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Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffolds:

This study compares the outcomes of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds in patients with stable CAD or ACS undergoing PCI. The study shows no significant differences in clinical outcomes between the two treatments.

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Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffolds:

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  1. Comparison of Everolimus- andBiolimus-Eluting Coronary StentsWith Everolimus-Eluting BioresorbableVascular Scaffolds:2-year Outcomes of the EVERBIO II Trial Serban Puricel, MD

  2. Disclosure Statement of Financial Interest I, Serban Puricel DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  3. Single-center, assessor-blinded, randomized controlled superiority trial with an allocation ratio of 1:1:1 enrolling a total of 240 patients Puricel et al. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801.

  4. End points • Patients with stable CAD or ACS undergoing PCI Clinical follow-up @ 1, 6, 9, 12 months, 2 & 5 y; Angio @ 9 months Primary endpoint In-stent late lumen loss (LLL) at 9 months • Secondary endpoints • In-segment LLL • Device-oriented MACE (cardiacdeath, tv myocardialinfarction and target-lesionrevascularization) • Patient-oriented MACE (death, myocardial infarction and any repeatrevascularization) • Stent thrombosis according to ARC

  5. Reminder I – Baseline characteristics characteristics

  6. Reminder II – Procedural characteristics

  7. Outcome at 9 months Non-superiority of the metallic stents for the angiographic or any of the clinical end points A post-hoc non-inferiority analysis showed non-inferiority (p<0.001) of the BVS for the primary angiographic end point

  8. 2-year ClinicalOutcome

  9. Survival free from DOCE logrank p-value= 0.12

  10. Landmark analysis DOCE logrank p-value= 0.35 logrank p-value= 0.16

  11. Survival free from POCE logrank p-value= 0.67

  12. Landmark analysis POCE logrank p-value= 0.73 logrank p-value= 0.47

  13. SubgroupanalysisDOCE In favour of EES/BES BVS p-value pinteraction <0.05 0.66 ACS 0.44 0.80 0.07 Diabetes 0.24 Complex (B2/C) 0.69 0.09 0.78

  14. Conclusions • No significantdifferenceswith regard to clinicaloutcomebetween EES/BES and BVS • (Rates of the device-oriented composite end point werehigher for pateintstreatedwith BVS) • Only one latescaffoldthrombosisoccurredthroughout the trial • (the mechanism of thisthrombosismayberelated to a processthatmanifestsitself as PSLIA on OCT)

  15. Cuculi et al. Circ Cardiovasc Interv. 2015 Oct;8(10):e002518.

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