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Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects

Comparative Analysis of Coronary Revascularization Approaches Within Gender and Sex Aspects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06749171
Acronym
CROWN-SAGA
Enrollment
400
Registered
2024-12-27
Start date
2016-01-01
Completion date
2024-02-01
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting, Coronary Artery Disease, Ischemic Heart Disease

Keywords

coronary artery bypass grafting, revascularization, OPCAB, ONCAB, NTA, MICSCAB, multiple arterial grafting, sequential grafts, composite grafts, cardiac surgery, women, sex, gender

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.

Interventions

PROCEDUREcoronary artery bypass grafting

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)

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MACCEfrom 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 monthsmajor adverse cardiac and cerebrovascular events - composite of all-cause mortality, myocardial infarction (MI), stroke or transient ischaemic attack (TIA) and repeat revascularization

Secondary

MeasureTime frameDescription
Deathfrom date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 monthsall-cause mortality

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026