Journal Club

Paper

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

Presenter

PS

Summary

BACKGROUND

In patients with coronary artery disease who receive metallic drug-eluting coronary
stents, adverse events such as late target-lesion failure may be related in part
to the persistent presence of the metallic stent frame in the coronary-vessel wall.
Bioresorbable vascular scaffolds have been developed to attempt to improve longterm
outcomes.

METHODS

In this large, multicenter, randomized trial, 2008 patients with stable or unstable
angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting
bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting
cobalt–chromium (Xience) stent (686 patients). The primary end point, which was
tested for both noninferiority (margin, 4.5 percentage points for the risk difference)
and superiority, was target-lesion failure (cardiac death, target-vessel myocardial
infarction, or ischemia-driven target-lesion revascularization) at 1 year.

RESULTS

Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and
in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95%
confidence interval, −0.5 to 3.9; P = 0.007 for noninferiority and P = 0.16 for superiority).
There was no significant difference between the Absorb group and the
Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P = 0.29), targetvessel
myocardial infarction (6.0% and 4.6%, respectively; P = 0.18), or ischemiadriven
target-lesion revascularization (3.0% and 2.5%, respectively; P = 0.50). Device
thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in
0.7% of patients in the Xience group (P = 0.13).

CONCLUSIONS

In this large-scale, randomized trial, treatment of noncomplex obstructive coronary
artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared
with an everolimus-eluting cobalt–chromium stent, was within the prespecified
margin for noninferiority with respect to target-lesion failure at 1 year.

Supplementary Material

ABSORB Japan trial
ABSORB China slides

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