Anticoagulant effectiveness and safety of new oral anticoagulants versus warfarin after heart valve replacement ： a meta-analysis / 中国药房

ABSTRACT

OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants （NOACs）and warfarin after heart valve replacement ，and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed，Cochrane Library ，Embase，Web of Science ，CNKI，Wanfang database and VIP ，clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion，the quality of included randomized controlled trials （RCTs）were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale （NOS），RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail：carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ，of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ，the incidence of stroke and systemic embolism （SSE）[OR＝0.71，95％CI（0.52，0.97），P＝0.03]，major bleeding [OR ＝0.40，95％CI （0.30，0.54），P＜0.000 01] and intracranial hemorrhage [OR ＝0.20，95％CI（0.04，0.95），P＝0.04] in trial group were significantly lower than warfarin group ；there was no significant difference in all-cause mortality between 2 groups [OR ＝1.25，95％CI（0.88， 1.79），P＝0.22]. After mechanical valve replacement/repair ，there were no significant difference in the incidence of SSE [OR ＝1.52， 95％CI（0.04，60.29），P＝0.82] or all-cause mortality [OR ＝0.26，95％CI（0.04，1.84），P＝0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ，the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR ＝0.20，95％CI（0.06， 0.74），P＝0.03]；but there was no significant difference in the incidence of major bleeding between 2 groups [OR ＝0.67，95％CI （0.19，2.38），P＝0.53]；when the follow-up time was longer than 3 months，there was no statistical significance in the incidence of SSE between 2 groups [OR ＝0.74，95％CI（0.54，1.02），P＝0.07]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.39，95％CI（0.29，0.52），P＜0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ，the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR ＝0.51，95％CI（0.29，0.92），P＝0.03]，but there was no significant difference in the incidence of major bleeding between 2 groups[OR＝0.58，95％CI（0.33，1.03），P＝0.06]. In cohort study ，there was no significant difference in the incidence of SSE between 2 groups [OR ＝1.03，95％CI（0.40，2.66），P＝0.95]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.20，95％CI（0.06，0.74），P＜0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair，the effectiveness and safety of NOACs are better than or similar to those of warfarin ；for the patients underwent mechanical valve replacement/repair ，there is no significant difference in the effectiveness and safety between NOACs and warfarin.