A prospective, randomized, multicenter study doing a Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent

1. COMPARE II (Comparison of the
Everolimus Eluting With the Biolimus A9
Eluting Stent)

2. COMPARE II (Comparison of the Everolimus
Eluting With the Biolimus A9 Eluting Stent)
P Smits (Maasstad Ziekenhuis, Rotterdam, the Netherlands)
EuroPCR 2012
• A prospective, randomized, multicenter study
• Population and design:
2707 "all-comers" patients
Randomized 2:1 to the Nobori biolimus-eluting stent (BES) or the
everolimus-eluting stent (EES; Xience/Promus) devices
• Primary outcome:
Composite of cardiac death, MI, or clinically driven TVR
TVR=target vessel revascularization

3. COMPARE II: Results
• At one year, rate of the COMPARE II outcomes
composite end point was End point BES (%) EES (%)
roughly 5%, in both groups,
reaching noninferiority for the Primary end point 5.2 4.8
Nobori stent Cardiac death, MI, clinical driven TLR 4.6 4.1
• Secondary efficacy and safety Cardiac death 0.8 0.8
end points were also no MI 2.8 2.5
different between groups
Clinically driven TLR 2.1 1.8
• Stent-thrombosis rates were Definite stent thrombosis 0.7 0.4
very low—1% or less for both
Definite or probable stent thrombosis 0.8 1.0
definite and definite/probable
stent thrombosis regardless of
stent type
TLR=target lesion revascularization; BES=biolimus-eluting stent; EES=everolimus-eluting stent

4. COMPARE II: Commentary*
"We are happy that we have another stent available that shows equal safety and
efficacy, but unfortunately the [stent-thrombosis] problem has not completely been
solved."
- Dr Pieter Smits
"The problem is, today's stents are so good, it's very difficult for a new stent to
demonstrate superiority. . . . At this point, for me, these results would not change
my practice. We need more data."
- Dr Kari Niemelä
"The committee that issues guidelines next year will need to take these results into
consideration."
- Dr William Wijns
*All comments from COMPARE II: Nobori biolimus stent matches everolimus stents in all-comers
(http://www.theheart.org/article/1400883.do)

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