This article describes an analysis of the long-term safety and efficacy of recombinant activated factor VII （rFVIIa） over a 10-year period. From the data of 1,718 bleeding episodes in 142 congenital hemophilia patients with inhibitors, 65％ showed improved clinical symptoms within 12 hours after rFVIIa injection. Overall, 88％ of bleeding episodes improved following treatment with rFVIIa. Median treatment was dosing period of 1.0 day with 3.0 injections of 103 μg/kg rFVIIa in the patient group without concomitant use of other hemostatic agents. Joint bleeds were most common （63％）, followed by muscle bleeds （14％） and subcutaneous hemorrhages （9％）. The dosing period was significantly longer for intracranial hemorrhage and gastrointestinal bleeds, and hematuria. Out of 8,097 bleeding episodes and a total of 24,778 injections in 144 patients, 5 thromboembolic events were reported in 4 patients.
Intravenous recombinant tissue plasminogen activator （IV rt-PA） was approved in 2005 in Japan, and it had a significant impact on acute stroke therapy. More than 50,000 patients were treated so far, but low adaptation rate of IV rt-PA was regarded as problem. Merci retriever and Penumbra system were approved in 2010 and 2011, respectively, and gradually spreading in Japan. However, the results of 3 randomized controlled trials were all negative in terms of superiority or non-inferiority of endovascular treatment compared to IV rt-PA or standard care. Next generation devices such as stent-like retrievers were shown to have better effect in clinical outcome compared to Merci retriever. It is expected that the efficacy of endovascular treatment will be confirmed by randomized controlled trials in the near future.