Study Results
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Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2021-05-13
2025-07-30
Brief Summary
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This study wants to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients in three subgroups of patients:
* Hybrid coronary revascularization strategy (coronary by-pass + PCI);
* Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
* Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.
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Detailed Description
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Aim of the study is to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients. Specifically, three subgroups will be analysed:
* Hybrid coronary revascularization strategy (HCR, coronary by-pass + PCI);
* Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
* Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).
The local Heart Team (cardiac surgeon, interventional cardiologist, clinical cardiologist and anaesthetist) will decide which patients will be referred for hybrid treatment. Typically, this happens when the Heart Team feels that hybrid treatment could reduce the overall risk of a combined procedure.
The patient population consists of adult patients with:
* Multi-vessel coronary artery disease (CAD) involving the left main and/or the left anterior descending artery with indication for revascularization;
* Severe, symptomatic valvular disease and CAD with indication for revascularization;
* Significant unilateral carotid stenosis and CAD with indication for revascularization.
In a previous data review board on the Heart Team activity, we recognized that 10% of discussed patients are referred for hybrid procedures (HP) and that observed operative mortality was strongly lower than that predicted by STS and EuroSCORE (2.5% versus 10.1% and 5.9%, respectively). Morbidity was not prospectively investigated. For sample size estimation, the investigators hypothesized that Morbidity might be reduced by 50% in HP group as compared with predicted STS. The mean expected STS morbidity estimated in the study population is 32.57%. Accordingly, a total number of 111 patients with an alpha error of 5% and a beta error of 20% has been calculated to be needed to test this hypothesis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hybrid coronary revascularization strategy (HCR)
Patients who undergo a combination of coronary artery bypass grafting and PCI.
Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
Hybrid valve and coronary disease correction
Patients who undergo a combination of surgical valve replacement and PCI.
Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
Surgical valve replacement
Surgical mitral and / or aortic valve replacement.
Hybrid coronary and carotid artery disease treatment
Patients who undergo a combination of coronary artery bypass grafting and carotid stenting.
Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
Carotid artery stenting
Carotid artery stenting.
Interventions
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Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
Surgical valve replacement
Surgical mitral and / or aortic valve replacement.
Carotid artery stenting
Carotid artery stenting.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* CAD with indication for revascularization
* Coronary anatomy as follows:
* Multivessel-CAD involving the left anterior descending (LAD) (proximal or mid) and/or the left main (LM) (ostial, mid-shaft or distal) with at least one further epicardial coronary artery requiring treatment (LCX or RCA), OR
* Single vessel disease involving the LAD and a major diagonal, both requiring independent revascularization with at least one stent
* Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiring surgery, with CAD (involving one or more vessels), suitable for PCI
* CAD with indication for revascularization with severe unilateral carotid stenosis (\>85%)
* Ability to tolerate, and no plans to interrupt dual antiplatelet therapy (DAPT) for:
* At least 6 months in presentation was stable CAD,
* At least 12 months if presentation was a biomarker-positive acute coronary syndrome (ACS)
* Willing to comply with the follow-up required by the protocol.
Exclusion Criteria
* Previous thoracic surgery involving the left pleural space (if a left thoracotomy approach is planned)
* Complicated or unsuccessful PCI within 30 days prior
* Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
* Cardiogenic shock at time of screening
* Any prior lung resection
* End-stage renal disease on dialysis
* Extra-cardiac illness that is expected to limit survival to less then 5 years
* Allergy or hypersensitivity to any of the study drugs or devices used in protocol
* Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgement of the investigator
* Pregnant at time of screening, or unwilling to use effective birth control measures while dual antiplatelet therapy is required.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Dr. Bruno
Clinical Professor
Principal Investigators
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Piergiorgio Bruno, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Countries
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References
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Other Identifiers
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3959
Identifier Type: -
Identifier Source: org_study_id
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