A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II)
Selected in The Lancet by R. Dworakowski
PW. Serruys, B. Chevalier, D. Dudek, A. Cequier, D. Carrié, A. Iniguez, M. Dominici, R.J. van der Schaaf, M. Haude, L. Wasungu, S. Veldhof, L. Peng, P. Staehr, M.J. Grundeken, Y. Ishibashi, H.M. Garcia-Garcia, Y. Onuma
The Lancet, Early Online Publication, 14 September 2014
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What is known
Bioresorbable scaffold (BVS) is a novel approach to treat coronary artery stenosis by providing transient scaffolding, with potential of full restoration of coronary physiology including vasomotion.
This is the first randomised study comparing everolimus-eluting BVS and everolimus-eluting metal stent (EES).
501 patients were randomly assigned to the BVS group or EES group (2:1).
- Despite lower acute lumen gain for BVS (2·85 mm2 vs 3·60 mm2, p<0·0001), resulting in a smaller lumen diameter or area post procedure, there was no difference in target lesion revascularisation (1% vs 2%, p=0.69) and target vessel revascularisation (2 vs 5%, p=0.15)
- 1-year composite device orientated endpoint (composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularisation) was similar (5% in BVS group vs 3% in EES group, p=0.35);
- Use of BVS was associated with fewer angina attacks after one year (22% vs 30%, p=0.04).
- 1-year patient-oriented clinical endpoint (composite of all death, any myocardial infarction, and all revascularisation) was 7% in the BVS group vs 9% EES group (p=0.47)
- There was no statistically significant difference in scaffold thrombosis (0.9% vs 0%, p=0.55)
The good news from this study is that BVS is as good as EES in regard to device oriented endpoints including TLR. Interestingly BVS was better in controlling angina, which might be related to mechanism of stent healing and/or some restoration of coronary vasomotion.
However BVS was not associated with statistically higher rate of stent thrombosis, there was a numerical difference against BVS. As the rate of stent thrombosis is rare, this study was not power to reach conclusion regarding this matter. Recently published registries have shown high rates of stent thrombosis varying between 2.1% and 3%, which might be related to suboptimal lesion preparation or/and BVS properties such as strut thickness (150μm). Use of stronger antiplatelets agents should be considered after using BVS.