Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies

Héctor Bueno, Amadeo Betriu, Magda Heras, Joaquín J Alonso, Angel Cequier, Eulogio J García, José L López-Sendón, Carlos Macaya, Rosana Hernández-Antolín, TRIANA Investigators, Héctor Bueno, Rosana Hernández-Antolín, Joaquín J Alonso, Amadeo Betriu, Angel Cequier, Eulogio J García, Magda Heras, José L López-Sendón, Carlos Macaya, José Azpitarte, Ginés Sanz, Angel Chamorro, Ramón López-Palop, Alex Sionis, Fernando Arós, Eulogio García-Fernández, Rafael Rubio, Felipe Hernández, Juan Carlos Tascón, José Moreu, Amadeu Betriu, Magda Heras, Rosana Hernández-Antolín, Antonio Fernández-Ortiz, César Morís, Ignacio Sánchez de Posada, Angel Cequier, Enrique Esplugas, Rafael Melgares, Francisco Bosa, Martín Jesús García-González, Román Lezáun, José Ramón Carmona, José Manuel Vázquez, Alfonso Castro-Beiras, Joan García Picart, José Domínguez de Rozas, José Díaz Fernández, Felipe Fernández Vázquez, Norberto Alonso, José Javier Zueco, José María San José, Alberto San Román, Carolina Hernández, José María Hernández García, Angel García Alcántara, Armando Bethencourt, Miquel Fiol, Xabier Mancisidor, Xabier Mancisidor, Rafael Ruiz, Rafael Hidalgo, Nicolás Sobrino, Isidoro González Maqueda, Alfonso Torres, Fernando Arós, Antonio Amaro, Michel Jaquet, Héctor Bueno, Amadeo Betriu, Magda Heras, Joaquín J Alonso, Angel Cequier, Eulogio J García, José L López-Sendón, Carlos Macaya, Rosana Hernández-Antolín, TRIANA Investigators, Héctor Bueno, Rosana Hernández-Antolín, Joaquín J Alonso, Amadeo Betriu, Angel Cequier, Eulogio J García, Magda Heras, José L López-Sendón, Carlos Macaya, José Azpitarte, Ginés Sanz, Angel Chamorro, Ramón López-Palop, Alex Sionis, Fernando Arós, Eulogio García-Fernández, Rafael Rubio, Felipe Hernández, Juan Carlos Tascón, José Moreu, Amadeu Betriu, Magda Heras, Rosana Hernández-Antolín, Antonio Fernández-Ortiz, César Morís, Ignacio Sánchez de Posada, Angel Cequier, Enrique Esplugas, Rafael Melgares, Francisco Bosa, Martín Jesús García-González, Román Lezáun, José Ramón Carmona, José Manuel Vázquez, Alfonso Castro-Beiras, Joan García Picart, José Domínguez de Rozas, José Díaz Fernández, Felipe Fernández Vázquez, Norberto Alonso, José Javier Zueco, José María San José, Alberto San Román, Carolina Hernández, José María Hernández García, Angel García Alcántara, Armando Bethencourt, Miquel Fiol, Xabier Mancisidor, Xabier Mancisidor, Rafael Ruiz, Rafael Hidalgo, Nicolás Sobrino, Isidoro González Maqueda, Alfonso Torres, Fernando Arós, Antonio Amaro, Michel Jaquet

Abstract

Aims: To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce.

Methods and results: Patients ≥75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enrolling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9%) and 34 (25.4%) in the fibrinolysis arm [odds ratio (OR), 0.69; 95% confidence interval (CI) 0.38-1.23; P = 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2%, P = 0.43), re-infarction (5.3 vs. 8.2%, P = 0.35), or disabling stroke (0.8 vs. 3.0%, P = 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7%, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95% CI 0.45-0.91).

Conclusion: Primary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available.

Trial registration: ClinicalTrials.gov NCT00257309.

Figures

Figure 1
Figure 1
Chart flow of management in patients randomized to the TRIANA study. PCI, percutaneous coronary intervention.
Figure 2
Figure 2
One-year Kaplan–Meier survival curves free of death, re-infarction, or disabling stroke (primary endpoint) (A) or all-cause mortality (B). PCI, percutaneous coronary intervention.
Figure 3
Figure 3
Odds ratio for efficacy of primary angioplasty compared with fibrinolysis according to different pre-defined subgroups. PCI, percutaneous coronary intervention.
Figure 4
Figure 4
Odd-ratios for mortality and the combined endpoint in the three randomized trials comparing primary percutaneous coronary intervention and fibrinolysis performed in very old patients with ST-segment elevation myocardial infarction. PCI, percutaneous coronary intervention.

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Source: PubMed

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