Serial Analysis of the Malapposed and Uncovered Struts of the New Generation of Everolimus-Eluting Bioresorbable Scaffold With Optical Coherence Tomography

doi:10.1016/j.jcin.2011.03.020

JACC: Cardiovascular Interventions

Volume 4, Issue 9, September 2011, Pages 992-1001

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Objectives

The aim of this study is to assess the serial changes in strut apposition and coverage of the bioresorbable vascular scaffolds (BVS) and to relate this with the presence of intraluminal masses at 6 months with optical coherence tomography (OCT).

Background

Incomplete strut/scaffold apposition (ISA) and uncovered struts are related to a higher risk of scaffold thrombosis. Bioresorbable vascular scaffolds can potentially avoid the risk of scaffold thrombosis because of its complete resorption. However, during the resorption period, the risk of scaffold thrombosis is unknown.

Methods

OCT was performed in 25 patients at baseline and 6 months. Struts were classified according to apposition, coverage, and presence of intraluminal masses. Persistent ISA was defined as malapposed struts present at baseline and follow-up, and late acquired ISA as ISA developing at follow-up, and scaffold pattern irregularities when the strut distribution suggested scaffold fracture.

Results

At baseline, 3,686 struts were analyzed: 128 (4%) were ISA, and 53 (1%) were located over side-branches (SB). At 6 months, 3,905 struts were analyzed: 32 (1%) ISA, and 35 (1%) at the SB. Persistent ISA was observed more frequently than late acquired-ISA (81% vs. 16%, respectively; 3% were unmatchable). Late acquired ISA was associated with scaffold pattern irregularities, which were related to overstretching of the scaffold. Uncovered struts (63 struts, 2%) were more frequently observed in ISA and SB struts, compared with apposed struts (29% vs. 1%; p < 0.01). Intraluminal masses (14 cross-sections, 3%; in 6 patients, 24%) were more frequently located at the site of ISA and/or uncovered struts (39% vs. 2% and 13% vs. 2%, respectively; p < 0.01).

Conclusions

The lack of strut apposition at baseline is related to the presence of uncovered struts and intraluminal masses at 6 month. An appropriate balloon/artery ratio respecting the actual vessel size and avoiding the overstretching of the scaffold can potentially decrease the risk of scaffold thrombosis. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)

Key Words

bioresorbable scaffolds

incomplete stent

late acquired incomplete stent

optical coherence tomography

strut apposition

uncovered struts

Abbreviations and Acronyms

BVS

bioresorbable vascular scaffolds

DES

drug-eluting stents

ISA

incomplete scaffold/strut apposition

IVUS

intravascular ultrasound

LAISA

late acquired incomplete scaffold/strut apposition

OCT

optical coherence tomography

side branch

Cited by (0)

: The Absorb Cohort B study has been funded by Abbott Vascular (Santa Clara, California). Dr. Windecker has received research grants from Abbott, Cordis, Medtronic, Biosensors, and Boston Scientific. Dr. Dudek has received research grants or served as consultant/advisory board member for Abbott, Adamed, AstraZeneca, Biotronik, Balton, Bayer, BBraun, BioMatrix, Boston Scientific, Boehringer Ingelheim, Bristol-Myers Squibb, Cordis, Cook, Eli Lilly, EuroCor, Glaxo, Invatec, Medtronic, The Medicines Co., MSD, Nycomed, Orbus-Neich, Pfizer, Possis, Promed, Sanofi-Aventis, Siemens, Solvay, Terumo, and Tyco. Dr. Smits has received travel fees from Abbott Vascular. Ms. Susan Veldhof and Dr. Rapoza are employees of Abbott Vascular. Dr. Ormiston is on the advisory board of and has received minor honoraria from Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.