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Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial): An Open-Label Randomized Controlled, Multicenter Study.

Wang SL, Wang CL, Wang PL, Xu H, Liu HY, Du JP, Zhang DW, Gao ZY, Zhang L, Fu CG, Lü SZ, You SJ, Ge JB, Li TC, Wang X, Yang GL, Liu HX, Mao JY, Li RJ, Chen LD, Lu S, Shi DZ, Chen KJ - Evid Based Complement Alternat Med (2013)

Bottom Line: The safety endpoint involved occurrence of major bleeding events.Conclusion.Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.

ABSTRACT
Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier time to event curve for secondary endpoint.
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fig3: Kaplan-Meier time to event curve for secondary endpoint.

Mentions: The secondary endpoints occurred in 14 (3.5%) in the treatment group and 35 (8.7%) in the control group (unadjusted HR 0.39, 95% CI 0.21 to 0.72, P = 0.002). After adjusting for the effects of covariates, the addition of CHMs to conventional treatment was associated with a significant reduction in the secondary endpoint compared with conventional treatment alone (adjusted HR 0.37, 95% CI 0.21 to 0.72, P = 0.002) (Table 2 and Figure 3(a)). Among the components of the endpoint, the cumulative incidence of readmission for ACS in the treatment group was lower than that in the control group (2.0% versus 5.9%, unadjusted HR 0.33, 95% CI 0.15 to 0.72, adjusted HR 0.29, 95% CI 0.13 to 0.65, P = 0.004) (Table 2 and Figure 3(b)). However, the incidence of stroke (0.7% versus 1.5%, unadjusted HR 0.49, 95% CI 0.12 to 0.97, adjusted HR 0.69, 95% CI 0.16 to 3.02, P = 0.307) and congestive HF (0.7% versus 1.2%, unadjusted HR 0.59, 95% CI 0.14 to 2.48, adjusted HR 0.52, 95% CI 0.12 to 2.36, P = 0.469) did not differ between the two groups.


Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial): An Open-Label Randomized Controlled, Multicenter Study.

Wang SL, Wang CL, Wang PL, Xu H, Liu HY, Du JP, Zhang DW, Gao ZY, Zhang L, Fu CG, Lü SZ, You SJ, Ge JB, Li TC, Wang X, Yang GL, Liu HX, Mao JY, Li RJ, Chen LD, Lu S, Shi DZ, Chen KJ - Evid Based Complement Alternat Med (2013)

Kaplan-Meier time to event curve for secondary endpoint.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3713597&req=5

fig3: Kaplan-Meier time to event curve for secondary endpoint.
Mentions: The secondary endpoints occurred in 14 (3.5%) in the treatment group and 35 (8.7%) in the control group (unadjusted HR 0.39, 95% CI 0.21 to 0.72, P = 0.002). After adjusting for the effects of covariates, the addition of CHMs to conventional treatment was associated with a significant reduction in the secondary endpoint compared with conventional treatment alone (adjusted HR 0.37, 95% CI 0.21 to 0.72, P = 0.002) (Table 2 and Figure 3(a)). Among the components of the endpoint, the cumulative incidence of readmission for ACS in the treatment group was lower than that in the control group (2.0% versus 5.9%, unadjusted HR 0.33, 95% CI 0.15 to 0.72, adjusted HR 0.29, 95% CI 0.13 to 0.65, P = 0.004) (Table 2 and Figure 3(b)). However, the incidence of stroke (0.7% versus 1.5%, unadjusted HR 0.49, 95% CI 0.12 to 0.97, adjusted HR 0.69, 95% CI 0.16 to 3.02, P = 0.307) and congestive HF (0.7% versus 1.2%, unadjusted HR 0.59, 95% CI 0.14 to 2.48, adjusted HR 0.52, 95% CI 0.12 to 2.36, P = 0.469) did not differ between the two groups.

Bottom Line: The safety endpoint involved occurrence of major bleeding events.Conclusion.Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.

ABSTRACT
Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

No MeSH data available.


Related in: MedlinePlus