Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects (CROWN-SAGA)

Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh

Status: Completed

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

Treatments: Procedure: coronary artery bypass grafting

Study type: Observational

Funder types: Other

Identifiers

NCT06749171

CROWN-SAGA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

400 participants in 2 patient groups

Women

Description:

Women undergoing CABG

Treatment:

Procedure: coronary artery bypass grafting

Men

Description:

Men undergoing CABG

Treatment:

Procedure: coronary artery bypass grafting