The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial

doi:10.1016/j.jcin.2016.03.027

JACC: Cardiovascular Interventions

Volume 9, Issue 12, 27 June 2016, Pages 1231-1242

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Abstract

Objectives

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up.

Background

Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent.

Methods

The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 − minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected.

Results

Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037).

Conclusions

BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)

Key Words

asymmetry

bioresorbable vascular scaffolds

eccentricity

expansion

Abbreviations and Acronyms

asymmetry index

BVS

bioresorbable vascular scaffold

DES

drug-eluting stent(s)

DoCE

device-oriented composite endpoint

EES

everolimus-eluting stent(s)

eccentricity index

IVUS

intravascular ultrasound

myocardial infarction

MLA

minimal lumen area

MSA

minimum scaffold/stent area

OSE

optimal scaffold/stent expansion

QCA

quantitative coronary angiography

Cited by (0)

: The ABSORB II trial was sponsored by Abbott Vascular. Dr. Lang has served as a consultant for Abbott Vascular, Medtronic, Biotronik, and Edwards Lifesciences. Dr. Egred has served as a proctor for Abbott Vascular; and has received honoraria for bioresorbable vascular scaffold workshops. Dr. Lesiak has received payments as an individual for advisory board and speaker honoraria from Abbott Vascular. Dr. Chevalier has served as a consultant for Abbott Vascular. Dr. Serruys has served on the international advisory board for Abbott Vascular; and on the advisory board for Boston Scientific. Dr. Onuma has served on the international advisory board for Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.