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Sex-related Differences in Outcome After Hybrid Coronary Revascularization

Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06023355
Acronym
SEX-HYBRID
Enrollment
1000
Registered
2023-09-05
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2023-11-29

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

Conditions

Coronary Artery Disease

Brief summary

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Detailed description

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. Limited by their sample size, these individual studies may have been under-powered to detect a difference. To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Interventions

PROCEDUREHYBRID

It involves the combination of a sternal sparing left internal mammary artery (LIMA) bypass and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for non-left anterior descending (LAD) lesions. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer in-hospital complications, and lower utilization of healthcare resources, while providing the key benefits of LIMA-LAD grafting.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

Patients with coronary artery disease and indication to cardiac surgery

Exclusion criteria

Contraindications to cardiac surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Overall MortalityUp to 1 yearAll causes deaths
Incidence of Composite End-pointUp to 1 yearCardiac death, myocardial infarction, stroke, bleeding

Contacts

Primary ContactFrancesco Pelliccia
f.pelliccia@mclink.it+390633062615
Backup ContactFabio Miraldi
f.pelliccia@mclink.it+390633062615

Outcome results

None listed

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