Department of Clinical, Internal Medicine, Anesthesiological and Cardiovascular Sciences, "Sapienza" University of Rome, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2023 Nov;27(21):10716-10729. doi: 10.26355/eurrev_202311_34352.
Combination and duration of antithrombotic therapy in order to prevent both stent thrombosis and thromboembolic complications after coronary artery stenting (PCI) in non-valvular atrial fibrillation (AF) is still debated. This uncertainty can be attributed mainly to the fact that the reference trials were open-label and not adequately powered in order to reach a definitive conclusion on ischemic endpoints (i.e., stent thrombosis). On these grounds, data from real-life studies could support evidence on dual antithrombotic treatment (DAT) safety (bleeding risk) and efficacy (stent thrombosis prevention). The aim of the meta-analysis is to investigate in both randomized controlled trials (RCTs) and observational studies (Obs) the risks and/or benefits related to DAT vs. triple antithrombotic treatment (TAT) regimens in patients affected by AF undergoing PCI.
RCTs and Obs were retrieved through PubMed database. The risk ratio with 95% confidence interval was used to compare the primary and the safety endpoints.
Meta-analysis demonstrated no significant differences between DAT vs. TAT for mortality. However, a two-fold higher mortality rate was registered in Obs than in RCTs. The Obs did not confirm the expected significant reduction in bleeding risk shown by the RCTs; however, the bleeding rates in Obs were more than three-fold those of RCTs. In Obs, a significant greater risk for stent thrombosis was observed in DAT than in TAT.
The safety and efficacy outcomes observed in RCTs are unrealistic with respect to the current clinical practice. So, more evidence is needed to have more exhaustive guidelines based on RCTs with homogeneous designs and protocols that should mimic real-life population and practice.
为了预防非瓣膜性心房颤动(AF)患者经皮冠状动脉介入治疗(PCI)后支架血栓形成和血栓栓塞并发症,联合应用抗栓治疗的时间和方式仍存在争议。这种不确定性主要归因于以下事实:参考试验为开放性标签,且没有足够的效力来得出关于缺血终点(即支架血栓形成)的明确结论。基于这些原因,真实世界研究的数据可以为双联抗栓治疗(DAT)的安全性(出血风险)和疗效(预防支架血栓形成)提供证据。本荟萃分析旨在研究 AF 合并 PCI 患者 DAT 与三联抗栓治疗(TAT)方案相比,在安全性和有效性方面的风险和/或获益。
通过 PubMed 数据库检索 RCTs 和观察性研究。采用风险比及其 95%置信区间来比较主要终点和安全性终点。
荟萃分析显示,DAT 与 TAT 相比,死亡率无显著差异。然而,观察性研究中登记的死亡率是 RCTs 的两倍。观察性研究并未证实 RCTs 所预期的出血风险降低具有显著意义;然而,观察性研究中的出血率是 RCTs 的三倍以上。在观察性研究中,DAT 组的支架血栓形成风险显著高于 TAT 组。
RCTs 观察到的安全性和疗效结果与当前的临床实践不符。因此,需要更多的证据来制定更全面的指南,这些指南应该基于具有统一设计和方案的 RCTs,以模拟真实人群和实践。