Abstract
Background
Although percutaneous coronary intervention (PCI) had become widely employed therapeutic procedure for coronary artery disease, stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved. While numerous empirical observations suggested Tongguan Capsules (通冠胶囊), a patented Chinese Medicine, could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on restenosis remained inadequate.
Objective
This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.
Methods
Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules (4.5 g/d) for 3 months. All patients received standard anti-platelet, anti-coagulation and lipid-decreasing treatments, concurrently. The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events (defined as cardiac death, myocardial infarction, and recurrence of symptoms requiring additional revascularization). The angiographic end point was restenosis rate at 6 months.
Conclusion
This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies, which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes. (registration number: ChiCTR-TRC- ChiCTR-IIR-17011407)
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Acknowledgements
The authors gratefully acknowledged the contributions of all the investigators, and participants of the trial.
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Zhou YS and Mao S drafted this manuscript; Guo LH and Zhang MZ designed the described study, Zou X and Gao XY made statistical analysis; Zhang MZ made critical revision of the manuscript and contributed to the rationalization of the study. All authors read and approved the final manuscript.
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The Clinical Research Ethical Committee at Guangdong Provincial Hospital of CM approved the research protocol (B2017-008-01).
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The authors declare that they have no competing interests.
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Supported by the National Natural Science Foundation of China (No. 81703848 and No. 81703877), the Natural Science Foundation of Guandong Province (No. 2017A030310123), CHEN Ke-ji Academic Thought Inheritance Studio (No. 201461) and SHI Zai-xiang Academic Thought Inheritance Studio (No. 201461)
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Zhou, Ys., Mao, S., Guo, Lh. et al. Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial. Chin. J. Integr. Med. 27, 16–23 (2021). https://doi.org/10.1007/s11655-020-2722-6
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DOI: https://doi.org/10.1007/s11655-020-2722-6