iVascular’s ANGIODAPT RCT of Abbreviated DAPT After PCI Begins Enrollment

December 14, 2023—iVascular announced the initiation of its first randomized trial of an abbreviated dual antiplatelet therapy (DAPT) regimen after implantation of the company’s Angiolite drug-eluting stent to treat patients with coronary artery disease (CAD).

According to Vascular, ANGIODAPT is a randomized controlled trial conducted to evaluate ischemic and bleeding outcomes after implantation of the Angiolite device and an abbreviated DAPT regimen of 1 month. It is designed as a two-by-two factorial, all-comers, multicenter trial.

The global investigation was launched with the first patient enrolled by Principal Investigator Manel Sabaté, MD, Head of the Interventional Cardiology Department at the Hospital Clinic Barcelona in Barcelona, Spain.

The study will include patients with CAD requiring percutaneous coronary intervention and DAPT. A total of 2,312 patients will be enrolled at 40 sites in Spain, Belgium, and France.

Patients will be randomized to either Angiolite or Xience (Abbott) stents, then assigned to abbreviated DAPT or standard-of-care DAPT. Follow-up will be conducted at 1, 6, and 12 months after the intervention and annually for 5 years.

The trial’s coprimary endpoints are:

• The rates of target lesion failure at 1 year between the Angiolite and Xience stents (tested for noninferiority) in both the abbreviated DAPT and standard-of-care DAPT regimen groups
• The rate of clinically relevant bleeding events at 1 year between abbreviated DAPT and standard-of-care DAPT (tested for superiority of the abbreviated DAPT arm)

The main secondary endpoint is the rate of ischemic events between both therapies (tested for noninferiority).

Other exploratory outcomes include rates of patient-oriented composite endpoints, myocardial infarction, target lesion and vessel revascularization, stent thrombosis, clinical device and procedural success, bleeding events, net adverse clinical endpoints, major adverse cardiac and cerebral events, and transfusions.

“The enrollment of the first patient in the ANGIODAPT trial is an important milestone to get robust evidence on a DAPT regimen in CAD patients who have received the Angiolite stent,” commented Dr. Sabaté in the company’s press release. “I am sure that the 2,300 patients will be enrolled on time thanks to the cooperation of the participant sites and their teams.”

Throughout the trial, patient safety and scientific integrity will be ensured by the study steering committee (Dr. Sabaté et al), along with a clinical events committee and a data safety monitoring board, noted iVascular.