• Neurology Clinical Trials
• Interventional Techniques & Devices
• Ischemia

According to the Primary Results of the Solitaire™ FR With the Intention for Thrombectomy Multicenter, Randomized Clinical Trial [SWIFT; NCT01054560], the Solitaire flow restoration (FR) device is superior to the Merci Retrieval System® in achieving successful recanalization that is almost free of symptomatic hemorrhagic transformation. Jeffrey L. Saver, MD, FAHA, FAAN, UCLA Stroke Center, Los Angeles, California, USA, reported outcomes from the study.

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.

• © 2012 MD Conference Express®