Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study
Leonardo De Luca1, Paolo Calabrò2, Fabio Chirillo3
1Department of Cardiosciences, Division of Cardiology, Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy.
Insights
The ARCANGELO study found cangrelor safe for acute coronary syndrome patients during PCI, with no severe bleeding linked to the drug. This provides preliminary confirmation of its safety profile in real-world practice.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- The ARCANGELO study assessed cangrelor safety in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).
- Real-world safety data is crucial for understanding drug performance beyond controlled trial settings.
Purpose of the Study:
- To evaluate the safety of cangrelor in ACS patients during PCI.
- To assess bleeding outcomes within 30 days post-PCI after transitioning to oral P2Y12 inhibitors.
Main Methods:
- Adult ACS patients treated with cangrelor at 28 centers were enrolled.
- Bleeding events (BARC classification), MACEs, and adverse events were recorded over 30 days post-PCI.
- Interim results from two-thirds of the enrollment period are presented.
Main Results:
- 17 bleeding events (mostly BARC Type 1-2) occurred in 320 patients.
- One BARC Type 3a bleed (hematoma) was noted.
- Four MACEs were recorded, including myocardial infarction and cardiac/non-cardiac deaths.
- No bleeding events were attributed to cangrelor.
Conclusions:
- Interim findings suggest cangrelor use in ACS patients undergoing PCI is not associated with severe bleeding.
- The study provides preliminary evidence supporting cangrelor's safety in daily clinical practice.
Background:
The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice.
Hypothesis:
The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines.
Methods:
Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two-thirds of the enrollment period are presented.
Results:
A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1-2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor.
Conclusions:
The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.
More Related Videos
10:28Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
05:41Left Anterior Descending Coronary Artery Ligation for Ischemia-Reperfusion Research: Model Improvement via Technical Modifications and Quality Control
Published on: December 16, 2022
Related Concept Videos
01:25Antianginal Drugs: Calcium Channel Blockers and Ranolazine
CCBs, a diverse class that includes dihydropyridines (nifedipine) and diphenylalkylamines (verapamil and diltiazem), exert their effect by blocking calcium channels in cardiac and smooth muscle cells. This...
01:27Coronary Artery Disease V: Interprofessional Care
01:30Acute Coronary Syndrome I: Introduction
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:26Angina IV: Management