Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study

The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown.

Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.

Study Overview

• Status: Completed
• Conditions: Coronary Revascularization; Syntax Score; Appropriateness
• Intervention / Treatment: Diagnostic test: real-time feedback of SYNTAX score category

• Study Type: Interventional
• Enrollment (Actual): 3245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • China National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
2. Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
3. Written informed consent.

Exclusion Criteria:

1. Have prior CABG;
2. Have stage PCI;
3. Have no assigned scenario in Chinese appropriate use criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYNTAX score category feedback group; A real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies.	Diagnostic test: real-time feedback of SYNTAX score category
No Intervention: Controlled group; Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inappropriate rate of coronary revascularization	Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.	1 month after study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of inappropriate PCI	Inappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.	1 month after study completion
The proportion of inappropriate CABG	Inappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.	1 month after study completion
The proportion of utilizing PCI procedures	The proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients	1 month after study completion
The proportion of utilizing CABG procedures	The proportion of patients who undergo coronary artery bypass graft (CABG) among total patients	1 month after study completion

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• Lin S, Zhang H, Chen SP, Rao CF, Wu F, Zhou FJ, Wang Y, Yan HB, Dou KF, Wu YJ, Tang YD, Xie LH, Guan CD, Xu B, Zheng Z. Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness. Chin Med J (Engl). 2020 Jun 5;133(11):1276-1284. doi: 10.1097/CM9.0000000000000827.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 3, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20160826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO