updatedacutetherapy中文翻译稿.pptVIP

* With the recommendations of the panel in mind, lets take a look at the MERCI Trial. The investigators hoped to show that the retriever could access and revascularize occluded vessels in patients experiencing ischemic stroke while minimizing adverse events. This hypothesis, then, employs the use of a surrogate endpoint – that of revascularization – rather than a clinical outcome. * As mentioned, the primary endpoint was that of revascularization and success was defined in relationship to the spontaneous recanalization seen in the placebo arm of the PROACT II study. * When comparing other outcome measures, I think it is most illustrative to look at patients with MCA occlusions in MERCI trial and compare them to not only the control patients in PROACT II, but also the actively treated patients. Firstly, you can see that patients in MERCI were a bit older, a bit sicker and treated a bit later than patients in PROACT II. Recanalization was greater than that in the control arm of PROACT II, but not than that in the actively treated arm. Mortality was greater in the overall MERCI as well as in the MERCI MCA patients than in either arm of PROACT II. Finally, the percentage of patients achieving a mRS score of 2 or less 90 days after stroke onset was similar in the overall MERCI and the PROACT II control group. In the MERCI MCA patients, outcome was slightly better but probably not different than that of the PROACT II control group. Importantly, outcome appears to be worse than in the actively treated patients in PROACT II. * It is also interesting to point out that in patients who underwent an unsuccessful attempt at mechanical embolectomy, mortality was markedly increased. * How about safety….. There were 8 SAEs in 114 patients, 2 strokes in previously uninvolved territories, likely due to distal embolization of clot, and 2 vessel dissections/perforations. The procedure itself was also associated with 2 vessel dissections and 2 vessel perforations. * 45%