Efficacy and Safety of Comprehensive Treatment in Patients with Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Self-controlled Cohort Study
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.
• Fulfilling all the following criteria before initiation of comprehensive treatment:
‣ 1 18 years of age or older, male or female.
‣ 2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
‣ 3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).
‣ 4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
‣ 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.
‣ 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).
‣ 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.