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N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.

Collaborators (242)

Van de Werf F, Armstrong P, Gershlick A, Goldstein P, Wilcox R, Van de Werf F, Sinnaeve P, Meert P, Armstrong P, Welsh R, Gershlick A, Wilcox R, Adgey J, Kendall J, Quinn T, Goldstein P, Steg G, Lambert Y, Huber K, Schreiber W, Piegas L, Carvalho A, Lopes RD, Zeymer U, Arntz H, Nanas J, Fresco C, Pesenti A, Aaberge L, Halvorsen S, Grajek S, Sulimov V, Ostojic M, Rosell F, Fox K, Montalescot G, Pollack C, Tijssen J, Weaver D, Brower R, Armstrong P, Fu Y, Jagasia P, Awad A, Siha H, Temple T, Welsh R, Maleki ND, Price C, Zheng Y, Wilms G, Thijs V, Lesaffre E, Bogaerts K, Belmans A, Kalema G, Bluhmki E, Vandenberghe K, Luys C, Broos K, Regelin A, Danays T, Bluhmki E, Goetz G, Delbé R, Fehse U, Bogaerts K, Temple T, Merlini L, Mazzoleni M, Marangione M, Merlini L, Mazzoleni M, Marangione M, Kaff A, Malzer R, Sebald D, Glogar D, Gyöngyösi M, Weidinger F, Weber H, Gaul G, Chmelizek F, Seidl S, Pichler M, Pretsch I, Vergion M, Herssens M, Van Haesendonck C, Saraiva JF, Sparenberg AL, Souza JA, Moraes JB, Sant'anna FM, Tarkieltaub E, Hansen JR, Oliveira EM, Leonhard O, Cantor W, Senaratne M, Aptecar E, Asseman P, Belle L, Belliard O, Berland J, Berthier A, Besnard C, Bonneau A, Bonnefoy E, Brami M, Canu G, Capellier G, Cattan S, Champagnac D, Chapon P, Cheval B, Claudel J, Cohen Tenoudji P, Coste P, Debierre V, Domergue R, Echahed K, El Khoury C, Ferrari E, Garrot P, Henry P, Jardel B, Jilwan R, Julie V, Ketelers R, Lapostolle F, Le Tarnec J, Livarek B, Mann Y, Marchand X, Pajot F, Perret T, Petit P, Probst V, Ricard Hibon A, Robin C, Salama A, Salengro E, Savary D, Schiele F, Soulat L, Tabone X, Taboulet P, Thicoïpe M, Torres J, Tron C, Vanzetto G, Villain-Coquet L, Piper S, Mochmann HC, Nibbe L, Schniedermeier U, Heuer H, Marx F, Schöls W, Lepper W, Grahl R, Muth G, Lappas G, Mantas I, Skoumbourdis E, Dilanas C, Kaprinis I, Vogiatzis I, Zarifis I, Spyromitros G, Konstantinides S, Symeonides D, Rossi GP, Bermano F, Ferlito S, Paolini P, Valagussa L, Della Rovere F, Miccoli F, Chiti M, Vergoni W, Comeglio M, Percoco G, Valgimigli M, Berget K, Skjetne O, Schartum-Hansen H, Andersen K, Rolstad OJ, Aguirre Zurita ON, Castillo León RP, Villar Quiroz AC, Glowka A, Kulus P, Kalinina S, Bushuev A, Barbarash O, Tarasov N, Fomin I, Makarov E, Markov V, Danilenko A, Volkova E, Frolenkov A, Burova N, Yakovlev A, Elchinskaya L, Boldueva S, Klein G, Kolosova I, Ovcharenko E, Fairushin R, Andjelic S, Vukcevic V, Neskovic A, Krotin M, Rajkovic T, Pavlovic M, Perunicic J, Kovacevic S, Petrovic V, Mitov V, Ruiz A, García-Alcántara A, Martínez M, Díaz J, Paz MA, Manzano FL, Martín C, Macaya C, Corral E, Fernández JJ, Martín F, García R, Siriwardena N, Rawstorne O, Baumbach A, Manoharan G, Menown I, McHechan S, Morgan D.

Author information

  • 1Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research, University of Alberta, Edmonton, Canada

Abstract

BACKGROUND:

It is not known whether prehospital fibrinolysis, coupled with timely coronary angiography, provides a clinical outcome similar to that with primary percutaneous coronary intervention (PCI) early after acute ST-segment elevation myocardial infarction (STEMI).

METHODS:

Among 1892 patients with STEMI who presented within 3 hours after symptom onset and who were unable to undergo primary PCI within 1 hour, patients were randomly assigned to undergo either primary PCI or fibrinolytic therapy with bolus tenecteplase (amended to half dose in patients ≥75 years of age), clopidogrel, and enoxaparin before transport to a PCI-capable hospital. Emergency coronary angiography was performed if fibrinolysis failed; otherwise, angiography was performed 6 to 24 hours after randomization. The primary end point was a composite of death, shock, congestive heart failure, or reinfarction up to 30 days.

RESULTS:

The primary end point occurred in 116 of 939 patients (12.4%) in the fibrinolysis group and in 135 of 943 patients (14.3%) in the primary PCI group (relative risk in the fibrinolysis group, 0.86; 95% confidence interval, 0.68 to 1.09; P=0.21). Emergency angiography was required in 36.3% of patients in the fibrinolysis group, whereas the remainder of patients underwent angiography at a median of 17 hours after randomization. More intracranial hemorrhages occurred in the fibrinolysis group than in the primary PCI group (1.0% vs. 0.2%, P=0.04; after protocol amendment, 0.5% vs. 0.3%, P=0.45). The rates of nonintracranial bleeding were similar in the two groups.

CONCLUSIONS:

Prehospital fibrinolysis with timely coronary angiography resulted in effective reperfusion in patients with early STEMI who could not undergo primary PCI within 1 hour after the first medical contact. However, fibrinolysis was associated with a slightly increased risk of intracranial bleeding. (Funded by Boehringer Ingelheim; ClinicalTrials.gov number, NCT00623623.).

Comment in

PMID:
23473396
[PubMed - indexed for MEDLINE]
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