Abstract：
BACKGROUND: The efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for the treatment of patients with left-sided bioprosthetic heart valves (BHV) and atrial fibrillation (AF) remain controversial. This study aims to perform a meta-analysis to evaluate the efficacy and safety of DOACs versus VKAs in this region.
METHODS: We retrieved all relevant randomized controlled studies and observational cohort studies, which critically assessed the efficacy and safety of DOACs versus VKAs among patients with left-sided BHV and AF in databases of PubMed, Cochrane, ISI Web of Sciences, and Embase. The efficacy outcomes of this meta-analysis were stroke events and all-cause death when the safety outcomes included major and any bleeding.
RESULTS: The analysis integrated 13 studies while enrolling 27,793 patients with AF and left-sided BHV. DOACs reduced the rate of stroke by 33% compared with VKAs (risk ratio [RR] 0.67; 95% CI 0.50-0.91), with no increased incidence of all-cause death (RR 0.96; 95% CI 0.82-1.12). For safety outcomes, major bleeding was reduced by 28% using DOACs rather than VKAs (RR 0.72; 95% CI 0.52-0.99), while there was no difference in the events of any bleeding (RR 0.84; 95% CI 0.68-1.03). In addition, in patients younger than 75 years old, the stroke rate was reduced by 45% in the population using DOACs (RR 0.55; 95% CI 0.37-0.84).
CONCLUSIONS: Our meta-analysis demonstrated that in patients with AF and BHV, compared with VKAs, using DOACs was associated with reduced stroke and major bleeding events without an increase of all-cause mortality and any bleeding. In the population younger than 75 years old, DOAC might be more effective in preventing cardiogenic stroke.
METHODS: We retrieved all relevant randomized controlled studies and observational cohort studies, which critically assessed the efficacy and safety of DOACs versus VKAs among patients with left-sided BHV and AF in databases of PubMed, Cochrane, ISI Web of Sciences, and Embase. The efficacy outcomes of this meta-analysis were stroke events and all-cause death when the safety outcomes included major and any bleeding.
RESULTS: The analysis integrated 13 studies while enrolling 27,793 patients with AF and left-sided BHV. DOACs reduced the rate of stroke by 33% compared with VKAs (risk ratio [RR] 0.67; 95% CI 0.50-0.91), with no increased incidence of all-cause death (RR 0.96; 95% CI 0.82-1.12). For safety outcomes, major bleeding was reduced by 28% using DOACs rather than VKAs (RR 0.72; 95% CI 0.52-0.99), while there was no difference in the events of any bleeding (RR 0.84; 95% CI 0.68-1.03). In addition, in patients younger than 75 years old, the stroke rate was reduced by 45% in the population using DOACs (RR 0.55; 95% CI 0.37-0.84).
CONCLUSIONS: Our meta-analysis demonstrated that in patients with AF and BHV, compared with VKAs, using DOACs was associated with reduced stroke and major bleeding events without an increase of all-cause mortality and any bleeding. In the population younger than 75 years old, DOAC might be more effective in preventing cardiogenic stroke.
摘要：
背景：直接口服抗凝剂（DOAC）与维生素K拮抗剂（VKAs）治疗左侧生物人工心脏瓣膜（BHV）和心房颤动（AF）患者的疗效和安全性仍存在争议。本研究旨在进行荟萃分析，以评估DOAC与VKAs在该地区的疗效和安全性。
方法：我们检索了所有相关的随机对照研究和观察性队列研究，在PubMed数据库中，对左侧BHV和AF患者中DOAC与VKAs的疗效和安全性进行了严格评估，科克伦,ISIWebofSciences,和Embase。该荟萃分析的疗效结果是卒中事件和全因死亡，而安全性结果包括严重出血和任何出血。
结果：该分析整合了13项研究，同时招募了27,793例房颤和左侧BHV患者。与VKAs相比，DOAC将卒中发生率降低了33%（风险比[RR]0.67;95%CI0.50-0.91），全因死亡发生率没有增加（RR0.96；95%CI0.82-1.12）。对于安全结果，使用DOAC而不是VKAs，主要出血减少了28%(RR0.72;95%CI0.52-0.99)，而任何出血事件没有差异（RR0.84;95％CI0.68-1.03）。此外,在75岁以下的患者中，使用DOAC的人群卒中发生率降低了45%(RR0.55;95%CI0.37~0.84).
结论：我们的荟萃分析表明，在房颤和BHV患者中，与VKAs相比，使用DOAC与卒中和大出血事件减少相关,而全因死亡率和出血没有增加.在75岁以下的人群中，DOAC可能更有效地预防心源性卒中。
方法：我们检索了所有相关的随机对照研究和观察性队列研究，在PubMed数据库中，对左侧BHV和AF患者中DOAC与VKAs的疗效和安全性进行了严格评估，科克伦,ISIWebofSciences,和Embase。该荟萃分析的疗效结果是卒中事件和全因死亡，而安全性结果包括严重出血和任何出血。
结果：该分析整合了13项研究，同时招募了27,793例房颤和左侧BHV患者。与VKAs相比，DOAC将卒中发生率降低了33%（风险比[RR]0.67;95%CI0.50-0.91），全因死亡发生率没有增加（RR0.96；95%CI0.82-1.12）。对于安全结果，使用DOAC而不是VKAs，主要出血减少了28%(RR0.72;95%CI0.52-0.99)，而任何出血事件没有差异（RR0.84;95％CI0.68-1.03）。此外,在75岁以下的患者中，使用DOAC的人群卒中发生率降低了45%(RR0.55;95%CI0.37~0.84).
结论：我们的荟萃分析表明，在房颤和BHV患者中，与VKAs相比，使用DOAC与卒中和大出血事件减少相关,而全因死亡率和出血没有增加.在75岁以下的人群中，DOAC可能更有效地预防心源性卒中。
