A Bioresorbable Everolimus-Eluting Scaffold Versus a Metallic Everolimus-Eluting Stent - COMPARE-ABSORB

Sep 25, 2018
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Presenter/Author:
Pieter Smits, MD, PhD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
09/25/2018
Date Updated:
09/25/2018
Original Posted Date:
09/25/2018
References

Contribution To Literature:

The COMPARE-ABSORB trial showed that the Absorb BVS is noninferior for target-lesion failure compared with cobalt-chromium-based Xience DES up to 1 year for cardiovascular outcomes in lesions/patients at high-risk for restenosis, but MI and device thrombosis were significantly higher with Absorb BVS.

Description:

The goal of the trial was to assess the safety and efficacy of Absorb BVS compared with Xience drug-eluting stents (DES) using appropriate implantation techniques in a population more likely to benefit from vascular restoration therapy.

Study Design

Patients were randomized in a 1:1 fashion to either Absorb BVS (n = 848) or cobalt-chromium-based Xience DES (n = 822). In the BVS arm, a strategy of PSP was utilized for appropriate implantation – predilation, appropriate sizing, and post-dilation to high pressures.

  • Total number of enrollees: 1,670
  • Duration of follow-up: 2 years
  • Mean patient age: 62 years
  • Percentage female: 22%
  • Percentage with diabetes: 35%

Inclusion criteria:

Patients with at least one of the following:

1) High-risk characteristics for restenosis

  • Known diabetes and/or multivessl disease of which more than one de novo target lesion to be treated with the study scaffold/stent

2) Complex de-novo target lesion

  • Lesion length >28 mm
  • Small vessels: reference vessel diameter (RVD) between 2.25-2.75 mm
  • Lesion with pre-existing total occlusion
  • Bifurcation with single device strategy

Exclusion criteria:

  • Patients at age >75 years
  • Renal insufficiency (glomerular filtration rate <30 ml/min)
  • Known left ventricular ejection fraction (LVEF) <30%
  • Life expectancy <7 years
  • Known nonadherence to dual antiplatelet therapy
  • Patients on oral anticoagulation (OAC) or novel OAC
  • Cardiogenic shock, Killip class >2
  • Target lesion reference vessel diameter <2.25 and >4.0 mm
  • ST-segment elevation myocardial infarction (STEMI) with target lesion RVD of >3.5 mm
  • Target lesion with in-stent/scaffold thrombosis or restenosis
  • Graft lesions as target lesions
  • Severe tortuosity of target vessel
  • Bifurcation target lesion with intended two-device strategy

Other salient features/characteristics:

  • Prior PCI: 24%
  • LVEF: 56%
  • Acute coronary syndrome: 50%
  • Multivessel PCI: 36%
  • Lesion length >28 mm: 29%
  • Intravascular ultrasound: 14%

Principal Findings:

The trial was terminated prematurely by the Data Safety and Monitoring Board following safety concerns from the ABSORB II and III trials. The primary outcome, target-lesion failure (cardiac death, target-vessel MI [TV-MI], ischemia-driven target-lesion revascularization) for BVS vs. Xience at 1 year, was 5.1% vs. 4.2% (p for noninferiority < 0.001, p for superiority = 0.35).

  • Cardiac death: 0.6% vs. 0.1%, p = 0.11
  • TV-MI: 4.0% vs. 2.1%, p = 0.02
  • Ischemia-driven revascularization: 2.4% vs. 2.7%, p = 0.69

Secondary outcomes for BVS vs. EES:

  • Acute device success: 96.8% vs. 92.4%, p < 0.0001
  • Stent/scaffold thrombosis: 2.0% vs. 0.6%, p = 0.01
  • All-cause mortality: 0.7% vs. 0.6%, p = 0.79

Interpretation:

The results of the COMPARE-ABSORB trial indicate that Absorb BVS is noninferior for target-lesion failure compared with cobalt-chromium-based Xience DES up to 1 year for cardiovascular outcomes in lesions/patients at high risk for restenosis. However, TV-MI and device thrombosis were significantly higher with Absorb BVS. All patients underwent the PSP technique with an aim to improve outcomes.

Results were similar to those noted in the ABSORB trials, with a similar signal of harm. In fact, COMPARE-ABSORB was stopped early due to persistent safety concerns from the ABSORB trials, particularly device thrombosis. As these signals were emerging, a number of protocol amendments were made to this trial, including extending the follow-up to 7 years, excluding vessels with RVD <2.5 mm, and extending dual antiplatelet therapy up to 36 months, among others. Despite this, BVS thrombosis rates remained higher than EES in this trial. The stent was commercially withdrawn in 2017. Longer-term data as well as trials with improved stent design and implementation techniques are awaited.

References:

Presented by Dr. Pieter C. Smits at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 25, 2018.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Chronic Angina

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Acute Coronary Syndrome, Chromium, Cobalt, Coronary Restenosis, Diabetes Mellitus, Dilatation, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Thrombosis


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