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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,113
Percutaneous coronary intervention
Percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents
Daejeon St. Mary's Hospital , The Catholic University of Korea
Daejeon, South Korea
Target-lesion failure (TLF)
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
Time frame: Within one year after the intervention
Number of participants with all cause death
Time frame: Within three years after the intervention
Number of participants with cardiac death
Time frame: Within three years after the intervention
Number of participants with myocardial infarction
periprocedural or spontaneous
Time frame: Within three years after the intervention
Number of participants with composite of death or myocardial infarction
Time frame: Within three years after the intervention
Number of participants with composite of cardiac death or myocardial infarction
Time frame: Within three years after the intervention
Number of participants with target-vessel revascularization
Time frame: Within three years after the intervention
Number of participants with target-lesion revascularization
Time frame: Within three years after the intervention
Number of participants with stent thrombosis
Stent thrombosis appropriate for Academic Research Consortium criteria
Time frame: Within three years after the intervention
Number of participants with target-vessel failure
composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR)
Time frame: Within three years after the intervention
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