Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study

Prior treatment

• Previous enrollment in this study.

Other illness

• Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
• Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al).
• Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
• Vital organ failure.
• Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
• Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.

Other

• Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
• Life expectancy \< 1 year.
• Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
• In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
• Participation in another study within 30 days.
• Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).

• Fulfilling all the following criteria before initiation of comprehensive treatment:
  • 1.1 18 years of age or older, male or female.
  • 1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
  • 1.3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).
  • 1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
  • 1.5 Hospitalization due to rapidly-progressive myocardial ischemia:
  • Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
  • Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
  • 1.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):
  • Occurred after the last coronary revascularization; and
  • Related to myocardial ischemia (location, extent, severity, et al).
  • 1.7 Evidence of inflammation:
  • At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate \[ESR\], high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or
  • Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
  • Receiving immunosuppressive therapy.
• Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy.