ARCANGELO: an observational, prospective study with acute coronary syndrome patients undergoing percutaneous coronary intervention who receive cangrelor transitioning to oral P2Y12 inhibitors

Abstract

Abstract Background The use of oral platelet P2Y12 receptor inhibitors, to reduce the risk of thrombotic complications related to Percutaneous Coronary Intervention (PCI), have some limitations in the acute phase, e.g., the delayed onset of action and lack of bioavailability in critical patients. Cangrelor is the only intravenous P2Y12 inhibitor, which based on its quick onset and offset of action is a valid alternative option for antiplatelet therapy, particularly for patients who are unable to take oral medications or for whom oral administration is not adequate. Notably, during the clinical development program of cangrelor, ticagrelor and prasugrel were not marketed and, therefore, the pivotal studies were conducted only with transitioning to clopidogrel. The aim of ARCANGELO study was the evaluation of the safety and effectiveness of cangrelor when administered to patients with Acute Coronary Syndrome (ACS) undergoing PCI in a real-world setting, including patients who received cangrelor transitioning to either clopidogrel, prasugrel, or ticagrelor. Methods Adult patients eligible to PCI for ACS who received cangrelor and who consented to take part in the study in 28 Italian centers, were followed in the 30 days after PCI. Bleedings, major adverse cardiac events (MACEs), and adverse events were recorded. The primary outcome was the incidence of any bleedings, according to BARC (Bleeding Academic Research Consortium) criteria, at 30 days post-PCI. Results A total of 1,004 patients were enrolled and 995 (99.2%) patients were eligible for analysis. Median (IQR) age was 65 (56-73) years, and 771 (77.5%) patients were males. 597 (59.9%) patients had ST-segment Elevation Myocardial Infarction; 509 (51.2%) patients had multi-vessel vessel coronary artery disease. A radial artery access was used in 926 (93.1%) patients and drug-eluting stents were implanted in almost all patients (n=972, 97.7%). All 995 patients included in the analysis received 30 micrograms/kg by intravenous bolus and 4 micrograms/kg/min by intravenous infusion. 730 patients (73.4%) were then transitioned to ticagrelor, 127 (12.8%) to prasugrel, and 138 (13.9%) to clopidogrel. 52 (5.2%) (95% CI 3.9% - 6.8%) patients experienced at least one bleeding event up to 30 days post-PCI. Five patients (0.5%) experienced at least one BARC type 3-5 (moderate-severe) bleeding (all type 3). Fourteen (1.4%) patients presented with at least one MACEs during observation (6 [0.6%] death, 7 [0.7%] myocardial infarction, 2 [0.2%] stent thrombosis). Six (0.6%) patients experienced at least one Treatment-Emergent Adverse Events related to cangrelor. Conclusions The results of this large real-world evidence study confirm that the use of cangrelor in patients with ACS undergoing PCI and transition strategy to the currently used P2Y12 oral inhibitors is safe and effective in daily practice.