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Mutant AKT1 in Proteus syndrome.

The authors Reply: We agree with Huisa that a trial comparing carotid revascularization with intensive medical management is needed in patients with asymptomatic carotid stenosis. Such a trial is currently being planned.1 Jiang and Yu point out that there have been more deaths beyond 30 days in the medical-management group of SAMMPRIS (one death from brain hemorrhage, one from myocardial infarction, one from cardiac arrest after coronaryartery bypass surgery, and three from nonvascular causes) than in the PTAS group (one sudden cardiac death and one death from nonvascular causes), but half of these deaths in both groups had nonvascular causes that were unrelated to study interventions. The insensitivity of all-cause mortality beyond 30 days to study interventions is the reason this outcome was not chosen as a primary end point. Since the medical management in SAMMPRIS was the same in both groups, the only adverse event that should be affected differently in the two treatment groups beyond 30 days was ischemic stroke in the territory of the symptomatic artery, which is why this outcome was chosen as a primary end point. The number of strokes in the territory beyond 30 days is currently 13 in each group (no fatal strokes in either group, 4 disabling strokes in the medicalmanagement group, and 1 disabling stroke in the PTAS group). We agree that follow-up of patients in the SAMMPRIS trial is important to evaluate whether stenting may provide any later benefit for preventing stroke — particularly disabling stroke — in the territory. We also agree that it will be important to identify subgroups at high risk for stroke despite aggressive medical management; however, identification of these patients does not necessarily imply that they will benefit from stenting. SAMMPRIS demonstrates this point, since all patients enrolled in the trial had high-risk features for stroke in the territory that were identified in the preceding WASID trial,2,3 yet these high-risk patients did not benefit from stenting. Similarly, extracranial– intracranial bypass was not more effective than medical management for preventing stroke in another trial involving high-risk patients with carotid occlusion and impaired cerebral hemodynamics.4 Therefore, any subgroups at high risk for stroke in the medical-management group of SAMMPRIS would need to be evaluated in future randomized trials to determine whether endovascular therapy has a role in treating those patients.