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Randomized Controlled Trial
. 2023 Jul 18;24(1):460.
doi: 10.1186/s13063-023-07497-5.

A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

Gwang-Seok Yoon #  1 , Seong-Huan Choi #  1 , Sung Woo Kwon  1 , Sang-Don Park  2 , Seong-Ill Woo  1
Affiliations
Randomized Controlled Trial

A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

Gwang-Seok Yoon et al. Trials. .

Abstract

Background: Percutaneous coronary intervention (PCI) has been developed using drug-eluting stents (DES); however, stent implantation is associated with concerns of stent thrombosis and target vessel revascularization (TVR). The stent diameter is a critical factor in TVR and clinical events. The nitrate administration in coronary angiography can dilate the reference vessel diameter, enabling accurate vessel size measurement and optimal stent implantation support. This study was designed to evaluate the effect of stent implantation in the maximally dilated coronary artery in patients with coronary artery disease (CAD).

Methods: This prospective double-blinded randomized (1:1) study is designed to compare the efficacy and safety between DES implantation into the nitrate-induced maximally dilated vessels and conventional DES implantation in patients with CAD. A total of 400 patients who underwent PCI with a sirolimus-eluting stent will be enrolled. The primary endpoint is the mean diameter of the deployed stents. Secondary endpoints include cardiac death, myocardial infarction, stent thrombosis, or ischemia-driven TVR 1 year after the procedure.

Discussion: This study will be the first randomized controlled trial to evaluate the effect of DES implantation on nitrate-induced maximally dilated vessels in patients with CAD.

Trial registration: The trial was registered on 18 June 2021 as Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels (ClinicalTrials.gov Identifier: NCT04931784).

Keywords: Coronary artery disease; Drug-eluting stent; Nitrates; Randomized controlled trial; Vasodilation.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
A flow-chart for the study. MI, myocardial infarction; PCI, percutaneous coronary intervention; SES, sirolimus-eluting stent; TVR, target vessel revascularization
See this image and copyright information in PMC

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