Comparison between implantation of drug-eluting stents under control of intravascular ultrasound and angiography: the randomized trial «orenburg». Part 1: study design, direct clinical results

DOI: https://doi.org/10.25512/DIR.2015.09.3.05

For quoting:
Demin V.V., Ilnickaya E.A., Galin P.Yu., Lomakina E.V., Demin D.V., Minakaeva N.Z., Dolgov S.A., Baryshnikov A.G., Murzajkina M.M., Lymareva M.L., Demin A.V., Kulinich T.N., Zherdev A.A. "Comparison between implantation of drug-eluting stents under control of intravascular ultrasound and angiography: the randomized trial «orenburg». Part 1: study design, direct clinical results". Journal Diagnostic & interventional radiology. 2015; 9(3); 31-43.

authors:

Demin V.V.

Ilnickaya E.A.

Galin P.Yu.

Lomakina E.V.

Demin D.V.

Minakaeva N.Z.

Dolgov S.A.

Baryshnikov A.G.

Murzajkina M.M.

Lymareva M.L.

Demin A.V.

Kulinich T.N.

Zherdev A.A.

keywords:

intravascular ultrasound

optical coherent tomography

drug-eluting stents

quantitative coronary arteriography

Abstract:

Aim: was to provide design and direct clinical outcomes of ORENBURG (Optimal dRug Eluting steNts implantation guided By combination of intravascular Ultrasound and optical coheRence tomoGraphy) - single-center randomized clinical trial.

Materials and methods: 1032 patients were included in this study These patients were treatec with 6 types of drug eluting stents. Patients were randomized not only to the type of implanted stent, but also to the type of guidance of the procedure: intravascular ultrasound (IVUS) - 676 patients, quantitative coronary arteriography (QCA) - 356 patients. Before the procedure was finished, all patients underwent optical coherence tomography (OCT) analysis. Regardless of its results no more adjacent procedures were performed.

Results: we provide characteristics of patients included in this study These characteristics showed an absence of significant differences between two groups of patients (IVUS and QCA groups) and between subgroups of patients, received different types of DES. While analyzing parameters of index procedure, it was emphasized that IVUS group involved a bigger number of patients with left main disease and bifurcation disease, and also a bigger number of stents per lesion, diameter of first stent, total length of used stents, maximal diameter of the postdilatation balloon. Characteristics of Nobori stent (range of sizes) can explain that significantly smaller diameter and length of the first and the second stent implanted, total length of stents per lesion, and maximal diameter of postdilatation balloon were recorded in the Nobori stent subgroup of patients. Besides that, in that subgroup were no patients with left main disease, smaller number of patients with angiographically evident calcifications, but was a bigger number of patients with circumflex artery disease. Immediate effect of the implantation was obtained in 100% of patients. According to the short-term follow-up, 1 patient died due to the myocardial infarction in the region of the untreated artery

Conclusion: angiographic data, and IVUS and OCT results of analyzed patients are going to be published in the next article.

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