Bleeding, Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
Percutaneous coronary intervention, Cangrelor, High bleeding risk, Coronary artery disease, Acute myocardial infarction
Brief summary
The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.
Detailed description
Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naïve to P2Y12 inhibitors. These recommendations are based on the large Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) program, which encompassed three randomized controlled trials (RCTs) enrolling both chronic and acute coronary syndromes. Consistently, the aforementioned studies showed the benefit of cangrelor in terms of ischemic events (mainly driven by a reduction of myocardial infarction - MI - and stent thrombosis - ST) in the face of an increased rate of minor bleeding. However, those RCTs were primarily focused on populations at considerable ischemic risk and with predictably low bleeding proneness, including young patients without bleeding risk features. In the contemporary practice, however, PCI is increasingly frequent in patients at high risk of bleeding, who are not formally prevented from being administered with cangrelor by international guidelines and possibly necessitate powerful and rapid-onset platelet inhibition while undergoing complex percutaneous revascularization. The present registry was therefore conceived at the scope of collecting data on the use of cangrelor in high bleeding risk (HBR) patients undergoing contemporary PCI. Specifically, it will assess the frequency of HBR patients in a real-world cohort of individuals treated with cangrelor and will compare the clinical outcomes of HBR and non-HBR patients.
Interventions
DRUGCangrelor
Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes
Sponsors
University of Campania Luigi Vanvitelli
Universita degli Studi di Genova
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes
Exclusion criteria
1\. Cangrelor administration as a bridge to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of NACE | 48 hours | A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hemorrhagic stroke | 48 hours | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of hemorrhage, involving the brain, spinal cord or retina |
| Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding | 48 hours | Bleeding grade 3 and 5 according to the ARC definition |
| Rate of myocardial infarction | During hospital stay (up to discharge day), on average 5 days | Myocardial infarction according to the 4th Universal definition |
| Rate of blood transfusion | During hospital stay (up to discharge day), on average 5 days | Blood transfusion during hospital stay |
| Rate of myocardial infarction (periprocedural) | 48 hours | Myocardial infarction (periprocedural) according to the 4th Universal definition |
| Rate of MACE | 48 hours | A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis |
| Rate of ischemic stroke | 48 hours | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of infarction, involving the brain, spinal cord or retina |
| Rate of cardiovascular death | 48 hours | Cardiovascular death according to the ARC definition |
| Rate of definite or probable stent thrombosis | 48 hours | Definite or probable stent thrombosis according to the ARC definition |
| Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding | 48 hours | Bleeding grade 2,3 and 5 according to the ARC definition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of thrombolysis in myocardial infarction (TIMI) major bleeding | 48 hours | Major bleeding according to the TIMI definition |
| Rate of thrombolysis in myocardial infarction (TIMI) minor bleeding | 48 hours | Minor bleeding according to the TIMI definition |
| Rate of all-cause death | 48 hours | All-cause death |
Countries
Italy
Contacts
Primary ContactItalo Porto, MD, PhD
Outcome results
None listed