Abstract

Background and objective: Although guidelines for secondary ischemic stroke have been developed, there is a gap between guidelines and real world. To investigate the current status of secondary ischemic stroke in China and improve the quality of stroke prevention, We design a recommended guideline based program (SMART trial) and implement it in clinic practice to evaluate the feasibility and efficacy of the program. Methods: We conducted a multicenter (47 centers), paralleled, randomized, open label, controlled trial. Patients were randomized to two groups: standard medical management group (SMART group) and usual care group. In SMART group, measures of intervention were chosen based on the stroke sub-type according to the TOAST classification. Advice were given to the patients on stroke prevention . In usual treatment group, measures of intervention were chosen by the physician according to his/her personal knowledge. The main outcomes were the proportion of the patient’s adherence to 5 recommended measures and proportion of patients achieving the treatment target over time, a composite measures (total number of measure performed divided by the total number of eligible patients) was calculated. Secondary outcome was the composite cardiovascular events including new onset ischemic stroke, acute coronary syndrome, new onset hemorrhage stroke, and all causes of deaths. Results: Three thousand eight hundred and twenty-one patientswere enrolled into the trial. 1795 patients in standard medical treatment group, 2026 patients in usual care group. Participation in SMART group was associated with improvements in 3 measures and 1 composite measures (one year follow up): antiplatelet agents use (81.1% versus 74.9% ), statins use (55.8% versus 32.9%), antihyperglycemic agents use ( 72.6% versus 66.9% )and composite measures (68.36% versus 58.33%).Increased proportion of patients achieving treatment target were noticed (18 months follow up): blood pressure <140/90mmHg(60.6% versus 42.9%), LDL-C <2.6mmol/L (11.4% versus 9%)and HbA1c≤ 7% ( 6% versus 4.8%). The composite cardiovascular events rate decreased (4.18% versus 4.84%). The cost in hospital reduced 4.66%. Conclusions: Standard medical management program was feasible and associated with improved quality and outcome in secondary ischemic stroke prevention. Large scale promotion of this program across China was warranted.

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