Coronary Artery Disease, Left Ventricular Cardiac Dysfunction
Conditions
Brief summary
The objective of this study is to evaluate the best treatment strategy in patients with critical coronary artery disease and severe left ventricular dysfunction. In details, main goal of the study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention.
Detailed description
Despite CABG being increasingly performed in patients with reduced EF, the literature lacks of data directly comparing the clinical outcomes of surgical versus percutaneous revascularization in patients with left ventricular dysfunction. The goal of this study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention (PCI). All patients affected by coronary artery disease who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023, and who meet the inclusion and exclusion criteria, will be included in the study. Each patient will be enrolled following an interview and the subsequent signing of the informed consent form. Data will then be recorded in a dedicated database. In detail, the following information will be collected: anamnestic data, description of the performed procedure, preoperative and postoperative laboratory test results, preoperative, intraoperative, and postoperative echocardiographic parameters (including follow-up visits up to 2 years after the procedure), length of stay in the Intensive Care Unit and in the general ward, and data regarding any intraoperative and postoperative complications (death, shock, pericardial effusion, stroke, myocardial infarction, need for postoperative PCI, rehospitalization, heart failure). All data recorded in the database are routinely collected for all patients undergoing this type of intervention, and no additional examinations will be performed on patients included in the study.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years old; * Written informed consent; * Indication to CABG surgery (both "on-pump" and "off-pump") or to PCI; * Preoperative EF ≤35%.
Exclusion criteria
* Inability to give written informed consent; * Emergency surgery; * Combined cardiac surgical procedures; * Previous cardiac surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | through study completion, an average of 1 year | Number of patients who died for any cause after CABG or PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality from cardiovascular causes | through study completion, an average of 1 year | Number of patients who died for cardiovascolar causes after CABG or PCI |
| Acute myocardial infarction | through study completion, an average of 1 year | Number of patients who experienced myocardial infarction after CABG or PCI |
| Rehospitalization from cardiovascular reasons | through study completion, an average of 1 year | Number of patients who needed rehospitalization after being discharged |
| Repeated revascularization | through study completion, an average of 1 year | Number of patients who needed repeated revascularization after CABG or PCI |
| Stroke | through study completion, an average of 1 year | Number of patients who had stroke after CABG or PCI |
Countries
Italy
Outcome results
None listed