Elsevier

JACC: Cardiovascular Interventions

Volume 10, Issue 18, 25 September 2017, Pages 1809-1815
JACC: Cardiovascular Interventions

Focus on Bioresorbable Vascular Scaffolds
Clinical, Angiographic, and Procedural Correlates of Acute, Subacute, and Late Absorb Scaffold Thrombosis

https://doi.org/10.1016/j.jcin.2017.06.067Get rights and content
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Abstract

Objectives

The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries.

Background

Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique.

Methods

From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome.

Results

Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter <1.85 mm (odds ratio [OR]: 3.1; p = 0.004), off dual antiplatelet therapy (DAPT) status (OR: 3.1 to 3.5; p = 0.006 to 0.053), no post-dilatation with >1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036).

Conclusions

Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation.

Key Words

Absorb
bioresorbable scaffold
thrombosis

Abbreviations and Acronyms

BRS
bioresorbable scaffold
BVS
Abbott bioresorbable vascular scaffold
DAPT
dual antiplatelet therapy
DES
drug-eluting stent(s)
MLD
minimal lumen diameter
OR
odds ratio
QCA
quantitative coronary angiography
RVD
reference vessel diameter

Cited by (0)

This study was supported by an investigator-initiated small grant from Abbott Vascular. Dr. Ellis has been a consultant for Abbott Vascular, Boston Scientific, and Medtronic. Dr. Kereiakes has received research funding from Abbott Vascular and Boston Scientific; and has been a consultant for Abbott Vascular, Boston Scientific, Svelte Medical Systems, Micell Technologies, and Sino Medical Sciences Technology. Dr. Stone has been a consultant for REVA Medical. Dr. van Guens has received institutional research grants from Abbott Vascular and Boston Scientific. Dr. Tamburino has served on the speakers bureaus of Abbott, Medtronic, Stentys, and Terumo. Dr. Gori has received speakers honoraria from Abbott. Dr. Kimura has received a research grant from Abbott Vascular. Dr. Sabate has been a consultant for Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.