The Barrow Ruptured Aneurysm Trial: 3-year results

2013 ◽  
Vol 119 (1) ◽  
pp. 146-157 ◽  
Author(s):  
Robert F. Spetzler ◽  
Cameron G. McDougall ◽  
Felipe C. Albuquerque ◽  
Joseph M. Zabramski ◽  
Nancy K. Hills ◽  
...  

Object The authors report the 3-year results of the Barrow Ruptured Aneurysm Trial (BRAT). The objective of this ongoing randomized trial is to compare the safety and efficacy of microsurgical clip occlusion and endovascular coil embolization for the treatment of acutely ruptured cerebral aneurysms and to compare functional outcomes based on clinical and angiographic data. The 1-year results have been previously reported. Methods Two-hundred thirty-eight patients were assigned to clip occlusion and 233 to coil embolization. There were no anatomical exclusions. Crossovers were allowed based on the treating physician's determination, but primary outcome analysis was based on the initial assignment to treatment modality. Patient outcomes were assessed independently using the modified Rankin Scale (mRS). A poor outcome was defined as an mRS score > 2. At 3 years' follow-up 349 patients who had actually undergone treatment were available for evaluation. Of the 170 patients who had been originally assigned to coiling, 64 (38%) crossed over to clipping, whereas 4 (2%) of 179 patients assigned to surgery crossed over to coiling. Results The risk of a poor outcome in patients assigned to clipping compared with those assigned to coiling (35.8% vs 30%) had decreased from that observed at 1 year and was no longer significant (OR 1.30, 95% CI 0.83–2.04, p = 0.25). In addition, the degree of aneurysm obliteration (p = 0.0001), rate of aneurysm recurrence (p = 0.01), and rate of retreatment (p = 0.01) were significantly better in the group treated with clipping compared with the group treated with coiling. When outcomes were analyzed based on aneurysm location (anterior circulation, n = 339; posterior circulation, n = 69), there was no significant difference in the outcomes of anterior circulation aneurysms between the 2 assigned groups across time points (at discharge, 6 months, 1 year, or 3 years after treatment). The outcomes of posterior circulation aneurysms were significantly better in the coil group than in the clip group after the 1st year of follow-up, and this difference persisted after 3 years of follow-up. However, while aneurysms in the anterior circulation were well matched in their anatomical location between the 2 treatment arms, this was not the case in the posterior circulation where, for example, 18 of 21 posterior inferior cerebellar artery aneurysms were in the clip group. Conclusions Based on mRS scores at 3 years, the outcomes of all patients assigned to coil embolization showed a favorable 5.8% absolute difference compared with outcomes of those assigned to clip occlusion, although this difference did not reach statistical significance (p = 0.25). Patients in the clip group had a significantly higher degree of aneurysm obliteration and a significantly lower rate of recurrence and retreatment. In post hoc analysis examining only anterior circulation aneurysms, no outcome difference between the 2 treatment cohorts was observed at any recorded time point. Clinical trial registration no.: NCT01593267 (ClinicalTrials.gov).

2015 ◽  
Vol 123 (3) ◽  
pp. 609-617 ◽  
Author(s):  
Robert F. Spetzler ◽  
Cameron G. McDougall ◽  
Joseph M. Zabramski ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  

OBJECT The authors report the 6-year results of the Barrow Ruptured Aneurysm Trial (BRAT). This ongoing randomized trial, with the final goal of a 10-year follow-up, compares the safety and efficacy of surgical clip occlusion and endovascular coil embolization in patients presenting with subarachnoid hemorrhage (SAH) from a ruptured aneurysm. The 1- and 3-year results of this trial have been previously reported. METHODS In total, 500 patients with an SAH met the entry criteria and were enrolled in the study. Of these patients, 471 were randomly assigned to the treatments: 238 to surgical clipping and 233 to endovascular coiling. Six patients who died before treatment and 57 patients with nonaneurysmal SAHs were excluded, leaving a total of 408 patients who underwent clipping (209 assigned) or coiling (199 assigned). Whether to treat patients within the assigned group or to cross over patients to the other group was at the discretion of the treating physician; 38% (75/199) of the patients assigned to coiling were crossed over to clipping and 1.9% (4/209) assigned to clipping were crossed over to coiling. The outcome data were collected by a dedicated nurse practitioner. The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. Six years after randomization, 336 (82%) of 408 patients who had been treated were available for examination. RESULTS On the basis of an mRS score of > 2, and similar to the results at the 3-year follow-up, no significant difference in outcomes (p = 0.24) was detected between the 2 treatment groups. Complete aneurysm obliteration at 6 years was achieved in 96% (111/116) of the clipping group and in 48% (23/48) of the coiling group (p < 0.0001). In the period between the 3- and 6-year follow-ups, 3 additional patients assigned to coiling and none assigned to clipping received retreatment, for overall retreatment rates of 4.6% (13/280) for clipping and 16.4% (21/128) for coiling (p < 0.0001). When aneurysm location was considered, the 6-year results continued to match the previously reported results, with no difference in outcome for anterior circulation aneurysms at most time points. Of the anterior circulation aneurysms assigned to coiling treatment, 42% (70/168) were crossed over to clipping treatment. The outcomes for posterior circulation aneurysms continued to favor coiling. The randomization process was unexpectedly skewed, with 18 of 21 treated aneurysms of the posterior inferior cerebellar artery (PICA) being assigned to clipping, but even when PICA aneurysms were removed from the analysis, outcomes for the posterior circulation aneurysms still favored coiling. CONCLUSIONS Although BRAT was statistically underpowered to detect small differences, these results suggest little difference in outcome between the 2 treatments for anterior circulation aneurysms. This was not the case for the posterior circulation aneurysms, where coil embolization appeared to provide a sustained advantage over clipping. Aneurysm obliteration rates in BRAT were significantly lower and retreatment rates significantly higher in the patients undergoing coiling than in those undergoing clipping. However, despite the fact that retreatment rates were higher after coiling, no recurrent hemorrhages were known to have occurred in patients undergoing coiling in BRAT who were followed up for 6 years. Sufficient questions remain about the relative benefits of the 2 treatment modalities to warrant further well-designed randomized trials.


2020 ◽  
Vol 132 (3) ◽  
pp. 771-776 ◽  
Author(s):  
Robert F. Spetzler ◽  
Cameron G. McDougall ◽  
Joseph M. Zabramski ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  

OBJECTIVEThe authors present the 10-year results of the Barrow Ruptured Aneurysm Trial (BRAT) for saccular aneurysms. The 1-, 3-, and 6-year results of the trial have been previously reported, as have the 6-year results with respect to saccular aneurysms. This final report comparing the safety and efficacy of clipping versus coiling is limited to an analysis of those patients presenting with subarachnoid hemorrhage (SAH) from a ruptured saccular aneurysm.METHODSIn the study, 362 patients had saccular aneurysms and were randomized equally to the clipping and the coiling cohorts (181 each). The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. The extent of aneurysm obliteration was adjudicated by a nontreating neuroradiologist.RESULTSThere was no statistically significant difference in poor outcome (mRS score > 2) or deaths between these 2 treatment arms during the 10 years of follow-up. Of 178 clip-assigned patients with saccular aneurysms, 1 (< 1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. After the initial hospitalization, 2 of 241 (0.8%) clipped saccular aneurysms and 23 of 115 (20%) coiled saccular aneurysms required retreatment (p < 0.001). At the 10-year follow-up, 93% (50/54) of the clipped aneurysms were completely obliterated, compared with only 22% (5/23) of the coiled aneurysms (p < 0.001). Two patients had documented rebleeding, both died, and both were in the assigned and treated coiled cohort (2/83); no patient in the clipped cohort (0/175) died (p = 0.04). In 1 of these 2 patients, the hemorrhage was not from the target aneurysm but from an incidental basilar artery aneurysm, which was coiled at the same time.CONCLUSIONSThere was no significant difference in clinical outcomes between the 2 assigned treatment groups as measured by mRS outcomes or deaths. Clinical outcomes in the patients with posterior circulation aneurysms were better in the coiling group at 1 year, but after 1 year this difference was no longer statistically significant. Rates of complete aneurysm obliteration and rates of retreatment favored patients who actually underwent clipping compared with those who underwent coiling.Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)


2008 ◽  
Vol 108 (3) ◽  
pp. 437-442 ◽  
Author(s):  
Patrick Mitchell ◽  
Richard Kerr ◽  
A. David Mendelow ◽  
Andy Molyneux

Object The present purpose is to define the sensitivity of the superiority of coil embolization observed in the International Subarachnoid Aneurysm Trial (ISAT) according to the rate of late rebleeding over a reasonable range, and to find the range of rebleeding rates for which it may be overturned. In the ISAT, coil embolization appears to be safer than clip ligation at 1 year, and clip occlusion has better long-term efficacy at preventing rebleeding. This leaves open the question of which is better in the longer term. Methods The authors calculate the life expectancy of patients following a subarachnoid hemorrhage (SAH) and compare the life expectancy of those who underwent coil embolization with those who underwent clip ligation in the ISAT cohort. Results The 1-year poor outcome rate following treatment climbs rapidly with advancing age. A consequence is that the absolute difference between the poor outcome rates after coil embolization and clip occlusion is lower in those < 50 years of age (3.3%) than it is for those > 50 years of age (10.1%). This difference may be enough to give clip application the advantage in the < 40-year-old group despite the small size of the difference in 1-year rebleeding rates thus far observed (0.152%). Conclusions When treating ruptured cerebral aneurysms, the advantage of coil embolization over clip ligation cannot be assumed for patients < 40 years old. In this age range the difference in the safety of the 2 procedures is small, and the better long-term protection from SAH afforded by clip placement may give this treatment an advantage in life expectancy for patients < 40 years of age.


2018 ◽  
Vol 15 (2) ◽  
pp. 30-35
Author(s):  
Pravesh Rajbhandari ◽  
Anish Neupane ◽  
Saujanya Rajbhandari ◽  
Pranaya Shrestha ◽  
Samir Acharya ◽  
...  

The aim of this study is to show the result of aneurysm coiling despite the difficulty in initiating neurointervention in Nepal. It is a retrospective study where only aneurysm that has undergone coiling are taken from 2017 to 2018.A total of eleven patients (male: female = 1: 10) with aneurysm were treated with Endovascular therapy. 9 cases were ruptured aneurysm while 3 were unruptured. 5 aneurysm were located in anterior circulation while 6 were located in posterior circulation. Out of eleven cases 4 were treated by simple coiling technique, while 2 underwent balloon assisted coiling, 3 stent assisted coiling, 1 pConus assisted coiling and 1 simple coiling and stent assisted coiling. Statistical analysis showed significant correlation between fisher grading scale with mRS score (P=0.013) suggesting lower fisher grade, and improved outcome similar to the result of prospective one year follow up of Barrow Ruptured Aneurysm Trial ( BRAT) study. With limited resources aneurysm coiling was performed at ANIAS with similar results to literature.Nepal Journal of Neuroscience, Volume 15, Number 2, 2018, page: 30-35


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
K Daga ◽  
M T Ahmad ◽  
M Taneja

Abstract The current literature regarding the morphology and presentations of strokes due to basilar artery stenosis/occlusion is limited. This pathology is a rare cause of stroke and its management is not clearly decided in guidelines or published literature. Moreover, posterior circulation strokes are reported to be more devastating than anterior circulation. We present a case of a 68-year-old male who presented in an acute setting with reduced consciousness, myoclonic jerks, weakness and nausea due to a stroke from an occluded mid-segment basilar artery. MRI showed evidence of left cerebellar and right occipital infarcts. Emergent cerebral angiography was performed, and he was immediately treated by thrombectomy and stenting (Stryker Wingspan stent). The patient made a full recovery within one week and remained well at follow-up 3 months post-procedure. Emergency recanalization of basilar artery strokes, by clot retrieval and stenting, should be considered as a treatment option.


2021 ◽  
pp. 0271678X2098239
Author(s):  
Adam E Goldman-Yassen ◽  
Matus Straka ◽  
Michael Uhouse ◽  
Seena Dehkharghani

The generalization of perfusion-based, anterior circulation large vessel occlusion selection criteria to posterior circulation stroke is not straightforward due to physiologic delay, which we posit produces physiologic prolongation of the posterior circulation perfusion time-to-maximum (Tmax). To assess normative Tmax distributions, patients undergoing CTA/CTP for suspected ischemic stroke between 1/2018-3/2019 were retrospectively identified. Subjects with any cerebrovascular stenoses, or with follow-up MRI or final clinical diagnosis of stroke were excluded. Posterior circulation anatomic variations were identified. CTP were processed in RAPID and segmented in a custom pipeline permitting manually-enforced arterial input function (AIF) and perfusion estimations constrained to pre-specified vascular territories. Seventy-one subjects (mean 64 ± 19 years) met inclusion. Median Tmax was significantly greater in the cerebellar hemispheres (right: 3.0 s, left: 2.9 s) and PCA territories (right: 2.9 s; left: 3.3 s) than in the anterior circulation (right: 2.4 s; left: 2.3 s, p < 0.001). Fetal PCA disposition eliminated ipsilateral PCA Tmax delays (p = 0.012). Median territorial Tmax was significantly lower with basilar versus any anterior circulation AIF for all vascular territories (p < 0.001). Significant baseline delays in posterior circulation Tmax are observed even without steno-occlusive disease and vary with anatomic variation and AIF selection. The potential for overestimation of at-risk volumes in the posterior circulation merits caution in future trials.


2018 ◽  
Vol 128 (1) ◽  
pp. 120-125 ◽  
Author(s):  
Robert F. Spetzler ◽  
Joseph M. Zabramski ◽  
Cameron G. McDougall ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  

OBJECTIVEThe Barrow Ruptured Aneurysm Trial (BRAT) is a prospective, randomized trial in which treatment with clipping was compared to treatment with coil embolization. Patients were randomized to treatment on presentation with any nontraumatic subarachnoid hemorrhage (SAH). Because all other randomized trials comparing these 2 types of treatments have been limited to saccular aneurysms, the authors analyzed the current BRAT data for this subgroup of lesions.METHODSThe primary BRAT analysis included all sources of SAH: nonaneurysmal lesions; saccular, blister, fusiform, and dissecting aneurysms; and SAHs from an aneurysm associated with either an arteriovenous malformation or a fistula. In this post hoc review, the outcomes for the subgroup of patients with saccular aneurysms were further analyzed by type of treatment. The extent of aneurysm obliteration was adjudicated by an independent neuroradiologist not involved in treatment.RESULTSOf the 471 patients enrolled in the BRAT, 362 (77%) had an SAH from a saccular aneurysm. Patients with saccular aneurysms were assigned equally to the clipping and the coiling cohorts (181 each). In each cohort, 3 patients died before treatment and 178 were treated. Of the 178 clip-assigned patients with saccular aneurysms, 1 (1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. There was no statistically significant difference in poor outcome (modified Rankin Scale score > 2) between these 2 treatment arms at any recorded time point during 6 years of follow-up. After the initial hospitalization, 1 of 241 (0.4%) clipped saccular aneurysms and 21 of 115 (18%) coiled saccular aneurysms required retreatment (p < 0.001). At the 6-year follow-up, 95% (95/100) of the clipped aneurysms were completely obliterated, compared with 40% (16/40) of the coiled aneurysms (p < 0.001). There was no difference in morbidity between the 2 treatment groups (p = 0.10).CONCLUSIONSIn the subgroup of patients with saccular aneurysms enrolled in the BRAT, there was no significant difference between modified Rankin Scale outcomes at any follow-up time in patients with saccular aneurysms assigned to clipping compared with those assigned to coiling (intent-to-treat analysis). At the 6-year follow-up evaluation, rates of retreatment and complete aneurysm obliteration significantly favored patients who underwent clipping compared with those who underwent coiling.Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Ajay K Wakhloo ◽  
Pedro Lylyk ◽  
Joost de Vries ◽  
Matthew J Gounis ◽  
Alexandra Biondi ◽  
...  

Objective: Validated through experimental studies a new generation of flow diverters (Surpass™ FD) was evaluated for treatment of intracranial aneurysms (IA). We present our multicenter preliminary clinical and angiographic experience. METHODS: To achieve the calculated flow disruption between the parent artery and aneurysm for thrombosis, single FDs were placed endovascularly in parent arteries. Implants measured 2.5-5.3mm in diameter with a length of 10-80mm. Patients were enrolled harboring a wide range large and giant wide-neck, fusiform and multiple small and blister-type aneurysm. Clinical and angiographic follow-up were performed at 1-3, 6, and 12 months. RESULTS: A total of 186 consecutive IA in 161 patients (mean age 57.1 years) were treated at 33 centers. Fifty-three aneurysms were smaller than 5 mm, 64 were 5-9.9mm in diameter, 47 were 10-20mm in diameter, and 22 were larger than 20mm (10.4±0.7mm, neck size 6.0±0.5mm [mean±SEM]) . The aneurysms originated in 63.4% from the internal carotid artery; 22% and 14.5% of the lesions were located in the anterior circulation distal to Circle of Willis and posterior circulation respectively. Technical success was achieved in 182 aneurysms (98%); average number of devices used per aneurysm was 1.05. Permanent morbidity and mortality during the follow-up period of mean 8.4months (range 1-24 months) including periprocedural complications for patients with aneurysms of the anterior circulation were encountered in 5 (3.7%) and 2 (1.5 %) patients respectively and 1 (3.7%) and 4 (14.8%) respectively for patients with aneurysms of the posterior circulation location. One-hundred-ten patients (70.5%) harboring 127 (70.2%) were available for clinical and angiographic follow-up and showed a complete or near complete aneurysm occlusion in 63 (81.8%) of the ICA. Aneurysms of the ICA≥10mm that were completely covered by FD and not previously stent-treated with a minimum of 6 months follow-up available in 16 patients showed a complete obliteration in 81.3% (n=13) and >90% occlusion in remaining 3 patients. CONCLUSION: Preliminary data demonstrate high safety and efficacy of a new generation of FD for a wide range of IA of the anterior and posterior circulation with a single implant.


2018 ◽  
Vol 128 (6) ◽  
pp. 1813-1822 ◽  
Author(s):  
Wei Ni ◽  
Hanqiang Jiang ◽  
Bin Xu ◽  
Yu Lei ◽  
Heng Yang ◽  
...  

OBJECTIVEMoyamoya disease (MMD) is occasionally accompanied by intracranial aneurysms. The purpose of this study was to delineate the efficacy of the authors’ current surgical strategy in the management of MMD-associated aneurysms of different types.METHODSBetween January 2007 and March 2016, a consecutive cohort of 34 patients with 36 MMD-associated aneurysms was enrolled in this prospective single-center cohort study. The lesions were classified as peripheral (17 aneurysms) or main trunk aneurysms (13 in the anterior circulation and 6 in the posterior circulation). For the peripheral aneurysms, revascularization with or without endovascular treatment was suggested. For the main trunk aneurysms, revascularization alone, revascularization with aneurysm clipping, or revascularization with aneurysm embolization were used, depending on the location of the aneurysms.RESULTSOf the peripheral aneurysms, 4 were treated endovascularly with staged revascularization, and 13 were treated solely with cerebral revascularization. Of the 13 main trunk aneurysms in the anterior circulation, 10 were clipped followed by revascularization, and 3 were coiled followed by staged cerebral revascularization. Of the 6 main trunk aneurysms in the posterior circulation, 4 underwent endovascular coiling and 2 were treated solely with revascularization. One patient died of contralateral intracerebral hemorrhage 6 months after the operation. No other patients suffered recurrent intracranial hemorrhage, cerebral ischemia, or aneurysm rupture. An angiographic follow-up study showed that all the bypass grafts were patent. Complete occlusion was achieved in all 21 aneurysms that were clipped or embolized. Of the remaining 15 aneurysms that were not directly treated, 12 of 13 peripheral aneurysms were obliterated during the follow-up, whereas 1 remained stable; 1 of 2 posterior main trunk aneurysms remained stable, and the other became smaller.CONCLUSIONSThe authors’ current treatment strategy may benefit patients with MMD-associated aneurysms.


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