Clinical Research
Long-Term Impact of Routinely Detected Early and Late Incomplete Stent Apposition: An Integrated Intravascular Ultrasound Analysis of the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Studies

https://doi.org/10.1016/j.jcin.2010.03.007Get rights and content
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Objectives

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.

Background

The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.

Methods

We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.

Results

There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.

Conclusions

Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.

Key Words

bare-metal stent
drug-eluting stent
intravascular ultrasound
stent apposition

Abbreviations and Acronyms

AMI
acute myocardial infarction
BMS
bare-metal stent(s)
ISA
incomplete stent apposition
IVUS
intravascular ultrasound
MACE
major adverse cardiovascular events
MI
myocardial infarction
PES
paclitaxel-eluting stent(s)
SES
sirolimus-eluting stent(s)
TVR
target vessel revascularization

Cited by (0)

Dr. Steinberg is a member of the Speakers' Bureau of Boston Scientific Corporation. Dr. Mintz has received grant support from Boston Scientific Corporation and Volcano Corporation, and is a consultant or a member of the Speakers' Bureau from Boston Scientific, Volcano, LightLab, and Terumo. Drs. Grube, Ellis, Ormiston, Turco, Stone, and Weissman have each received grant support (>$10,000) from Boston Scientific Corporation.