What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) (n=70199). Intervention: Bivalirudin vs. Heparin. Primary outcome: All-cause mortality (RR 0.94, 95% CI 0.85-1.04, p=0.24).

What does this research mean for the field?

Bivalirudin shows no significant difference in all-cause mortality compared to heparin in patients with acute coronary syndrome undergoing PCI, but significantly reduces the incidence of short-term bleeding while increasing the risk of acute stent thrombosis. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

February 10, 2025Open Access

The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis

YZYou ZhaiJilin University HSHongcai ShangBeijing University of Chinese Medicine YLYan LiKindeva Drug Delivery (United States)

Resultado clave

Bivalirudin showed no significant difference in all-cause mortality (RR 0.94) compared to heparin in patients with acute coronary syndrome undergoing PCI, but significantly reduced the incidence of short-term bleeding.

Diseño del estudio

Tipo

Meta-Analysis (n=70,199)

PICO estructurado

Does bivalirudin reduce adverse cardiovascular events and bleeding compared to heparin in patients with acute coronary syndrome undergoing PCI?

Población

70,199 patients with acute coronary syndrome (STEMI, NSTEMI, and unstable angina) undergoing percutaneous coronary intervention (PCI) pooled from 27 RCTs.

Intervención

Bivalirudin (typically 0.75 mg/kg bolus followed by 1.75 mg/kg/h maintenance) during PCI.

Comparador

Heparin (typically 60-100 IU/kg bolus) with or without glycoprotein IIb/IIIa inhibitors during PCI.

Resultado

All-cause mortality, major adverse cardiovascular events (MACEs), incidence of recurrent myocardial infarction, stent thrombosis, short-term bleeding, revascularization, and retransfusion.hard clinical

In patients with ACS undergoing PCI, bivalirudin reduces short-term bleeding and retransfusion compared to heparin, but is associated with a higher risk of acute stent thrombosis and revascularization.

Resultado numérico

Estimación del efecto: RR 0.94 (95% CI 0.85-1.04)

valor p: p=0.24

Limitaciones

Only studies in Chinese and English languages were included, which may lead to retrieval bias
There were variations in the doses of bivalirudin and heparin administered
Subgroup analysis based on doses was not performed
Many of the studies incorporated into the research lacked precision in terms of detailed dose stratification

Resumen

BACKGROUND: Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of thrombosis. However, bleeding-related complications during antithrombotic therapy remain a major barrier to effective treatment and can often lead to adverse outcomes. This meta-analysis aimed to determine the efficacy and safety of bivalirudin and heparin in patients with ACS after PCI. METHODS: Randomized controlled trials (RCTs) on the efficacy and safety of bivalirudin versus heparin in patients with ACS after PCI were identified from the PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang, and VIP database until August 2024. The outcomes included all-cause mortality, major adverse cardiovascular events (MACEs), incidence of recurrent myocardial infarction, stent thrombosis, short-term bleeding, revascularization, and retransfusion. Meta-analysis was performed using RevMan 5.3 and Stata 12.0 softwares. The included studies were assessed for risk of bias using the Cochrane risk-of-bias assessment tool. RESULTS: A total of 70,199 patients from 27 randomized controlled trials (RCTs) were analyzed in this review. There were no significant differences between the bivalirudin and heparin groups in terms of all-cause mortality, major adverse cardiovascular events (MACEs), recurrent myocardial infarction, stent thrombosis within 30 days, or subacute stent thrombosis. Specifically, the incidence of short-term bleeding (P = 0.001) and retransfusion (P = 0.001) was significantly lower in the bivalirudin group compared to the heparin group. Conversely, the incidence of acute stent thrombosis (P < 0.0001) and revascularization (P = 0.009) was significantly higher in the bivalirudin group. CONCLUSIONS: Compared with heparin, bivalirudin has definite anticoagulant effect in patients with acute myocardial infarction after PCI, and the risk of bleeding and the incidence of retransfusion were lower in the bivalirudin group. This review helps doctors in PCI management choose bivalirudin or heparin more precisely based on patients' conditions for better treatment and fewer adverse events.

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