Abstract
Aim: To investigate the compliance and the outcome of Traditional Chinese Medicine (TCM) in patients with coronary heart disease (CHD) after treatment of revascularization.Methods: In this prospective cohort study, the non-exposure group (NEG), low-exposure group (LEG), and high-exposure group (HEG) were divided after 2 years follow-up. The primary outcome was a composite of death from cardiovascular causes, non-lethal myocardial infarction, heart transplantation, or stroke. Time-to-event data were evaluated by using the Cox regression analysis with hazard ratios (HRs) and 95% CIs. Then, the two-sided p-values were calculated by using the Cox models. In order to indicate the therapeutic effects of TCM on the CHD after revascularization, the survival analysis and the nested case–control study were conducted separately.Results: There were 1,003 patients with CHD enrolled, 356 patients (35.49%) did not choose the TCM, 379 patients (37.79%) used the TCM seldom, and only 268 patients (26.72%) used TCM regularly. A total of 653 patients with revascularization participated in the prospective cohort study. Over the duration of the trial, the primary endpoints occurred in 12 (4.35%), 11 (4.80%), and 2 (1.35%) patients in the NEG, LEG, and HEG, while the secondary endpoints occurred in 84 (30.43%), 57 (24.89%), and 15 (10.14%) patients in the NEG, LEG, and HEG, respectively. The occurrence time of secondary endpoint events in HEG was significantly postponed (p < 0.001) compared with the other cohorts. The Cox regression analysis indicated that the HRs in the primary endpoints, the secondary endpoint events, the major adverse cardiac and cerebrovascular events (MACCE), and the composite endpoint events for HEG were all around 0.3 (p < 0.05) and HRs for LEG were all around 0.8. The results of the nested case–control study showed that the TCM exposure was significantly different between the cases and controls in the secondary endpoints (p < 0.05), while no significant difference in the primary endpoints (p > 0.05), but the percentage of HEG in the cases was extremely lower than the controls.Conclusion: The HEG-TCM may improve the outcomes of the patients with CHD after treatment of revascularization.Registration: http://www.chictr.org.cn. Unique identifier: ChiCTR-OOC-17012995.
Highlights
Cardiovascular disease (CVD) is the leading cause of premature morbidity and mortality in the world [1,2,3,4,5,6], of which coronary heart disease (CHD) is the most prevalent and accounts for one-third to one-half of the cardiovascular disease (CVD) cases [7]
They were Tianjin Chest Hospital representing Western Medical Hospital, the Second Affiliated Hospital of Tianjin University of Traditional Chinese medicine (TCM), and the TCM Hospital of Beichen District representing TCM hospital to get the situation about the TCM treatment accepted by the patients with CHD and evaluate the therapeutic effects of TCM on the patients with CHD after treatment of revascularization
This study was conducted in accordance with the recommendations of Ethics Committees of the Second Affiliated Hospital of Tianjin University of TCM and the protocol was approved by the Ethics Committees with registration number 2017-046-01
Summary
Cardiovascular disease (CVD) is the leading cause of premature morbidity and mortality in the world [1,2,3,4,5,6], of which coronary heart disease (CHD) is the most prevalent and accounts for one-third to one-half of the CVD cases [7]. Patients with CHD might be individual differences in pathogenesis, disease progression, and genetic background, which need combination of several conventional Western medicines to relief symptoms and the risk of adverse effects would increase. TCM with multitargets, multipathways, and individual regimen is significant complementary to the Western medicine and is an effectively alternative therapy for the patients, commonly used in CHD treatments in China and other Asian countries [18]. It is always reported that many TCM have been widely used to treat CHD in clinical practice, there are still lack more information on practice patterns and therapeutic effects of TCM treatment, especially for disease management and endpoints [19, 20]
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