Resolute all comers trial
Objective:
To compare the efficacy and safety of the new
generation ZES stent versus the everolimus
eluting stent.
Study:
Multicenter, single blind, randomized noninferiority trial.
Population: Patients with stable CAD and ACS (NSTEMI,
STEMI, UA). Size 2.25-4 mm. No restrictions
on no of stents, no of treated lesions, lesion
length, treated vessel
Endpoint: TLF: cardiac death, MI, clinically driven TLR at
1 year f-up.
Resolute all comers trial
Patients
enrolled
N=2292
Zotarolimus
DES
(EndeavorResolute)
N=1140
Planned f-up
angio 13 m.
20% of patients
Everolimus
DES
(Xience V)
N=1152
Planned f-up
angio 13 m.
20% of patients
Resolute all comers trial
Event rate at 1 year f-up (%)
p=0.94
p=0.08
p=0.92
p=0.50
zotarolimus
10
p=0.01
everolimus
8,3
8,2
5
1,6
2,8
4,2
4,1
3,9
3,4
1,2
0,3
0
TLF
death
MI
TLR
Stent thromb
Resolute all comers trial
QCA at 13 months f-up angio
30
0,5
21,65
20
Late loss (mm)
19,76
10
0,27
5,2
6,5
0
0,19
0,15
0,06
0,0
in-stent % DS
binary restenosis
in segment
in-stent
Resolute all comers trial
Conclusion: At follow-up the new generation ZES
(Endeavor-Resolute) was found to be noninferior to the everolimus eluting Xience V
stent in a population of patients with minimal
exclusion criteria.
Serruys et al. N Engl J Med 2010;363:136-46