Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study

Abstract

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.

Comparative effectiveness of Cangrelor in patients with acute coronary syndrome undergoing percutaneous coronary intervention: an observational investigation from the M.O.Ca. registry

“…Notwithstanding the randomized nature, the CHAMPION studies present some limitations which have been widely recognized over time. Firstly the CHAMPION population was at relatively low ischemic risk since more than 30% of patients were addressed to PCI because of CCS 25 , which does not reflect the prevalent clinical setting in which the drug has been used, so far, in the real-world as suggested by several recent registries 23 , 24 , 26 . The second and probably the main point of criticism against the CHAMPION studies is the use of Clopidogrel in the control arm, despite more than two third of patients had ACS.…”

Safety of cangrelor and transition to oral P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: the ARCANGELO study

“…The ARCANGELO observational study is a non-imposed post-authorization safety study (PASS) category 3, 27 registered before the beginning of the patient’s enrolment in October 2020 (registration number NCT04471870) 28 as part of the cangrelor risk management plan. The study protocol and preliminary results from the ARCANGELO study’s interim analysis were presented in a previous article, 28 showing a good safety profile.…”

Dual Antiplatelet Therapy with Parenteral P2Y12 Inhibitors: Rationale, Evidence, and Future Directions

“…Furthermore, the ongoing multicenter, randomized, double blind trial DAPT-SHOCK-AMI (Dual Antiplatelet Therapy for Shock Patients with Acute Myocardial Infarction; ClinicalTrials.gov Identifier: NCT03551964) will provide results on the comparison between the combination of cangrelor and crushed ticagrelor versus ticagrelor alone in patients with AMI complicated by initial cardiogenic shock and treated with pPCI. The ARCANGELO (Italian Prospective Study on Cangrelor) is a recently published multicenter, observational, prospective cohort study that included patients with ACS undergoing PCI who had not received an oral P2Y 12 inhibitor before the PCI procedure and in whom oral therapy with P2Y 12 inhibitors was not feasible or desirable; this study aimed to assess the safety of cangrelor in daily practice [64]. The primary endpoint is the incidence of any hemorrhage, according to Bleeding Academic Research Consortium (BARC) criteria, in the 30 days following the PCI, calculated as the ratio between the number of patients experiencing at least one event during the 30-day observation period and the total number of evaluable patients.…”