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Endovascular thrombectomy may benefit patients with stroke with large infarcts, an analysis suggests. The intervention may be more likely to benefit patients who “are treated early and have a core volume less than 100 cm3,” researchers reported in JAMA Neurology.
Clinical trials evaluating thrombectomy have largely excluded patients with large ischemic cores. To examine whether thrombectomy produces reasonable functional and safety outcomes in patients with stroke with large infarcts, compared with medical management alone, the investigators conducted a prespecified secondary analysis of data from the Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) study.
A nonrandomized study
Amrou Sarraj, MD, of the University of Texas, Houston, and his coauthors analyzed data from 105 patients in the prospective, multicenter cohort study, which enrolled patients between January 2016 and February 2018. Their analysis included data from patients who had large ischemic cores on CT (Alberta Stroke Program Early CT Score, 0-5) or on CT perfusion images (an ischemic core volume of at least 50 cm3). The SELECT study included patients with moderate to severe stroke and anterior circulation large-vessel occlusion who presented up to 24 hours from the time they last were known to be well. In the SELECT study, local investigators decided whether patients received endovascular thrombectomy or medical management alone in a nonrandomized fashion.
The 105 patients had a median age of 66 years, and 43% were female. Of the patients with large infarcts, 62 (59%) received endovascular thrombectomy plus medical management, and the rest received medical management alone.
At 90 days, 31% of the patients who received endovascular thrombectomy achieved functional independence (modified Rankin Scale score of 0-2), compared with 14% of patients who received medical management alone (odds ratio, 3.27). In addition, endovascular thrombectomy was associated with better functional outcome, less infarct growth (44 vs. 98 mL), and smaller final infarct volume (97 vs. 190 mL).
The rates of neurologic worsening and symptomatic intracerebral hemorrhage were similar in both treatment groups, while mortality was lower among patients who received thrombectomy (29% vs. 42%). The likelihood of functional independence with endovascular thrombectomy decreased by 40% with each 1-hour delay in treatment and by 42% with each 10-cm3 increase in stroke volume.
Of 10 patients with core volumes greater than 100 cm3 who received endovascular thrombectomy, none had a favorable outcome.
“Although the odds of good outcomes for patients with large cores who received [endovascular thrombectomy] markedly decline with increasing core size and time to treatment, these data suggest potential benefits,” Dr. Sarraj and colleagues concluded. “Randomized clinical trials are needed.”
The authors noted that the results “did not reach significance after adjusting for baseline imbalances” and that “the small sample size limits the power of this analysis.”
The study was funded by an unrestricted grant from Stryker Neurovascular to the University of Texas. Dr. Sarraj is a consultant, speaker bureau member, and advisory board member for Stryker and is the principal investigator for a planned randomized, controlled trial (SELECT 2) funded by an unrestricted grant from Stryker to his institution. In addition, he is a site principal investigator for the TREVO Registry and DEFUSE 3 trials. Coauthors reported financial ties with Stryker and various device and pharmaceutical companies.
SOURCE: Sarraj A et al. JAMA Neurol. 2019 Jul 29. doi: 10.1001/jamaneurol.2019.2109.
Patients who had thrombectomies had improved outcomes in an unadjusted statistical analysis, but these differences did not remain significant after adjustment for baseline age, clinical severity, and other key prognostic variables. However, the analysis was underpowered.
A key finding was that favorable outcomes in patients with large core volumes was strongly time dependent, which was consistent with previous data from the Highly Effective Reperfusion Using Multiple Endovascular Devices (HERMES) collaboration.
Faster treatment is the key to maximizing benefit for patients with poor collateral blood flow and a large ischemic core at baseline. As treatment work flow improves and more patients are transported directly to a thrombectomy-capable center, the number who benefit from reperfusion, despite a large ischemic core, is likely to further increase.
Ongoing randomized clinical trials are assessing the practical question of who to treat with thrombectomy when the estimated ischemic core volume is large.
Bruce C. V. Campbell, MBBS, PhD , of the University of Melbourne made these comments in an accompanying editorial. He reported research support from the several Australian research foundations. He also reported unrestricted grant funding for the Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial (EXTEND-IA) trial to the Florey Institute of Neuroscience and Mental Health in Parkville, Australia, from Covidien (Medtronic).
Patients who had thrombectomies had improved outcomes in an unadjusted statistical analysis, but these differences did not remain significant after adjustment for baseline age, clinical severity, and other key prognostic variables. However, the analysis was underpowered.
A key finding was that favorable outcomes in patients with large core volumes was strongly time dependent, which was consistent with previous data from the Highly Effective Reperfusion Using Multiple Endovascular Devices (HERMES) collaboration.
Faster treatment is the key to maximizing benefit for patients with poor collateral blood flow and a large ischemic core at baseline. As treatment work flow improves and more patients are transported directly to a thrombectomy-capable center, the number who benefit from reperfusion, despite a large ischemic core, is likely to further increase.
Ongoing randomized clinical trials are assessing the practical question of who to treat with thrombectomy when the estimated ischemic core volume is large.
Bruce C. V. Campbell, MBBS, PhD , of the University of Melbourne made these comments in an accompanying editorial. He reported research support from the several Australian research foundations. He also reported unrestricted grant funding for the Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial (EXTEND-IA) trial to the Florey Institute of Neuroscience and Mental Health in Parkville, Australia, from Covidien (Medtronic).
Patients who had thrombectomies had improved outcomes in an unadjusted statistical analysis, but these differences did not remain significant after adjustment for baseline age, clinical severity, and other key prognostic variables. However, the analysis was underpowered.
A key finding was that favorable outcomes in patients with large core volumes was strongly time dependent, which was consistent with previous data from the Highly Effective Reperfusion Using Multiple Endovascular Devices (HERMES) collaboration.
Faster treatment is the key to maximizing benefit for patients with poor collateral blood flow and a large ischemic core at baseline. As treatment work flow improves and more patients are transported directly to a thrombectomy-capable center, the number who benefit from reperfusion, despite a large ischemic core, is likely to further increase.
Ongoing randomized clinical trials are assessing the practical question of who to treat with thrombectomy when the estimated ischemic core volume is large.
Bruce C. V. Campbell, MBBS, PhD , of the University of Melbourne made these comments in an accompanying editorial. He reported research support from the several Australian research foundations. He also reported unrestricted grant funding for the Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial (EXTEND-IA) trial to the Florey Institute of Neuroscience and Mental Health in Parkville, Australia, from Covidien (Medtronic).
Endovascular thrombectomy may benefit patients with stroke with large infarcts, an analysis suggests. The intervention may be more likely to benefit patients who “are treated early and have a core volume less than 100 cm3,” researchers reported in JAMA Neurology.
Clinical trials evaluating thrombectomy have largely excluded patients with large ischemic cores. To examine whether thrombectomy produces reasonable functional and safety outcomes in patients with stroke with large infarcts, compared with medical management alone, the investigators conducted a prespecified secondary analysis of data from the Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) study.
A nonrandomized study
Amrou Sarraj, MD, of the University of Texas, Houston, and his coauthors analyzed data from 105 patients in the prospective, multicenter cohort study, which enrolled patients between January 2016 and February 2018. Their analysis included data from patients who had large ischemic cores on CT (Alberta Stroke Program Early CT Score, 0-5) or on CT perfusion images (an ischemic core volume of at least 50 cm3). The SELECT study included patients with moderate to severe stroke and anterior circulation large-vessel occlusion who presented up to 24 hours from the time they last were known to be well. In the SELECT study, local investigators decided whether patients received endovascular thrombectomy or medical management alone in a nonrandomized fashion.
The 105 patients had a median age of 66 years, and 43% were female. Of the patients with large infarcts, 62 (59%) received endovascular thrombectomy plus medical management, and the rest received medical management alone.
At 90 days, 31% of the patients who received endovascular thrombectomy achieved functional independence (modified Rankin Scale score of 0-2), compared with 14% of patients who received medical management alone (odds ratio, 3.27). In addition, endovascular thrombectomy was associated with better functional outcome, less infarct growth (44 vs. 98 mL), and smaller final infarct volume (97 vs. 190 mL).
The rates of neurologic worsening and symptomatic intracerebral hemorrhage were similar in both treatment groups, while mortality was lower among patients who received thrombectomy (29% vs. 42%). The likelihood of functional independence with endovascular thrombectomy decreased by 40% with each 1-hour delay in treatment and by 42% with each 10-cm3 increase in stroke volume.
Of 10 patients with core volumes greater than 100 cm3 who received endovascular thrombectomy, none had a favorable outcome.
“Although the odds of good outcomes for patients with large cores who received [endovascular thrombectomy] markedly decline with increasing core size and time to treatment, these data suggest potential benefits,” Dr. Sarraj and colleagues concluded. “Randomized clinical trials are needed.”
The authors noted that the results “did not reach significance after adjusting for baseline imbalances” and that “the small sample size limits the power of this analysis.”
The study was funded by an unrestricted grant from Stryker Neurovascular to the University of Texas. Dr. Sarraj is a consultant, speaker bureau member, and advisory board member for Stryker and is the principal investigator for a planned randomized, controlled trial (SELECT 2) funded by an unrestricted grant from Stryker to his institution. In addition, he is a site principal investigator for the TREVO Registry and DEFUSE 3 trials. Coauthors reported financial ties with Stryker and various device and pharmaceutical companies.
SOURCE: Sarraj A et al. JAMA Neurol. 2019 Jul 29. doi: 10.1001/jamaneurol.2019.2109.
Endovascular thrombectomy may benefit patients with stroke with large infarcts, an analysis suggests. The intervention may be more likely to benefit patients who “are treated early and have a core volume less than 100 cm3,” researchers reported in JAMA Neurology.
Clinical trials evaluating thrombectomy have largely excluded patients with large ischemic cores. To examine whether thrombectomy produces reasonable functional and safety outcomes in patients with stroke with large infarcts, compared with medical management alone, the investigators conducted a prespecified secondary analysis of data from the Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) study.
A nonrandomized study
Amrou Sarraj, MD, of the University of Texas, Houston, and his coauthors analyzed data from 105 patients in the prospective, multicenter cohort study, which enrolled patients between January 2016 and February 2018. Their analysis included data from patients who had large ischemic cores on CT (Alberta Stroke Program Early CT Score, 0-5) or on CT perfusion images (an ischemic core volume of at least 50 cm3). The SELECT study included patients with moderate to severe stroke and anterior circulation large-vessel occlusion who presented up to 24 hours from the time they last were known to be well. In the SELECT study, local investigators decided whether patients received endovascular thrombectomy or medical management alone in a nonrandomized fashion.
The 105 patients had a median age of 66 years, and 43% were female. Of the patients with large infarcts, 62 (59%) received endovascular thrombectomy plus medical management, and the rest received medical management alone.
At 90 days, 31% of the patients who received endovascular thrombectomy achieved functional independence (modified Rankin Scale score of 0-2), compared with 14% of patients who received medical management alone (odds ratio, 3.27). In addition, endovascular thrombectomy was associated with better functional outcome, less infarct growth (44 vs. 98 mL), and smaller final infarct volume (97 vs. 190 mL).
The rates of neurologic worsening and symptomatic intracerebral hemorrhage were similar in both treatment groups, while mortality was lower among patients who received thrombectomy (29% vs. 42%). The likelihood of functional independence with endovascular thrombectomy decreased by 40% with each 1-hour delay in treatment and by 42% with each 10-cm3 increase in stroke volume.
Of 10 patients with core volumes greater than 100 cm3 who received endovascular thrombectomy, none had a favorable outcome.
“Although the odds of good outcomes for patients with large cores who received [endovascular thrombectomy] markedly decline with increasing core size and time to treatment, these data suggest potential benefits,” Dr. Sarraj and colleagues concluded. “Randomized clinical trials are needed.”
The authors noted that the results “did not reach significance after adjusting for baseline imbalances” and that “the small sample size limits the power of this analysis.”
The study was funded by an unrestricted grant from Stryker Neurovascular to the University of Texas. Dr. Sarraj is a consultant, speaker bureau member, and advisory board member for Stryker and is the principal investigator for a planned randomized, controlled trial (SELECT 2) funded by an unrestricted grant from Stryker to his institution. In addition, he is a site principal investigator for the TREVO Registry and DEFUSE 3 trials. Coauthors reported financial ties with Stryker and various device and pharmaceutical companies.
SOURCE: Sarraj A et al. JAMA Neurol. 2019 Jul 29. doi: 10.1001/jamaneurol.2019.2109.
FROM JAMA NEUROLOGY
Key clinical point: and who have a core volume less than 100 mL.
Major finding: At 90 days, 31% of the patients who received endovascular thrombectomy achieved functional independence (modified Rankin Scale score of 0-2), compared with 14% of patients who received medical management alone (odds ratio, 3.27).
Study details: A prespecified secondary analysis of nonrandomized data from 105 patients in the Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) study.
Disclosures: The study was funded by an unrestricted grant from Stryker Neurovascular. Dr. Sarraj is a consultant, speaker bureau member, and advisory board member for Stryker and is the principal investigator for a planned randomized, controlled trial (SELECT 2) funded by an unrestricted grant from Stryker to his institution. Coauthors reported financial ties with Stryker and various device and pharmaceutical companies.
Source: Sarraj A et al. JAMA Neurol. 2019 Jul 29. doi: 10.1001/jamaneurol.2019.2109.