iVascular has announced the release of three-year observational data concerning its Angiolite cobalt-chromium sirolimus-eluting stent. The three-year follow-up results from RANGO, an observational, prospective, multicentre registry were presented at EuroPCR 2022 (17–20 May, Paris, France) by Armando Pérez de Prado (University Hospital of León, León, Spain).
Non-selected patients who underwent percutaneous coronary intervention (PCI) with at least one Angiolite stent were enrolled in the registry and are currently being followed out to five years. The objective of the study is to evaluate the efficacy and safety of Angiolite and confirm the outcomes of previous pre-clinical and clinical studies.
The registry has primary endpoints of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (CD-TLR). Secondary endpoints include target vessel failure (TVF), major adverse cardiovascular events (MACE) and stent thrombosis.
The three-year follow-up results from 646 patients presented by Pérez de Prado showed that patients presented with high complexity coronary disease (prevalence of previous MI (18.4%), previous coronary revascularisation (23.4%), clinical presentation as ST-segment elevation MI (STEMI, 23.1%), and multivessel disease (47.8%)) and 58.4% of the treated lesions were classified as B2/C showing high complexity.
Three-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 three-year- follow up were also low 3.1%, 3.1% and 8%, respectively supporting the outstanding clinical performance and safety of Angiolite stent, iVascular said in a press release.
Additionally, two 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 three-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 small vessels subgroup, TLF, TVF and MACE rates were 5.2%, 6.9% and 15.5%, respectively.
