1.Efficacy and safety of new oral anticoagulants versus warfarin for left ventricular thrombus:a meta-analysis
Qiang ZHOU ; Yueyue ZANG ; Yingying TAO ; Xiaohui HUANG ; Yanzi WU ; Yuansu YANG ; Meng WEI
China Pharmacy 2022;33(24):3034-3039
OBJECTIVE To compare the efficacy and safety of new oral anticoagulants (NOACs) and warfarin in the treatment of left ventricular thrombus (LVT), and to provide evidenced-based reference for rational drug use in clinic. METHODS Retrieved from PubMed, Cochrane Library, Embase, Ovid Medline, CNKI, Wanfang and VIP during the inceptions to March 2022, after screening the literature and extracting data, the quality of randomized controlled trials (RCTs) was evaluated by using bias risk evaluation tool recommended by Cochrane systematic evaluator manual. Newcastle Ottawa Scale was used to evaluate the quality of cohort studies, and RevMan 5.3 software was used for meta-analysis and bias risk analysis. RESULTS A total of 13 studies were included in the analysis, including 2 RCTs, 11 cohort studies and 2 261 patients; results of meta-analysis showed that there was no statistical significance in the incidence of complete LVT resolution [OR=1.05, 95%CI(0.81,1.37), P=0.71], the incidence of stroke/systemic embolism [OR=0.89, 95%CI(0.67,1.18), P=0.42], the incidence of massive haemorrhage [OR= 0.61, 95%CI(0.19,1.97), P=0.41], the incidence of rehospitalization [OR=0.84, 95%CI(0.49,1.46), P=0.54] or all-cause mortality [OR=0.93, 95%CI(0.56,1.56), P=0.79] between 2 groups. The incidence of any bleeding event in trial group was significantly lower than that control group[OR= 025-80863493。0.65, 95%CI(0.45,0.93), P=0.02]. Subgroup analysis showed that complete LVT resolution of patients with follow-up ≤6 months in trial group was significantly higher than control group, and the incidence of any bleeding event was significantly lower in patients with follow-up >6 months and in the European region than control group (P<0.05). There was no statistically significant difference in the rate of complete LVT resolution in patients with follow-up>6 months, the incidence of any bleeding event in patients from Asia and America, or the incidence of any bleeding event in the two groups included in the RCT or the cohort study (P>0.05). The publication bias analysis showed that publication bias was less likely in the rate of complete LVT resolution but more likely in the incidence of any bleeding event. CONCLUSIONS NOACs can eliminate thrombus faster in the early stage, but with the prolongation of anticoagulation time, the efficacy of NOACs is comparable to warfarin, and the safety of NOACs in any bleeding event is better than warfarin.
2.Anticoagulant effectiveness and safety of new oral anticoagulants versus warfarin after heart valve replacement : a meta-analysis
Qiang ZHOU ; Sifan WU ; Xiyao WANG ; Yuansu YANG ; Yingying TAO ; Xiaohui HUANG ; Meng WEI
China Pharmacy 2022;33(2):230-235
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.