Abstract 125: A Randomized Trial Comparing Primary Angioplasty versus Stent Placement for Symptomatic Intracranial Stenosis
Introduction: The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) was prematurely terminated due to excessively high rate of stroke and death in patients randomized to intracranial stent placement. Equivalent results with primary angioplasty in several uncontrolled studies will continue to raise the question that a policy of mandatory stent placement may have led to a higher peri-procedural stroke and death without a clear evidence of incremental benefit.
Methods: The primary aim of the study is to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. The study prospectively evaluated acute,1-month, 6 month, and 1-year efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment.
Results: A total of 18 patients were recruited in the study; mean age [±SD] was 64.7±15.1 years, 12 were men. Of these 18, 10 were randomized to primary angioplasty and 8 were randomized to angioplasty followed by self expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients respectively. The total fluoroscopic time (mean [±SD] was lower in patients undergoing primary angioplasty 37 [±11] mins versus those undergoing angioplasty followed by self expanding stent 42 [±9] mins, p=.309. The 1 month stroke and death rate was very low in both patient groups (1 of 10 versus none of 8 patients).
Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty followed by stent placement is feasible. The immediate procedural outcomes with primary angioplasty are comparable to stent placement and warrant further studies.
- © 2012 by American Heart Association, Inc.