After the positive pre-clinical and clinical results with Angiolite, the cobalt-chromium sirolimus-eluting stent of iVascular, the company decided to further assess Angiolite performance in a non-selected, real-world population: the RANGO Registry.
RANGO is an observational, prospective, multicentric real-world registry in which 646 daily practice non-selected patients who underwent a PCI with at least one Angiolite stent were enrolled and are currently followed up until 5 years. The objective of RANGO is to evaluate the efficacy and safety of Angiolite and confirm the good outcomes of the previous studies. The primary endpoint is Target Lesion Failure, a composite of Cardiac death, Target Vessel Myocardial Infarction (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR). Secondary endpoints include TVF, MACE, and stent thrombosis.
The 3-year follow-up results of RANGO were presented at EuroPCR 2022 by Dr. Pérez de Prado, the PI of the study. 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%)) and 58.4% of the treated lesions were classified as B2/C showing high complexity. 3-year all-cause death, cardiac death, and MI rates showed very low values: 4.2%, 1.6%, and 2.3%, respectively. Also, definite or probable device thrombosis occurred in only 0.7% of patients. TLF, TVF and MACE rates at 3 -year- follow-up were also low 3.1%, 3.1%, and 8.0%, respectively supporting the outstanding clinical performance and safety of Angiolite stent.
Additionally, 2 subgroup analysis were predefined and also presented: patients with diabetes mellitus (N=199) and those with stents placed in small vessels (≤2.5 mm, N=116). The 3-year results in these subgroups were not far from those observed in the global population: in diabetics, TLF, TVF and MACE rates were 3.5%, 5.0%, and 18.1%, respectively; in the small vessels subgroup, TLF, TVF and MACE rates were 5.2%, 6.9%, and 15.5%, respectively.
So, those results corroborate and confirm the excellent and outstanding efficacy and safety profile of Angiolite observed in previous studies. The PI of the study 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.
