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.
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.
Study Type
OBSERVATIONAL
Enrollment
900
Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes
Università degli Studi della Campania "Luigi Vanvitelli"
Caserta, Italy
RECRUITINGUniversity of Genoa
Genova, Italy
RECRUITINGRate of NACE
A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding
Time frame: 48 hours
Rate of MACE
A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis
Time frame: 48 hours
Rate of cardiovascular death
Cardiovascular death according to the ARC definition
Time frame: 48 hours
Rate of myocardial infarction (periprocedural)
Myocardial infarction (periprocedural) according to the 4th Universal definition
Time frame: 48 hours
Rate of ischemic stroke
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
Time frame: 48 hours
Rate of hemorrhagic stroke
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
Time frame: 48 hours
Rate of definite or probable stent thrombosis
Definite or probable stent thrombosis according to the ARC definition
Time frame: 48 hours
Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bleeding grade 2,3 and 5 according to the ARC definition
Time frame: 48 hours
Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding
Bleeding grade 3 and 5 according to the ARC definition
Time frame: 48 hours
Rate of MACE
A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of cardiovascular death
Cardiovascular death according to the ARC definition
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of myocardial infarction
Myocardial infarction according to the 4th Universal definition
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of ischemic stroke
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
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of hemorrhagic stroke
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
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of definite or probable stent thrombosis
Definite or probable stent thrombosis according to the ARC definition
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of blood transfusion
Blood transfusion during hospital stay
Time frame: During hospital stay (up to discharge day), on average 5 days