Chronic Kidney Diseases, Coronary Artery Disease
Conditions
Keywords
Chronic Kidney Diseases, Coronary Artery Disease, Orsiro stent
Brief summary
Orsiro™ or Orsiro\_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro\_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR\< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR \< 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.
Interventions
PROCEDUREPercutaneous coronary intervention
Percutaneous coronary intervention
DEVICEOrsiro™ or Orsiro_Mission™ stent
Percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents
Sponsors
The Catholic University of Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years of age or older * Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents
Exclusion criteria
* Patient with a life expectancy of less than one year * Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time * Cardiogenic shock * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target-lesion failure (TLF) | Within one year after the intervention | Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with all cause death | Within three years after the intervention | — |
| Number of participants with cardiac death | Within three years after the intervention | — |
| Number of participants with myocardial infarction | Within three years after the intervention | periprocedural or spontaneous |
| Number of participants with composite of death or myocardial infarction | Within three years after the intervention | — |
| Number of participants with stent thrombosis | Within three years after the intervention | Stent thrombosis appropriate for Academic Research Consortium criteria |
| Number of participants with target-vessel revascularization | Within three years after the intervention | — |
| Number of participants with target-lesion revascularization | Within three years after the intervention | — |
| Number of participants with target-vessel failure | Within three years after the intervention | composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR) |
| Number of participants with composite of cardiac death or myocardial infarction | Within three years after the intervention | — |
Countries
South Korea
Outcome results
None listed