Combined Intravenous and Intra-Arterial Recanalization for Acute Ischemic Stroke: The Interventional Management of Stroke Study

• Published in: Stroke (1970) Vol. 35; no. 4; pp. 904 - 911
• Format: Journal Article
• Language: English
• Published: United States 01.04.2004
• Subjects: Acute Disease; Adolescent; Adult; Aged; Brain Ischemia - diagnosis; Brain Ischemia - drug therapy; Female; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - therapeutic use; Humans; Infusions, Intra-Arterial; Infusions, Intravenous; Male; Middle Aged; Pilot Projects; Stroke - diagnosis; Stroke - drug therapy; Thrombolytic Therapy; Time Factors; Tissue Plasminogen Activator - administration & dosage; Tissue Plasminogen Activator - adverse effects; Tissue Plasminogen Activator - therapeutic use
• ISSN: 0039-2499; 1524-4628; 1524-4628
• DOI: 10.1161/01.STR.0000121641.77121.98

Background and Purpose— To investigate the feasibility and safety of a combined intravenous (IV) and intra-arterial (IA) approach to recanalization in patients with ischemic stroke. Materials and Methods— Subjects ages 18 to 80 with an NIH Stroke Scale (NIHSS) ≥10 at baseline had IV recombinant tissue plasminogen activator (rt-PA) started (0.6 mg/kg, 60 mg maximum over 30 minutes) within 3 hours of onset. Additional rt-PA was then administered via microcatheter at the site of the thrombus up to a total dose of 22 mg over 2 hours of infusion or until thrombolysis. Primary comparisons were with similar subsets of placebo and rt-PA–treated subjects from the NINDS rt-PA Stroke Trial. Results— The 80 subjects had a median baseline NIHSS score of 18. The median time to initiation of IV rt-PA was 140 minutes as compared with 108 minutes for placebo and 90 minutes for rt-PA–treated subjects in the NINDS rt-PA Stroke Trial. The 3-month mortality in Interventional Management Study (IMS) subjects (16%) was numerically lower but not statistically different than the mortality of placebo (24%) and rt-PA–treated subjects (21%) in the NINDS rt-PA Stroke Trial. The rate of symptomatic intracerebral hemorrhage (6.3%) in IMS subjects was similar to that of rt-PA–treated subjects (6.6%) but higher than the rate in placebo-treated subjects (1.0%, P =0.018) in the NINDS rt-PA Stroke Trial. IMS subjects had a significantly better outcome at 3 months than NINDS placebo-treated subjects for all outcome measures (odds ratios ≥2). Conclusions— A randomized trial of standard IV rt-PA as compared with a combined IV and IA approach is needed.