Jump to comment:

• Response from the SAMMPRIS Trial Principal Investigators regarding inaccuracies in this editorial
  Colin P Derdeyn
  Published on: 13 April 2016

• Published on: 13 April 2016

  Response from the SAMMPRIS Trial Principal Investigators regarding inaccuracies in this editorial

  • Colin P Derdeyn, Physician
  • Other Contributors:
    • David Fiorella, Marc I Chimowitz

  As the Principal Investigators for the Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke (SAMMPRIS) trial, we are compelled to address a few inaccuracies regarding this study in the recent editorial by Dr. Alexander.

  The first point is the patient population. The SAMMPRIS population was the right patient population to test. We had very good data from the Warfarin vers...

  Show More

  As the Principal Investigators for the Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke (SAMMPRIS) trial, we are compelled to address a few inaccuracies regarding this study in the recent editorial by Dr. Alexander.

  The first point is the patient population. The SAMMPRIS population was the right patient population to test. We had very good data from the Warfarin versus Aspirin for Symptomatic Intracranial Disease (WASID) trial that patients with recently symptomatic severe stenosis were at the highest risk for recurrent stroke 1. This high risk population offered the best chance for showing a benefit with revascularization. Much of the criticism in the editorial has the benefit of hindsight. The hemodynamic versus embolic mechanisms for stroke may be important in defining groups that benefit from angioplasty in the future 2. This distinction does not matter for extracranial carotid disease, as revascularization works regardless of mechanism. It may matter for intracranial atherosclerotic disease. Finally, in designing a trial, there are always groups of patients that will not be included, such as the high risk unstable patients described in the editorial. Our data does not address treatment of these patients one way or the other and that should not be a criticism of the trial.

  Second, the Wingspan stent was not used off-label in the trial. It is true that we used the stent under a Food and Drug Administration Investigational Device Exemption that was not the same as the Humanitarian Device Exemption (HDE) for the stent. This does not make the SAMMPRIS results "dubious". SAMMPRIS conclusively showed that angioplasty and stenting for the high risk WASID population was worse than aggressive medical management. Moreover, a subgroup analysis in patients who had failed antithrombotic therapy at the time of their qualifying event for SAMMPRIS (i.e., those patients that met the HDE criteria) also showed that angioplasty and stenting was worse than aggressive medical management in these patients (Lutsep, et al., 2012 International Stroke Conference, Los Angeles, CA).

  Finally, there was never a policy that all 20 cases of angioplasty and stenting submitted for credentialing had to be with the Wingspan device, as stated by Dr. Alexander. We required documentation of 20 consecutive intracranial angioplasty and/or stenting cases and accepted experience with similar devices 3. These cases and their outcomes were carefully reviewed by a credentialing committee composed of experienced neuro interventionists. The fact that interventionists with the least experience with Wingspan had similar event rates as those with the highest experience indicates that this system identified a very capable group of neurointerventionists (Derdeyn, et al., 2012 International Stroke Conference, Los Angeles, CA). In at least one of the carotid stenting trials mentioned by Dr. Alexander, some interventionists were allowed to participate without the requisite experience as long as they were proctored during the procedure 4. Others were allowed in with as few as five total carotid angioplasty and stenting cases (with any device). This was not permitted in SAMMPRIS.

  We agree wholeheartedly that we still have much to learn about this disease and its treatment.

  Sincerely,

  References:

  1. Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006;113:555-563 2. Derdeyn CP. Mechanisms of ischemic stroke secondary to large artery atherosclerotic disease. Neuroimaging Clin N Am. 2007;17:303-311, vii-viii 3. Chimowitz MI, Lynn MJ, Turan TN, Fiorella D, Lane BF, Janis S, Derdeyn CP. Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial. J Stroke Cerebrovasc Dis. 2011;20:357-368 4. Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lievre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touze E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660-1671

  Conflict of Interest:

  None declared

  Show Less

  Conflict of Interest:
  None declared.

  • Back to top