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Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy

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Abstract

We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared with the results from a cohort of 485 STEMI patients undergoing primary PCI without additional imaging. Imaging of the infarct-related artery at baseline (and follow-up) was successful in 92.2 % (96.6 %) of patients using OCT and in 93.2 % (95.5 %) using IVUS. Imaging of the non-infarct-related vessels was successful in 88.7 % (95.6 %) using OCT and in 90.5 % (93.3 %) using IVUS. Periprocedural complications occurred <2.0 % of OCT and none during IVUS. There were no differences throughout 2 years between the imaging and control group in terms of MACE (16.7 vs. 13.3 %, adjusted HR1.40, 95 % CI 0.77–2.52, p = 0.27). Multi-modality three-vessel i.c. imaging in STEMI patients undergoing primary PCI is consistent a high degree of success and can be performed safely without impact on cardiovascular events at long-term follow-up.

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Abbreviations

ARC:

Academic research consortium

CI:

Confidence interval

DES:

Drug-eluting stent

MACE:

Major adverse cardiac event

MI:

Myocardial infarction

ST:

Stent thrombosis

TLF:

Target lesion failure

TLR:

Target lesion revascularization

IVUS:

Intravascular ultrasound

IVUS-VH:

IVUS virtual histology

OCT:

Optical coherence tomography

PCI:

Percutaneous coronary intervention

STEMI:

ST-elevation myocardial infarction

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Conflict of interest

The authors report the following conflicts of interest/financial disclosures: Dr. Räber has received speaker fees and research support from St. Jude Medical. Prof. Meier has received has received educational and research support to the institution from Abbott, Cordis, Boston Scientific, and Medtronic. Prof. Windecker has received research contracts to the institution from Biotronic and St. Jude. Prof. Wenaweser has received honoraria and lecture fees from Medtronic and Edwards Lifesciences. Prof. Roffi reported receiving grants from Boston Scientific, Abbott Vascular, Medtronic, and Biosensor; and payment for lectures from Lilly-Daiichi Sankyo. Prof. Lüscher reports research grants to the institution from Biosensors, Biotronik, Boston Scientific, and Medtronic All other authors reported no conflicts of interest.

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Correspondence to Lorenz Räber.

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The IBIS4 trial was supported by the Swiss National Science Foundation, and is registered at:

http://www.clinicaltrials.gov/ct2/show/NCT00617084.

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Taniwaki, M., Radu, M.D., Garcia-Garcia, H.M. et al. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy. Int J Cardiovasc Imaging 31, 915–926 (2015). https://doi.org/10.1007/s10554-015-0631-0

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