Percutaneous coronary intervention (PCI) is currently the primary therapy of coronary interventions for coronary artery disease, improving the outcome of coronary artery disease and the quality of patient survival, and reducing the mortality of coronary artery disease. However, with the latest technical support of drug-coated stents, restenosis conditions still occur in 10% of patients. Conventional treatments to prevent stent restenosis, such as antiplatelet drugs, statin lipid-lowering drugs or re-interventional procedures, can cause secondary harm to patients because of the risks of bleeding, liver function impairment, tortuous stenosis or occlusion of the operated artery. Traditional Chinese Medicine (TCM) has been used for thousands of years to treat coronary heart disease, and modern studies have shown that TCM can reduce inflammatory factors, improve cardiac function and lipid metabolism, regulate vascular endothelial cell function, and reduce the occurrence of major adverse cardiovascular events (MACE) in the distant future in patients after PCI. Although TCM has unique advantages in the treatment of post-PCI, there is great heterogeneity among the outcome indicators of TCM treatment after PCI. For example, some studies focusing on the effect of TCM on the process of myocardial fibrosis after PCI, and some studies focusing on the improvement of clinical symptoms, lipids, inflammation and vascular endothelial function by TCM. Heterogeneity among clinical studies of TCM for post-PCI prevents comparisons of efficacy among studies and hinders the subsequent inclusion of high-quality evidence such as systematic review. Therefore, there is an urgent need to standardize and unify clinical study outcomes after TCM for post-PCI to improve the quality of TCM clinical study evidence. Core outcome sets (COS) are an agreed standard set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare. COS allows comparison of outcomes between clinical studies and also merging outcomes between different studies to avoid wasting clinical resources. Due to the reduction of clinical outcome reporting bias, COS can enhance the evidence level of clinical studies and improve the convincing of TCM efficacy. After reviewing the literature of clinical studies related to coronary artery disease after PCI and searching the COMET database of coronary artery disease-related ongoing or finished COS studies, no COS studies of TCM intervention after PCI were found. Therefore, it is of great value to develop a core outcome set for clinical trials of TCM for post-PCI coronary artery disease.
ContributorsPrincipal investigator:
Di Zhang and Liyun He, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, Beijing, China
Tiancai Wen, Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medicine Sciences, Beijing, China
Disease Category: Heart & circulation
Disease Name: Coronary artery disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Pharmaceutical industry representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Systematic review
A literature review and systematic review were conducted to review the published outcomes of Traditional Chinese Medicine (TCM) for the treatment of coronary artery disease after percutaneous coronary intervention (PCI). Patient-related outcomes were obtained by combining interviews and semi-structured discussions with patients after PCI for coronary artery disease. The above two outcomes were combined to form a pool of outcomes to construct a Delphi questionnaire. The outcomes for inclusion in the consensus meeting were identified through two rounds of the Delphi questionnaire. Through the consensus meeting, the final core outcomes set for the post-PCI treatment of coronary artery disease with TCM was obtained.