Blood-Activating and Stasis-Removing Chinese Patent Medicine in Perioperative Period of Percutaneous Coronary Intervention for Myocardial Infarction: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Controlled Trials.

内容摘要

The aim of this study is to evaluate the efficacy and safety of blood-activating and stasis-removing Chinese patent medicines (BASR-CPMs) during the perioperative period of percutaneous coronary intervention (PCI) for myocardial infarction (MI). We searched eight databases (PubMed, Embase, the Cochrane Library, Web of Science, CNKI, WanFang Data, SinoMed, and VIP) from database inception to February 15, 2025, for randomized controlled trials (RCTs) comparing standard care plus BASR-CPMs versus standard care alone (or with other BASR-CPMs) in MI patients undergoing PCI. A Bayesian network meta-analysis was conducted to estimate relative effects. Primary outcomes included major adverse cardiovascular events (MACE) and major adverse cardiac and cerebrovascular events (MACCE), while key secondary outcomes included thrombolysis in MI (TIMI) grade 3 flow, angina, and bleeding events. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool. The certainty of evidence was evaluated using the GRADE framework. A protocol of the systematic review and network meta-analysis was registered with PROSPERO (CRD420251048208). We included 160 RCTs (21,147 participants) evaluating 25 BASR-CPMs. Regarding hard clinical endpoints, no BASR-CPMs differed significantly from standard care for MACE or MACCE at any time point. For example, Tongxinluo capsule showed no significant reduction in MACE at 1 month (relative risk [RR] 0.62, 95% credible interval [CrI] 0.11 to 1.70; low certainty). Tongxinluo capsule may improve TIMI grade 3 flow immediately after PCI (RR = 1.12, 95% CrI: 1.04-1.26; low certainty) and at 3 months (RR = 1.47, 95% CrI: 1.10-1.98; moderate certainty). Danhong injection (RR = 1.15, 95% CrI: 1.02-1.31) and Shexiang Baoxin pill (RR = 1.15, 95% CrI: 1.02-1.30) may also improve TIMI grade 3 flow immediately after PCI (moderate certainty). For reducing angina incidence at 1 and 6 months, Tongxinluo, Danhong, Salvianolate injection, Shexiang Baoxin, Guanxin Shutong, and Shexiang Tongxin dripping pill showed potential benefits (low to high certainty). Most interventions did not increase bleeding risk, and Tongxinluo possibly reduced adverse effects (low certainty). Exploratory findings suggest that BASR-CPMs, notably Tongxinluo, Danhong, and Shexiang Baoxin, improve immediate reperfusion and reduce angina recurrence post-PCI in MI patients. These intermediate benefits do not translate into reductions in hard clinical outcomes. Further rigorous RCTs are needed to confirm their long-term impact on MACE and MACCE.