Efficacy of Sodium Tanshinone IIA Sulfonate in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Controlled, Randomized Trial

Abstract

Background

Sodium tanshinone IIA sulfonate (STS) has been widely used by Chinese medicine practitioners for chronic cardiovascular diseases. However, its direct clinical efficacy in patients with acute coronary syndrome following percutaneous coronary intervention (PCI) has not been reported yet. The present trial aimed to investigate potential cardioprotection of STS in patients undergoing PCI for non-ST elevation acute coronary syndrome (NSTE-ACS).

Methods

In a randomized, double-blind, placebo-controlled trial, 372 patients with NSTE-ACS were randomly assigned to receive STS (n = 192) or saline (n = 180) for 2 days before and 3 days after PCI along with standard therapy. The primary endpoint was the composite incidence of major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, repeated revascularization of the target vessel, and stent thrombosis, within 30 days after PCI.

Results

The 30-day MACEs occurred in 18.8% of the patients in the STS group and in 27.2% of the patients in the control group (P = 0.038); this difference was mostly driven by reduction of myocardial infarction incidence (17.2% vs. 26.7%, P = 0.027). Post-procedural elevation of troponin-I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001). Multivariable analysis identified STS as a predictor of decreased risk of MACE occurrence (odds ratio: 0.60, 95% confidence interval: 0.36 to 0.99; P = 0.045).

Conclusion

Addition of STS to the standard treatments recommended by the current practice guidelines in patients with NSTE-ACS undergoing PCI could reduce myocardial injury and the occurrence of short-term cardiovascular events, primarily driven by non-fatal myocardial infarction.

Trial Registration

ChiCTR-TRC-14005182

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Abbreviations

ACS:

Acute coronary syndrome

AE:

Adverse event

DSMB:

Data and safety monitoring board

hs-CRP:

High-sensitive C-reactive protein

MACE:

Major adverse cardiovascular event

NSTE-ACS:

non-ST segment elevation acute coronary syndrome

NSTEMI:

Non-ST elevation myocardial infarction

MI:

Myocardial infarction

OR:

Odds ratios

PCI:

Percutaneous coronary intervention

PMI:

Periprocedural myocardial injury

STEMI:

ST-segment elevation acute coronary syndrome

STS:

sodium tanshinone IIA sulfonate group

TIMI:

Thrombolysis in myocardial infarction

URL:

Upper reference limit

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Acknowledgements

The authors gratefully acknowledge the contributions of all staff for their participation in the STAMP study.

Funding

This study was funded by the National Science Foundation (No. 81703877& 81703848), a Featured Innovative Project from Guangdong Provincial Universities (2019KTSCX029), Young Talents Support Project from the China Association of Chinese Medicine (2019-QNRC2-C06), the Youth Talent Development Program from Guangzhou University of Chinese Medicine (to Shuai MAO), and the Team for the prevention and treatment of acute myocardial infarction with Chinese medicine (2019KCXTD009). The sponsors had no role in project development, the collection of data, or the preparation of this manuscript, nor the decision to publish.

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Authors

Contributions

S.M. drafted this manuscript; L.H.G. and M.Z.Z. designed the described study; X.J.Z. and Z.L. completed the statistical analysis; H.C.S. designed the randomization and concealment for this study; S.M., X.J.Z., Q.L., X.F.W., X.H.D. performed the study; A.H. contributed to the interpretation of the data and made critical revision of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Minzhou Zhang.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Mao, S., Wang, L., Zhao, X. et al. Efficacy of Sodium Tanshinone IIA Sulfonate in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Controlled, Randomized Trial. Cardiovasc Drugs Ther (2020). https://doi.org/10.1007/s10557-020-07077-8

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Keywords

  • Sodium tanshinone IIA sulfonate
  • Periprocedural myocardial infarction
  • Non-ST segment elevation acute coronary syndrome
  • Percutaneous coronary intervention