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CENTURY: Bioresorbable polymer sirolimus-eluting stent safe, effective at 2 years
A bioresorbable polymer sirolimus-eluting stent showed procedural success and suppression of neointimal proliferation at 6 months and was safe and effective at 2 years in patients with CAD, according to research published in EuroIntervention.
“The ease of implantation, potent antiproliferative properties and excellent safety profile make the Ultimaster drug-eluting stent a valid alternative for treatment of patients similar to those enrolled in this trial,” the researchers wrote.
Emanuele Barbato, MD, of the Cardiovascular Center Aalst, Belgium, and colleagues enrolled 105 patients (mean age, 61 ± 8 years; 76% men; 113 lesions) with CAD for the first-in-man, multicenter, single-arm CENTURY study. The researchers studied the performance, safety and efficacy of the Ultimaster (Terumo Corp) thin-strut cobalt-chromium stent, made with an abluminally gradient-coated polymer.
Angiographic follow-up was scheduled for 6 months. Additionally, 45 patients had IVUS assessments and 20 had OCT assessments.
The researchers looked for in-stent late lumen loss as the primary endpoint. Clinical, IVUS and OCT outcomes served as secondary endpoints. Clinical follow-up data were available up to 2 years and continuing until 5 years.
The procedure showed 97.1% success, and the device showed 100% success. Late lumen loss was 0.04 ± 0.35 mm. The rate of binary restenosis was 0.9% and neointimal volume obstruction confirmed by IVUS was 1.02 ± 1.62%. Based on OCT, mean strut coverage was 96.2% with 1.66 ± 4.02 malapposed struts.
Three (2.9%) periprocedural MI and one (0.9%) spontaneous MI occurred — neither related to the target vessel; no deaths occurred in the study.
At 1 year, the target lesion failure rate was 3.8% and the target lesion revascularization rate was 1.9%; at 2 years, the rates rose to 5.7% and 2.8%, respectively. One case of acute definite stent thrombosis was observed.
The researchers note that with its rapid and complete polymer bioresorption, the device is comparable to a bare-metal stent within 3 to 4 months.
“These features could make the Ultimaster DES an attractive option in patients at high bleeding risk, if ongoing clinical trials demonstrate the safety of early withdrawal of dual antiplatelet therapy.” – by Allegra Tiver
Disclosure: The CENTURY study was funded by Terumo Corp. The researchers report no relevant financial disclosures.