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N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.

Facilitated PCI in patients with ST-elevation myocardial infarction.

Collaborators (230)

Ellis SG, Armstrong PW, Betriu A, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Topol EJ, Barnathan ES, Effron MB, Topol EJ, Herrmann HC, Neumann FJ, Deckelbaum L, Effron MB, Holmes D, Harrington R, Knudtson M, Lee K, White H, Kosmider M, Tendera M, Hamankiewicz M, Pluta W, Miarka J, Szczuka K, Gil R, Buszman P, Prochaczek F, Gruszka A, Miekus P, Krauze-Wielicka M, Trusz-Gluza M, Miatskowski Z, Ogórek M, Ponikowski P, Ciecwierz D, Binio Z, Dudek D, Goszczyńska M, Sierant M, Adamus J, Rekosz J, Kielkowicz K, Majcher Z, Sobocik H, Opolski G, Frycz J, Kowalewski J, Rzezniczak J, de Belder MA, Oldroyd K, Dawkins K, de Belder A, Signy M, Shyam-Sundar A, Adgey A, Khan MM, Owens C, Byrne J, Fath-Ordoubadi F, Moriarty A, El-Harari M, Hogg K, Motwani J, Walker D, Stepanek P, Synek O, Havlik V, Klimsa Z, Svitil P, Fabik L, Reichert P, Florian J, Sedlacek J, Chrastecka N, Prodelal P, Horny I, Kopal V, Kral R, Stumar J, Cernosek B, Konvicka O, Satura P, Grunfeldova H, Janousek J, Kala M, Micudova N, Siegelova J, Kral J, Sulak P, Gocal R, Kellnerova I, Vavra P, Kosova E, Koziel V, Mildnerova L, Navratil P, Richter M, Armstrong B, Schneider JE, Lee AB, Rivera E, Moscucci M, Shani J, Ramee SR, Wilentz JR, Bachinsky W, Bush HS, Abdul-Karin A, Roongsritong C, Hermany P, Istfan P, Katopodis JN, Lachterman BS, Marzo KP, Srivastava N, Bach RG, Dillon WC, Ettinger SM, Harris B, Jones S, Lai P, Saperia G, Singh S, Stapleton DD, Uretsky B, DeGregoria M, Heinrichs D, Jones AA, Leimbach WN Jr, Papadakos S, Puma J, Quesada R, Tolerico PH, Katz O, Ecollan P, Chouihed T, Janssens L, Van der Stighelen H, Van Brabandt H, Hutse W, Taeymans Y, Van den Heuvel P, Bultynck K, Van Haesendonck C, Vertongen P, Lederballe O, Jensen SE, Sorensen EV, Dodt KK, Petersen J, Gotzsche LB, Sigurd B, Sejersen HM, Nielsen H, Van Boven AJ, Betriu A, Zarauza J, Artigas Reventos A, Mainar Tello V, Goicolea Ruigómez J, Carrasco Barea JA, Macaya Miguel C, Zueco J, Picón Barrera J, Bruguera i Cortada J, Galassi A, Giani P, Piti A, Pesola A, Galli M, Klugmann S, Reimers B, Amoroso G, Petronio AS, Bande A, Mangiameli S, Verna E, Bracchetti D, Casella G, Pachinger O, Leisch F, Zenker G, Schreiber W, Stark G, Veegh W, Neunteufl T, Böck R, Gaul G, Weber H, Mihov A, Goudev A, Doganov A, Popov A, Rifai N, Schuster CJ, Koch KC, Wichert H, Amendt K, Bernsmeier R, Haase K, Münzel T, Halbritter R, Meier J, Benedek IS, Dorobantu M, Capalneanu R, Arsenescu C, Deleanu D, Nanea IT, Macin SM, Salzberg SM, Garcia Escudero AM, Ahuad Guerrero RA, Botto FO, Diez FA, Garrido MA, Miraglia ED, Sokn FJ, Guetta V, Bodenstein WM, Conradie C, Marks DS, Broens BH, Myburgh DP, van Amstel A, Davidsson K, Estlinbaum W, Gosselin G.

Abstract

BACKGROUND:

We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI).

METHODS:

In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization.

RESULTS:

A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49).

CONCLUSIONS:

Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)

Copyright 2008 Massachusetts Medical Society.

PMID:
18499565
[PubMed - indexed for MEDLINE]
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