ENDEAVOR IV trial

Randomized effectives	773 / 775 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	mean 36 mo
Number of centre	80
Geographic area	US
Hypothesis	Non inferiority
Primary endpoint	target vessel failure (death,MI, TVR)

Results

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

MACE

84 / 734
101 / 733
0,83 [0,63;1,09]

All cause death

29 / 734
32 / 733
0,91 [0,55;1,48]

cardiac death

12 / 734
17 / 733
0,70 [0,34;1,47]

MI (fatal and non fatal)

16 / 734
36 / 733
0,44 [0,25;0,79]

target-vessel revascularization

73 / 734
80 / 733
0,91 [0,67;1,23]

target lesion revascularisation

48 / 734
44 / 733
1,09 [0,73;1,62]

4y stent thrombosis (ARC)

8 / 734
12 / 733
0,67 [0,27;1,62] 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
MACE	84 / 734 (11,4%)	101 / 733 (13,8%)	0,83	[0,63;1,09]	at 3 years
All cause death	29 / 734 (4,0%)	32 / 733 (4,4%)	0,91	[0,55;1,48]	at 3 years
cardiac death	12 / 734 (1,6%)	17 / 733 (2,3%)	0,70	[0,34;1,47]	at 3 years
MI (fatal and non fatal)	16 / 734 (2,2%)	36 / 733 (4,9%)	0,44	[0,25;0,79]	at 3 years
target-vessel revascularization	73 / 734 (9,9%)	80 / 733 (10,9%)	0,91	[0,67;1,23]	at 3 years
target lesion revascularisation	48 / 734 (6,5%)	44 / 733 (6,0%)	1,09	[0,73;1,62]	at 3 years
4y stent thrombosis (ARC)	8 / 734 (1,1%)	12 / 733 (1,6%)	0,67	[0,27;1,62]	definite/probable at 3 years
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)
MACE	11,44%	13,78%	-23,3‰
All cause death	3,95%	4,37%	-4,1‰
cardiac death	1,63%	2,32%	-6,8‰
MI (fatal and non fatal)	2,18%	4,91%	-27,3‰
target-vessel revascularization	9,95%	10,91%	-9,7‰
target lesion revascularisation	6,54%	6,00%	5,4‰
4y stent thrombosis (ARC)	1,09%	1,64%	-5,5‰

Meta-analysis of all similar trials:

Trials register #	NCT00217269
Study web site link	,

unpublished (or not yet fully published) trial

Leon MB. Endeavor Clinical Program Overview,. FDA Advisory Panel, October 10th, 2007
Pubmed | Hubmed | Fulltext

Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease.. JACC Cardiovasc Interv 2009 Aug;2:779-84
Pubmed | Hubmed | Fulltext

Leon MB, Kandzari DE, Eisenstein EL, Anstrom KJ, Mauri L, Cutlip DE, Nikolsky E, O'Shaughnessy C, Overlie PA, Kirtane AJ, McLaurin BT, Solomon SL, Douglas JS Jr, Popma JJ. Late Safety, Efficacy, and Cost-Effectiveness of a Zotarolimus-Eluting Stent Compared With a Paclitaxel-Eluting Stent in Patients With De Novo Coronary Lesions 2-Year Follow-Up From the ENDEAVOR IV Trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).. JACC Cardiovasc Interv 2009 Dec;2:1208-18 - 10.1016/j.jcin.2009.10.008
Pubmed | Hubmed | Fulltext

Leon MB, Nikolsky E, Cutlip DE, Mauri L, Liberman H, Wilson H, Patterson J, Moses J, Kandzari DE. Improved late clinical safety with zotarolimus-eluting stents compared with paclitaxel-eluting stents in patients with de novo coronary lesions: 3-year follow-up from the ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial.. JACC Cardiovasc Interv 2010;3:1043-50 - 10.1016/j.jcin.2010.07.008
Pubmed | Hubmed | Fulltext