TRIANA trial

Related trials

Treatments

Studied treatment

Tenecteplase + UFH (+/- clopidogrel)

Control treatment

Primary angioplasty
single weight-adjusted dose of TNK along with UFH (60 U/kg bolus plus infusion with an aPTT 1.5-2)

Treatments description

Stent (%)

84%

Patients

>=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for thrombolytic therapy

Inclusion criteria

age >=75 years; chest pain or any symptom of myocardial ischemia >=20 minutes of duration, not responding to nitrate therapy within first 6 hours and at least one of the following: ST-elevation >=2 mm in >=2 precordial leads, ST-elevation >=1 mm in >=2 anterior leads, or de novo (or probably de novo) LBBB

Exclusion criteria

Cardiogenic shock, estimated door-to-balloon time >120 minutes, administration of thrombolysis within 14 days prior to randomization, GP IIa/IIIb inhibitor within 24 hours prior to randomization, or LMWH within 8 hours prior to randomization, current oral anticoagulant treatment, suspected AMI secondary to occlusion of a coronary lesion treated previously with PCI, known renal failure, reduced expected life expectancy (<12 months), documented contraindication to the use of thrombolytics, including active internal bleeding or known history of hemorrhagic diathesis; history of previous stroke; intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair; major surgery, parenchymal biopsy, ocular surgery or severe trauma within 6 weeks prior to randomization; unexplained puncture in a non-compressible vascular location within 24 hours of randomization; confirmed arterial hypertension during the acute phase prior to randomization with one reliable measurement of systolic BP>180 mmHg or diastolic BP >110 mmHg; known thrombocytopenia < 100.000 platelets/�L; prolonged (>20 minutes) or traumatic cardiopulmonary resuscitation in the 2 weeks prior to randomization; symptoms or signs suggesting aortic dissection

Baseline characteristics

Delay to treatment (PTCA vs thr)	195min (Thr) / 245min (PCI)
% female	44%
mean age	81y

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

MACE

NA / 132
NA / 134
classic 1,46 [0,81;2,63]

reinfarction

NA / 132
NA / 134
classic 1,60 [0,60;4,26]

In-hospital death

NA / 132
NA / 134
classic 1,31 [0,67;2,56]

stroke (fatal and non fatal)

NA / 132
NA / 134
classic 4,03 [0,44;36,86] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)

Meta-analysis of all similar trials:

Reference(s)

Trials register #

NCT00257309

Clauw et al. The efficacy and safety of milnacpran in the treatment of fibromyalgia. 2007, poster 716

Pubmed | Hubmed | Fulltext

Bueno H, Betriu A, Heras M, Alonso JJ, Cequier A, Garc�a EJ, L�pez-Send�n JL, Macaya C, Hern�ndez-Antol�n R. 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 2010;: - 10.1093/eurheartj/ehq375

Pubmed | Hubmed | Fulltext

TRIANA study, 2009

Treatments

Patients

Method and design

Results

Reference(s)