Trial reportEuropean heart journal2014
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.
Trial report in European heart journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04475536 (A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.), which is not on this map. Cited by 51 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
Who cites it
51 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative efficacy of different Chinese patent medicines in preventing restenosis after percutaneous coronary intervention: a systematic review and Bayesian network meta-analysis of randomized clinical trials.Frontiers in pharmacology · 2023Pooled it
- Efficacy and Safety of Novel Oral P2Y12 Receptor Inhibitors in Patients With ST-Segment Elevation Myocardial Infarction Undergoing PCI: A Systematic Review and Meta-Analysis.Journal of cardiovascular pharmacology · 2017Pooled it
- Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021Trial
- Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.Journal of the American Heart Association · 2016Trial
- Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies).The American journal of cardiology · 2016Trial
- Vascular response to bioresorbable polymer sirolimus-eluting stent vs. permanent polymer everolimus-eluting stent at 9-month follow-up: an optical coherence tomography sub-study from the CENTURY II trial.European heart journal. Cardiovascular Imaging · 2016Trial
- Long-term survival after multiple arterial coronary artery bypass grafting compared with percutaneous coronary intervention: a systematic review and meta-analysis.Surgery today · 2026Review
- The efficacy of biodegradable polymer everolimus-eluting stents in patients with cardiac allograft vasculopathy.JHLT open · 2025Article
- Drug-Eluting Stent Use in Percutaneous Coronary Interventions-A Narrative Review.Journal of clinical medicine · 2025Review
- Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer Ultimaster™ in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry.Korean circulation journal · 2024Article
- Variability in research culture across busy catheterisation labs in the Asia-Pacific region.AsiaIntervention · 2024Article
- Cells in Atherosclerosis: Focus on Cellular Senescence from Basic Science to Clinical Practice.International journal of molecular sciences · 2023Review
- Evolution of Coronary Stent Platforms: A Brief Overview of Currently Used Drug-Eluting Stents.Journal of clinical medicine · 2023Review
- Five-year clinical outcomes of a 2.25 mm sirolimus-eluting stent in Japanese patients with very small coronary artery disease: final results of the CENTURY JSV study.Cardiovascular intervention and therapeutics · 2023Article
- Outcomes and regional differences in practice in a worldwide coronary stent registry.Heart (British Cardiac Society) · 2022Observational
- A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022Article
- Comparison of Contemporary Drug-Eluting Stents in Patients Undergoing Complex High-Risk Indicated Procedures.JACC. Asia · 2022Article
- Complete revascularization optimizes patient outcomes in multivessel coronary artery disease: Data from the e-Ultimaster registry.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022Article
- Incidence and natural history of coronary evagination after implanted biodegradable polymer sirolimus-eluting stent.European heart journal open · 2022Article
- Late neointimal volume reduction is observed following biodegradable polymer-based drug eluting stent in porcine model.International journal of cardiology. Heart & vasculature · 2021Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
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 NUMBER: UMIN000006940.
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