter-Svensson T, Karlsson A, Grändås M, Karlsson J, Koch A, Swahn E, Logander E, Sarkar N, Hage C, Larsson L, Hammerman A, Romero J, Betriu A, Bosch X, Bordes Siscar P, Fernández Vazquez F, Sanchís J, Antorrena I, Suarez J, Balaguer Recena J, Hernández J, Moreu J, Bethencourt A, Macaya Miguel C, Atar D, Ytre-Arne K, Hysing J, Flagstad E, Eritsland J, Hoffmann P, Endresen K, Otterstad JE, Thybo NK, Kallhovd A, Omdal TR, Lutterbey G, Carrageta M, Vinhaf H, Ferreira J, Teles R, Providencia L, Monteiro P, da Silva PC, Diaz NC, Sim K, Tchai D, Zambahari R, Abdullah M, Chee K, Loke L, Ismail OB, Tan Saw Ean SN, El Allaf D, Gits F, Vincent M, Van Gils K, Dujardin K, Colpaert V, Lancellotti P, Celentano C, Renard D, De Velter I, Purnode P, Van Gils K, Kiss RG, Kiss N, Merkely B, Bárczi G, Edes I, Fülöp L, Lupkovics G, Papp E, White H, Cunningham L, Wong S, Caveney D, Hart H, McAnnalley G, Devlin GP, Low L, Wong A, Leow W, Tan H, Low M, Lee S, Kong S, Yu C, Yue M, Lindroos M, Järvensivu O, Groundstroem K, Koskinen R, Hartikainen J, Ollikainen H, Chew D, Edwards C, Rankin J, Ferguson L, Lehman R, Morrison H, Hill A, Conway B, Singh B, A'Campo M, Sonmez K, Yaymaci B, Kozan O, Akdeniz B, Ergene O, Yuksek U, Grande P, Galatius S, Jensen JS, Jensen T, Adgey J, Gammon B, Connolly D, Wtam Y, de Belder M, Radford L, Goode G.

Author information

  • 1TIMI (Thrombolysis in Myocardial Infarction) Study Group, Brigham and Women's Hospital, Boston, MA 02115, USA. rgiugliano@partners.org

Abstract

BACKGROUND:

Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is unknown.

METHODS:

We compared a strategy of early, routine administration of eptifibatide with delayed, provisional administration in 9492 patients who had acute coronary syndromes without ST-segment elevation and who were assigned to an invasive strategy. Patients were randomly assigned to receive either early eptifibatide (two boluses, each containing 180 microg per kilogram of body weight, administered 10 minutes apart, and a standard infusion > or = 12 hours before angiography) or a matching placebo infusion with provisional use of eptifibatide after angiography (delayed eptifibatide). The primary efficacy end point was a composite of death, myocardial infarction, recurrent ischemia requiring urgent revascularization, or the occurrence of a thrombotic complication during percutaneous coronary intervention that required bolus therapy opposite to the initial study-group assignment ("thrombotic bailout") at 96 hours. The key secondary end point was a composite of death or myocardial infarction within the first 30 days. Key safety end points were bleeding and the need for transfusion within the first 120 hours after randomization.

RESULTS:

The primary end point occurred in 9.3% of patients in the early-eptifibatide group and in 10.0% in the delayed-eptifibatide group (odds ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.23). At 30 days, the rate of death or myocardial infarction was 11.2% in the early-eptifibatide group, as compared with 12.3% in the delayed-eptifibatide group (odds ratio, 0.89; 95% CI, 0.79 to 1.01; P=0.08). Patients in the early-eptifibatide group had significantly higher rates of bleeding and red-cell transfusion. There was no significant difference between the two groups in rates of severe bleeding or nonhemorrhagic serious adverse events.

CONCLUSIONS:

In patients who had acute coronary syndromes without ST-segment elevation, the use of eptifibatide 12 hours or more before angiography was not superior to the provisional use of eptifibatide after angiography. The early use of eptifibatide was associated with an increased risk of non-life-threatening bleeding and need for transfusion. (ClinicalTrials.gov number, NCT00089895.)

2009 Massachusetts Medical Society

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PMID:
19332455
[PubMed - indexed for MEDLINE]
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