MD Conference Express ISC 2012 - (Page 18)
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SWIFT was a 21-site, blinded endpoint observer, international, active comparator, noninferiority trial that tested the Solitaire™ FR as the initial device against the Merci Retriever® as the initial device. The purpose of the study was to demonstrate substantial equivalence of the Solitaire FR revascularization device with the legally marketed Merci retrieval system. The primary efficacy endpoint was successful recanalization—TIMI 2 or 3 flow in all treatable vessels— with no symptomatic intracranial hemorrhage, assessed at completion of the first device strategy prior to rescue therapy. Secondary efficacy endpoints were time to recanalization, good neurological outcome at 90 days, and global disability at 90 days. Key inclusion criteria included ability to be treated within 8 hours of onset, National Institute of Health Stroke Scale (NIHSS) 8 to 29, and proximal intracranial occlusion. Enrollment totaled 144 patients at 18 sites; 113 were randomized 1:1 to receive treatment with the Solitaire FR (n=58) or Merci device (n=55). All baseline demographic features were similar, with no significant differences. Higher rates of atrial fibrillation (p=0.02) was the only significant difference in medical and neurological history (44.8% in the Solitaire group vs 67.3% in the Merci group). Of the 58 patients who were randomized to Solitaire FR, 60.7% (34/56) achieved the primary trial endpoint versus 24.1% (13/54) with the Merci device (noninferiority p<0.0001; superiority p=0.0001). Rescue therapy was used in 20.7% (12/58) of Solitaire patients versus 43.6% (24/55) of Merci patients (noninferiority p<0.0001; superiority p=0.015). Good neurological outcomes at 90 days (defined as modified Rankin Scale [mRS] score ≤2 or equal to the prestroke mRS if >2, or NIHSS score improvement ≥10) were achieved by 58.2% (32/55) of Solitaire patients versus 33.3% (16/48) of Merci patients (noninferiority p=0.0001; superiority p=0.017). Mortality at 90 days occurred in 17.2% (10/58) of the Solitaire patients versus 38.2% (21/55) of the Merci patients (noninferiority p=0.0001; superiority p=0.020). sICH occurred in 1.7% (1/58) of the Solitaire FR patients versus 10.9% (6/55) of the Merci patients (noninferiority p<0.0001; superiority p=0.057). Total intracranial hemorrhage percentages were 17.2% in the Solitaire FR group versus 38.2% in the Merci group (noninferiority p=0.0001; superiority p=0.020). In the Solitaire group, 8.6% of patients suffered study device-related serious adverse events (SAEs) versus 16.4% in the Merci group (p=0.26).
The percentages for all procedure-related SAEs were 13.8% in the former versus 16.4% in the latter (p=0.80). The first patient was enrolled in February 2010. At the end of July 2011, the trial met the interim efficacy stopping rule and was halted by the Data Safety Monitoring Board, Steering Committee, and sponsor for overwhelming efficacy.
FIA II Seeks Genetic Underpinnings of Familial Intracranial Aneurysm
Written by Rita Buckley
Prior studies indicate that genetic factors are important in the formation and rupture of intracranial aneurysms (IAs) [Broderick JP et al. BMC Med Genet 2005]. Joseph P. Broderick, MD, University of Cincinnati, Cincinnati, Ohio, USA, presented initial results from the Familial Intracranial Aneurysm Study II [FIA II; NCT00071565]. Most deaths from subarachnoid hemorrhage (SAH) are due to rapid and massive brain injury from the initial bleeding; therefore, prevention of aneurysm formation is of paramount importance. Scientific evidence suggests that a genetic component plays an important role in the development of IAs, but the specific genes that are involved have not been identified. The purposes of FIA II were to identify genes that may increase the risk of aneurysm development in the brain and to determine the effect of environmental factors, such as cigarette smoking and high blood pressure, on the expression of those genes. According to Dr. Broderick, approaches to dissect the genetic contribution to IAs have had mixed results. Linkage has been largely unsuccessful and, to this point, has not identified genetic variants that are associated with a risk of IA. Genomewide association studies (GWAS) have been somewhat successful, identifying several replicated genes with modest effect size (OR approximately 1.2 to 1.3), but again have yet to identify specific variants within these genes that are causally related to IA. Whole exome sequencing (WES) is a promising new approach that focuses on the coding region of the genome (the exome). This method is designed to find variants that affect protein structure or function, which are relatively common in Mendelian disorders. WES complements GWAS but is best suited to the identification of rare (r)
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April 2012
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Table of Contents for the Digital Edition of MD Conference Express ISC 2012
MD Conference Express ISC 2012
From Neurovascular Laboratory to Clinic: A Journey Through Time
No Compelling Evidence to Use Warfarin or Aspirin in Heart Failure Patients
AXIS 2 Clinical Outcomes No Different Than Placebo
SAMMPRIS: 30-Day Outcomes After Angioplasty and Stenting
Aggressive Medical Therapy Benefits Those Who Fail Antithrombotic Therapy
Initial Clinical Results with TREVO® Mechanical Thrombectomy Device are Promising
Linking sICH Definitions to Outcomes
Solitaire™ Flow Restoration Device Achieves Successful Recanalization Free of Symptomatic Hemorrhage Transformation
FIA II Seeks Genetic Underpinnings of Familial Intracranial Aneurysm
SPS3 Study Does Not Support the Use of Combination Therapy for Stroke Prevention
Novel Agent NA-1 Proves that Ischemic Neuroprotection is Possible in Older Patients
Acute Endovascular Treatment
Neuroimaging
Stroke Guidelines: Current Recommendations in Principle and Practice
The Rising Trend of Ischemic Stroke in the Young
Advanced Neuroimaging Adds Time, Reduces Endovascular Treatment in Clinical Practice
MD Conference Express ISC 2012
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