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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