颅内动脉粥样硬化相关RCT试验.pptVIP

颅内动脉粥样硬化狭窄治疗相关RCT试验;三个提前终止的RCT试验;RCT- NO.1;Background;151 Patients with 50 to 99% stenosis of an intracranial artery were identified by reviewing the results of consecutive angiograms performed at participating centers between 1985 and 1991.;Figure. Graph shows Kaplan-Meier estimates of proportion of patients remaining free of ischemic stroke, myocardial infarction, or sudden death in those treated with warfarin (upper curve) or aspirin (lower curve).;Methods;After 569 patients had undergone randomization, enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin.;;;Conclusions;Stenting versus Aggressive Medical Therapyfor Intracranial Arterial Stenosis;Background;Methods;Currently, the mean duration of followup, which is ongoing, is 11.9 months.;Conclusions;Aggressive medical management;Aspirin plus clopidogrel;Aggressive medical management;14.7%;;With the announcement of the safety concern and early termination of the SAMMPRIS trial, the Data Safety Monitoring Board (DSMB) of ESASIS study met on April 28, 2011 and reviewed the 30-day safety data (combined stroke and death) for 77 patients randomized as of April 20, 2011. In his letter to the Executive Committee, the Chair of the DSMB commented that ‘…The safety data for the medical group is comparable to the 6% reported for the medical arm of the SAMMPRIS study, whereas the safety data for the stenting group is not comparable to the 14% reported for the stent arm of the SAMMPRIS study’ and recommended that ‘the ESASIS trial continues recruitment butwith close monitoring of safety.’;The jury is still out on the benefit/risk ratio of angioplasty and stenting for intracranial arterial stenosis.