Accurate identification of potential critical coronary lesions for the reduction of risk of cardiovascular events: study protocol for a randomized, open-label, active-controlled multi-center trial

Abstract

Background and objectives: The allocation of coronary artery disease patients with moderate coronary stenoses to interventional therapy or conservative treatment is a challenge because there is a lack of effective and accurate methods for identifying critical coronary lesions. This study is planned to determine whether therapy guided by identification of high-risk coronary plaque can reduce the risk of major adverse cardiovascular events (MACEs) in patients with critical lesions (50–75% stenoses).Design: This is a randomized, open-label, active-controlled multi-center trial.Methods: A total of 246 patients with suspected coronary artery disease will receive treatment guided by multimodality assessment (including risk factor score [RFS], fractional flow reserve [FFR], intravascular ultrasound [IVUS], or intracoronary optical coherence tomography [OCT] of coronary plaque) (RFS + FFR/IVUS/OCT group) versus treatment guided by routine assessment with 2D quantitative coronary angiography (QCA group).Outcome measures: The primary endpoint will be MACEs from baseline to 24 months. The secondary endpoint will be the overall economic burden on patients from enrollment to the end of the 24 months.Discussion: This study will assess the noninferiority of the treatment regimen for patients diagnosed with critical coronary lesions. The results may help to guide therapy to reduce the risk of MACEs.Ethics and dissemination: This study was approved by the Medical Ethics Committee of Southeast University (approval number: 2017ZDSYLL023-p01). Dissemination plans include presentations at scientific conferences and publication in scientific journals.Trial registration: ClinicalTrials.gov Identifier: NCT03195621, registered on June 22, 2017.