Background The recent results of the SWIFT and TREVO-2 trials demonstrated better recanalisation and efficacy rates with the SOLITAIRE FR and TREVO devices compared to the MERCI retriever; however, limited post-marketing data exists on use of the SOLITAIRE FR device in clinical practice. The North American SOLITAIRE Acute Stroke (NASA) Registry aimed to assess the real-world performance of the SOLITAIRE FR device in comparison to the results from the SWIFT and TREVO-2 clinical trials.
Method The investigator-initiated NASA Registry recruited clinical sites within North America to submit demographic, clinical presentation, site-adjudicated angiographic and clinical outcome data on consecutive patients treated with the SOLITAIRE FR. Symptomatic intracranial haemorrhage (sICH) was defined as any parenchymal haematoma, SAH, or IVH associated with a worsening of the NIHSS score by ≥ 4 within 24 hours. The primary outcome was achieving TIMI ≥ 2 or TICI ≥ 2a revascularisation. Secondary outcomes were mRS at 3 months, mortality, and sICH. The data was housed and analysed by a central coordinating site, the Medical College of Wisconsin.
Results To date, 343 patients underwent treatment for acute ischaemic stroke using the SOLITAIRE FR device in 20 North American centres. Baseline demographics were: Mean age of 67.3 ± 15.2; Median of 70 (IQR55–79) years of age; the group was equally divided between women 49% (167/343), with majority white 74% (250/343). Median baseline NIHSS was 18 (IQR14–23). Mean time from onset to groin (TOG) was 368.3 ± 241 minutes; mean fluoroscopy time of 33 ± 26 minutes; and a mean procedure time of 103 ± 64.6 minutes. Recanalisation Outcome: The primary outcome showed a TIMI ≥ 2 rate of 83.3% (285/343) and a TICI ≥ 2a rate of 87.2% (299/343), compared to the operator reported TIMI ≥ 2 rate of 83% in SWIFT and TICI ≥ 2a rate of 85% in TREVO-2. Clinical Outcome: The 90-day mRS was available in 90.1% (309/243) of NASA patients. A mRS ≤ 2 was demonstrated in 41.4% (109/309), compared to 37% (SWIFT) and 40% (TREVO-2). The rate of sICH was 10% (34/341), compared to 2% (SWIFT) and 4% (TREVO-2). 90-day mortality was 30.4% (94/309) vs 17.2%
Conclusion The NASA Registry demonstrated that the SOLITAIRE FR device performance in clinical practice is comparable to the SWIFT clinical trial results.
Disclosures O. Zaidat: None. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. N. Mueller-Kronast: None. W. Holloway: None. J. English: None. I. Linfante: None. G. Dabus: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. A. Yoo: None. A. Abou-Chebl: None. P. Chen: None.
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