Clinical Research
Optical Coherence Tomography Assessment of In Vivo Vascular Response After Implantation of Overlapping Bare-Metal and Drug-Eluting Stents

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Objectives

We designed a randomized trial exploiting optical coherence tomography (OCT) to assess coverage and apposition of overlapping bare-metal stents (BMS) and drug-eluting stents (DES) in human coronary arteries.

Background

Overlapping DES impair healing in animals. Optical coherence tomography allows accurate in vivo assessment of stent strut coverage and apposition.

Methods

Seventy-seven patients with long coronary stenoses were randomized to overlapping sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), or BMS. The primary goal of the study was to determine the rate of uncovered/malapposed struts in overlap versus nonoverlap segments, according to stent type, at 6-month follow-up with OCT.

Results

A total of 53,047 struts were analyzed. The rate of uncovered/malapposed struts was 1.5 ± 3.4% and 0.6 ± 2.7% in overlap versus nonoverlap BMS (p = NS), respectively, and 4.3 ± 11% and 3.6 ± 8% in overlap versus nonoverlap DES (p = NS), respectively. There were no differences in the rates of uncovered/malapposed struts between overlapping BMS and DES, likely due to low frequency of uncovered/malapposed struts in ZES (0.1 ± 0.4%), which offset the higher rates observed in SES (6.7 ± 9.6%) and PES (6.7 ± 16.5%, p < 0.05). Overlap segments showed greater neointimal volume obstruction versus nonoverlap segments in all DES (p < 0.05 for all DES types). Strut-level neointimal thickness at overlap and nonoverlap segments were lowest in SES (0.16 ± 0.1 mm and 0.12 ± 0.1 mm, respectively) compared with PES (0.27 ± 0.1 mm and 0.20 ± 0.1 mm, respectively), ZES (0.40 ± 0.16 mm and 0.33 ± 0.13 mm, respectively), and BMS (0.55 ± 0.31 mm and 0.53 ± 0.25 mm, respectively, p < 0.05).

Conclusions

As assessed by OCT the impact of DES on vascular healing was similar at overlapping and nonoverlapping sites. However, strut malapposition, coverage pattern, and neointimal hyperplasia differ significantly according to DES type. (Optical Coherence Tomography for Drug Eluting Stent Safety [ODESSA]; NCT00693030)

Key Words

coronary artery disease
optical coherence tomography
percutaneous transluminal coronary angioplasty
stent

Abbreviations and Acronyms

BMS
bare-metal stent(s)
DES
drug-eluting stent(s)
IVUS
intravascular ultrasound
LST
late stent thrombosis
NIH
neointimal hyperplasia
OCT
optical coherence tomography
PES
paclitaxel-eluting stent(s)
SES
sirolimus-eluting stent(s)
SIT
strut-level intimal thickness
ZES
zotarolimus-eluting stent(s)

Cited by (0)

This work was supported by Ospedali Riuniti di Bergamo and the University Hospitals and Case Western Reserve University, with unrestricted grant support from Medtronic Vascular and Boston Scientific Corporation. Dr. Guagliumi reports receiving consulting fees from Boston Scientific and Volcano and receiving grant support from LightLab, Medtronic Vascular, Boston Scientific, and Abbott Vascular. Dr. Biondi-Zoccai reports receiving consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Invatec, and Medtronic. Dr. Costa reports receiving consulting fees from LightLab, Medtronic, Scitech, Cordis, Boston Scientific, and Abbott Vascular.