iVascular’s Angiolite DES Evaluated at 3 Years in the RANGO Registry

July 26, 2022—iVascular announced that 3-year results from the RANGO registry, which is evaluating the company’s Angiolite cobalt-chromium, sirolimus-eluting stent in a real-world population, were presented by Principal Investigator Pérez de Prado, MD, at the EuroPCR 2022 conference held May 17-20 in Paris, France.

According to the company, RANGO is an observational, prospective, multicenter registry composed of daily practice, nonselected patients who underwent percutaneous coronary intervention with at least one Angiolite stent. The registry has enrolled 646 patients with follow-up to 5 years.

iVascular stated that the objective of RANGO is to evaluate the efficacy and safety of Angiolite and confirm the good outcomes of the previous preclinical and clinical studies that have shown positive results. The primary endpoint is target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization. Secondary endpoints include target vessel failure (TVF), major adverse cardiac events (MACE), and stent thrombosis.

Patients showed high-complexity coronary disease: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). Additionally, 58.4% of the treated lesions were classified as B2/C, indicating high complexity.

At 3 years, data supporting the clinical performance and safety of the Angiolite stent included the following:

• All-cause death, cardiac death, and MI rates were 4.2%, 1.6%, and 2.3%, respectively.
• Definite or probable device thrombosis occurred in 0.7% of patients.
• TLF, TVF, and MACE rates were 3.1%, 3.1%, and 8%, respectively.

Additionally, two subgroup analyses that were predefined and presented included patients with diabetes mellitus (n = 199) and patients with stents placed in small vessels of ≤ 2.5 mm (n = 116).

The 3-year results in these subgroups, which were similar to those observed in the global population, include:

• In diabetic patients, TLF, TVF, and MACE rates were 3.5%, 5%, and 18.1%, respectively.
• In the small vessels subgroup, TLF, TVF, and MACE rates were 5.2%, 6.9%, and 15.5%, respectively.

The company concluded that these results corroborate and confirm the excellent and outstanding efficacy and safety profile of Angiolite observed in previous studies. iVascular noted in the press release that Dr. Prado is confident in the clinical performance of the stent and highlights that the follow-up of 5 years will be very useful to discard late events.