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