A Majjhoo

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry

Background and Purpose— Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. Methods— STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. Results— A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab–adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. Conclusions— This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry

Background Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice. Methods Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH). Results A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH. Conclusion The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations.

CT perfusion guided delayed recanalization with favorable outcome in pediatric stroke

There are no approved treatment options for acute ischemic stroke in the pediatric population. A case is presented of a 16-year-old boy with acute left-sided weakness who was transferred to our institution on the third day after onset of symptoms and after deterioration in his condition. He had right internal carotid artery occlusion beyond the origin of the ophthalmic artery. CT perfusion study showed a large area of penumbra in the right middle cerebral artery distribution. Recanalization was achieved with self-expanding stent placement and mechanical thrombectomy. Post procedure CT perfusion study showed resolution of the penumbra. At the 3 month follow-up, his modified Rankin Scale score was 1 and at 1 year it was 0. A subset of pediatric patients with acute ischemic stroke secondary to large intracranial arterial occlusion may be potential candidates for this treatment approach.

P-021 TREVO Stent-Retriever Acute Stroke (TRACK) Post-marketing Registry: Interim Revascularization and Clinical Outcome Results Compared to TREVO-2 and NASA Registry

Background Although industry sponsored trials for newer mechanical thrombectomy devices for treatment of acute ischemic stroke (AIS) are promising, limited post-marketing data exist on the use of the TREVO device in every day clinical practice. Objective The ongoing TREVO Stent-Retriever Acute Stroke (TRACK) Registry aimed to assess the real-world safety, angiographic, and clinical efficacy of the TREVO device in comparison to the results from the TREVO-2 clinical trial and post-marketing North American SOLITAIRE Stent-Retriever Acute (NASA) Stroke Registry. Design/methods The TRACK Registry recruited clinical sites within the USA. Demographic, clinical, angiographic, and outcome data on patients treated with the TREVO device were collected. Symptomatic intracranial haemorrhage (sICH) was defined as any parenchymal hematoma, SAH, or IVH associated with a worsening of the NIHSS score by ≥4 within 24 h. The primary outcome was achieving TICI ≥2a revascularization. Secondary outcomes were mRS at 3 months, mortality, and sICH. Results 12 centers contributed data on 93 patients for this interim analysis. Baseline demographics were: women 61.3% (57/93), white 78.5% (73/93), mean age 64.9 ± 17.8 years, median baseline NIHSS of 17 (IQR 14–22), mean fluoroscopic time 37.5 ± 31.9 min, and a mean procedure time of 101 ± 69.1 min. The TICI ≥ 2a and TICI ≥ 2b revascularization rates were 85.6% (77/90) and 65.6% (59/90), compared to the operator reported TICI ≥ 2a rate of 85% in TREVO-2 and 87.5% in NASA, and TICI ≥ 2b rate of 72.5% in NASA. A good outcome of mRS ≤ 2 was demonstrated in 43.0% (40/93), compared to 40% (TREVO-2) and 42% (NASA). The rate of sICH was 8.4% (7/83), compared to 4% (TREVO-2) and 9.9% NASA. 90-day mortality was 21.5% (20/93) versus 29% in TREVO-2 and 30.2% in NASA. Conclusion The investigator initiated post marketing TRACK Registry demonstrates that the TREVO stent-retriever performance in clinical practice is comparable to the TREVO-2 trial and post-marketing NASA Registry. Disclosures O. Zaidat: 1; C; Stryker Neurovascular. A. Castonguay: None. E. Veznedaroglu: None. M. Binning: None. A. Alshekhlee: None. M. Abraham: None. S. Mehta: None. R. El Khoury: None. A. Majjhoo: None. E. Lin: None. M. Kabbani: None. M. Froehler: None. T. Nguyen: None.

O-004 Analysis of M2 Occlusions within TREVO Acute Ischemic Stroke (TRACK) stent-retriever Thrombectomy Registry

Background and purpose Several recent randomized clinical trials have demonstrated the safety and efficacy of mechanical thrombectomy with stent retrievers for acute ischemic stroke patients with anterior circulation occlusions. However, these trials have limited enrollment of patients with M2 occlusions. Here, we sought to examine the clinical and angiographic outcomes of patients with M2 occlusions in the Trevo Acute Ischemic Stroke (TRACK) stent-retriever thrombectomy multicenter registry. Methods Data from the investigator-initiated TRACK Registry (631 consecutive AIS patients, 23 clinical centers) was used to examine and compare demographic, clinical, and angiographic outcomes of patients with M1 versus M2 occlusions who were treated with TREVO as first treatment device. Results Of the 631 patients enrolled in the TRACK registry, 84 (13.3%) had M2 and 344 (54.5%) had M1 occlusions. Mean age was similar between the M1 and M2 cohorts, 66.5 ± 14.4 and 64.7 ± 3.8 years (p = 0.34), respectively. M2 patients had a lower median baseline NIHSS at presentation (14 (IQR 7–9) versus 18(IQR 14–22), p ≤ 0.0001). Time of onset to groin puncture (347 ± 237.4 and 361 ± 232.3, p = 0.63) and total procedural time (85.9 ± 49.9 and 78.3 ± 64.5, p = 0.4) was similar between the M1 and M2 cohorts. The number of passes with TREVO device was greater in the M1 cohort (Median, 2 (IQR 1–3) versus 1(IQR 1–2), p = 0.01) as well as use of rescue therapy (20.2% versus 9.8%, p = 0.03). Patients with M2 occlusions achieved a higher rate of TICI 3 revascularization after the 1st pass with TREVO device compared to those with M1 occlusions (55.8% versus 40.4%, p = 0.01). There was no significant difference in time to revascularization (78.6 ± 50.7 versus 71.6 ± 45.3, p = 0.2), revascularization success (≥TICI 2 b) (80.5% versus 76.2%, p = 0.4), symptomatic intracranial hemorrhage (5.6% versus 6.0%, p = 0.9), 90 day modified Rankin Scale score 0–2 (51.0% versus 57.4%, p = 0.35), or mortality (16.1% versus 13.2%, p = 0.6) between the M1 and M2 groups, respectively. Conclusions Patients with M2 Occlusions are more likely to achieve complete recanalization from the first pass with Trevo stent retriever device than M1 occlusion. In addition, the M2 cohort had a numerically higher rate of good clinical outcome and less rate of mortality than M1 group. This substudy is limited by lack of a control M2 group without mechanical thrombectomy. Disclosures A. Castonguay: None. R. Nogueira: None. J. English: None. S. Satti: None. H. Farid: None. E. Veznedaroglu: None. M. Binning: None. A. Puri: None. N. Vora: None. R. Budzik: None. G. Dabus: None. I. Linfante: None. V. Janardhan: None. A. Alshekhlee: None. M. Abraham: None. R. Edgell: None. M. Taqi: None. R. El Khoury: None. M. Mokin: None. M. Mokin: None. A. Majjhoo: None. M. Kabbani: None. M. Froehler: None. I. Finch: None. S. Ansari: None. R. Novakovic: None. T. Nguyen: None. O. Zaidat: None.