• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Coronary Artery Disease

• Cardiology
• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Coronary Artery Disease

New generation drug-eluting stents (DESs) are increasingly efficient and safe. The ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS) is thought to reduce long-term complications, including neoatherosclerosis and very late stent thrombosis. The effectiveness of the BVS has been demonstrated in patients with noncomplex lesions but it is increasingly being used in patients with complex lesions. The objective of the Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stent trial [EVERBIO II; NCT01711931], presented by Stéphane Cook, MD, University of Fribourg, Fribourg, Switzerland, was to compare the efficacy of the BVS with the best-in-class new generation DESs—the everolimus-eluting stent (EES PROMUS ELEMENT) and biolimus-eluting stent (BES BIOMATRIX FLEX).

Patients with stable coronary artery disease (CAD) or acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI) were randomized to the EES (n = 80), BES (n = 80), or BVS (n = 78). Clinical follow-up took place at 1, 6, 9, and 12 months and 2 and 5 years, with angiography at 9 months. The primary end point was in-stent late lumen loss (LLL) at 9 months. Secondary end points were in-segment LLL, patient-oriented major acute cardiac events (MACE; death, myocardial infarction [MI], and target vessel revascularization [TVR]), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis.

There were no significant differences in baseline characteristics between the 3 groups. No significant difference was observed in the cumulative frequency of in-stent LLL between the EES and BES groups combined (EES/BVS; 0.25 ± 0.36 mm) and the BVS group (0.28 ± 0.39 mm; P = .30). At nine months, there was no significant difference in the cumulative frequency of in-stent LLL between the EES (0.24 ± 0.32 mm), BES (0.25 ± 0.41 mm), and BVS (0.28 ± 0.39 mm) groups.

Stratified analysis found no significant differences in in-stent LLL between the EES/BES and BVS groups in patients with or without diabetes, ACS, or complex lesions.

In-segment LLL was significantly more frequent with the BVS (0.30 ± 0.44 mm) vs the EES/BES (0.19 ± 0.42 mm; P = .03). Stratified analysis found no significant differences in in-segment LLL between the EES/BES and BVS groups in patients with or without diabetes, ACS, or complex lesions.

There were no significant differences in dual antiplatelet therapy (DAPT) use in the EES/BES vs BVS, EES vs BVS, and BES vs BVS groups. No significant differences were observed in clinical outcomes at 9 months, including device-oriented MACE, patient-oriented MACE, TVR, and stent thrombosis, in the EES/BES vs BVS, EES vs BVS, and BES vs BVS groups.

This study had several limitations. It was not powered for noninferiority or to detect differences in clinical event rates. The study was performed in a single center with uniform procedural strategies that limit generalizations to other centers. Additionally, the investigators did not address the effect of the BVS on thrombotic risk.

In a patient population with minimal exclusion criteria and using LLL as an early and robust marker for restenosis, the BVS demonstrated satisfactory angiographic and clinical outcomes compared with the EES/BES. In-segment LLL was slightly but significantly higher with the BVS compared with the EES/BES. A possible explanation for this difference may be the modest and transient constrictive effect at the scaffold edges [Gogas B et al. JACC Cardiovasc Interv. 2012]. These results reinforce the authors' primary hypothesis of DES superiority within 6 to 12 months. The optimal DAPT duration after BVS implantation is not known.

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