Shelley Wood

May 17, 2012

May 16, 2012 (Paris, France) — The "next-generation" Nobori biolimus-eluting stent (BES) (Terumo) is noninferior to market-leading everolimus-eluting stents (EES; Xience V, Prime, Promus) at one year, results of the COMPARE II trial suggest.

Dr Pieter Smits

But at least at 12-month follow-up, there is no signal that the device, which boasts a bioerodable polymer, is any safer than the stents that use a permanent polymer coating. Dr Pieter Smits (Maasstad Ziekenhuis, Rotterdam, the Netherlands) presented the COMPARE II trial results here at a EuroPCR 2012 late-breaking clinical-trial session.

The trial randomized 2707 "all-comers" patients 2:1 to the Nobori stent or the Xience/Promus devices, tracking a primary composite end point of cardiac death, MI, or clinically driven target vessel revascularization (TVR).

At one year, the rate of this composite end point was similar, at roughly 5%, in both groups, reaching the prespecified definition of noninferiority for the Nobori. Secondary efficacy and safety end points were also no different between groups. Of note, stent-thrombosis rates, again no different between stent groups, were very low--1% or less for both definite and definite/probable stent thrombosis regardless of stent type.

COMPARE II Outcomes

End point BES (%) EES (%)
Primary end point 5.2 4.8
Cardiac death, MI, clinically driven TLR 4.6 4.1
Cardiac death 0.8 0.8
MI 2.8 2.5
Clinically driven TLR 2.1 1.8
Definite stent thrombosis 0.7 0.4
Definite or probable stent thrombosis 0.8 1.0

TLR=target lesion revascularization

BES=biolimus-eluting stent

EES=everolimus-eluting stent

Speaking during a Tuesday morning press conference, Smits acknowledged that one of the primary aims of a bioerodable polymer stent is to have a stent that shows "no stent thrombosis," based on the presumption that better endothelial healing with these stents would reduce thrombus formation.

"So 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," he said.

Pointing to the four-year LEADERS results, Smits noted that other studies of stents with bioerodable polymers have taken longer than one year to show a difference in safety, since the bioerodable polymer takes six to nine months to disappear. "So there may be a difference later on, [potentially with] less very late thrombosis."

Discussing COMPARE II following its late-breaker presentation, Dr Kari Niemelä (Tampere University Hospital, Finland) observed, "The problem is, today's stents are so good, it's very difficult for a new stent to demonstrate superiority."

Dr William Wijns

"The real story" with COMPARE II, predicted Niemelä, "starts after 12 months, and therefore what happens in the coming years is very important. . . . At this point, for me, these results would not change my practice. We need more data."

Smits, however, says he is already using the Nobori in 50% of his patients, and not in any specific subset. The stent costs roughly the same as the everolimus-stents at his institution, he said.

Also of note, Dr William Wijns (Cardiovascular Center, Aalst, Belgium) told reporters, is that COMPARE II raises the level of data for the Nobori stent, at least in Europe, where the device is already approved and covered by PCI guidelines. "So the committee who issues guidelines next year will need to take these results into consideration," Wijns said.

Smits disclosed receiving institutional research contracts from Abbott Vascular, Boston Scientific, and Terumo and consulting payments from Blue Medical.

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