Coronary Artery Calcification, Coronary Artery Disease, Coronary Occlusion, Coronary Stenosis, Coronary Syndrome, Coronary Thrombosis, Myocardial Infarction (MI), Radiation Toxicity
Conditions
Keywords
PCI,DES, Radiation
Brief summary
In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.
Detailed description
A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria). The following criteria were employed to delineate complex or very complex angioplasties: * Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI) * Angioplasty of a Bifurcation Lesion (CBL-PCI) The following definitions pertain to the classification of angioplasty procedures: * Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity. * Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity. * Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.
Interventions
DEVICENon Complex PCI
The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).
DEVICEComplex PCI
The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.
Sponsors
Centre Cardiologique du Nord
Clinica Mediterranea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 days | The primary end point of the study is the rate of death |
| Myocardial Infarction | 30 days | The primary end point of the study is the rate of myocardial infarction |
| Stent Thrombosis | 30 days | The primary end point of the study is the rate of stent thrombosis |
| Acute Kidney Injury | 30 days | The primary end point of the study is the rate of acute kidney injury |
| Coronary Obstruction Requiring Intervention | 30 days | The primary end point of the study is the rate of coronary obstruction requiring intervention |
| Increase in Tnl and Tnt Levels | 30 days | The primary end point of the study is the rate in increase of Tnl and Tnt levels |
| Rehospitalization | 30 days | The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Revascularization | 1 year | The secondary end point of the study is the rate of target vessel revascularization |
| Target Lesion Revascularization | 1 year | The secondary end point of the study is the rate of target lesion revascularization |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrancesco Nappi, MD
Centre Cardiologique du Nord
Outcome results
None listed