Final 5-year outcomes of the Epic02 – RANGO study: A real-world registry of the durable fluoroacrylate polymer-based sirolimus-eluting Angiolite® stent

Abstract

Background

Clinical results at mid-term of Angiolite, a cobalt-chromium sirolimus-eluting stent, in a non-selected, real-world population were demonstrated to be excellent. 5-year follow-up was planned to exclude late complications.

Methods

We conducted an observational, prospective, multicenter study (RANGO) in different clinical indications with independent event adjudication and data monitoring. All consecutive patients with at least 1 Angiolite stent implanted who gave their informed consent were included. The primary endpoint was the occurrence of target lesion failure (TLF). The secondary endpoints were the individual components of the primary endpoint, Patient-oriented Composite Endpoint (PoCE), and stent thrombosis. We present the 5-year clinical results in the entire population and in 2 predefined subgroups: diabetics and small-vessel disease (≤2.5 mm).

Results

646 patients with high-risk features (previous MI 18.4 %, previous coronary revascularization 23.4 %, ST-elevation MI 23.1 %, and multivessel disease 47.8 %) were included. Only 18 patients (2.8 %) were lost at 5-years follow-up. The final outcomes were: TLF 8.7 %, PoCE 21.8 %, and stent thrombosis 1.2 %. The small-vessel subgroup showed slightly worse results (TLF, 10.3 %; PoCE, 24.1 %; thrombosis, 0 %), as diabetic subgroup also did (TLF, 11.1 %; PoCE, 29.1 %; thrombosis, 1.0 %). Multivariable analysis showed variables significantly associated with TLF: chronic kidney disease, prior PCI or CABG and lesion calcification; and those associated with PoCE were age, atrial fibrillation, prior PCI, lesion calcification and chronic kidney disease.

Conclusions

The 5-years results of this observational study of Angiolite stent in a real-world population corroborate the outstanding results observed in the mid-term. No signals of late complications were detected.