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.  

References 

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3.    Demin V.V. Klinicheskoe rukovodstvo po vnutrisosudistomu ultrazvukovomu skanirovaniyu [Clinical guide to intravascular ultrasound]. Orenburg: Yuzhnyj Ural [South Ural]. 2005; 400.[In Russ].

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Abstract:

Aim: was to provide data of examination of patients of single-center randomized clinical trial ORENBURG (results of angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), which were made at different stages of primary operations).

Materials and methods: 1032 patients were enrolled into this trial and uniformly distributed into 6 subgroups, representing 6 different types of drug-eluted stents implanted. Patients in this study were also divided into IVUS guidance and angiography guidance subgroups in 2 to 1 ratio. All patients underwent the OCT examination at the final stage of the procedure, and according to OCT results, no additional interventions were performed. Data of instrumental studies was analyzed with use of modern statistical methods and programs.

Results: according to angiographic data, in-segment lesion length and lumen volume before the operation were higher in IVUS group. After intervention, lumen volume was still higher, and % diameter stenosis and % area stenosis were lower in IVUS group in comparison with angiography group. Comparison of IVUS and angiography data after predilatation showed that IVUS was associated with bigger absolute values of minimum lumen diameter (MLD) and minimum lumen area (MLA), while % diameter stenosis and % area stenosis were similar between two groups. At control IVUS and OCT studies the region of the maximum residual stenosis did not usually match with the site of the baseline maximum stenosis. Quantitative data in these segments significantly differed. According to control IVUS data, additional angioplasty in stent was needed in 10,1 % of patients. Additional procedure allowed to improve all quantitative indicators. Implantations of different types of stents were performed using similar interventional technic but randomized by selection of stent eluting. Nevertheless, initial technical parameters of endoprosthesis affected quantitative results of the implantation. Nobori stent showed biggest differences in quantitative results of implantation in comparison with other types of stents and to the whole group.

Conclusion: ORENBURG is second large trial in terms of volume, and second large trial that was initiated, and which was dedicated to the comparison of interventional strategies using drug-eluting stents under intravascular visualization or angiography guidance. The minimal incidence of MACE was registered during the period of in-hospital stay Only one case of cardiac death was registered, and it was not associated with the region of the treated artery. Results of ORENBURG trial confirm the tendency to absolute measures recieved by intravascular methods of visualization, and used for characterization of defeated vessel excess absolute measures received by angiography.

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