Original title: Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. Referencia: Puricel S. et al. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801.
The everolimus eluting bioresorbable scaffold (BVS) is effective at treating simple lesions in stable patients but it has yet to be assessed against the best-in-class DES.
This study compared BVS performance against everolimus and biolimus eluting stent performance in a population where the sole exclusion criterion was a reference vessel diameter of > 4 mm.
The EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) is a single center study that randomized 1:1:1 to BVS, everolimus eluting stent or biolimus eluting stent.
Primary end point was angiographic late lumen loss at 9 months and secondary end points were a composite of MACE events (death, infarction and revascularization) both patient oriented and device oriented, and stent thrombosis at 9 months follow up.
Follow up angiography was performed on 216 patients (90.7% of the population) at 9 months. Angiographic primary end point was similar between the BVS group (0.28 ± 0.39 mm) and the DES group (0.25 ± 0.36 mm; p=0.30). Combined patient oriented secondary end points were similar (27% vs 26%; p=0.83) and so were the device oriented secondary end points (12% vs 9%; p=0.6).
Conclusion
The last generation drug eluting metal stents was not superior to the everolimus eluting bioresorbable scaffold in terms of angiographic and clinical outcomes in an unselected population.
Editorial Comment
These outcomes differs from those of the multicenter registry GHOST-EU published in EuroIntervention, which showed more acute thrombosis in patients receiving the bioresorbable scaffold. The reason behind these GHOST-EU registry outcomes was the unselected population. Despite this fact, the present study also included and unselected population.
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