COMPARE II: Biolimus-Eluting Stent Rivals Everolimus-Eluting Stent in All-Comers Trial

In an unselected population, a biolimus A9-eluting stent has proven noninferior to an everolimus-eluting stent, according to results from the randomized COMPARE II trial presented at TCT 2012.

Peter C. Smits, MD, of Maasstad Hospital Rotterdam, The Netherlands, and colleagues enrolled 2,707 patients at 12 European sites with minimal inclusion and exclusion criteria. In all, 1,795 patients received the Nobori biolimus A9-eluting stent (BES; Terumo), featuring an abluminal biodegradable polymer, and 912 received the permanent-polymer Xience V/Promus everolimus-eluting stent (EES; Abbott/Boston Scientific). There were no significant differences between the groups at baseline; 74% of all patients were male, 22% had diabetes and 58% were treated for acute coronary syndromes.

After 1 year, BES met noninferiority criteria compared with EES for the primary composite endpoint of cardiac death, nonfatal MI or TVR (P<.0001). All of the components as well as TLR and Academic Research Consortium-defined definite/probable stent thrombosis were equivalent between the 2 devices (see Table).

Table. One-Year Results

*P = NS for all superiority comparisons.

“According to the COMPARE II trial, the biodegradable polymer-coated biolimus-eluting stent is as safe and efficacious as the current standard of a thin strut everolimus-eluting stent with a durable and biocompatible polymer,” Smits told TCT Daily. “Additionally, the [positive] results with the biodegradable-polymer BES may open new, shorter dual antiplatelet therapy strategies, without compromising safety.”

Smits said the large size of COMPARE II is a major strength, as is its use of an independent core lab and clinical research organization (Cardialysis) to adjudicate clinical events. With these strengths, he said, the trial has only minor limitations. For example, due to logistical and production issues in Japan, some patients randomized to BES did not actually receive the device, though Smits reported that per protocol analyses did not alter the results.

COMPARE II is slated to continue through 3- and 5-year follow-up analyses, which hopefully will indicate whether BES reduce very late stent thrombosis compared with EES. The LEADERS trial pitted another BES, the Biomatrix Flex (Biosensors), against the Cypher Select sirolimus-eluting stent (Cordis). In results presented at TCT 2011, the biolimus A9 device was more protective against stent thrombosis at 4 years than the first-generation device.

Dislosures:

• Dr. Smits reports receiving speaking and travel fees from Terumo and Abbott Vascular.