Díaz de la Llera study - description and results

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This trial is included in the following systematic reviews and meta-analyses:

acute myocardial infarction - myocardial revascularization - all type of patients

acute myocardial infarction - PCI - all type of patients

coronary artery disease - revascularization with drug eluting stent - acute myocardial infarction

ZEST AMI (vs SES), 2009 - zotarolimus ES vs sirolimus ES

TRIANA, 2009 - primary ballon angioplasty vs tenecteplase

NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis

DEBATER (SES vs BMS), 2009 - sirolimus ES vs bare-metal stent

Juwana, 2009 - sirolimus ES vs paclitaxel ES

ZEST AMI (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent

PASEO, 2009 - drug ES vs bare-metal stent

CARESS, 2008 - thrombolysis + angioplasty vs immediate thrombolysis

SORT OUT II, 2008 - sirolimus ES vs paclitaxel ES

HORIZONS-AMI Stent, 2008 - paclitaxel ES vs bare-metal stent

MISSION, 2008 - sirolimus ES vs bare-metal stent

DEDICATION, 2008 - drug ES vs bare-metal stent

Díaz de la Llera, 2007 - sirolimus ES vs bare-metal stent

SESAMI, 2007 - sirolimus ES vs bare-metal stent

TYPHOON, 2006 - sirolimus ES vs bare-metal stent

PROSIT, 2006 - sirolimus ES vs paclitaxel ES

HAAMU-STENT, 2006 - paclitaxel ES vs bare-metal stent

PASSION, 2006 - paclitaxel ES vs bare-metal stent

WEST, 2006 - systematic PCI (+stent) vs no systematic PCI

CAPITAL AMI, 2005 - thrombolysis + angioplasty vs immediate thrombolysis

Di Lorenzo et al., 2005 - sirolimus ES vs paclitaxel ES

ZWOLLE 6, 2005 - primary stenting vs ballon angioplasty

CAPITAL AMI, 2005 - systematic PCI (+stent) vs no systematic PCI

Treatments

Studied treatment	sirolimus-eluting stents
Control treatment	uncoated stents
Concomittant treatment	abciximab bolus 0.25µg/kg, infuson 0.125µg/kg/min for 12 hours; heparin bolus 17U/kg [max 7000U] aditional dose for ACT 200-250s; aspirin loasing dose 300-500mg then 100mg/d indefinitely; clopidogrel loading dose 300 or 600 mg then 75mg/d for at leat 1 (BMS) or 9 months (SES)

Patients

primary percutaneous coronary intervention for acute myocardial infarction with ST-segment elevation

Exclusion criteria

reference diameter <2.25 mm and >4.0 mm by visual estimation in the infarction-related artery (IRA)

Baseline characteristics

age	64.47
history of MI (%)	7.37
diabetes (%)	27.46
Smoker (%)	68.3
unstable angina (%)	0%
LAD (%)	42.36
RCA (%)	43.67
LCx (%)	13.26
lesion length (mm)	29.54 (stent)
male (%)	79.19
Lesion diameter inclusion criteria	2.25-4.0 mm
left main coronary artery disease	0.81
STEMI	100%
Stable angina	0%
single vessel patients	53.44
multi vessels patients	46.56

Method and design

Randomized effectives	60 / 54 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	1y
Geographic area	Spain
Hypothesis	Superiority
Primary endpoint	cardiac death, MI, TLR

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Death at 30D	2 / 60 (3,3%)	2 / 54 (3,7%)	0,90	[0,13;6,17]
Death or nonfatal reinfarction at 30D	3 / 60 (5,0%)	3 / 54 (5,6%)	0,90	[0,19;4,27]
Urgent TVR at 30D	1 / 60 (1,7%)	1 / 54 (1,9%)	0,90	[0,06;14,04]
Acute or subacute stent thrombosis at 30D	1 / 60 (1,7%)	1 / 54 (1,9%)	0,90	[0,06;14,04]
Death/reinfarction/urgent TVR at 30D	3 / 60 (5,0%)	3 / 54 (5,6%)	0,90	[0,19;4,27]
Death at 1y	3 / 60 (5,0%)	2 / 54 (3,7%)	1,35	[0,23;7,78]
Death or nonfatal reinfarction at 1y	4 / 60 (6,7%)	3 / 54 (5,6%)	1,20	[0,28;5,12]
TVR at 1y	0 / 60 (0,8%)	3 / 54 (5,6%)	0,15	[0,01;2,93]
Late stent thrombosis at 1y	1 / 60 (1,7%)	0 / 54 (0,9%)	1,80	[0,06;52,60]
Total death/reinfarction/TVR at 1y	4 / 60 (6,7%)	6 / 54 (11,1%)	0,60	[0,18;2,01]

Reference(s)

Trials register #