EVERBIO II: Everolimus-Eluting Bioresorbable Scaffold vs. Everolimus-Eluting and Biolimus-Eluting Metallic Stents in CAD Patients
In a patient population with minimal exclusion criteria and using late lumen loss (LLL) as an early and robust marker for restenosis, bioresorbable vascular scaffold (BVS) demonstrates “satisfactory angiographic and clinical outcomes” compared to everolimus-eluting stents (EES) and biolimus-eluting stents (BES), according to results of the EVERBIO II trial presented Sept. 16 at TCT 2014.
Spearheaded by principal investigator Stéphane Cook, MD, University and Hospital Fribourg, Switzerland, the trial sought to assess the efficiency and safety of the Absorb bioresorbable vascular scaffold and its ability to reduce long-term complications such as neoatherosclerosis and very late stent thrombosis. Testing the device against the EES and BES, the trial divided its study population into respective treatment groups (BVS, n=78; EES, n=80; BES, n=80).
Clinical outcomes at nine months showed that the BVS arm experienced nine device-oriented major adverse cardiac events, while the EES and BES arms had 11 and four respectively. Results also showed the BVS arm experienced 21 patient-oriented major adverse cardiac events (all-cause mortality, myocardial infarction, revascularization, target vessel revascularization), while EES and BES had 26 and 15 respectively.
Cook and colleagues note that in-segment LLL was slightly but significantly higher in BVS compared to EES/BES, and that a possible explanation to this difference could be due to the modest and transient constrictive effect found at scaffold edges, reinforcing the group’s hypothesis that a drug-eluding stent is superior within the 6-12 month timeframe.
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