Abstract：
OBJECTIVE: The efficacy and safety of bivalirudin when used concurrently with glycoprotein IIb/IIIa inhibitors (GPI) is uncertain. In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) and to explore the impact of differential use (greater and balanced) of GPI.
METHODS: Online databases were queried from inception to March 2023 to identify eight randomized controlled trials (n = 22,483) for inclusion. The primary outcomes included all-cause mortality, major bleeding, major adverse cardiovascular events (MACE), and net adverse clinical events (NACE). Secondary efficacy endpoints included cardiac death, reinfarction, stent thrombosis (ST), and stroke. Data were pooled using a random-effects model to derive risk ratios (RRs) and 95% confidence intervals (CIs).
RESULTS: When compared to heparin, bivalirudin was associated with a significant reduction in all-cause mortality (RR 0.83; 95% CI 0.72-0.97; P = 0.02), major bleeding (RR 0.73; 95% CI 0.57-0.93; P = 0.01), cardiac death (RR 0.79; 95% CI 0.66-0.94; P = 0.01), and NACE (RR 0.80; 95% CI 0.72-0.89; P < 0.0001). However, while the bivalirudin arm showed an increased likelihood of ST in the greater GPI subgroup (RR 1.70; 95% CI 1.13-2.56; P = 0.01), it was associated with a decreased likelihood of ST in the balanced GPI subgroup (RR 0.40; 95% CI 0.24-0.65; P = 0.0003).
CONCLUSIONS: Overall, our findings suggest that bivalirudin may be a more efficacious intervention than heparin for reducing certain adverse events in patients with STEMI undergoing primary PCI.
METHODS: Online databases were queried from inception to March 2023 to identify eight randomized controlled trials (n = 22,483) for inclusion. The primary outcomes included all-cause mortality, major bleeding, major adverse cardiovascular events (MACE), and net adverse clinical events (NACE). Secondary efficacy endpoints included cardiac death, reinfarction, stent thrombosis (ST), and stroke. Data were pooled using a random-effects model to derive risk ratios (RRs) and 95% confidence intervals (CIs).
RESULTS: When compared to heparin, bivalirudin was associated with a significant reduction in all-cause mortality (RR 0.83; 95% CI 0.72-0.97; P = 0.02), major bleeding (RR 0.73; 95% CI 0.57-0.93; P = 0.01), cardiac death (RR 0.79; 95% CI 0.66-0.94; P = 0.01), and NACE (RR 0.80; 95% CI 0.72-0.89; P < 0.0001). However, while the bivalirudin arm showed an increased likelihood of ST in the greater GPI subgroup (RR 1.70; 95% CI 1.13-2.56; P = 0.01), it was associated with a decreased likelihood of ST in the balanced GPI subgroup (RR 0.40; 95% CI 0.24-0.65; P = 0.0003).
CONCLUSIONS: Overall, our findings suggest that bivalirudin may be a more efficacious intervention than heparin for reducing certain adverse events in patients with STEMI undergoing primary PCI.
摘要：
目的：比伐卢定与糖蛋白IIb/IIIa抑制剂（GPI）同时使用时的疗效和安全性尚不确定。在这篇系统综述和荟萃分析中，我们旨在评估比伐卢定与肝素在接受直接经皮冠状动脉介入治疗(PCI)的ST段抬高型心肌梗死(STEMI)患者中的疗效和安全性,并探讨不同使用(更高和平衡)GPI的影响.
方法：从开始到2023年3月，对在线数据库进行了查询，以确定纳入的8项随机对照试验（n=22,483）。主要结果包括全因死亡率，大出血,主要不良心血管事件（MACE），和净不良临床事件（NACE）。次要疗效终点包括心脏死亡，再梗死,支架内血栓形成(ST),和中风。使用随机效应模型汇总数据，以得出风险比（RR）和95％置信区间（CI）。
结果：与肝素相比，比伐卢定与全因死亡率显著降低相关(RR0.83;95%CI0.72-0.97;P=0.02),大出血（RR0.73；95%CI0.57-0.93；P=0.01），心源性死亡（RR0.79；95%CI0.66-0.94；P=0.01），和NACE（RR0.80；95%CI0.72-0.89；P<0.0001）。然而,而Bivalirudin组显示在GPI较大的亚组中ST的可能性增加(RR1.70;95%CI1.13-2.56;P=0.01),它与平衡GPI亚组ST的可能性降低相关(RR0.40;95%CI0.24-0.65;P=0.0003).
结论：总体而言，我们的研究结果表明,在接受直接PCI治疗的STEMI患者中,比伐卢定可能是比肝素更有效的干预措施.
方法：从开始到2023年3月，对在线数据库进行了查询，以确定纳入的8项随机对照试验（n=22,483）。主要结果包括全因死亡率，大出血,主要不良心血管事件（MACE），和净不良临床事件（NACE）。次要疗效终点包括心脏死亡，再梗死,支架内血栓形成(ST),和中风。使用随机效应模型汇总数据，以得出风险比（RR）和95％置信区间（CI）。
结果：与肝素相比，比伐卢定与全因死亡率显著降低相关(RR0.83;95%CI0.72-0.97;P=0.02),大出血（RR0.73；95%CI0.57-0.93；P=0.01），心源性死亡（RR0.79；95%CI0.66-0.94；P=0.01），和NACE（RR0.80；95%CI0.72-0.89；P<0.0001）。然而,而Bivalirudin组显示在GPI较大的亚组中ST的可能性增加(RR1.70;95%CI1.13-2.56;P=0.01),它与平衡GPI亚组ST的可能性降低相关(RR0.40;95%CI0.24-0.65;P=0.0003).
结论：总体而言，我们的研究结果表明,在接受直接PCI治疗的STEMI患者中,比伐卢定可能是比肝素更有效的干预措施.
