iVascular has announced the initiation of its first randomised trial of an abbreviated dual antiplatelet therapy (DAPT) regimen after implantation of the angiolite drug-eluting stent (DES).
The first patient was enrolled by the team of the principal investigator of the trial, Manel Sabaté (Hospital Clinic Barcelona, Barcelona, Spain) launching the ANGIODAPT global investigation.
The trial is iVascular’s 2×2 factorial, all-comer, multicentre, randomised controlled trial set up to evaluate the ischaemic and bleeding outcomes after iVascular angiolite stent implantation and an abbreviated DAPT regimen of one month. A total of 2,312 patients with coronary artery disease, who require percutaneous coronary intervention (PCI) and DAPT, will be included across 40 sites located in Spain, Belgium and France.
Patients will be randomised firstly to one two stents types (angiolite vs. Xience [Abbott]) and secondly assigned to one of the treatment options (abbreviated DAPT vs. standard of care DAPT) and will be followed up one, six and 12-months after the intervention and annually for five years.
The trial’s two co-primary endpoints are to determine the rate of target lesion failure (TLF) at one-year between the angiolite and Xience stent family (tested for non-inferiority) in both the ‘abbreviated DAPT’ and the ‘standard-of-care DAPT’ regimen groups. The co-primary endpoint is to determine the rate of clinically relevant bleeding events at one year between ‘abbreviated DAPT’ and the ‘standard-of-care DAPT’ (tested for superiority of the ‘abbreviated-DAPT arm’).
The main secondary endpoint is to determine the rate of ischaemic events between both therapies (tested for non-inferiority). Moreover, other exploratory outcomes such as the rate of patient-oriented composite endpoint, myocardial infarction (MI), target lesion and vessel revascularisation, stent thrombosis, clinical device and procedural success, bleeding events, net adverse clinical endpoints, the major adverse cardiac and cerebral events and transfusion rates will be assessed.
Throughout the trial, the steering committee, the clinical events committee (CEC) and the data safety monitoring board (DSMB) will ensure the safety of the patients and the scientific integrity of the study.
Sabaté stated: “The enrolment of the first patient in the ANGIODAPT trial is an important milestone to get robust evidence on DAPT regimen in CAD patients who have received angiolite stent. I am sure that the 2,300 patients will be enrolled on time thanks to the cooperation of the participant sites and their teams.”
