Coronary
Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy

https://doi.org/10.1016/j.jcin.2016.10.019Get rights and content
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Abstract

Objectives

The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus.

Background

Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population.

Methods

In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%.

Results

Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF.

Conclusions

The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.

Key Words

bioresorbable vascular scaffolds
coronary artery disease
diabetes

Abbreviations and Acronyms

BVS
bioresorbable vascular scaffold
CL
confidence limit
DES
drug-eluting stent(s)
EES
everolimus-eluting stent
MI
myocardial infarction
PCI
percutaneous coronary intervention
PG
performance goal
QCA
quantitative coronary angiography
RVD
reference vessel diameter
TLF
target lesion failure
TV-MI
target vessel myocardial infarction

Cited by (0)

The ABSORB EXTEND, ABSORB II, ABSORB III, and ABSORB Japan trials have been sponsored and funded by Abbott Vascular. Dr. Kereiakes has received research funding from Abbott Vascular and Boston Scientific; and has served as a consultant for Abbott Vascular, Boston Scientific, Svelte Medical Systems, Micell Technologies, and Sino Medical Sciences Technology. Drs. Ellis and Chevalier have served as consultants for Abbott Vascular. Dr. Kimura has served on the advisory board of and received research grant support from Abbott Vascular. Dr. Abizaid has received research grant support from Abbott Vascular. Dr. Zhao, Susan Veldhof, Minh-Thien Vu, and Dr. Zhang are full time employees of Abbott Vascular. Dr. Onuma has served on the advisory board of Abbott Vascular. Dr. Stone has served as consultant for Reva Corp. Dr. Serruys has reported that he has no relationships relevant to the contents of this paper to disclose.