A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

Abstract

AimThe aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan.Methods and resultsThe CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively.ConclusionThe new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up.Study registration numberUMIN000006940.

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

“…Therefore, to the best of our knowledge this is the first study which evaluated the preclinical in-vivo and vascular tissue response to a novel generation SES and directly compared the healing with current golden standard, the everolimus eluting fluropolymer EES (Xience Pro). This is important in translation to already published clinical trials of similar technologies, which have shown non-inferior clinical and angiographic outcomes between novel generation SES and fluropolymer EES with regard to the incidence of major adverse cardiac events [5,10,21].…”

“…It has been shown that autonomously sirolimus and its derivatives (everolimus, zotarolimus) have similar effects on vascular response and clinical outcomes [4,5], therefore it has been postulated that the polymer and release kinetics were responsible for the negative tissue effect and clinical outcomes. The early generation SES consisted of non-erodible PEVA/PBMA polymers and thick strut profile stent platform which caused anaphylactic and inflammatory reactions, resulting in impaired vessel healing and ultimately adverse thrombotic events [6].…”

“…Furthermore, sirolimus elution has been optimized to balance between safety and efficacy [8]. These technological refinements resulted in non-inferior clinical outcomes of second generation SES when compared to everolimus eluting stents (EES) in large randomized trials [5,[9][10][11]. However, the underlying temporal tissue vascular response, has been not well described.…”

Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study

“…To verify whether the clinical outcomes of Ultimaster are affected by the stent diameter, we compared the results from the present study with those of the CENTURY II study, a pivotal study of Ultimaster stents that used stents with a diameter of 2.5-4.0 mm [14]. The CENTURY II study included an all-comer cohort (cohort B) and a cohort with more restrictive inclusion criteria compliant with Japanese regulations (cohort JR).…”

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

“…24 Third, our meta-analysis was limited to FDA-approved new-generation DES and we did not include new biodegradable polymerbased DES. [36][37][38] …”