This two-center retrospective cohort study will use de-identified electronic health records from June 1, 2021 through June 1, 2026 to compare patients with coronary heart disease-related chronic left ventricular dysfunction or chronic heart failure and Qi and Yin deficiency syndrome who initiated Yiqi Fumai lyophilized injection within 24 hours after a common time zero with eligible patients who did not initiate the drug within 24 hours. Treatment was determined during routine care and was not assigned by the researchers. The planned cohort includes 200 randomly sampled records, comprising 150 initiators and 50 non-initiators. The primary economic outcome is total direct medical cost during the index hospitalization, and the primary comparative-effectiveness outcome is heart-failure-related rehospitalization within 90 days after time zero. Baseline differences will be addressed primarily using propensity-score overlap weighting.
The index date was from June 1, 2021 through June 1, 2026, the patient received inpatient or systematic clinical care at a participating center, and the patient was 40 to 80 years of age at time zero, with no restriction by sex.
The medical record supports protocol-defined coronary heart disease-related chronic left ventricular dysfunction or coronary heart disease with chronic heart failure.
The record contains sufficient information on functional class, echocardiography, BNP or NT-proBNP, medications, treatment course, laboratory tests, direct medical costs for the index hospitalization, heart-failure-related rehospitalization through 90 days, death, and follow-up for the prespecified analyses.
Qi and Yin deficiency syndrome or a related Qi-and-Yin-deficiency pattern can be determined from the medical record according to the prespecified adjudication rules.
Critical diagnostic, index, exposure, outcome, or cost information is missing to an extent that prevents eligibility classification or the prespecified analysis.
Evidence supporting coronary heart disease is insufficient, or heart failure is caused primarily by a noncoronary condition.
Acute myocardial infarction, acute coronary syndrome, cardiogenic shock, or another critical illness dominates the index episode.
Time zero cannot be reliably reconstructed, or initiation or non-initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero cannot be clearly classified. Otherwise, patients will not be excluded from the primary analysis solely because subsequent treatment lasted less than 7 days, a 10-day course was not completed, treatment was discontinued, or crossover occurred. Patients who initiated the drug after 24 hours remain assigned to the non-initiation strategy in the primary intention-to-treat analogue.
Patients aged 40 to 80 years who received inpatient or systematic clinical care at either participating center with an index date from June 1, 2021 through June 1, 2026; whose records support protocol-defined coronary heart disease-related chronic left ventricular dysfunction or chronic heart failure and Qi and Yin deficiency syndrome; and whose electronic records permit reconstruction of time zero, eligibility, baseline covariates, 24-hour treatment strategy, clinical outcomes, and direct medical costs.
Case-control
Retrospective
Yiqi Fumai Lyophilized Injection
DrugExposure is defined by initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero in routine care. The actual preparation, dose, diluent, infusion rate, treatment dates, cumulative dose, cumulative duration, discontinuation reason, completion of a 10-day course, and subsequent crossover will be abstracted when documented. The researchers did not assign treatment.
Total Direct Medical Cost From Time Zero Through the End of the Index Hospitalization
Total direct medical cost incurred from time zero to discharge from the index hospitalization or in-hospital death, whichever occurs first, will be calculated from itemized medical records using quantity multiplied by unit price and standardized to 2026 Chinese yuan. Cost incurred from admission to time zero will be treated as a baseline covariate. Total cost for the complete index hospitalization will be evaluated in a sensitivity analysis. The estimated average is for registration planning and does not truncate observation; every index admission is followed to its actual endpoint.
Incidence of First Heart-Failure-Related Rehospitalization Within 90 Days
The cumulative incidence of the first unplanned rehospitalization after index discharge for which heart failure is the primary diagnosis or there is clearly documented worsening of heart failure will be estimated through 90 days after time zero. Death before rehospitalization will be treated as a competing risk. Adjusted absolute risk, risk difference, relative effect, and 95% confidence intervals will be reported.
Incidence of First Heart-Failure-Related Rehospitalization Within 30 Days
The cumulative incidence of the first unplanned heart-failure-related rehospitalization within 30 days after time zero will be estimated using the same event definition as the 90-day primary comparative-effectiveness outcome, with death treated as a competing risk.
Incidence of Heart-Failure-Related Rehospitalization or All-Cause Death Within 90 Days
The proportion of patients with either an unplanned heart-failure-related rehospitalization after index discharge or death from any cause within 90 days after time zero will be reported as a composite supportive outcome. Time to the first component will be used.
Incidence of All-Cause Death Within 90 Days
The proportion of patients who died from any cause within 90 days after time zero will be reported. The date and source of death ascertainment will be recorded when available.
Incidence of Cardiovascular Death Within 90 Days
The proportion of patients with death classified as cardiovascular in origin within 90 days after time zero will be reported according to the prespecified source hierarchy and adjudication rules.
Total Heart-Failure-Related Direct Medical Cost Through Day 90
When supported by the available records, direct medical costs through Day 90 will include the index hospitalization and documented heart-failure-related emergency visits, outpatient encounters, and rehospitalizations. Costs will be standardized to 2026 Chinese yuan. The exact cost categories, price adjustment, and handling of incomplete interfacility utilization will be prespecified in the health economic analysis plan.
Percent Change in NT-proBNP During the Index Hospitalization
The baseline value is the result closest to time zero within the preceding 24 hours and, for initiators, before the first dose. The follow-up value is the result closest to Day 11 within Days 7 through 14. For early discharge, the last result within 48 hours before discharge will be used and flagged. BNP and NT-proBNP will not be pooled. Percentage change will be calculated for patients with paired values.
Change in Left Ventricular Ejection Fraction During the Index Hospitalization
Baseline LVEF is the closest documented value from 30 days before time zero through time zero and, for initiators, must precede the first dose. Values obtained only within the first 48 hours after time zero will be flagged as expanded-window measurements and used only descriptively or in sensitivity analyses. The in-hospital follow-up value is the last result from Day 3 after time zero through discharge. Change is reported in percentage points.
Change in Left Ventricular Ejection Fraction at 90-Day Follow-Up
Change in LVEF from the prespecified baseline value to the value closest to Day 90 within a plus or minus 30-day window will be reported in percentage points. This window will be analyzed separately from the in-hospital LVEF window.
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