Abstract：
OBJECTIVE: This meta-analysis aimed to evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and type 2 valvular heart disease (VHD).
METHODS: We searched the PubMed, LILACS, and MEDLINE databases to retrieve, randomized controlled trials (RCTs) comparing NOACs and VKAs in patients with AF and type 2 VHD, excluding mitral stenosis (moderate to severe, of rheumatic origin) or mechanical heart valves. The efficacy outcomes assessed were stroke and systemic embolism (SE), while safety outcomes included major bleeding and intracranial hemorrhage (ICH).
RESULTS: Seven RCTs, including 16,070 patients with AF and type 2 VHD, were included. NOACs reduced the risk of stroke/SE (relative risk [RR], 0.75; 95% confidence interval [CI], 0.64-0.89; P = 0.0005), with no significant difference in major bleeding (RR, 0.88; 95% CI, 0.64-1.21; P = 0.43). The risk of ICH was reduced with NOACs (RR, 0.46; 95% CI, 0.27-0.77; P = 0.003). For patients with AF and bioprosthetic heart valve (five trials, 2805 patients), stroke/SE risks (RR, 0.65, 95% CI, 0.44-0.96) with NOACs were superior to VKAs. Major bleeding risks without ENVISAGE TAVI AF trial (RR, 0.53; 95% CI, 0.30-0.94; P = 0.03) with NOACs were superior to VKAs. The risks of ICH (RR, 0.61; 95% CI 0.34-1.09; P = 0.09) with NOACs were comparable to VKAs.
CONCLUSIONS: NOACs demonstrate efficacy and safety in patients with AF and type 2 VHD and reduce the risk of stroke/SE and ICH when compared with those with VKAs.
METHODS: We searched the PubMed, LILACS, and MEDLINE databases to retrieve, randomized controlled trials (RCTs) comparing NOACs and VKAs in patients with AF and type 2 VHD, excluding mitral stenosis (moderate to severe, of rheumatic origin) or mechanical heart valves. The efficacy outcomes assessed were stroke and systemic embolism (SE), while safety outcomes included major bleeding and intracranial hemorrhage (ICH).
RESULTS: Seven RCTs, including 16,070 patients with AF and type 2 VHD, were included. NOACs reduced the risk of stroke/SE (relative risk [RR], 0.75; 95% confidence interval [CI], 0.64-0.89; P = 0.0005), with no significant difference in major bleeding (RR, 0.88; 95% CI, 0.64-1.21; P = 0.43). The risk of ICH was reduced with NOACs (RR, 0.46; 95% CI, 0.27-0.77; P = 0.003). For patients with AF and bioprosthetic heart valve (five trials, 2805 patients), stroke/SE risks (RR, 0.65, 95% CI, 0.44-0.96) with NOACs were superior to VKAs. Major bleeding risks without ENVISAGE TAVI AF trial (RR, 0.53; 95% CI, 0.30-0.94; P = 0.03) with NOACs were superior to VKAs. The risks of ICH (RR, 0.61; 95% CI 0.34-1.09; P = 0.09) with NOACs were comparable to VKAs.
CONCLUSIONS: NOACs demonstrate efficacy and safety in patients with AF and type 2 VHD and reduce the risk of stroke/SE and ICH when compared with those with VKAs.
摘要：
目的：本荟萃分析旨在评估非维生素K拮抗剂口服抗凝药（NOAC）与维生素K拮抗剂（VKAs）在房颤（AF）和2型心脏瓣膜病（VHD）患者中的疗效和安全性。
方法：我们搜索了PubMed，LILACS,和MEDLINE数据库来检索，随机对照试验（RCT）比较NOAC和VKAs在房颤和2型VHD患者中的作用，排除二尖瓣狭窄（中度至重度，风湿性起源）或机械心脏瓣膜。评估的疗效结果是卒中和全身性栓塞（SE），而安全性结局包括大出血和颅内出血（ICH）。
结果：七个RCT，包括16,070例房颤和2型VHD患者，包括在内。NOAC降低了卒中/SE的风险(相对风险[RR]，0.75；95%置信区间[CI]，0.64-0.89；P=0.0005），大出血无显著差异(RR，0.88；95%CI，0.64-1.21；P=0.43）。NOAC降低了ICH的风险(RR，0.46；95%CI，0.27-0.77；P=0.003）。对于房颤和生物心脏瓣膜患者(五项试验，2805名患者），卒中/SE风险(RR，0.65，95%CI，0.44-0.96）的NOAC优于VKAs。无ENVISAGETAVIAF试验的主要出血风险(RR，0.53；95%CI，0.30-0.94；P=0.03）NOAC优于VKAs。ICH的风险(RR，0.61；95%CI0.34-1.09；P=0.09）与VKAs相当。
结论：NOACs在房颤和2型VHD患者中具有有效性和安全性，与VKAs患者相比，可降低卒中/SE和ICH的风险。
方法：我们搜索了PubMed，LILACS,和MEDLINE数据库来检索，随机对照试验（RCT）比较NOAC和VKAs在房颤和2型VHD患者中的作用，排除二尖瓣狭窄（中度至重度，风湿性起源）或机械心脏瓣膜。评估的疗效结果是卒中和全身性栓塞（SE），而安全性结局包括大出血和颅内出血（ICH）。
结果：七个RCT，包括16,070例房颤和2型VHD患者，包括在内。NOAC降低了卒中/SE的风险(相对风险[RR]，0.75；95%置信区间[CI]，0.64-0.89；P=0.0005），大出血无显著差异(RR，0.88；95%CI，0.64-1.21；P=0.43）。NOAC降低了ICH的风险(RR，0.46；95%CI，0.27-0.77；P=0.003）。对于房颤和生物心脏瓣膜患者(五项试验，2805名患者），卒中/SE风险(RR，0.65，95%CI，0.44-0.96）的NOAC优于VKAs。无ENVISAGETAVIAF试验的主要出血风险(RR，0.53；95%CI，0.30-0.94；P=0.03）NOAC优于VKAs。ICH的风险(RR，0.61；95%CI0.34-1.09；P=0.09）与VKAs相当。
结论：NOACs在房颤和2型VHD患者中具有有效性和安全性，与VKAs患者相比，可降低卒中/SE和ICH的风险。
