iVascular has announced positive five-year results of the RANGO registry, demonstrating the long-term safety and efficacy of the Angiolite Sirolimus drug-eluting stent (DES) in unselected patients representing everyday clinical practice.
This extensive follow-up period underscores the durability and reliability of the Angiolite stent, reinforcing its role in cardiovascular care, iVascular says in a press release.
Angiolite has shown promising results in previous studies. The RANGO study aims to provide real-world evidence on the long-term safety and efficacy of the Angiolite stent in a diverse patient population.
The RANGO study is a prospective, single-arm, multicentre, observational, multinational registry. The study included 654 patients enrolled in 16 academic medical centres in Spain and Portugal between June 2017 and July 2018. The primary objective was to evaluate the target lesion failure (TLF) at five years, defined as cardiac death, myocardial infarction (MI) not clearly attributable to a non-intervention vessel, and clinically driven target lesion revascularisation (TLR). Secondary objectives included target vessel failure (TVF), patient-oriented composite endpoint (PoCE), and stent thrombosis.
Over the course of five years, the all-cause mortality rate was 13.4%, being the cardiac cause of death only in 5.9%. The incidence of MI was 5.1% and stent thrombosis was notably low at 1.2%. In the group only treated with Angiolite the TLF rate was 7.7%, the TVF rate was 8.7% and stent thrombosis was only 0.9%.
Armando Pérez de Prado (University Hospital of León, León, Spain) the principal investigator of the study, commented: “The five-year results of the RANGO registry are very encouraging, fully comparable to previous results of other DES and confirm the efficacy and safety of the Angiolite stent in a wide variety of patients. These findings reinforce the confidence in using this device in everyday clinical practice.
“The low rate of stent thrombosis and cardiac mortality highlight the long-term safety of the device, and the low incidence of target lesion failure rate and patient-oriented composite endpoint underscore Angiolite stent efficacy in improving clinical outcomes and patient quality of life.”
