Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients

Summary

General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients \>=75 years old with ST-segment elevation or LBBB AMI \<6 hours of evolution without contraindications for TT. Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients \>=75 years old with AMI. Participating Centers: 27 Spanish hospitals performing \>50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE). Procedure: Diagnosis of inclusion/exclusion criteria --\> Centralized randomization --\> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.

Timeline

Start

2005-04

Primary completion

2008-02

Completion

2008-12

Publications

• Background Bardaji A, Bueno H, Fernandez-Ortiz A, Cequier A, Auge JM, Heras M. [Type of treatment and short-term outcome in elderly patients with acute myocardial infarction admitted to hospitals with a primary coronary angioplasty facility. The TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) Registry]. Rev Esp Cardiol. 2005 Apr;58(4):351-8. Spanish.
• Background Cequier A, Bueno H, Auge JM, Bardaji A, Fernandez-Ortiz A, Heras M. [Characteristics and mortality following primary percutaneous coronary intervention for acute myocardial infarction in Spain. Results from the TRIANA 1 (TRatamiento del Infarto Agudo de miocardio eN Ancianos) Registry]. Rev Esp Cardiol. 2005 Apr;58(4):341-50. Spanish.
• Results Bueno H, Betriu A, Heras M, Alonso JJ, Cequier A, Garcia EJ, Lopez-Sendon JL, Macaya C, Hernandez-Antolin R; TRIANA Investigators. 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. Eur Heart J. 2011 Jan;32(1):51-60. doi: 10.1093/eurheartj/ehq375. Epub 2010 Oct 22.

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