Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II | Clinical Trial - EVERBIO II

Feb 23, 2015
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Fonds Scientifique Cardiovasculaire (Fribourg, Switzerland)
Date Published:
02/23/2015
Original Posted Date:
02/23/2015
References

Description:

The goal of the trial was to compare angiographic outcomes between bioresorbable vascular scaffold stents (BVS), biolimus-eluting stents (BES), and everolimus-eluting stents (EES).

Contribution to the Literature: This study suggests similar angiographic outcomes at 9 months between BVS, BES, and EES.

Study Design

Patients with coronary artery disease (CAD) were randomized in a 1:1:1 fashion to either Absorb BVS (n = 78), Biomatrix Flex stent [BES] (n = 80) or Promus Element EES (n = 80).

Inclusion criteria:

  • Age >18 years
  • Symptomatic CAD
  • Total number of enrollees: 238
  • Duration of follow-up: 9 months
  • Mean patient age: 65 years
  • Percentage female: 20%
  • Percentage diabetics: 23%
  • Previous percutaneous coronary intervention (PCI): 31%
  • Indication for PCI: stable angina (50%), silent ischemia (12%), non–ST-segment myocardial infarction (NSTEMI) (20%), STEMI (10%)

Exclusion criteria:

  • Reference vessel size >4.0 mm
  • Known or presumed hypersensitivity to heparin, antiplatelet drugs, or contrast dye not controllable with standard premedication

Principal Findings:

The primary outcome, in-stent late lumen loss at 9 months, was similar between the BVS (0.28 mm), BES (0.25 mm), and EES arms (0.24 mm) (p = 0.30).

Secondary outcomes:

  • Acute recoil: 9.5% vs. 6.9% vs. 6.2% (p < 0.01)
  • Binary restenosis at 9 months: 6% vs. 6% vs. 7% (p = 1.0)
  • MACE: 27% vs. 19% vs. 33% (p = 0.83)
  • Repeat revascularization: 24% vs. 19% vs. 30% (p = 0.99)
  • Stent thrombosis: 1% vs. 0% vs. 0% (p = 0.33)

Interpretation:

Among patients with CAD, BVS, BES, and EES were noted to have similar angiographic outcomes at 9 months in this single-center study, despite a higher rate of acute recoil immediately post-implant. Stent thrombosis rates were low and similar between the three arms as well. This trial presents early comparative data between BVS, BES, and currently utilized second-generation drug-eluting stents. Data from larger multicenter trials in different and more complex subsets with longer follow-up are awaited.

References:

Puricel S, Arroyo D, Corpataux N, et al. Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With Everolimus-Eluting Bioresorbable Vascular Scaffolds. J Am Coll Cardiol 2015;65:791-801.

Keywords: Angina, Stable, Coronary Artery Disease, Percutaneous Coronary Intervention, Stents, Sirolimus, Drug-Eluting Stents, Thrombosis


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