Suboptimal stent deployment is associated with subacute stent thrombosis: Optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study

doi:10.1016/j.ahj.2014.11.012

American Heart Journal

Volume 169, Issue 2, February 2015, Pages 249-256

https://doi.org/10.1016/j.ahj.2014.11.012 Get rights and content

Background

Acute or subacute stent thrombosis (ST) is a well-described complication usually causing acute coronary syndromes and, in the worst case scenario, sudden cardiac death. In this study, we aimed at exploring the potential role of optical coherence tomography (OCT) in the understanding of the mechanism of ST.

Methods

Twenty-one consecutive patients, after acute coronary syndromes due to a definite subacute ST, were assessed with OCT and matched 1:2 with 42 patients undergoing OCT for scheduled follow-up. Optical coherence tomography assessment was focused on features indicative of nonoptimal stent deployment: underexpansion, malapposition, edge dissection, and reference lumen narrowing.

Results

Optical coherence tomography revealed a minimum stent area sensibly smaller in the ST group (5.6 ± 2.6 vs 6.8 ± 1.7 mm²; P = .03) with a higher incidence of stent underexpansion when compared with the control group (42.8% vs 16.7%; P = .05). Dissection at stent edges was more commonly detected in ST group (52.4% vs 9.5%; P < .01). No significant differences between the 2 groups were observed for malapposition (52.4% vs 38.1%; P = .651) and reference lumen narrowing (19.0% vs 4.8%; P = .172). At least 1 OCT finding indicative of suboptimal stent deployment was detectable in 95.2% of patients experiencing ST versus 42.9% of the control group (P < .01).

Conclusions

Optical coherence tomography assessment in patients experiencing subacute ST revealed nonoptimal stent deployment in almost all cases with higher incidence of stent underexpansion and edge dissection, potentially explaining the cause of this adverse event. The adoption of an OCT-guided percutaneous coronary intervention protocol could have a potential for the prevention of ST in complex cases.

Section snippets

Study design and patient population

The present study was conceived as a prospective investigation in which all the study centers agreed to perform manual thrombus-aspiration followed by OCT evaluation in every patient presenting with suspected ST.

We retrospectively collected 25 consecutive patients with subacute ST in 5 independent centers between January 2010 and January 2012. All patients presented with ACS related to a definite ST occurring between 24 hours and 30 days after implantation of either bare-metal stents (BMS) or

Statistical analysis

Continuous data were expressed as mean ± SD and categorical data as count and proportions (%). Comparisons were performed by the χ² tests and unpaired t test as appropriate. All tests were 2 sided, and an α level of .05 was considered statistically significant.

To compare the OCT findings in patients with subacute ST included in the present study, a case-matched control (1:2) group of patients without ST, undergoing OCT for follow-up assessment of previously deployed stent, was selected from the

Ethical and legal considerations

The respect for the rights of the patients was guaranteed in each phase of the study in accordance with the Declaration of Helsinki and its current revision. Ethical approval was waived in the light of the observational retrospective design.

No extramural funding was used to support this work. The authors are solely responsible for the design and conduct of this study, all study analyses and drafting and editing of the paper.

Results

The demographic and procedural characteristics of the patients are depicted in the Table I, Table II. There were no significant differences regarding the main demographic variables that may impact on the subacute ST risk. In particular, the percentage of ST-elevation miocardial infarction as initial clinical presentation, DES/BMS ratio, stent length, and diameter were comparable in the 2 groups. The percentage of patients receiving dual anti-platelet regimen with thienopirydine and aspirine was

Discussion

The major findings of the present study are the following: (1) OCT definition of nonoptimal stent deployment is strictly associated with an increased risk of ST and (2) stent underexpansion and dissection at stent edges seem to be the main determinants of thrombosis in the early phases after implantation.

Most of the studies with intravascular imaging modalities that addressed the pathophysiology of ST were focused on the occurrence of late-occurring events.

Based on previous intravascular

Limitations

The article has some limitations. The studied population is small and nonrandomized due to the complexity of the study design. In fact, subacute ST remains exceedingly rare, and it was not simple to recruit a sufficient number of patients experiencing ST and interrogated with FD-OCT after thrombus aspiration. Although limited in size, this study remains a unique effort to obtain OCT information. Furthermore, the high incidence of suboptimal results in the ST group made possible to convey a

Conclusions

Optical coherence tomography is able to reveal nonoptimal stent deployment in most patients who experience subacute ST. Stent underexpansion and edge dissection are confirmed as main determinants of ST in the early phase after implantation. The potential impact of OCT guidance to optimize PCI outcome seems promising and requires further investigations.

References (26)

S.D. Wiviott et al.
Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial
Lancet
(2008)
F. Alfonso et al.
New insights on stent thrombosis: in praise of large nationwide registries for rare cardiovascular events
JACC Cardiovasc Interv
(2012)
E.J. Armstrong et al.
Clinical presentation, management, and outcomes of angiographically documented early, late, and very late stent thrombosis
JACC Cardiovasc Interv
(2012)
P. Buonamici et al.
Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis
J Am Coll Cardiol
(2007)
G.S. Mintz et al.
American college of cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology task force on clinical expert consensus documents
J Am Coll Cardiol
(2001)
A.N. Tenaglia et al.
Intracoronary ultrasound predictors of adverse outcomes after coronary artery interventions
J Am Coll Cardiol
(1992)
G. Guagliumi et al.
Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging
JACC Cardiovasc Interv
(2012)
G.S. Mintz et al.
Intravascular ultrasound in the drug-eluting stent era
J Am Coll Cardiol
(2006)
F. Prati et al.
Local delivery versus intracoronary infusion of abciximab in patients with acute coronary syndromes
J Am Coll Cardiol Intv
(2010)
G.J. Tearney et al.
Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies. A report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation
J Am Coll Cardiol
(2012)

M. Haude et al.

Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de-novo coronary lesions: 12-month results of the prospective, multi-center, first-in-man BIOSOLVE-I trial

Lancet

(2013)

K. Fujii et al.

Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation an intravascular ultrasound study

J Am Coll Cardiol

(2005)

F. Schiele et al.

Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies—with and without intravascular ultrasound guidance. Resist study group. Restenosis after ivus guided stenting

J Am Coll Cardiol

(1998)

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: All the authors gave substantial contributions to the conception and realization of this multicenter study and approved the final version of the manuscript.

: The authors have no conflict of interest to declare.

: This work was not supported by any funder.

View full text

Clinical InvestigationPrevention and RehabilitationSuboptimal stent deployment is associated with subacute stent thrombosis: Optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study

Background

Methods

Results

Conclusions

Section snippets

Study design and patient population

Statistical analysis

Ethical and legal considerations

Results

Discussion

Limitations

Conclusions

Lancet

JACC Cardiovasc Interv

JACC Cardiovasc Interv

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

JACC Cardiovasc Interv

J Am Coll Cardiol

J Am Coll Cardiol Intv

J Am Coll Cardiol

Lancet

J Am Coll Cardiol

J Am Coll Cardiol

Clinical Investigation
Prevention and Rehabilitation
Suboptimal stent deployment is associated with subacute stent thrombosis: Optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study