Published online before print June 29, 2006, doi: 10.1161/01.STR.0000231684.19828.0d
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(Stroke. 2006;37:1962.)
© 2006 American Heart Association, Inc.
Letters to the Editor |
Intra-Arterial Thrombolysis for Acute Ischemic Stroke
Stroke Unit, "Niguarda Ca’ Granda" Hospital, Milan, Italy
Neurointerventional Unit, Istituto Scientifico Universitario San Raffaele, Milan, Italy
To the Editor:
We were very interested in reading the article by Lindsberg and Mattle.1 This systematic analysis included 344 patients treated with intra-arterial (IA) thrombolysis for basilar artery occlusion reported in 10 studies published between 1988 and 2004. These case series, along with those on anterior circulation stroke,2–6 contributed to extend the knowledge and the improvement of technical procedures of IA thrombolysis, but they can hardly be used as evidence of efficacy because the natural history of an acute brain attack is variable and sometimes unpredictable. The limit of inferences from case series is even greater if IA thrombolysis is compared with what is now considered the standard treatment of brain attack, ie, intravenous (IV) alteplase.7 The indirect comparison made by Lindsberg and Mattle1 between IA and IV thrombolysis cannot generate evidence but just hypothesis. The same principle applies for many other authors2–6 that in the field of IA thrombolysis, where randomized controlled trials (RCTs) are lacking, make comparisons between their series of cases and placebo or alteplase arm of the National Institutes of Neurological Disorders and Stroke (NINDS) trial.7 We definitely agree with Lindsberg and Mattle1 that the time to perform a RCT comparing the 2 approaches has come, and we are in line with guidelines for the early management of patients with ischemic stroke, from Stroke Council of the American Heart Association/American Stroke Association,8 stating that "therapy should not be withheld from patients who are eligible for treatment with intravenous thrombolysis so that medications can be administered intraarterially, except in the setting of a comparative research clinical trial". Actually, we are among the proponents of an ongoing RCT called SYNTHESIS comparing IA versus IV alteplase for acute ischemic stroke.9 Thirty patients have been randomized up to now. The planned sample size is about 350 patients because the trial purpose is to attest a consistent benefit of the IA administration as compared with the IV one (at least 15% of absolute risk reduction between the 2 treatment groups). We do not think such a trial should "be quite large to find a significant difference in functional outcome variable,"1 because the amount of resources required for IA thrombolysis is justified only if the superiority of IA thrombolysis as compared with the IV one is reasonably wide.
Publication of further case series on IA thrombolysis should be discouraged, in order to favor the production of RCTs and avoid that IA thrombolysis remain a virtuosistic play for few rather than a therapy to test against the burden of stroke.
Acknowledgments
Disclosures
None.
References
- Lindsberg PJ, Mattle HP. Therapy of Basilar Artery Occlusion. A Systematic Analysis Comparing Intra-Arterial and Intravenous Thrombolysis. Stroke. 2006; 37: 922–928.
[Abstract/Free Full Text] - IMS Study Investigators. Combined intravenous and intra-arterial recanalization for acute ischemic stroke: the Interventional Management of Stroke Study. Stroke. 2004; 35: 904–912.
[Abstract/Free Full Text] - Bourekas EC, Slivka AP, Shah R, Sunshine J, Suarez JI. Intraarterial thrombolytic therapy within 3 hours of the onset of stroke. Neurosurgery. 2004; 54: 39–44.[Medline] [Order article via Infotrieve]
- Smith WS, Sung G, Starkman S, Saver JL, Kidwell CS, Gobin YP, Lutsep HL, Nesbit GM, Grobelny T, Rymer MM, Silverman IE, Higashida RT, Budzik RF, Marks MP; MERCI Trial Investigators. Safety and efficacy of mechanical embolectomy in acute ischemic stroke. Results of the MERCI trial. Stroke. 2005; 36: 1432–1440.
[Abstract/Free Full Text] - Ramee SR, Subramanian R, Felberg RA, McKinley KL, Jenkins JS, Collins TJ, Dawson RC, White CJ. Catheter-Based Treatment for Patients With Acute Ischemic Stroke Ineligible for Intravenous Thrombolysis. Stroke. 2004; 35: e109–e111.
[Abstract/Free Full Text] - Mangiafico S, Cellerini M, Nencini P, Gensini G, Inzitari D. Intravenous tirofiban with intra-arterial urokinase and mechanical thrombolysis in stroke: preliminary experience in 11 cases. Stroke. 2005; 36: 2154–2158.
[Abstract/Free Full Text] - The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995; 333: 1581–1587.
[Abstract/Free Full Text] - Adams H, Adams R, Del Zoppo G, Goldstein LB. Guidelines for the early management of patients with ischemic stroke: 2005 guidelines update a scientific statement from the Stroke Council of the American Heart Association/American Stroke Association. Stroke. 2005; 36: 916–923.
[Free Full Text] - SYNTHESIS. Protocol may be found at the following web sites: http://www.ospedaleniguarda.it/zprogetti.htm, http://www.strokeforum.org/, http://www.cochraneneuronet.org/events.html.
This article has been cited by other articles:
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  B. Vatankhah, F. Schlachetzki, and H. J. Audebert Therapy of Basilar Artery Occlusion: Individual Protocols Needed Stroke, June 1, 2007; 38(6): e29 - e29. [Full Text] [PDF]
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