Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction - ISAR-Absorb MI

Feb 05, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Deutsches Herzzentrum Munchen
Date Published:
12/05/2018
Date Updated:
02/05/2019
Original Posted Date:
02/05/2019
References

Contribution To Literature:

The ISAR-Absorb MI trial showed that BVS was noninferior to durable polymer DES for percent diameter stenosis at angiographic follow-up.

Description:

The goal of the trial was to evaluate the everolimus-eluting bioresorbable scaffold (BVS) compared with the durable polymer everolimus-eluting stent (DES) among patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI).


Study Design

  • Randomized
  • Parallel

Patients with acute MI undergoing PCI were randomized to BVS (n = 173) versus DES (n = 89).

  • Total number of enrollees: 262
  • Duration of follow-up: 1 year (clinical follow-up); 6-8 months (angiographic follow-up)
  • Mean patient age: 62 years
  • Percentage female: 20%
  • Percentage with diabetes: 22%

Inclusion criteria:

  • ST-segment elevation MI (STEMI) or NSTEMI with visible thrombus
  • Reference vessel diameter 2.5-3.9 mm

Exclusion criteria:

  • Left main lesion
  • Severely calcified lesion
  • Bifurcation lesion
  • In-stent restenosis
  • Contraindication to antiplatelet therapy

Principal Findings:

The primary outcome, in-segment percent diameter stenosis, occurred in 24.6% of the BVS group compared with 27.3% of the DES group (p for noninferiority < 0.001).

Among patients with STEMI, in-segment percent diameter stenosis was 23.7% in the BVS group compared with 29.3% in the DES group, and among patients with NSTEMI, in-segment percent diameter stenosis was 27.8% in the BVS group compared with 22.2% in the DES group (p for interaction = 0.004).

Secondary device-oriented outcomes:

  • Definite device thrombosis: 1.2% of the BVS group versus 2.3% of the DES group (p = not significant [NS])
  • Cardiac death, MI, or target lesion revascularization: 7.0% of the BVS group versus 6.7% of the DES group (p = NS)

Interpretation:

Among patients with acute MI (STEMI or high-risk NSTEMI) undergoing PCI, the BVS was noninferior to the DES. In-segment percent diameter stenosis was noninferior between treatment groups. There was evidence for treatment interaction such that patients with STEMI appeared to derive greater benefit from BVS. There were no apparent safety concerns with the BVS since definite stent thrombosis and device-related adverse cardiac events were similar between the treatment groups.

It is important to place this study in the context of other studies. In the ABSORB-STEMI TROFI II trial, which was conducted in STEMI patients, an intravascular ultrasound marker for vessel healing and device-related adverse events was similar between BVS and DES groups. Among stable ischemic heart disease patients, the ABSORB III trial showed a trend toward more target lesion failure at 12 months with BVS compared with DES. A meta-analysis of over 10,000 patients (59% with acute coronary syndromes) demonstrated that BVS patients were associated with a higher risk of MI and definite/probable stent thrombosis compared with DES patients. Poor sales and safety concerns led to the removal of this device from the worldwide market. It is possible that STEMI is a clinical scenario that deserves further careful study with BVS.

References:

Byrne RA, Alfonso F, Schneider S, et al. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J 2019;40:167-76.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Absorbable Implants, Acute Coronary Syndrome, Angiography, Coronary Stenosis, Constriction, Pathologic, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Polymers, Stents, Thrombosis


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