Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects

Completed

• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Artery Bypass Grafting

• Registration Number: NCT06749171
• Lead Sponsor: Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh

Brief Summary

The aim of this observational single-centre study is the optimization of coronary artery bypass grafting (CABG) tactics considering gender and sex approach on the basis of complex comparative evaluation of surgical revascularization techniques. Patients enrolled in the study are divided into groups based on sex, as well as into stratum of surgery techniques.

Objectives of the study are:

1. To evaluate the preoperative profile of women and men referred for CABG.

2. To give a comparative assessment of CABG outcomes in the short-term and long-term postoperative period in patients of both sexes.

3. To carry out the comparative analysis of short-term and long-term outcomes of different CABG techniques for each sex.

4. To analyse the causes and identify predictors of complications and mortality after CABG in the female and male cohort.

5. To determine an optimal selection strategy of surgical revascularization technique for patients of different sexes based on the conducted comparative gender-sex analysis of modern coronary surgery techniques.

Detailed Description

This retrospective-prospective single-centre study aims to conduct an in-depth comparative analysis of the impact of preoperative profile and range of surgical techniques in coronary artery bypass grafting (CABG) surgery on short-term and long-term outcomes in women and men.

The study included a sample of 400 patients (200 women and 200 men) who underwent CABG between January 2016 and July 2023. Patients enrolled in the study were divided into groups based on sex with the following propensity score matching (PSM) analysis, as well as into stratum of surgery techniques - ONCAB (on-pump coronary artery bypass grafting), OPCAB (off-pump coronary artery bypass grafting), NTA (no-touch aorta technique), MICSCAB (minimally invasive multiple coronary artery bypass grafting). Furthermore, the impact of multiple arterial grafting (MAG), total arterial revascularization (TAR), composite and sequential grafting on outcomes was analyzed for each sex.

Included patients were evaluated for 112 various parameters of preoperative profile, intraoperative characteristics, in-hospital and long-term postoperative data. Perioperative data was obtained from the centre's digital medical information system. Long-term data was gathered from the regional state health information system by tracking patients' chronology of outpatient visits and complaints, subsequent hospital admissions, clinical and laboratory tests.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2023-07-31
• Study Completion: 2024-02-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients with multivessel coronary artery disease requiring CABG;
• age ≥ 18 years;
• patients residing in the Perm region.

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Exclusion Criteria

• single-vessel CABG;
• redo CABG;
• concomitant coronary artery disease and caroid artery disease and/or valvular disease and/or rhythm disorders requiring surgical treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACCE	from date of hospital discharge until the date of first documented major adverse cardiac and cerebrovascular event, through study completion, up to an average of 30 months	major adverse cardiac and cerebrovascular events - composite of all-cause mortality, myocardial infarction (MI), stroke or transient ischaemic attack (TIA) and repeat revascularization

Secondary Outcome Measures

Name	Time	Method
Death	from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months	all-cause mortality

Trial Locations

Locations (1)

Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov; 🇷🇺 Perm, Perm Kray, Russian Federation