Adult patients with coronary heart disease who have received PCI treatment and have at least one chronic comorbidity
Conditions
Interventions
Control group (Everolimus-eluting stents or Zotarolimus-eluting stents):None
Treatment group (Arsenic Trioxide Drug-Coated Sten):None
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Diagnosed as coronary heart disease by coronary angiography, and received arsenic trioxide drug-coated stents, everolimus-eluting stents or zotarolimus-eluting stents therapy; 3. Combined with at least one of the following comorbidities: (1) Diabetes mellitus (HbA1c >=6.5% or under treatment with hypoglycemic drugs); (2) Chronic kidney disease (eGFR 30 - 59 mL/min/1.73 m^2); (3) Hypertension (SBP >=140 mmHg or under treatment with antihypertensive drugs); (4) Heart failure (NYHA II - IV or LVEF <50%); (5) History of stroke; (6) History of peripheral arterial disease (PAD); (7) History of COPD (FEV1/FVC <0.7); (8) History of cancer; (9) At high risk of bleeding (defined by ARC-HBR); 4. Understand the study procedures, be willing to undergo follow-up, and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1.Acute myocardial infarction with cardiogenic shock; 2.Life expectancy less than one year; 3.Known abnormal heavy metal metabolism or allergy to aspirin, heparin, clopidogrel, ticagrelor, stainless steel alloys, arsenic trioxide, everolimus, zotalimus, contrast agent; 4.Participating in any other interventional clinical trials; 5.Pregnant or breast-feeding women; 6.Not suitable to participate in this study by investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net Adverse Clinical Event (NACE) composite endpoint within 12 months after PCI (endpoint type: time-to-event): including all-cause death, stroke, myocardial infarction, revascularization, and Ble; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel revascularization;Myocardial Infarction;PCI related Myocardial Infarction;Target Vessel Myocardial Infarction;Ischemia-Driven Target Lesion Revascularization;BARC 2, 3 or 5 type bleeding;Definite or probable stent/scaffold thrombosis;Cardiovascular death;Target lesion revascularization;Target Lesion Failure (TLF): including cardiovascular death, Target Vessel Myocardial Infarction (TV-MI), and clinically driven Target Lesion Revascularization (TLR);;death;Patient-Oriented Composite Endpoint (PoCE): including all-cause death, myocardial infarction, stroke, and revascularization;;Device-Oriented Composite Endpoint (DoCE): including cardiovascular death, target vessel myocardial infarction, and clinical or ischemia-driven target lesion revascularization;;Revascularization;Major Adverse Cardiovascular and Cerebrovascular Events (MACCE):cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and clinically driven target vessel revascularization.; | — |
Countries
China
Contacts
Public ContactBo Yu
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed