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Initiate Danhong Injection before or after percutaneous coronary intervention for microvascular obstruction in
Xiaoyu Zhang1, Guihua Tian1, Zhaofeng Shi1
1Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.
Insights
This study investigates Danhong Injection for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). It assesses efficacy and optimal timing to prevent microvascular obstruction (MVO).
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Microvascular obstruction (MVO) lacks proven treatments in ST-elevation myocardial infarction (STEMI).
- Danhong Injection's effects are noted, but rigorous evidence and optimal timing are uncertain.
- A need exists for evidence-based interventions to improve STEMI outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of Danhong Injection in STEMI patients.
- To determine the optimal intervention timing (preoperative vs. postoperative) of Danhong Injection.
- To assess Danhong Injection's impact on preventing MVO post-percutaneous coronary intervention (PCI).
Main Methods:
- The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind trial.
- 336 STEMI patients receiving PCI will be randomized to conventional treatment, preoperative, or postoperative Danhong Injection.
- Primary outcome: ST-segment resolution (STR) ≥70% at 90 min post-PCI; secondary outcomes include cardiac function, biomarkers, and infarct size.
Main Results:
- Primary outcome data on ST-segment resolution (STR) will be analyzed.
- Secondary outcomes include Thrombolysis in Myocardial Infarction (TIMI) flow, myocardial perfusion, ejection fraction, and inflammatory markers.
- Safety outcomes, including adverse events and cardiovascular events, will be recorded.
Conclusions:
- This trial will provide crucial data on Danhong Injection's efficacy and safety in STEMI.
- The study aims to establish the optimal timing for Danhong Injection intervention.
- Findings are expected to inform treatment strategies for preventing MVO in STEMI patients.
Background:
No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain.
Methods:
The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12-item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators.
Discussion:
This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI.
Trial Registration:
Chinese Clinical Trial Registry, ChiCTR1900021440. Registered on February 21, 2019.
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