HORIZONS-AMI Stent trial

Related trials

Treatments

Studied treatment

paclitaxel-eluting stents (Taxus)

Control treatment

BMS (Express)

Concomittant treatment

aspirin indefinitely, and thienopyridine use was mandated up to 6 months, and strongly encouraged thereafter

Remarks

Patients received either unfractionated heparin and a glycoprotein (GP) IIb/IIIa inhibitor (eptifibatide or abciximab) or bivalirudin with provisional GP IIb/IIIa inhibitors in a 2 x 2 factorial design

Patients

ST-elevation myocardial infarction

Inclusion criteria

STEMI >20 minutes and <12 hours in duration (ST-segment elevation of >=1 mm in >=2 contiguous leads; or presumably new left bundle branch block or true posterior MI with ST depression of >=1 mm in >=2 contiguous anterior leads); Patients with cardiogenic shock, left main disease, etc., were not excluded Age >=18 years The presence of at least one acute infarct artery target vessel in which all significant lesions are eligible for stenting with study stents, and all such lesions have a visually estimated reference diameter >=2.25 mm and <=4.0 mm Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification); Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)

Exclusion criteria

Contraindication to any of the study medications Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for the present admission (prior unfractionated heparin allowed) Current use of Coumadin History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke; stroke or transient ischemic attack within 6 months or any permanent neurologic deficit; gastrointestinal or gastrourinary bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count <100,000 cells/mm3 or hemoglobin <10 g/dl Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post-enrollment Bifurcation lesion definitely requiring implantation of stents in both the main vessel and a side branch Infarct-related artery is an unprotected left main >100 mm of study stent length anticipated Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent High likelihood of coronary artery bypass grafting within 30 days anticipated

Baseline characteristics

age	59.6 y
diabetes (%)	16%
lesion length (mm)	30.8 vs 27.3 mm
reference-vessel diameter	2.9 mm
Lesion diameter inclusion criteria	2.25 - 4 mm
Female (%)	23%

Results

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

MACE

NA / 2257
NA / 749
1,02 [0,77;1,35]

All cause death

79 / 2257
26 / 749
1,01 [0,65;1,56]

MI (fatal and non fatal)

84 / 2257
34 / 749
0,82 [0,56;1,21]

target-vessel revascularization

NA / 2257
NA / 749
0,65 [0,49;0,86]

target lesion revascularisation

NA / 2257
NA / 749
0,59 [0,42;0,83]

angiographic restenosis

NA / 2257
NA / 749
0,44 [0,33;0,58]

Stent thrombosis (any, end of follow up)

70 / 2257
25 / 749
0,93 [0,59;1,46]

2 yr Death (all cause)

NA / 2257
NA / 749
0,83 [0,57;1,20]

2 yr MACE

NA / 2257
NA / 749
0,98 [0,77;1,25]

2 yr TLR

NA / 2257
NA / 749
0,58 [0,44;0,76] 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	79 / 2257 (3,5%)	26 / 749 (3,5%)	1,01	[0,65;1,56]		0
MI (fatal and non fatal)	84 / 2257 (3,7%)	34 / 749 (4,5%)	0,82	[0,56;1,21]		0
Stent thrombosis (any, end of follow up)	70 / 2257 (3,1%)	25 / 749 (3,3%)	0,93	[0,59;1,46]		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	3,50%	3,47%	0,3‰
MI (fatal and non fatal)	3,72%	4,54%	-8,2‰
Stent thrombosis (any, end of follow up)	3,10%	3,34%	-2,4‰

Meta-analysis of all similar trials:

HORIZONS-AMI Stent study, 2008

Treatments

Patients

Method and design

Results

Reference(s)