DEDICATION 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	DES currently used with or without distal protection 47% sirolimus, 40% paclitaxel, 13% zotarolimus
Control treatment	BMS with or without distal protection
Remarks	patients were also randomized to treatment with or without distal protection using a filter wire system (factorial design)

Patients

patients referred within 12 hours from symptom onset of an ST-elevation myocardial infarction

Inclusion criteria

chest pain of >30-minute duration; cumulated ST-segment elevation of >4 mm in at least 2 contiguous leads; >18 years of age; high-grade stenosis or occlusion of a coronary artery without excessive tortuosity or calcification prohibiting advancement of a filter wire to the distal vascular bed of the vessel

Exclusion criteria

previous myocardial infarction in the target vessel area, development of cardiogenic shock before enrollment, culprit lesions in an unprotected left main coronary artery, gastrointestinal bleeding within 1 month, pregnancy, known renal failure, life expectancy <1 year

Baseline characteristics

age	62.2
history of MI (%)	6.55
diabetes (%)	10.4
Smoker (%)	53.7
LAD (%)	41.5
RCA (%)	46
LCx (%)	12.5
male (%)	73.15
single vessel patients	62.5

Method and design

Randomized effectives	313 / 313 (studied vs. control)
Design	Factorial plan
Blinding	open
Follow-up duration	8 mo (15 mo, 3y)
Number of centre	2
Geographic area	Denmark.
Hypothesis	Superiority
Primary endpoint	loss of the lumen diameter
Remarks

Remarks / Comments

Results

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

All cause death

16 / 313
8 / 313
classic 2,00 [0,87;4,61]

Stent thrombosis (any, end of follow up)

7 / 313
8 / 313
classic 0,88 [0,32;2,38]

4 yr TLR

NA / 313
NA / 313
0,67 [0,39;1,16]

cardiac death

13 / 313
5 / 313
classic 2,60 [0,94;7,21]

2 yr TLR

19 / 313
51 / 312
0,37 [0,22;0,61]

target-vessel revascularization

16 / 313
41 / 313
0,39 [0,22;0,68]

MACE

28 / 313
45 / 313
0,62 [0,40;0,97]

4 yr MI

NA / 313
NA / 313
classic 1,49 [0,72;3,09]

4 yr stent thrombosis

NA / 313
NA / 313
classic 1,98 [0,67;5,85]

2 yr MACE

36 / 313
57 / 312
0,63 [0,43;0,93]

2 yr Death (all cause)

33 / 313
20 / 312
classic 1,64 [0,97;2,80] 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
All cause death	16 / 313 (5,1%)	8 / 313 (2,6%)	2,00	[0,87;4,61]		0
cardiac death	13 / 313 (4,2%)	5 / 313 (1,6%)	2,60	[0,94;7,21]		0
2 yr TLR	19 / 313 (6,1%)	51 / 312 (16,3%)	0,37	[0,22;0,61]	at 3 years	0
target-vessel revascularization	16 / 313 (5,1%)	41 / 313 (13,1%)	0,39	[0,22;0,68]		0
MACE	28 / 313 (8,9%)	45 / 313 (14,4%)	0,62	[0,40;0,97]		0
Stent thrombosis (any, end of follow up)	7 / 313 (2,2%)	8 / 313 (2,6%)	0,88	[0,32;2,38]		0
2 yr MACE	36 / 313 (11,5%)	57 / 312 (18,3%)	0,63	[0,43;0,93]	at 3 years	0
2 yr Death (all cause)	33 / 313 (10,5%)	20 / 312 (6,4%)	1,64	[0,97;2,80]	3 year	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	5,11%	2,56%	2,6%
cardiac death	4,15%	1,60%	2,6%
2 yr TLR	6,07%	16,35%	-102,8‰
target-vessel revascularization	5,11%	13,10%	-79,9‰
MACE	8,95%	14,38%	-54,3‰
Stent thrombosis (any, end of follow up)	2,24%	2,56%	-3,2‰
2 yr MACE	11,50%	18,27%	-67,7‰
2 yr Death (all cause)	10,54%	6,41%	4,1%

Reference(s)

Trials register #

NCT00192868

Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klvgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrm T, Btker HE, Saunamki K, Krusell LR, Jrgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kber L, Kofoed KF, Terkelsen CJ, Lassen JF. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial.. Circulation 2008 Sep 9;118:1155-62
Pubmed | Hubmed | Fulltext

External links about this trial

cardiosource