EVERBIO II: Angiographic Outcomes Similar for BVS, EES, BES

According to results from a single-center, all-comers study, a bioresorbable vascular scaffold (BVS) yields angiographic and clinical outcomes comparable to the two best-in-class DES.

For the EVERBIO II trial, Stéphane Cook, MD, of the University Medical Center Fribourg, Switzerland, and colleagues assigned 80 patients to treatment with an everolimus-eluting BVS (Absorb, Abbott Vascular), 80 patients to a durable polymer everolimus-eluting stent (EES; Promus Element, Boston Scientific) and 80 patients to a biodegradable polymer biolimus A9-eluting stent (BES; Biomatrix Flex, Biosensors).

At 9 months, the clinical follow-up rate was 99%, and the angiographic follow-up rate was 89%. For the primary endpoint of in-stent late lumen loss at 9 months on quantitative coronary angiography, the BVS group demonstrated comparable outcomes to the combined EES/BES group (see Figure).

However, in-segment late lumen loss, a secondary endpoint, was slightly but significantly higher in the BVS group compared with the EES/BES group (0.30 ± 0.44 mm vs. 0.19 ± 0.42 mm; P=.03).

Results of a stratified analysis of the primary endpoint indicated that in-stent late lumen loss was similar for the EES/BES compared with the BVS among subgroups of patients with diabetes (P=.66), ACS (P=.25) and complex lesions (P=.11).

There were no significant differences among the three groups with regard to dual antiplatelet therapy (DAPT) use at 6 months (P=.37 for EES/BES vs. BVS) or 9 months (P=.48 for EES/BES vs. BVS).

“I want to emphasize that at 9 months, there was no definite or probable stent thrombosis,” Cook added.

Device-oriented MACE was similar between the BVS group and the two stent groups (P=.6). Similarly, patient-oriented MACE was comparable for the BVS group and the DES groups (P=.83).

“In a patient population with minimal exclusion criteria and using late lumen loss as an early and robust marker for restenosis, BVS demonstrated satisfactory angiographic and clinical outcomes compared to EES and BES,” Cook said. He added that the modest and transient constrictive effect found at scaffold edges may explain the limited increase in in-segment late lumen loss associated with the BVS. “This reinforces our primary hypothesis of DES superiority within the 6- to 12-month time frame. Optimal DAPT duration after BVS is unknown,” Cook added.

Disclosures:

• Cook reports speaker fees/honoraria from Abbott Vascular, Biosensors, Boston Scientific and St. Jude Medical and receives support from the Swiss National Science Foundation.