Clinical trial NCT06749171: Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects
Official title: Comparative Analysis of Coronary Revascularization Approaches Within Gender and Sex Aspects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Coronary Artery Bypass Grafting
Keywords: coronary artery bypass grafting
revascularization
OPCAB
ONCAB
NTA
MICSCAB
multiple arterial grafting
sequential grafts
composite grafts
cardiac surgery
women
sex
gender
Lead sponsor: Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were sampled from a cohort of 7945 CABG patients in accordance with the eligibility criteria and time period, followed by use of random number generating method to enrol 200 females and 200 males.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACCE
timeFrame: 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
Secondary outcomes:
measure: Death
timeFrame: from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months
Other outcomes:
Locations:
city: Perm
country: Russian Federation
facility: Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov
state: Perm Kray
Study officials:
References:
citation: Lilothia S.H. Timeline of scientific knowledge in the field of coronary artery bypass surgery focusing in the gender and sex perspective. Complex Issues of Cardiovascular Diseases. 2024;13(2): 196-202. DOI: 10.17802/2306-1278-202413-2-196-202
citation: Lilothia S. H. Gender inequality and cardiovascular diseases. Russian Journal of Cardiology. 2024;29(6):5873. doi: 10.15829/1560-4071-2024-5873. EDN LPEYQM