Objective

2

To observe the effectiveness and safety of

Xingeng No.Ⅱ Granules

（心梗2号颗粒剂） in preventing and treating left ventricular remodeling in patients with

qi

deficiency and blood stasis syndrome following percutaneous coronary intervention （PCI） for ST-segment elevation myocardial infarction （STEMI）.

Methods

2

In this randomized controlled trial， patients with

qi

deficiency and blood stasis syndrome after PCI for STEMI were randomly assigned to treatment group and control group at a 1∶1 ratio， with 66 patients in each group. In the control group， patients only received conventional western medicine after surgery， while the treatment group additionally received the granules （8 g per dose， twice daily）， for a treatment duration of 8 weeks in both groups. The primary outcome was the incidence of left ventricular remodeling within 6 months after surgery. The secondary outcomes were the incidence of major adverse cardiovascular and cerebrovascular events （MACCE） within 6 months， all-cause mortality， stent thrombosis， BARC Ⅲ and V bleeding events， rehospitalization due to acute heart failure， and severe complications of STEMI. Traditional Chinese medicine （TCM） syndrome scores at 1 day and 1， 2， and 6 months after surgery was evaluated. Adverse events during the study were recorded to evaluate safety.

Results

2

Six cases dropped out from both the treatment group and the control group. The full analysis set （FAS） analysis showed that the incidence of left ventricular remodeling in the treatment group was 16.67% （11/66）， significantly lower than 40.91% （27/66） in the control group （

P

=0.004）. The per protocol set （PPS） analysis also showed lower incidence of left ventricular remodeling in the treatment group （20.37%， 11/54） than in the control group （49.09%， 27/55） with significant differe

nce （

P

=0.002）. Within 6 month after surgery， 0 patients in the treatment group and 4 out of 60 patients （6.67%） in the control group were readmitted to hospital for acute heart failure， with significantly higher rate in the control group （

P

=0.042）. Neither group of patients experienced recurrent myocardial infarction， target vessel revascularization， in-stent thrombosis， or severe complications of STEMI. There was no statistically significant difference between groups in the incidence of stroke， cardiovascular mortality， all-cause mortality， BARC Ⅲ and V bleeding events （

P

＞0.05）. At 1 day after surgery， there was no statistically significant difference in TCM syndrome score between the groups （

P

＞0.05）； while 1， 2 and 6 months after surgery， TCM syndrome score in the treatment group was significantly lower than that in the control group （

P

＜0.05）. Analysis of the safety dataset （SS） showed that the incidence of adverse events in the treatment group was 7.41% （4/60）， while in the control group it was 16.36% （9/57）， showing no statistically significant difference （

P

= 0.117）.

Conclusion

2

In addition to conventional western medicine，

Xingeng No.Ⅱ Granules

can reduce the incidence of left ventricular remodeling and the incidence of rehospitalization due to acute heart failure in STEMI patients with

qi

deficiency and blood stasis syndrome after PCI， with good safety profile.