I presented the sub-analysis of ATIS-NVAF trials, which is a randomized control trial conducted in Japan. The design is oral anticoagulant monotherapy versus oral anticoagulant monotherapy plus antiplatelet therapy on outcomes; outcomes are there are several outcomes such as a composite of ischemic and cardiovascular events plus major bleeding, and secondary outcomes are ischemic stroke and all-cause mortality, and the safety outcomes are a measure of readings and clinically non-relevant readings, so we focused on the systolic blood pressure at admission at enrollment study enrollment to assess how baseline systolic blood pressure modifies the combination therapy...
I presented the sub-analysis of ATIS-NVAF trials, which is a randomized control trial conducted in Japan. The design is oral anticoagulant monotherapy versus oral anticoagulant monotherapy plus antiplatelet therapy on outcomes; outcomes are there are several outcomes such as a composite of ischemic and cardiovascular events plus major bleeding, and secondary outcomes are ischemic stroke and all-cause mortality, and the safety outcomes are a measure of readings and clinically non-relevant readings, so we focused on the systolic blood pressure at admission at enrollment study enrollment to assess how baseline systolic blood pressure modifies the combination therapy. We assess the systolic blood pressure; we define two different subgroups of normal systolic blood pressure groups and high systolic blood pressure groups. The normal systolic blood pressure we defined as under 130, and high systolic blood pressure is defined as over 130, according to many guidelines. And in each strata, we assessed the effect of a combination of antiplatelet and anticoagulant therapy versus oral anticoagulant monotherapy. In analysis, we performed Kaplan-Meier and Cox proportional hazard models using models. We obtained some results, some important results. The first is regarding the primary outcome of composite of ischemic and cardiovascular events and major bleedings; in the normal systolic blood pressure group, it shows a lower incidence of events in combination therapy; on the other hand, the higher systolic blood pressure was no difference, but combined, there was significant interaction between normal and systolic blood pressure stratum and combination therapy, and we think combination therapy would be effective in normal systolic blood pressure levels as under 130. And other, regarding other outcomes such as ischemic stroke or bleeding, ischemic stroke or death, there’s no significant difference, but a difference in addition, safety; as for safety outcomes, normal systolic blood pressure levels did not change between monotherapy and combination therapy, so in summary, our results demonstrate that combination therapy shows the benefit in the normal systolic blood pressure group without increasing blood, increasing hemorrhagic events, so also our results only used baseline systolic blood pressure, and the ATIS-NVAF trial was a trial, and patients were followed during, followed for two years, so we have to analyze the longitudinal blood pressure data during two years, but at least our results indicate the baseline systolic blood pressure effect protectively, to protect, effect protective for the combination therapy.
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