Comparison of the Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug-Eluting Metal Stent in Acute ST-Elevation Myocardial Infarction - ABSORB-STEMI TROFI II

Aug 28, 2018
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Presenter/Author:
Patrick W. Serruys, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Summary Supplemental Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Date Presented:
09/01/2015
Date Published:
08/20/2018
Date Updated:
08/28/2018
Original Posted Date:
10/09/2015
References

Contribution To Literature:

The ABSORB STEMI TROFI II trial showed that implantation of a BVS resulted in good arterial healing, which was similar to an everolimus-eluting metal stent.

Description:

The goal of the trial was to evaluate treatment with the everolimus-eluting bioresorbable vascular scaffold (BVS) compared with the everolimus-eluting metal stent among subjects with ST-segment elevation myocardial infarction (STEMI).

Study Design

  • Randomized
  • Parallel

Subjects with STEMI were randomized after partial establishment of coronary flow to a BVS (n = 95) vs. an everolimus-eluting metal stent (n = 96).

  • Total number of enrollees: 191
  • Duration of follow-up: 6 months
  • Mean patient age: 59 years
  • Percentage female: 18%
  • Percentage diabetics: 19%

Inclusion criteria:

  • STEMI within 24 hours of symptom onset
  • Vessel size 2.25-3.8 mm

Exclusion criteria:

  • Cardiogenic shock
  • Severe vessel tortuosity or calcification

    Other salient features/characteristics:

    • Onset of symptoms to partial restoration of coronary flow: 177 minutes in the BVS group vs. 185 minutes in the metal stent group
    • Nominal diameter of the scaffold/stent: 3.25 mm in the BVS group vs. 3.12 mm in the metal stent group (p = 0.005)
    • Post-dilatation performed: 51% in the BVS group vs. 26% in the metal stent group (p < 0.001)

    Principal Findings:

    The primary outcome, healing score at 6 months, was 1.74 in the BVS group vs. 2.80 in the metal stent group (p for noninferiority < 0.001, p for superiority = 0.053).

    Secondary outcomes were in-device late loss: 0.20 mm in the BVS group vs. 0.08 mm in the metal stent group (p = 0.01). Also, cardiovascular death, MI, or revascularization was 1.1% in the BVS group vs. 0% in the metal stent group. The one event in the BVS group was due to stent thrombosis.

    Outcomes at 3 years: Vasoconstriction to acetylcholine in the scaffold or stented segment was 77.8% with BVS vs. 25.0% with metal stent (p = 0.008). Vasodilatation to nitroglycerin in the scaffold or stented segment was 61.1% with BVS vs. 18.8% with metal stent (p = 0.018).

    Interpretation:

    Among individuals with STEMI, implantation of a BVS resulted in nearly complete vessel healing, which was noninferior to the everolimus-eluting metal stent. Clinical events were low; however, there was one case of stent thrombosis with the BVS. BVS was associated with likely restoration of infarct-related artery vasomotor function. Future trials powered for clinical events are warranted.

    References:

    Gomez-Lara J, Brugaletta S, Ortega-Paz L, et al. Long-Term Coronary Functional Assessment of the Infarct-Related Artery Treated With Everolimus-Eluting Bioresorbable Scaffolds or Everolimus-Eluting Metallic Stents: Insights of the TROFI II Trial. JACC Cardiovasc Interv 2018;11:1559-71.

    Sabaté M, Windecker S, Iñiguez A, et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial. Eur Heart J 2016;37:229-40.

    Presented by Dr. Patrick Serruys at the European Society of Cardiology Congress, London, September 1, 2015.

    Keywords: Dilatation, Acute Coronary Syndrome, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Stents, Thrombosis, ESC Congress


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