Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure

Prior treatment

• 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.

Other illness

• 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.

Other

• Critical diagnostic, index, exposure, outcome, or cost information is missing to an extent that prevents eligibility classification or the prespecified analysis.
• Another Qi-tonifying and Yin-nourishing Chinese medicine injection, decoction, or proprietary Chinese medicine with overlapping effects was used during the relevant treatment period and its contribution cannot be distinguished.
• The record is a duplicate treatment episode. For a patient with multiple eligible episodes, only the first eligible index hospitalization will be retained for the primary analysis.

• 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.
• The record is eligible for research use under ethics and data-governance requirements and can be de-identified before analysis; a waiver of informed consent must be documented when applicable.
• The index date, first treatment date and time, daily and cumulative dose, treatment duration, discontinuation, completion, and crossover can be verified when Yiqi Fumai lyophilized injection was used.
• Time zero, eligibility, and baseline variables can be reliably reconstructed, and initiation or non-initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero can be clearly classified.
• Prespecified baseline covariates can be abstracted, including age, sex, body mass index, history and grade of hypertension, cardiovascular risk, smoking, alcohol use, antihypertensive treatment, NYHA class, LVEF, BNP or NT-proBNP, heart-failure duration, comorbidities, guideline-directed medical therapy, diuretic intensity, baseline cost, and study center.
• Acute conditions after time zero, treatment crossover, rescue treatment, and documented Chinese medicines or nonpharmacologic traditional Chinese medicine therapies, including their indication and start and stop dates, can be abstracted. Post-baseline variables will not be included in the baseline propensity-score model.