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Medical Therapy Beats Intracranial Stenting Even Over the Long Term

December 3, 2013

Medical Therapy Beats Intracranial Stenting Even Over the Long Term

  1. Hooman Kamel, MD

After 2 years of follow-up in the SAMMPRIS trial, there was no excess of late strokes in the medical therapy group to offset the excess of early strokes in the intervention group.

  1. Hooman Kamel, MD

Given the historical inadequacy of medical therapy for symptomatic intracranial atherosclerosis, researchers conducting the SAMMPRIS trial (NEJM JW Neurol Sep 20 2011) enrolled 451 patients with recently symptomatic 70% to 99% stenosis and randomly assigned them to receive aggressive medical therapy with or without intracranial stenting. The trial was stopped early in 2011 because the intervention group experienced significantly more strokes, mostly in the immediate periprocedural period. The original study report covered <1 year of follow-up, arousing concern that the medical therapy group would experience more strokes over the long term, thus offsetting the early harm from stenting. In response, the SAMMPRIS investigators have now published updated results with a minimum of 24 months of follow-up in all patients.

Over a median 32.4 months of follow-up, the medical therapy group had a significantly lower cumulative rate of the primary outcome (14.1% versus 20.6% at the 2-year mark) and of any stroke (17.2% versus 23.3% at the 2-year mark). The early divergence in outcome rates did not narrow over time; the difference in absolute risk for the primary endpoint between groups was 8.9% at 30 days and 9.0% at 3 years. A worst-case scenario analysis assuming that all patients lost to follow-up in the medical arm had a stroke, compared with none in the intervention arm, still indicated no benefit from intracranial stenting. Several subgroup analyses failed to identify any set of patients who benefited from stenting, including patients with multiple infarcts while already on antithrombotic therapy.

Comment

This study clearly shows that intracranial stenting for symptomatic atherosclerosis harms patients in the short term without providing any offsetting benefits over the long term. Given this finding, proponents of intracranial angioplasty without stenting need to demonstrate its efficacy in a randomized trial before routinely applying it. In the meantime, our focus should be on optimal delivery of aggressive medical therapy in these high-risk patients.

  • Disclosures for Hooman Kamel, MD at time of publication Consultant / Advisory board Genentech Grant / research support American Heart Association

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Reader Comments (2)

Dr. V Kantariya MD Physician, Family Medicine/General Practice

Stenting or Aggressive Medical Treatment for preventing Reccurent Stroke? The long-term outcomes support the aggresive medical therapy then stenting in high-risk patients. Make the right choice!

Ajoy Sodani, MBBS, MD, DM Physician, Neurology, SAIMS Medical College & PG Institute, Indore (India)

In last decade or so, medical management of stroke has undergone a sea change. Better understanding of and resulting sharper focus on the optimal control of blood pressure, lipids, life style and use of medication for endothelial remodeling, calls for a relook on all the studies published without proving aggressive medical therapy to the control population. For example, in the NIND tPa trial (N Engl J Med 1995;333:1581-7.) the controls practically did not received any medical therapy, not only they were deprived of benefits of treatment with aspirin in first 24 hours, but they were subjected to potential harms of lowering the blood pressure in acute phase. The power of aggressive
medical treatment, if factored in judicially , may change the whole paradigm of treating stroke, acute as well as chronic.

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