Have medical therapy and stenting been fairly compared? A repercussion upon termination of recruitment in the SAMMPRIS trial

Int J Stroke. 2011 Aug;6(4):312-4. doi: 10.1111/j.1747-4949.2011.00634.x.

Abstract

The recruitment of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis, an National Institute of Neurological Disorders and Stroke-funded clinic trial evaluating aggressive medical therapy vs. adjunctive intracranial angioplasty and stenting in high-grade symptomatic intracranial stenosis, was prematurely terminated by the study Data Safety Monitoring Board. The significantly higher 30-day stroke and death rate in the stenting arm led to a conclusion from the National Institute of Neurological Disorders and Stroke and the Executive Committee that aggressive medical management alone was superior to angioplasty combined with stenting. The authors discussed on the potential pitfalls, which may render this conclusion premature and explained the needs for continuing efforts in investigating treatment for intracranial stenosis.

MeSH terms

  • Angioplasty / instrumentation
  • Aspirin / therapeutic use
  • Carotid Stenosis / therapy*
  • Clinical Trials as Topic*
  • Clopidogrel
  • Humans
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Platelet Aggregation Inhibitors / therapeutic use
  • Stents / adverse effects*
  • Stroke / prevention & control*
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • United States

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Aspirin