PARIS, FRANCE - June 29, 2020 - one-year total population clinical outcome data from e-ULTIMASTER - the world's largest registry of patients treated with a drug-eluting stent (DES) - have reinforced the trust cardiologists worldwide have in the Ultimaster DES while providing valuable insight into treating a range of high-risk patients.
"The study outcome was excellent," said Professor Marco Roffi, University Hospital of Geneva, Switzerland. "The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year. This was less than 5% across all study sites," he said. "The second important point is that the rate of definite or probable stent thrombosis at 1 year was below 1%."
The data were presented by Professor Marco Roffi, Professor Mamas Mamas, Keele University, UK; Dr Bernard Chevalier, Institut Cardiovasculaire Paris-Sud, France; and Professor David Hildick-Smith, Nuffield Health, UK, during a late-breaking clinical trial session at PCR eCourse 2020.
e-ULTIMASTER is a global real-word registry of over 37,000 patients from 378 hospitals across four continents. One-year clinical outcomes of the total population were reported, together with sub-analyses for geographic particularities and of three pre-specified high-risk subsets (bifurcation, multivessel disease and complex-PCI). Professor Roffi said the registry offered unique insight into regional differences in patient complexity and techniques used but that overall outcomes where consistent across geographies.
Professor Mamas said large global registries like e-ULTIMASTER have great value. "We know that randomised controlled trials (RCTs) are recruiting more selective cohorts. Registries recruit real world populations - the sort of patients we see in everyday practice," he said. "They are important because they capture a much wider geographical spread than many RCTs are able to and they also include many patients with comorbidities who are otherwise excluded."
Dr Chevalier pointed to the excellent balance between quality and quantity of data, with three important criteria. "First was the quality of risk-based monitoring that included on-site and extensive on-line data verification; secondly, we had independent adjudication of all endpoint related clinical events; and finally, we had a high rate of follow up of more than 95% at 1 year," he said.
Commenting on other important findings, Professor Mamas said that when looking at patients with complex PCI, while the overall outcomes were also very favourable, the study showed there was a strong correlation between the number of complex PCI features and ischemic as well as bleeding outcomes, indicating that the data will help clinicians personalize their treatment approach for each patient.
The excellent 1-year outcome data was also reproduced in the challenging subset of patients undergoing bifurcation treatment, with real-world evidence on the value of POT (proximal optimization technique), was emphasized by Dr Chevalier.
"The e-ULTIMASTER registry, with over 37,000 patients, is the largest ever real-life global PCI registry with contemporary stents and highlights our commitment to interventional cardiology and clinical research," said Toshi Osada, President of the Cardiac and Vascular company, Terumo Corporation. "This registry enables physicians to explore outcomes and identify best treatment options for patients with complex pathology and anatomy and adds power to the available and growing body of clinical evidence about bioresorbable polymers and Ultimaster DES," he added.
The PCR eCourse panel review of the data can be viewed on demand here.
Pushing the boundaries of science and medical engineering for the improvement of health: Ultimaster combines an optimal balance between stent design for ultimate conformability with simultaneous polymer resorption and drug release, to match the procedure-triggered biological response in the vessel.*1 This results in optimal vessel recovery and potentially shortened DAPT time.*2
Data on file at Terumo Corporation (Doc nr. BioRes02-T).
Ultimaster IFU. 1 month DAPT CE Mark approved for patients in need. Patients should be maintained on clinically adequate post-procedural antiplatelet therapy according to the current guidelines. In case of need, dual antiplatelet therapy can be discontinued earlier, but not before one month.
About Terumo Europe
Terumo Europe is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and productionfacilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.